Mary D'Alton - Academia.edu (original) (raw)

Papers by Mary D'Alton

Research paper thumbnail of Effect of corticosteroids for fetal maturation on perinatal outcomes, February 28—March 2, 1994

American Journal of Obstetrics and Gynecology, 1995

The National Institutes of Health Consensus Development Conference on the Effect of Corticosteroi... more The National Institutes of Health Consensus Development Conference on the Effect of Corticosteroids for Fetal Maturation on Perinatal Outcomes brought together specialists in obstetrics, neonatology, pharmacology, epidemiology, and nursing; basic scientists in physiology and cellular biology; and the public to address the following questions: (1) For what conditions and purposes are antenatal corticosteroids used, and what is the scientific basis for that use? (2) What are the short-term and long-term benefits of antenatal corticosteroid treatment? (3) What are the short-term and long-term adverse effects for the infant and mother? (4) What is the influence of the type of corticosteroid, dosage, timing and circumstances of administration, and associated therapy on treatment outcome? (5) What are the economic consequences of this treatment? (6) What are the recommendations for use of antenatal corticosteroids? and (7) What research is needed to guide clinical care? Following 1 1/2 days of presentations by experts and discussion by the audience, a consensus panel weighed the evidence and prepared their consensus statement. The consensus panel concluded that antenatal corticosteroid therapy for fetal maturation reduces mortality, respiratory distress syndrome, and intraventricular hemorrhage in preterm infants. These benefits extend to a broad range of gestational ages (24-34 weeks) and are not limited by gender or race. Although the beneficial effects of corticosteroids are greatest more than 24 hours after beginning treatment, treatment less than 24 hours in duration may also improve outcomes. The benefits of antenatal corticosteroids are additive to those derived from surfactant therapy. In the presence of preterm premature rupture of the membranes, antenatal corticosteroid therapy reduces the frequency of respiratory distress syndrome, intraventricular hemorrhage, and neonatal death, although to a lesser extent than with intact membranes. Whether this therapy increases either neonatal or maternal infection is unclear. However, the risk of intraventricular hemorrhage and death from prematurity is greater than the risk from infection. Data from trials with followup of children up to 12 years indicate that antenatal corticosteroid therapy does not adversely affect physical growth or psychomotor development. Antenatal corticosteroid therapy is indicated for women at risk of premature delivery with few exceptions and will result in a substantial decrease in neonatal morbidity and mortality, as well as substantial savings in health care costs. The use of antenatal corticosteroids for fetal maturation is a rare example of a technology that yields substantial cost savings in addition to improving health.

Research paper thumbnail of Intrapartum management of category II fetal heart rate tracings: towards standardization of care

American Journal of Obstetrics and Gynecology, Aug 1, 2013

Research paper thumbnail of 241: Baseline risk assessment for peripartum maternal critical care interventions

American Journal of Obstetrics and Gynecology

Due to the association of AMA with stillbirth, many women of AMA are undergoing IOL. We sought to... more Due to the association of AMA with stillbirth, many women of AMA are undergoing IOL. We sought to determine if nulliparous women of AMA undergoing IOL are more likely to have adverse obstetric outcomes when compared to women who are expectantly managed (EM). STUDY DESIGN: This was a retrospective cohort study of women 35 years who delivered at a single center from June 2011 to December 2014. Women undergoing IOL were compared to women with EM at 39 weeks. Group differences in demographics, obstetric and neonatal outcomes were assessed using T-test, Wilcoxon, Chi-square and Fisher's exact tests as appropriate. Analyses of outcomes adjusted for Bishop score (BS) and/or gestational age (GA) were done using multivariable logistic regression. RESULTS: A total of 816 patients met inclusion criteria which included maternal age 35, nulliparity, and singleton gestation at 39 weeks. Of these, 428 (52%) were induced and 388 (48%) were not induced. The IOL group was significantly older (age 38 vs 36, p<0.001), of a later GA (40.3 vs 40.1w, P¼0.002), with a lower median BS (3 vs 8, p<0.001). Women in the IOL group had an increase in cesarean delivery (CD) compared to the EM group, (48.6% vs. 34%, p<0.001) (Table 1). When controlling for BS >5, the difference in CD rate between the two groups was not statistically significant (36.2% vs. 31.5%; p¼0.37). Interestingly, a high proportion of the IOL group had lower BS compared to the EM group (BS 0-3 (IOL vs. EM): 54% vs 7.2%; BS 9-13: 5.1% vs 30.9%). A Chi-square test demonstrated a significant difference in this distribution of the BS between the IOL vs. EM groups (Table 2). When a subgroup analysis was performed for women age 35-39 vs 40 and above, the CD rates were higher in the older age group for both IOL and EM groups (IOL group, CD rates in age 35-39 vs. 40+ 44.3% vs 56.1% (p¼0.02); EM group, CD rates in age 35-39 vs. 40+ 30.4% vs 42.9% (p¼0.02)). CONCLUSION: In our population, women 35 years old who undergo IOL are not more likely to have CD compared to those expectantly managed. With similar BS on admission, there was no difference in CD rate. Therefore, the difference in CD rate is not due to IOL or EM, but rather due to differences in BS. The BS may help guide clinicians when discussing IOL or EM to AMA nulliparous patients.

Research paper thumbnail of TSH and FT4 Reference Intervals in Pregnancy: A Systematic Review and Individual Participant Data Meta-Analysis

The Journal of Clinical Endocrinology & Metabolism

Context Interpretation of thyroid function tests during pregnancy is limited by the generalizabil... more Context Interpretation of thyroid function tests during pregnancy is limited by the generalizability of reference intervals between cohorts due to inconsistent methodology. Objective (1) To provide an overview of published reference intervals for thyrotropin (TSH) and free thyroxine (FT4) in pregnancy, (2) to assess the consequences of common methodological between-study differences by combining raw data from different cohorts. Methods (1) Ovid MEDLINE, EMBASE, and Web of Science were searched until December 12, 2021. Studies were assessed in duplicate. (2) The individual participant data (IPD) meta-analysis was performed in participating cohorts in the Consortium on Thyroid and Pregnancy. Results (1) Large between-study methodological differences were identified, 11 of 102 included studies were in accordance with current guidelines; (2) 22 cohorts involving 63 198 participants were included in the meta-analysis. Not excluding thyroid peroxidase antibody–positive participants led to...

Research paper thumbnail of Characteristics of Deliveries Resulting in Neonatal Hypoxic Ischemic Encephalopathy: A Multi-Centred Retrospective Case Series

OBJECTIVE: To characterize clinical management of deliveries resulting in neonatal hypoxic ischem... more OBJECTIVE: To characterize clinical management of deliveries resulting in neonatal hypoxic ischemic encephalopathy. DESIGN: Retrospective case series SETTING: Three academic referral medical centers in the United States POPULATION: All neonates ≥35 weeks’ gestation with HIE based on cord blood pH<7.0, base deficit of ≥12.0mmol/L, along with relevant radiological, laboratory, and clinical findings. METHODS: Clinical management was characterized based on whether (i)delivery occurred within 120 minutes of presentation, (ii)delivery occurred due to a sentinel event such as cord prolapse or uterine rupture, and (iii)the fetal heart rate tracing(FHR) demonstrated variability, accelerations, or both upon presentation and in the half hour before delivery. MAIN OUTCOME MEASURES: Relationship of mode of delivery to FHR tracing characteristics at delivery. Obstetric outcomes, labour course and management were analysed. RESULTS: Of 144,904 deliveries, 102 maternal-newborn dyads met criteria....

