Andrew Elimian - Academia.edu (original) (raw)

Papers by Andrew Elimian

Research paper thumbnail of 730: Doppler velocimetry: A comparison of the intrafetal to extrafetal segments of the umbilical artery(UA)

American Journal of Obstetrics and Gynecology, Dec 1, 2007

Insonation of the UA in the amniotic cavity can be challenging in multiple gestations and can be ... more Insonation of the UA in the amniotic cavity can be challenging in multiple gestations and can be influenced by the adjacent umbilical arterial and venous pulsations. Our objectives were to provide normal data for Doppler volicimetry in the intrafetal paravesical segment of the UA and compare doppler indices between the intrafetal paravesical segment with the extrafetal amniotic segment of the UA. STUDY DESIGN: Consecutive consenting women between 18 and 42 weeks of gestation were enrolled. Systolic/diastolic (S/D), resistive index (RI), pulsatility index (PI) were determined by sonographers insonating the UA at the two locations. The segment insonated first was alternated. RESULTS: The median, (10th,90th percentile) of the S/D of the intrafetal segment were significantly higher than the extrafetal segment [3.2(2.31,4.85) vs 2.7(2.10,3.93), Pϭ.0001]. The S/Ds in the intrafetal segment were higher than the extrafetal segment in 80.6% of instances. Similar results were obtained for RI and PI. CONCLUSION: Doppler indices are significantly higher in the intrafetal paravesical segment of the UA than in te extrafetal segment. Our normogram might be clinically useful when the extrafetal UA is difficult to insonate or when obtained indices might be unreliable.

Research paper thumbnail of Evaluating Progestogens for Preventing Preterm birth International Collaborative (EPPPIC): meta-analysis of individual participant data from randomised controlled trials

The Lancet, 2021

Evidence before this study Preterm birth is the most common cause of neonatal morbidity and morta... more Evidence before this study Preterm birth is the most common cause of neonatal morbidity and mortality globally, and it is unclear if giving a progestogen during pregnancy to asymptomatic women at high risk of preterm birth reduces the risk of preterm birth. Previous reviews focused on a single form of progestogen in at-risk subpopulations, and no individual participant data (IPD) meta-analysis of 17-hydroxyprogesterone caproate (17-OHPC) in single gestation pregnancies had been done. We considered published and unpublished trials that completed primary data collection before July 31, 2016, (12 months before data collection began). We searched MEDLINE, Embase, CINAHL, the Maternity and Infant Care Database, and relevant trial registers, with a final search date of July 30, 2019. Trialists were invited to identify additional trials. Received IPD were checked thoroughly and risk of bias was assessed. Added value of this study We included participant-level data from 31 trials, including more than 11,000 women and 16,000 offspring, in the largest IPD meta-analysis of progestogens used to prevent preterm birth to date. Included trials were generally at low risk of bias. For the high-risk population included in trials of singleton pregnancies (predominantly participants with a previous spontaneous preterm birth or sonographic short cervix), analyses showed that both vaginal progesterone and 17-OHPC reduced the risk of preterm birth before 34 weeks compared with control. Evidence of benefit in reducing preterm birth before 34 weeks was more certain for vaginal progesterone, but there was no clear evidence that either vaginal progesterone or 17-OHPC was superior. A consistent direction of benefit was noted for other birth and neonatal outcomes, including preterm birth before 28 weeks, preterm birth before 37 weeks, perinatal mortality, and composite serious neonatal complications. We noted possible variations in the size of treatment effect by risk factor, but there was no conclusive evidence that the relative effect of treatment varied according to participant characteristics within our high-risk dataset. There was no evidence of benefit in unselected multifetal pregnancies, although our dataset included few women with both multifetal gestation and other risk factors, such as short cervix. Implications of all the available evidence Vaginal progesterone and 17-OHPC both reduced birth before 34 weeks in high-risk singleton pregnancies. Given increased underlying risk, absolute risk reduction is greater for women with a short cervix, hence treatment might be most useful for these women. Maternal complications were possibly increased with exposure, indicating a need for further study of safety. Additional evaluation of long-term infant outcomes is also required. Further investigation of women with a previous preterm birth and longer cervical length (>30 mm) might be required to substantiate that the risk-benefit ratio in this group is clinically favourable. Evidence for oral progesterone was insufficient to support clinical decision making. Shared decision making with women with a high-risk singleton pregnancy should discuss individual risk, potential benefits, harms, and practicalities of intervention. Treatment of unselected multifetal pregnancies with a progestogen is not supported by the evidence.

Research paper thumbnail of An evaluation of nutritional and vasoactive stimulants as risk factors for gastroschisis: a pilot study

The Journal of Maternal-Fetal & Neonatal Medicine, 2018

Objective: To evaluate poor maternal nutrition, environmental exposures and vasoactive stimulants... more Objective: To evaluate poor maternal nutrition, environmental exposures and vasoactive stimulants as potential risk factors for gastroschisis. Methods: A case-control study was conducted among singleton pregnancies diagnosed in a tertiary teaching hospital in a 22-month period. Cases of gastroschisis were matched to controls at the time of diagnosis by race and maternal age. Demographics, periconceptual exposures, nutritional biomarkers and illicit drug hair analysis were evaluated. Analyses were performed using conditional logistic regression. Results-Thirty gastroschisis cases and 76 controls were studied with no associations observed for illicit drug use or serum levels of ferritin, iron, B6, B12, folate or zinc. Neither prescription medication nor over the counter mediation use differed between cases and controls. Following adjustment for insurance, education, low BMI and nulliparity, mothers of gastroschisis cases had an increased odds of alcohol use one month prior and/or during early pregnancy compared to controls, with adjusted OR 3.19 (95% CI 1.01-11.61). Conclusions: Our findings suggest that further investigation of vasoactive stimulants such as alcohol is warranted in the search to identify risk factors for gastroschisis.

Research paper thumbnail of Vaginal progesterone vs intramuscular 17α‐hydroxyprogesterone caproate for prevention of recurrent spontaneous preterm birth in singleton gestations: systematic review and meta‐analysis of randomized controlled trials

Ultrasound in Obstetrics & Gynecology, 2017

ABSTRACTObjectiveRandomized controlled trials (RCTs) have recently compared intramuscular 17α‐hyd... more ABSTRACTObjectiveRandomized controlled trials (RCTs) have recently compared intramuscular 17α‐hydroxyprogesterone caproate (17‐OHPC) with vaginal progesterone for reducing the risk of spontaneous preterm birth (SPTB) in singleton gestations with prior SPTB. The aim of this systematic review and meta‐analysis was to evaluate the efficacy of vaginal progesterone compared with 17‐OHPC in prevention of SPTB in singleton gestations with prior SPTB.MethodsSearches of electronic databases were performed to identify all RCTs of asymptomatic singleton gestations with prior SPTB that were randomized to prophylactic treatment with either vaginal progesterone (intervention group) or intramuscular 17‐OHPC (comparison group). No restrictions for language or geographic location were applied. The primary outcome was SPTB < 34 weeks. Secondary outcomes were SPTB < 37 weeks, < 32 weeks, < 28 weeks and < 24 weeks, maternal adverse drug reaction and neonatal outcomes. The summary measure...

Research paper thumbnail of A randomized controlled trial of intramuscular versus vaginal progesterone for the prevention of recurrent preterm birth

International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics, Jan 18, 2016

To compare the efficacy of intramuscular hydroxyprogesterone caproate with that of vaginal proges... more To compare the efficacy of intramuscular