Research paper thumbnail of Building an obstetric intensive care unit during the COVID-19 pandemic at a tertiary hospital and selected maternal-fetal and delivery considerations

Seminars in Perinatology, 2020

During the novel Coronavirus Disease 2019 pandemic, New York City became an international epicent... more During the novel Coronavirus Disease 2019 pandemic, New York City became an international epicenter for this highly infectious respiratory virus. In anticipation of the unfortunate reality of community spread and high disease burden, the Anesthesia and Obstetrics and Gynecology departments at NewYork-Presbyterian / Columbia University Irving Medical Center, an academic hospital system in Manhattan, created an Obstetric Intensive Care Unit on Labor and Delivery to defray volume from the hospital's preexisting intensive care units. Its purpose was threefold: (1) to accommodate the anticipated influx of critically ill pregnant and postpartum patients due to novel coronavirus, (2) to care for critically ill obstetric patients who would previously have been transferred to a non-obstetric intensive care unit, and (3) to continue caring for our usual census of pregnant and postpartum

Research paper thumbnail of Characteristics and Outcomes of 241 Births to Women With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection at Five New York City Medical Centers

Obstetrics & Gynecology, 2020

OBJECTIVE: To describe the characteristics and birth outcomes of women with severe acute respirat... more OBJECTIVE: To describe the characteristics and birth outcomes of women with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection as community spread in New York City was detected in March 2020. METHODS: We performed a prospective cohort study of pregnant women with laboratory-confirmed SARS-CoV-2 infection who gave birth from March 13 to April 12, 2020, identified at five New York City medical centers. Demographic and clinical data from delivery hospitalization records were collected, and follow-up was completed on April 20, 2020. RESULTS: Among this cohort (241 women), using evolving criteria for testing, 61.4% of women were asymptomatic for coronavirus disease 2019 (COVID-19) at the time of admission. Throughout the delivery hospitalization, 26.5% of women met World Health Organization criteria for mild COVID-19, 26.1% for severe, and 5% for critical. Cesarean birth was the mode of delivery for 52.4% of women with severe and 91.7% with critical COVID-19. The sing...

Research paper thumbnail of Telehealth for High-Risk Pregnancies in the Setting of the COVID-19 Pandemic

American Journal of Perinatology, 2020

As New York City became an international epicenter of the novel coronavirus disease 2019 (COVID-1... more As New York City became an international epicenter of the novel coronavirus disease 2019 (COVID-19) pandemic, telehealth was rapidly integrated into prenatal care at Columbia University Irving Medical Center, an academic hospital system in Manhattan. Goals of implementation were to consolidate in-person prenatal screening, surveillance, and examinations into fewer in-person visits while maintaining patient access to ongoing antenatal care and subspecialty consultations via telehealth virtual visits. The rationale for this change was to minimize patient travel and thus risk for COVID-19 exposure. Because a large portion of obstetric patients had underlying medical or fetal conditions placing them at increased risk for adverse outcomes, prenatal care telehealth regimens were tailored for increased surveillance and/or counseling. Based on the incorporation of telehealth into prenatal care for high-risk patients, specific recommendations are made for the following conditions, clinical s...

Research paper thumbnail of Cesarean delivery in the United States 2005 through 2014: a population-based analysis using the Robson 10-Group Classification System

American Journal of Obstetrics and Gynecology, 2018

BACKGROUND: Cesarean delivery has increased steadily in the United States over recent decades wit... more BACKGROUND: Cesarean delivery has increased steadily in the United States over recent decades with significant downstream health consequences. The World Health Organization has endorsed the Robson 10-Group Classification System as a global standard to facilitate analysis and comparison of cesarean delivery rates. OBJECTIVE: Our objective was to apply the Robson 10-Group Classification System to a nationwide cohort in the United States over a 10-year period. STUDY DESIGN: This population-based analysis applied the Robson 10-Group Classification System to all births in the United States from 2005 through 2014, recorded in the 2003 revised birth certificate format. Over the study 10-year period, 27,044,217 deliveries met inclusion criteria. Five parameters (parity including previous cesarean, gestational age, labor onset, fetal presentation, and plurality), identifiable on presentation for delivery, were used to classify all women included into 1 of 10 groups. RESULTS: The overall cesarean rate was 31.6%. Group-3 births (singleton, term, cephalic multiparas in spontaneous labor) were most common, while group-5 births (those with a previous cesarean) accounted for the most cesarean deliveries increasing from 27% of all cesareans in 2005 through 2006 to >34% in 2013 through 2014. Breech pregnancies (groups 6 and 7) had cesarean rates >90%. Primiparous and multiparous women who had a prelabor cesarean (groups 2b and 4b) accounted for over one quarter of all cesarean deliveries. CONCLUSION: Women with a previous cesarean delivery represent an increasing proportion of cesarean deliveries. Use of the Robson criteria allows standardized comparisons of data and identifies clinical scenarios driving changes in cesarean rates. Hospitals and health organizations can use the Robson 10-Group Classification System to evaluate quality and processes associated with cesarean delivery.

Research paper thumbnail of SMFM Special Report: Putting the "M" back in MFM: Addressing education about disparities in maternal outcomes and care

American journal of obstetrics and gynecology, 2018

At the 36th Annual meeting of the Society for Maternal-Fetal Medicine (SMFM), leaders in the fiel... more At the 36th Annual meeting of the Society for Maternal-Fetal Medicine (SMFM), leaders in the field of maternal-fetal medicine (MFM) convened to address maternal outcome and care inequities from 3 perspectives: (1) education, (2) clinical care, and (3) research. Meeting attendees identified knowledge gaps regarding disparities within the provider community; reviewed possible frameworks to address these knowledge gaps; and identified models with which to address key clinical issues. Collaboration and communication between all stakeholders will be needed to gain a better understanding of these prevailing disparities and formulate strategies to eliminate them.

Research paper thumbnail of First-Trimester and Second-Trimester Maternal Serum Biomarkers as Predictors of Placental Abruption

Obstetrics & Gynecology, 2017

OBJECTIVE: We hypothesized that the origins of abruption may extend to the stages of placental im... more OBJECTIVE: We hypothesized that the origins of abruption may extend to the stages of placental implantation; however, there are no reliable markers to predict its development. Based on this hypothesis, we sought to evaluate whether first-trimester and second-trimester serum analytes predict placental abruption. METHODS: We performed a secondary analysis of data of 35,307 women (250 abruption cases) enrolled in the First and Second Trimester Evaluation of Risk cohort (1999–2003), a multicenter, prospective cohort study. Percentiles (based on multiples of the median) of first-trimester (pregnancy-associated plasma protein A and total and free β-hCG) and second-trimester (maternal serum alpha-fetoprotein, unconjugated estriol, and inhibin-A) serum analytes were examined in relation to abruption. Associations are based on risk ratio (RR) and 95% confidence interval (CI). RESULTS: Women with an abnormally low pregnancy-associated plasma protein A (fifth percentile or less) were at increa...

Research paper thumbnail of Hospital Delivery Volume, Severe Obstetrical Morbidity, and Failure to Rescue

American journal of obstetrics and gynecology, Jan 22, 2016

In the setting of persistently high risk for maternal mortality and severe obstetric morbidity, l... more In the setting of persistently high risk for maternal mortality and severe obstetric morbidity, little is known about the relationship between hospital delivery volume and maternal outcomes. The objectives of this analysis were (i) to determine maternal risk for severe morbidity during delivery hospitalizations by hospital delivery volume in the United States; and (ii) to characterize, by hospital volume, the risk for mortality in the setting of severe obstetrical morbidity - a concept known as failure to rescue. This cohort study evaluated 50,433,539 delivery hospitalizations across the United States from 1998 to 2010. The main outcome measures were (i) severe morbidity defined as a composite of any one of fifteen diagnoses representative of acute organ injury and critical illness, and (ii) failure to rescue, defined as death in the setting of severe morbidity. The prevalence of severe morbidity rose from 471.2 to 751.5 cases per 100,000 deliveries from 1998 to 2010, an increase of...

Research paper thumbnail of Gastroschisis: epidemiology and mode of delivery, 2005-2013

American journal of obstetrics and gynecology, Sep 26, 2016

Gastroschisis is a severe congenital anomaly the etiology of which is unknown. Research evidence ... more Gastroschisis is a severe congenital anomaly the etiology of which is unknown. Research evidence supports attempted vaginal delivery for pregnancies complicated by gastroschisis in the absence of obstetric indications for cesarean delivery. The objectives of the study evaluating pregnancies complicated by gastroschisis were to determine the proportion of women undergoing planned cesarean vs attempted vaginal delivery and to provide up-to-date epidemiology on the risk factors associated with this anomaly. This population-based study of US natality records from 2005 through 2013 evaluated pregnancies complicated by gastroschisis. Women were classified based on whether they attempted vaginal delivery or underwent a planned cesarean (n = 24,836,777). Obstetrical, medical, and demographic characteristics were evaluated. Multivariable log-linear regression models were developed to determine the factors associated with the mode of delivery. Factors associated with the occurrence of the ano...

Research paper thumbnail of An Inverse Relationship Between Weight and Free Thyroxine During Early Gestation Among Women Treated for Hypothyroidism

Thyroid, 2015

Background: Following treatment sufficient to normalize thyrotropin (TSH), nonpregnant hypothyroi... more Background: Following treatment sufficient to normalize thyrotropin (TSH), nonpregnant hypothyroid adults display higher free thyroxine (FT 4) concentrations than a reference population. Our aim is to determine whether FT 4 concentrations are higher during pregnancy among women treated for hypothyroidism and whether their weight is associated with FT 4 levels. Weight/FT 4 relationships have not previously been reported in treated hypothyroid adults (either pregnant or nonpregnant). Methods: Thyroid-related measurements were available from over 10,000 women at two early pregnancy time periods from the FaSTER (First and Second Trimester Evaluation of Risk for Fetal aneuploidy) trial (1999-2002). All women were receiving routine prenatal care. Present analyses were restricted to 9267 reference women and 306 treated, hypothyroid women with TSH between the 2nd and 98th reference percentiles. We compared FT 4 values between those groups at 11-14 and 15-18 weeks' gestation, using linear regression to estimate FT 4 /maternal weight relationships, after accounting for treatment and other potential covariates. Results: In comparison to reference women, median FT 4 values and percent of FT 4 values ‡95th reference percentile were significantly higher in treated women at both 11-14 and 15-18 weeks' gestation (p < 0.001) overall and after stratification by weight into tertiles. Among both treated and reference women, median FT 4 decreased monotonically with increasing weight, regardless of anti-thyroperoxidase antibody status. Maternal age, maternal weight, and treatment status were important predictors of FT 4 levels (p < 0.001, defined by partial r 2 values of 1% or higher). Anti-thyroperoxidase antibody status, TSH values (after logarithmic transformation), and all interaction terms were well below an r 2 of 1%. FT 4 levels were 1.45 pmol/L higher in treated than reference women, independent of other factors. Maternal age and weight reduced FT 4 levels by 0.0694 pmol/L/ y and 0.0208 pmol/L/kg, respectively. Conclusions: FT 4 concentrations are higher among treated hypothyroid pregnant women than among reference women, and higher maternal weight is associated with lower FT 4 levels, regardless of treatment status. This inverse relationship is not associated with higher TSH levels. While no immediate clinical implications are attached to the current observations, increased peripheral deiodinase activity in the presence of higher weight might explain these findings. Further investigation appears worthy of attention.

Research paper thumbnail of Cross-trimester repeated measures testing for Down's syndrome screening: an assessment

Health technology assessment (Winchester, England), 2010

To provide estimates and confidence intervals for the performance (detection and false-positive r... more To provide estimates and confidence intervals for the performance (detection and false-positive rates) of screening for Down's syndrome using repeated measures of biochemical markers from first and second trimester maternal serum samples taken from the same woman. Stored serum on Down's syndrome cases and controls was used to provide independent test data for the assessment of screening performance of published risk algorithms and for the development and testing of new risk assessment algorithms. 15 screening centres across the USA, and at the North York General Hospital, Toronto, Canada. 78 women with pregnancy affected by Down's syndrome and 390 matched unaffected controls, with maternal blood samples obtained at 11-13 and 15-18 weeks' gestation, and women who received integrated prenatal screening at North York General Hospital at two time intervals: between 1 December 1999 and 31 October 2003, and between 1 October 2006 and 23 November 2007. Repeated measurements...

Research paper thumbnail of Impact of Adjusting for the Reciprocal Relationship Between Maternal Weight and Free Thyroxine During Early Pregnancy

Thyroid, 2013

for the First and Second Trimester Risk of Aneuploidy (FaSTER) Research Consortium Background: Am... more for the First and Second Trimester Risk of Aneuploidy (FaSTER) Research Consortium Background: Among euthyroid pregnant women in a large clinical trial, free thyroxine (FT4) measurements below the 2.5th centile were associated with a 17 lb higher weight (2.9 kg/m 2) than in the overall study population. We explore this relationship further. Methods: Among 9351 women with second trimester thyrotropin (TSH) measurements between 1st and 98th centiles, we examine: (i) the weight/FT4 relationship; (ii) percentages of women in three weight categories at each FT4 decile; (iii) FT4 concentrations in three weight categories at each TSH decile; and (iv) impact of adjusting FT4 for weight-in the reference group and in 190 additional women with elevated TSH measurements. Results: FT4 values decrease steadily as weight increases (p < 0.0001 by ANOVA) among women in the reference group (TSH 0.05-3.8 IU/L). TSH follows no consistent pattern with weight. When stratified into weight tertiles, 48% of women at the lowest FT4 decile are heavy; the percentage decreases steadily to 22% at the highest FT4 decile. Median FT4 is lowest in heaviest women regardless of the TSH level. In the reference group, weight adjustment reduces overall variance by 2.9%. Fewer FT4 measurements are at either extreme (below the 5th FT4 centile: 4.8% before adjustment, 4.7% after adjustment; above the 95th FT4 centile: 5.0% and 4.7%, respectively). Adjustment places more light weight women and fewer heavy women below the 5th FT4 centile; the converse above the 95th centile. Between TSH 3.8 and 5 IU/L, the FT4 percentage below the 5th FT4 centile is not elevated (3.8% before adjustment, 3.1% after adjustment). Percentage of FT4 values above the 95th centile, however, is lower (1.5% before adjustment, 0.8% after adjustment). Above TSH 5 IU/L, 25% of women have FT4 values below the 5th FT4 centile; weight adjustment raises this to 30%; no FT4 values remain above the 95th FT4 centile. Conclusions: During early pregnancy, TSH values are not associated with weight, unlike nonpregnant adults. Lower average FT4 values among heavy women at all TSH deciles partially explain interindividual differences in FT4 reference ranges. The continuous reciprocal relationship between weight and FT4 explains lower FT4 with higher weight. Weight adjustment refines FT4 interpretation.

Research paper thumbnail of Birth Weight, Breast Cancer and the Potential Mediating Hormonal Environment

PLoS ONE, 2012

Background: Previous studies have shown that woman's risk of breast cancer in later life is assoc... more Background: Previous studies have shown that woman's risk of breast cancer in later life is associated with her infants birth weights. The objective of this study was to determine if this association is independent of breast cancer risk factors, mother's own birth weight and to evaluate association between infants birth weight and hormonal environment during pregnancy. Independent association would have implications for understanding the mechanism, but also for prediction and prevention of breast cancer. Methods and Findings: Risk of breast cancer in relation to a first infant's birth weight, mother's own birth weight and breast cancer risk factors were evaluated in a prospective cohort of 410 women in the Framingham Study. Serum concentrations of estriol (E3), anti-estrogen alpha-fetoprotein (AFP), and pregnancy-associated plasma protein-A (PAPP-A) were measured in 23,824 pregnant women from a separate prospective cohort, the FASTER trial. During follow-up (median, 14 years) 31 women (7.6 %) were diagnosed with breast cancer. Women with large birth weight infants (in the top quintile) had a higher breast cancer risk compared to other women (hazard ratio (HR), 2.5; 95% confidence interval (CI), 1.2-5.2; P = 0.012). The finding was not affected by adjustment for birth weight of the mother and traditional breast cancer risk factors (adjusted HR, 2.5; 95% CI, 1.2-5.6; P = 0.021). An infant's birth weight had a strong positive relationship with the mother's serum E3/ AFP ratio and PAPP-A concentration during pregnancy. Adjustment for breast cancer risk factors did not have a material effect on these relationships. Conclusions: Giving birth to an infant with high birth weight was associated with increased breast cancer risk in later life, independently of mother's own birth weight and breast cancer risk factors and was also associated with a hormonal environment during pregnancy favoring future breast cancer development and progression.

Research paper thumbnail of Scientific Evidence Underlying the American College of Obstetricians and Gynecologists' Practice Bulletins

Obstetrics & Gynecology, 2011

Clinical guidelines are an important source of guidance for clinicians. Few studies have examined... more Clinical guidelines are an important source of guidance for clinicians. Few studies have examined the quality of scientific data underlying evidence-based guidelines. We examined the quality of evidence that underlies the recommendations made by the American College of Obstetricians and Gynecologists (the College). METHODS: The current practice bulletins of the College were examined. Each bulletin makes multiple recommendations. Each recommendation is categorized based on the quality and quantity of evidence that underlies the recommendation into one of three levels of evidence: A (good and consistent evidence), B (limited or inconsistent evidence), or C (consensus and opinion). We analyzed the distribution of levels of evidence for obstetrics and gynecology recommendations. RESULTS: A total of 84 practice bulletins that offered 717 individual recommendations were identified. Forty-eight (57.1%) of the guidelines were obstetric and 36 (42.9%) were gynecologic. When all recommendations were considered, 215 (30.0%) provided level A evidence, 270 (37.7%) level B, and 232 (32.3%) level C. Among obstetric recommendations, 93 (25.5%) were level A, 145 (39.7%) level B, and 117 (34.8%) level C. For the gynecologic recommendations, 122 (34.7%) were level A, 125 (35.5%) level B, and 105 (29.8%) level C. The gynecology recommendations were more likely to be of level A evidence than the obstetrics recommendations (P‫.)940.؍‬ CONCLUSION: One third of the recommendations put forth by the College in its practice bulletins are based on good and consistent scientific evidence.

Research paper thumbnail of Impact of Maternal Age on Obstetric Outcome

Obstetrics & Gynecology, 2005

for the FASTER Consortium* OBJECTIVE: To estimate the effect of maternal age on obstetric outcome... more for the FASTER Consortium* OBJECTIVE: To estimate the effect of maternal age on obstetric outcomes. METHODS: A prospective database from a multicenter investigation of singletons, the FASTER trial, was studied. Subjects were divided into 3 age groups: 1) less than 35 years, 2) 35-39 years, and 3) 40 years and older. Multivariable logistic regression analysis was used to assess the effect of age on outcomes after adjusting for race, parity, body mass index, education, marital status, smoking, medical history, use of assisted conception, and patient's study site. RESULTS: A total of 36,056 women with complete data were available: 28,398 (79%) less than 35 years of age; 6,294 (17%) 35-39 years; and 1,364 (4%) 40 years and older. Increasing age was significantly associated with miscarriage (adjusted odds ratio ͓adjOR͔2.0 and 2.4 for ages 35-39 years and age 40 years and older, respectively), chromosomal abnormalities (adjOR 4.0 and 9.9), congenital anomalies (adjOR 1.4 and 1.7), gestational diabetes (adjOR 1.8 and 2.4), placenta previa (adjOR 1.8 and 2.8), and cesarean delivery (adjOR 1.6 and 2.0). Patients aged 35-39 years were at increased risk for macrosomia (adjOR 1.4). Increased risk for abruption (adjOR 2.3), preterm delivery (adjOR 1.4), low birth weight (adjOR 1.6), and perinatal mortality (adjOR 2.2) was noted in women aged 40 years and older. CONCLUSION: Increasing maternal age is independently associated with specific adverse pregnancy outcomes. Increasing age is a continuum rather than a threshold effect.

Research paper thumbnail of Maternal Thyroid Hypofunction and Pregnancy Outcome

Obstetrics & Gynecology, 2008

OBJECTIVE-To estimate whether maternal thyroid hypofunction is associated with complications. MET... more OBJECTIVE-To estimate whether maternal thyroid hypofunction is associated with complications. METHODS-A total of 10,990 patients had first-and second-trimester serum assayed for thyroid-stimulating hormone (TSH), free thyroxine (freeT4), and antithyroglobulin and antithyroid peroxidase antibodies. Thyroid hypofunction was defined as 1) subclinical hypothyroidism: TSH levels above the 97.5th percentile and free T4 between the 2.5th and 97.5th percentiles or 2) hypothyroxinemia: TSH between the 2.5th and 97.5th percentiles and free T4 below the 2.5th percentile. Adverse outcomes were evaluated. Patients with thyroid hypofunction were compared with euthyroid patients (TSH and free T4 between the 2.5th and 97.5th percentiles). Patients with and without antibodies were compared. Multivariable logistic regression analysis adjusted for confounders was used. RESULTS-Subclinical hypothyroidism was documented in 2.2% (240 of 10,990) in the first and 2.2% (243 of 10,990) in the second trimester. Hypothyroxinemia was documented in 2.1% (232 of 10,990) in the first and 2.3% (247 of 10,990) in the second trimester. Subclinical hypothyroidism was not associated with adverse outcomes. In the first trimester, hypothyroxinemia was associated with preterm labor (adjusted odds ratio [aOR] 1.62; 95% confidence interval [CI] 1.00-2.62) and macrosomia (aOR 1.97; 95% CI 1.37-2.83). In the second trimester, it was associated with gestational diabetes (aOR 1.7; 95% CI 1.02-2.84). Fifteen percent (1,585 of 10,990) in the first and 14% (1,491 of 10,990) in the second trimester had antithyroid antibodies. When both antibodies were positive in either trimester, there was an increased risk for preterm premature rupture of membranes (P = .002 and P<.001, respectively).

Research paper thumbnail of Effect of corticosteroids for fetal maturation on perinatal outcomes, February 28—March 2, 1994

American Journal of Obstetrics and Gynecology, 1995

The National Institutes of Health Consensus Development Conference on the Effect of Corticosteroi... more The National Institutes of Health Consensus Development Conference on the Effect of Corticosteroids for Fetal Maturation on Perinatal Outcomes brought together specialists in obstetrics, neonatology, pharmacology, epidemiology, and nursing; basic scientists in physiology and cellular biology; and the public to address the following questions: (1) For what conditions and purposes are antenatal corticosteroids used, and what is the scientific basis for that use? (2) What are the short-term and long-term benefits of antenatal corticosteroid treatment? (3) What are the short-term and long-term adverse effects for the infant and mother? (4) What is the influence of the type of corticosteroid, dosage, timing and circumstances of administration, and associated therapy on treatment outcome? (5) What are the economic consequences of this treatment? (6) What are the recommendations for use of antenatal corticosteroids? and (7) What research is needed to guide clinical care? Following 1 1/2 days of presentations by experts and discussion by the audience, a consensus panel weighed the evidence and prepared their consensus statement. The consensus panel concluded that antenatal corticosteroid therapy for fetal maturation reduces mortality, respiratory distress syndrome, and intraventricular hemorrhage in preterm infants. These benefits extend to a broad range of gestational ages (24-34 weeks) and are not limited by gender or race. Although the beneficial effects of corticosteroids are greatest more than 24 hours after beginning treatment, treatment less than 24 hours in duration may also improve outcomes. The benefits of antenatal corticosteroids are additive to those derived from surfactant therapy. In the presence of preterm premature rupture of the membranes, antenatal corticosteroid therapy reduces the frequency of respiratory distress syndrome, intraventricular hemorrhage, and neonatal death, although to a lesser extent than with intact membranes. Whether this therapy increases either neonatal or maternal infection is unclear. However, the risk of intraventricular hemorrhage and death from prematurity is greater than the risk from infection. Data from trials with followup of children up to 12 years indicate that antenatal corticosteroid therapy does not adversely affect physical growth or psychomotor development. Antenatal corticosteroid therapy is indicated for women at risk of premature delivery with few exceptions and will result in a substantial decrease in neonatal morbidity and mortality, as well as substantial savings in health care costs. The use of antenatal corticosteroids for fetal maturation is a rare example of a technology that yields substantial cost savings in addition to improving health.

Research paper thumbnail of Intrapartum management of category II fetal heart rate tracings: towards standardization of care

American Journal of Obstetrics and Gynecology, Aug 1, 2013

Research paper thumbnail of 241: Baseline risk assessment for peripartum maternal critical care interventions

American Journal of Obstetrics and Gynecology

Due to the association of AMA with stillbirth, many women of AMA are undergoing IOL. We sought to... more Due to the association of AMA with stillbirth, many women of AMA are undergoing IOL. We sought to determine if nulliparous women of AMA undergoing IOL are more likely to have adverse obstetric outcomes when compared to women who are expectantly managed (EM). STUDY DESIGN: This was a retrospective cohort study of women 35 years who delivered at a single center from June 2011 to December 2014. Women undergoing IOL were compared to women with EM at 39 weeks. Group differences in demographics, obstetric and neonatal outcomes were assessed using T-test, Wilcoxon, Chi-square and Fisher's exact tests as appropriate. Analyses of outcomes adjusted for Bishop score (BS) and/or gestational age (GA) were done using multivariable logistic regression. RESULTS: A total of 816 patients met inclusion criteria which included maternal age 35, nulliparity, and singleton gestation at 39 weeks. Of these, 428 (52%) were induced and 388 (48%) were not induced. The IOL group was significantly older (age 38 vs 36, p<0.001), of a later GA (40.3 vs 40.1w, P¼0.002), with a lower median BS (3 vs 8, p<0.001). Women in the IOL group had an increase in cesarean delivery (CD) compared to the EM group, (48.6% vs. 34%, p<0.001) (Table 1). When controlling for BS >5, the difference in CD rate between the two groups was not statistically significant (36.2% vs. 31.5%; p¼0.37). Interestingly, a high proportion of the IOL group had lower BS compared to the EM group (BS 0-3 (IOL vs. EM): 54% vs 7.2%; BS 9-13: 5.1% vs 30.9%). A Chi-square test demonstrated a significant difference in this distribution of the BS between the IOL vs. EM groups (Table 2). When a subgroup analysis was performed for women age 35-39 vs 40 and above, the CD rates were higher in the older age group for both IOL and EM groups (IOL group, CD rates in age 35-39 vs. 40+ 44.3% vs 56.1% (p¼0.02); EM group, CD rates in age 35-39 vs. 40+ 30.4% vs 42.9% (p¼0.02)). CONCLUSION: In our population, women 35 years old who undergo IOL are not more likely to have CD compared to those expectantly managed. With similar BS on admission, there was no difference in CD rate. Therefore, the difference in CD rate is not due to IOL or EM, but rather due to differences in BS. The BS may help guide clinicians when discussing IOL or EM to AMA nulliparous patients.

Research paper thumbnail of TSH and FT4 Reference Intervals in Pregnancy: A Systematic Review and Individual Participant Data Meta-Analysis

The Journal of Clinical Endocrinology & Metabolism

Context Interpretation of thyroid function tests during pregnancy is limited by the generalizabil... more Context Interpretation of thyroid function tests during pregnancy is limited by the generalizability of reference intervals between cohorts due to inconsistent methodology. Objective (1) To provide an overview of published reference intervals for thyrotropin (TSH) and free thyroxine (FT4) in pregnancy, (2) to assess the consequences of common methodological between-study differences by combining raw data from different cohorts. Methods (1) Ovid MEDLINE, EMBASE, and Web of Science were searched until December 12, 2021. Studies were assessed in duplicate. (2) The individual participant data (IPD) meta-analysis was performed in participating cohorts in the Consortium on Thyroid and Pregnancy. Results (1) Large between-study methodological differences were identified, 11 of 102 included studies were in accordance with current guidelines; (2) 22 cohorts involving 63 198 participants were included in the meta-analysis. Not excluding thyroid peroxidase antibody–positive participants led to...

Research paper thumbnail of Characteristics of Deliveries Resulting in Neonatal Hypoxic Ischemic Encephalopathy: A Multi-Centred Retrospective Case Series

OBJECTIVE: To characterize clinical management of deliveries resulting in neonatal hypoxic ischem... more OBJECTIVE: To characterize clinical management of deliveries resulting in neonatal hypoxic ischemic encephalopathy. DESIGN: Retrospective case series SETTING: Three academic referral medical centers in the United States POPULATION: All neonates ≥35 weeks’ gestation with HIE based on cord blood pH<7.0, base deficit of ≥12.0mmol/L, along with relevant radiological, laboratory, and clinical findings. METHODS: Clinical management was characterized based on whether (i)delivery occurred within 120 minutes of presentation, (ii)delivery occurred due to a sentinel event such as cord prolapse or uterine rupture, and (iii)the fetal heart rate tracing(FHR) demonstrated variability, accelerations, or both upon presentation and in the half hour before delivery. MAIN OUTCOME MEASURES: Relationship of mode of delivery to FHR tracing characteristics at delivery. Obstetric outcomes, labour course and management were analysed. RESULTS: Of 144,904 deliveries, 102 maternal-newborn dyads met criteria....

Research paper thumbnail of Building an obstetric intensive care unit during the COVID-19 pandemic at a tertiary hospital and selected maternal-fetal and delivery considerations

Seminars in Perinatology, 2020

During the novel Coronavirus Disease 2019 pandemic, New York City became an international epicent... more During the novel Coronavirus Disease 2019 pandemic, New York City became an international epicenter for this highly infectious respiratory virus. In anticipation of the unfortunate reality of community spread and high disease burden, the Anesthesia and Obstetrics and Gynecology departments at NewYork-Presbyterian / Columbia University Irving Medical Center, an academic hospital system in Manhattan, created an Obstetric Intensive Care Unit on Labor and Delivery to defray volume from the hospital's preexisting intensive care units. Its purpose was threefold: (1) to accommodate the anticipated influx of critically ill pregnant and postpartum patients due to novel coronavirus, (2) to care for critically ill obstetric patients who would previously have been transferred to a non-obstetric intensive care unit, and (3) to continue caring for our usual census of pregnant and postpartum

Research paper thumbnail of Characteristics and Outcomes of 241 Births to Women With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection at Five New York City Medical Centers

Obstetrics & Gynecology, 2020

OBJECTIVE: To describe the characteristics and birth outcomes of women with severe acute respirat... more OBJECTIVE: To describe the characteristics and birth outcomes of women with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection as community spread in New York City was detected in March 2020. METHODS: We performed a prospective cohort study of pregnant women with laboratory-confirmed SARS-CoV-2 infection who gave birth from March 13 to April 12, 2020, identified at five New York City medical centers. Demographic and clinical data from delivery hospitalization records were collected, and follow-up was completed on April 20, 2020. RESULTS: Among this cohort (241 women), using evolving criteria for testing, 61.4% of women were asymptomatic for coronavirus disease 2019 (COVID-19) at the time of admission. Throughout the delivery hospitalization, 26.5% of women met World Health Organization criteria for mild COVID-19, 26.1% for severe, and 5% for critical. Cesarean birth was the mode of delivery for 52.4% of women with severe and 91.7% with critical COVID-19. The sing...

Research paper thumbnail of Telehealth for High-Risk Pregnancies in the Setting of the COVID-19 Pandemic

American Journal of Perinatology, 2020

As New York City became an international epicenter of the novel coronavirus disease 2019 (COVID-1... more As New York City became an international epicenter of the novel coronavirus disease 2019 (COVID-19) pandemic, telehealth was rapidly integrated into prenatal care at Columbia University Irving Medical Center, an academic hospital system in Manhattan. Goals of implementation were to consolidate in-person prenatal screening, surveillance, and examinations into fewer in-person visits while maintaining patient access to ongoing antenatal care and subspecialty consultations via telehealth virtual visits. The rationale for this change was to minimize patient travel and thus risk for COVID-19 exposure. Because a large portion of obstetric patients had underlying medical or fetal conditions placing them at increased risk for adverse outcomes, prenatal care telehealth regimens were tailored for increased surveillance and/or counseling. Based on the incorporation of telehealth into prenatal care for high-risk patients, specific recommendations are made for the following conditions, clinical s...

Research paper thumbnail of Cesarean delivery in the United States 2005 through 2014: a population-based analysis using the Robson 10-Group Classification System

American Journal of Obstetrics and Gynecology, 2018

BACKGROUND: Cesarean delivery has increased steadily in the United States over recent decades wit... more BACKGROUND: Cesarean delivery has increased steadily in the United States over recent decades with significant downstream health consequences. The World Health Organization has endorsed the Robson 10-Group Classification System as a global standard to facilitate analysis and comparison of cesarean delivery rates. OBJECTIVE: Our objective was to apply the Robson 10-Group Classification System to a nationwide cohort in the United States over a 10-year period. STUDY DESIGN: This population-based analysis applied the Robson 10-Group Classification System to all births in the United States from 2005 through 2014, recorded in the 2003 revised birth certificate format. Over the study 10-year period, 27,044,217 deliveries met inclusion criteria. Five parameters (parity including previous cesarean, gestational age, labor onset, fetal presentation, and plurality), identifiable on presentation for delivery, were used to classify all women included into 1 of 10 groups. RESULTS: The overall cesarean rate was 31.6%. Group-3 births (singleton, term, cephalic multiparas in spontaneous labor) were most common, while group-5 births (those with a previous cesarean) accounted for the most cesarean deliveries increasing from 27% of all cesareans in 2005 through 2006 to >34% in 2013 through 2014. Breech pregnancies (groups 6 and 7) had cesarean rates >90%. Primiparous and multiparous women who had a prelabor cesarean (groups 2b and 4b) accounted for over one quarter of all cesarean deliveries. CONCLUSION: Women with a previous cesarean delivery represent an increasing proportion of cesarean deliveries. Use of the Robson criteria allows standardized comparisons of data and identifies clinical scenarios driving changes in cesarean rates. Hospitals and health organizations can use the Robson 10-Group Classification System to evaluate quality and processes associated with cesarean delivery.

Research paper thumbnail of SMFM Special Report: Putting the "M" back in MFM: Addressing education about disparities in maternal outcomes and care

American journal of obstetrics and gynecology, 2018

At the 36th Annual meeting of the Society for Maternal-Fetal Medicine (SMFM), leaders in the fiel... more At the 36th Annual meeting of the Society for Maternal-Fetal Medicine (SMFM), leaders in the field of maternal-fetal medicine (MFM) convened to address maternal outcome and care inequities from 3 perspectives: (1) education, (2) clinical care, and (3) research. Meeting attendees identified knowledge gaps regarding disparities within the provider community; reviewed possible frameworks to address these knowledge gaps; and identified models with which to address key clinical issues. Collaboration and communication between all stakeholders will be needed to gain a better understanding of these prevailing disparities and formulate strategies to eliminate them.

Research paper thumbnail of First-Trimester and Second-Trimester Maternal Serum Biomarkers as Predictors of Placental Abruption

Obstetrics & Gynecology, 2017

OBJECTIVE: We hypothesized that the origins of abruption may extend to the stages of placental im... more OBJECTIVE: We hypothesized that the origins of abruption may extend to the stages of placental implantation; however, there are no reliable markers to predict its development. Based on this hypothesis, we sought to evaluate whether first-trimester and second-trimester serum analytes predict placental abruption. METHODS: We performed a secondary analysis of data of 35,307 women (250 abruption cases) enrolled in the First and Second Trimester Evaluation of Risk cohort (1999–2003), a multicenter, prospective cohort study. Percentiles (based on multiples of the median) of first-trimester (pregnancy-associated plasma protein A and total and free β-hCG) and second-trimester (maternal serum alpha-fetoprotein, unconjugated estriol, and inhibin-A) serum analytes were examined in relation to abruption. Associations are based on risk ratio (RR) and 95% confidence interval (CI). RESULTS: Women with an abnormally low pregnancy-associated plasma protein A (fifth percentile or less) were at increa...

Research paper thumbnail of Hospital Delivery Volume, Severe Obstetrical Morbidity, and Failure to Rescue

American journal of obstetrics and gynecology, Jan 22, 2016

In the setting of persistently high risk for maternal mortality and severe obstetric morbidity, l... more In the setting of persistently high risk for maternal mortality and severe obstetric morbidity, little is known about the relationship between hospital delivery volume and maternal outcomes. The objectives of this analysis were (i) to determine maternal risk for severe morbidity during delivery hospitalizations by hospital delivery volume in the United States; and (ii) to characterize, by hospital volume, the risk for mortality in the setting of severe obstetrical morbidity - a concept known as failure to rescue. This cohort study evaluated 50,433,539 delivery hospitalizations across the United States from 1998 to 2010. The main outcome measures were (i) severe morbidity defined as a composite of any one of fifteen diagnoses representative of acute organ injury and critical illness, and (ii) failure to rescue, defined as death in the setting of severe morbidity. The prevalence of severe morbidity rose from 471.2 to 751.5 cases per 100,000 deliveries from 1998 to 2010, an increase of...

Research paper thumbnail of Gastroschisis: epidemiology and mode of delivery, 2005-2013

American journal of obstetrics and gynecology, Sep 26, 2016

Gastroschisis is a severe congenital anomaly the etiology of which is unknown. Research evidence ... more Gastroschisis is a severe congenital anomaly the etiology of which is unknown. Research evidence supports attempted vaginal delivery for pregnancies complicated by gastroschisis in the absence of obstetric indications for cesarean delivery. The objectives of the study evaluating pregnancies complicated by gastroschisis were to determine the proportion of women undergoing planned cesarean vs attempted vaginal delivery and to provide up-to-date epidemiology on the risk factors associated with this anomaly. This population-based study of US natality records from 2005 through 2013 evaluated pregnancies complicated by gastroschisis. Women were classified based on whether they attempted vaginal delivery or underwent a planned cesarean (n = 24,836,777). Obstetrical, medical, and demographic characteristics were evaluated. Multivariable log-linear regression models were developed to determine the factors associated with the mode of delivery. Factors associated with the occurrence of the ano...

Research paper thumbnail of An Inverse Relationship Between Weight and Free Thyroxine During Early Gestation Among Women Treated for Hypothyroidism

Thyroid, 2015

Background: Following treatment sufficient to normalize thyrotropin (TSH), nonpregnant hypothyroi... more Background: Following treatment sufficient to normalize thyrotropin (TSH), nonpregnant hypothyroid adults display higher free thyroxine (FT 4) concentrations than a reference population. Our aim is to determine whether FT 4 concentrations are higher during pregnancy among women treated for hypothyroidism and whether their weight is associated with FT 4 levels. Weight/FT 4 relationships have not previously been reported in treated hypothyroid adults (either pregnant or nonpregnant). Methods: Thyroid-related measurements were available from over 10,000 women at two early pregnancy time periods from the FaSTER (First and Second Trimester Evaluation of Risk for Fetal aneuploidy) trial (1999-2002). All women were receiving routine prenatal care. Present analyses were restricted to 9267 reference women and 306 treated, hypothyroid women with TSH between the 2nd and 98th reference percentiles. We compared FT 4 values between those groups at 11-14 and 15-18 weeks' gestation, using linear regression to estimate FT 4 /maternal weight relationships, after accounting for treatment and other potential covariates. Results: In comparison to reference women, median FT 4 values and percent of FT 4 values ‡95th reference percentile were significantly higher in treated women at both 11-14 and 15-18 weeks' gestation (p < 0.001) overall and after stratification by weight into tertiles. Among both treated and reference women, median FT 4 decreased monotonically with increasing weight, regardless of anti-thyroperoxidase antibody status. Maternal age, maternal weight, and treatment status were important predictors of FT 4 levels (p < 0.001, defined by partial r 2 values of 1% or higher). Anti-thyroperoxidase antibody status, TSH values (after logarithmic transformation), and all interaction terms were well below an r 2 of 1%. FT 4 levels were 1.45 pmol/L higher in treated than reference women, independent of other factors. Maternal age and weight reduced FT 4 levels by 0.0694 pmol/L/ y and 0.0208 pmol/L/kg, respectively. Conclusions: FT 4 concentrations are higher among treated hypothyroid pregnant women than among reference women, and higher maternal weight is associated with lower FT 4 levels, regardless of treatment status. This inverse relationship is not associated with higher TSH levels. While no immediate clinical implications are attached to the current observations, increased peripheral deiodinase activity in the presence of higher weight might explain these findings. Further investigation appears worthy of attention.

Research paper thumbnail of Cross-trimester repeated measures testing for Down's syndrome screening: an assessment

Health technology assessment (Winchester, England), 2010

To provide estimates and confidence intervals for the performance (detection and false-positive r... more To provide estimates and confidence intervals for the performance (detection and false-positive rates) of screening for Down's syndrome using repeated measures of biochemical markers from first and second trimester maternal serum samples taken from the same woman. Stored serum on Down's syndrome cases and controls was used to provide independent test data for the assessment of screening performance of published risk algorithms and for the development and testing of new risk assessment algorithms. 15 screening centres across the USA, and at the North York General Hospital, Toronto, Canada. 78 women with pregnancy affected by Down's syndrome and 390 matched unaffected controls, with maternal blood samples obtained at 11-13 and 15-18 weeks' gestation, and women who received integrated prenatal screening at North York General Hospital at two time intervals: between 1 December 1999 and 31 October 2003, and between 1 October 2006 and 23 November 2007. Repeated measurements...

Research paper thumbnail of Impact of Adjusting for the Reciprocal Relationship Between Maternal Weight and Free Thyroxine During Early Pregnancy

Thyroid, 2013

for the First and Second Trimester Risk of Aneuploidy (FaSTER) Research Consortium Background: Am... more for the First and Second Trimester Risk of Aneuploidy (FaSTER) Research Consortium Background: Among euthyroid pregnant women in a large clinical trial, free thyroxine (FT4) measurements below the 2.5th centile were associated with a 17 lb higher weight (2.9 kg/m 2) than in the overall study population. We explore this relationship further. Methods: Among 9351 women with second trimester thyrotropin (TSH) measurements between 1st and 98th centiles, we examine: (i) the weight/FT4 relationship; (ii) percentages of women in three weight categories at each FT4 decile; (iii) FT4 concentrations in three weight categories at each TSH decile; and (iv) impact of adjusting FT4 for weight-in the reference group and in 190 additional women with elevated TSH measurements. Results: FT4 values decrease steadily as weight increases (p < 0.0001 by ANOVA) among women in the reference group (TSH 0.05-3.8 IU/L). TSH follows no consistent pattern with weight. When stratified into weight tertiles, 48% of women at the lowest FT4 decile are heavy; the percentage decreases steadily to 22% at the highest FT4 decile. Median FT4 is lowest in heaviest women regardless of the TSH level. In the reference group, weight adjustment reduces overall variance by 2.9%. Fewer FT4 measurements are at either extreme (below the 5th FT4 centile: 4.8% before adjustment, 4.7% after adjustment; above the 95th FT4 centile: 5.0% and 4.7%, respectively). Adjustment places more light weight women and fewer heavy women below the 5th FT4 centile; the converse above the 95th centile. Between TSH 3.8 and 5 IU/L, the FT4 percentage below the 5th FT4 centile is not elevated (3.8% before adjustment, 3.1% after adjustment). Percentage of FT4 values above the 95th centile, however, is lower (1.5% before adjustment, 0.8% after adjustment). Above TSH 5 IU/L, 25% of women have FT4 values below the 5th FT4 centile; weight adjustment raises this to 30%; no FT4 values remain above the 95th FT4 centile. Conclusions: During early pregnancy, TSH values are not associated with weight, unlike nonpregnant adults. Lower average FT4 values among heavy women at all TSH deciles partially explain interindividual differences in FT4 reference ranges. The continuous reciprocal relationship between weight and FT4 explains lower FT4 with higher weight. Weight adjustment refines FT4 interpretation.

Research paper thumbnail of Birth Weight, Breast Cancer and the Potential Mediating Hormonal Environment

PLoS ONE, 2012

Background: Previous studies have shown that woman's risk of breast cancer in later life is assoc... more Background: Previous studies have shown that woman's risk of breast cancer in later life is associated with her infants birth weights. The objective of this study was to determine if this association is independent of breast cancer risk factors, mother's own birth weight and to evaluate association between infants birth weight and hormonal environment during pregnancy. Independent association would have implications for understanding the mechanism, but also for prediction and prevention of breast cancer. Methods and Findings: Risk of breast cancer in relation to a first infant's birth weight, mother's own birth weight and breast cancer risk factors were evaluated in a prospective cohort of 410 women in the Framingham Study. Serum concentrations of estriol (E3), anti-estrogen alpha-fetoprotein (AFP), and pregnancy-associated plasma protein-A (PAPP-A) were measured in 23,824 pregnant women from a separate prospective cohort, the FASTER trial. During follow-up (median, 14 years) 31 women (7.6 %) were diagnosed with breast cancer. Women with large birth weight infants (in the top quintile) had a higher breast cancer risk compared to other women (hazard ratio (HR), 2.5; 95% confidence interval (CI), 1.2-5.2; P = 0.012). The finding was not affected by adjustment for birth weight of the mother and traditional breast cancer risk factors (adjusted HR, 2.5; 95% CI, 1.2-5.6; P = 0.021). An infant's birth weight had a strong positive relationship with the mother's serum E3/ AFP ratio and PAPP-A concentration during pregnancy. Adjustment for breast cancer risk factors did not have a material effect on these relationships. Conclusions: Giving birth to an infant with high birth weight was associated with increased breast cancer risk in later life, independently of mother's own birth weight and breast cancer risk factors and was also associated with a hormonal environment during pregnancy favoring future breast cancer development and progression.

Research paper thumbnail of Scientific Evidence Underlying the American College of Obstetricians and Gynecologists' Practice Bulletins

Obstetrics & Gynecology, 2011

Clinical guidelines are an important source of guidance for clinicians. Few studies have examined... more Clinical guidelines are an important source of guidance for clinicians. Few studies have examined the quality of scientific data underlying evidence-based guidelines. We examined the quality of evidence that underlies the recommendations made by the American College of Obstetricians and Gynecologists (the College). METHODS: The current practice bulletins of the College were examined. Each bulletin makes multiple recommendations. Each recommendation is categorized based on the quality and quantity of evidence that underlies the recommendation into one of three levels of evidence: A (good and consistent evidence), B (limited or inconsistent evidence), or C (consensus and opinion). We analyzed the distribution of levels of evidence for obstetrics and gynecology recommendations. RESULTS: A total of 84 practice bulletins that offered 717 individual recommendations were identified. Forty-eight (57.1%) of the guidelines were obstetric and 36 (42.9%) were gynecologic. When all recommendations were considered, 215 (30.0%) provided level A evidence, 270 (37.7%) level B, and 232 (32.3%) level C. Among obstetric recommendations, 93 (25.5%) were level A, 145 (39.7%) level B, and 117 (34.8%) level C. For the gynecologic recommendations, 122 (34.7%) were level A, 125 (35.5%) level B, and 105 (29.8%) level C. The gynecology recommendations were more likely to be of level A evidence than the obstetrics recommendations (P‫.)940.؍‬ CONCLUSION: One third of the recommendations put forth by the College in its practice bulletins are based on good and consistent scientific evidence.

Research paper thumbnail of Impact of Maternal Age on Obstetric Outcome

Obstetrics & Gynecology, 2005

for the FASTER Consortium* OBJECTIVE: To estimate the effect of maternal age on obstetric outcome... more for the FASTER Consortium* OBJECTIVE: To estimate the effect of maternal age on obstetric outcomes. METHODS: A prospective database from a multicenter investigation of singletons, the FASTER trial, was studied. Subjects were divided into 3 age groups: 1) less than 35 years, 2) 35-39 years, and 3) 40 years and older. Multivariable logistic regression analysis was used to assess the effect of age on outcomes after adjusting for race, parity, body mass index, education, marital status, smoking, medical history, use of assisted conception, and patient's study site. RESULTS: A total of 36,056 women with complete data were available: 28,398 (79%) less than 35 years of age; 6,294 (17%) 35-39 years; and 1,364 (4%) 40 years and older. Increasing age was significantly associated with miscarriage (adjusted odds ratio ͓adjOR͔2.0 and 2.4 for ages 35-39 years and age 40 years and older, respectively), chromosomal abnormalities (adjOR 4.0 and 9.9), congenital anomalies (adjOR 1.4 and 1.7), gestational diabetes (adjOR 1.8 and 2.4), placenta previa (adjOR 1.8 and 2.8), and cesarean delivery (adjOR 1.6 and 2.0). Patients aged 35-39 years were at increased risk for macrosomia (adjOR 1.4). Increased risk for abruption (adjOR 2.3), preterm delivery (adjOR 1.4), low birth weight (adjOR 1.6), and perinatal mortality (adjOR 2.2) was noted in women aged 40 years and older. CONCLUSION: Increasing maternal age is independently associated with specific adverse pregnancy outcomes. Increasing age is a continuum rather than a threshold effect.

Research paper thumbnail of Maternal Thyroid Hypofunction and Pregnancy Outcome

Obstetrics & Gynecology, 2008

OBJECTIVE-To estimate whether maternal thyroid hypofunction is associated with complications. MET... more OBJECTIVE-To estimate whether maternal thyroid hypofunction is associated with complications. METHODS-A total of 10,990 patients had first-and second-trimester serum assayed for thyroid-stimulating hormone (TSH), free thyroxine (freeT4), and antithyroglobulin and antithyroid peroxidase antibodies. Thyroid hypofunction was defined as 1) subclinical hypothyroidism: TSH levels above the 97.5th percentile and free T4 between the 2.5th and 97.5th percentiles or 2) hypothyroxinemia: TSH between the 2.5th and 97.5th percentiles and free T4 below the 2.5th percentile. Adverse outcomes were evaluated. Patients with thyroid hypofunction were compared with euthyroid patients (TSH and free T4 between the 2.5th and 97.5th percentiles). Patients with and without antibodies were compared. Multivariable logistic regression analysis adjusted for confounders was used. RESULTS-Subclinical hypothyroidism was documented in 2.2% (240 of 10,990) in the first and 2.2% (243 of 10,990) in the second trimester. Hypothyroxinemia was documented in 2.1% (232 of 10,990) in the first and 2.3% (247 of 10,990) in the second trimester. Subclinical hypothyroidism was not associated with adverse outcomes. In the first trimester, hypothyroxinemia was associated with preterm labor (adjusted odds ratio [aOR] 1.62; 95% confidence interval [CI] 1.00-2.62) and macrosomia (aOR 1.97; 95% CI 1.37-2.83). In the second trimester, it was associated with gestational diabetes (aOR 1.7; 95% CI 1.02-2.84). Fifteen percent (1,585 of 10,990) in the first and 14% (1,491 of 10,990) in the second trimester had antithyroid antibodies. When both antibodies were positive in either trimester, there was an increased risk for preterm premature rupture of membranes (P = .002 and P<.001, respectively).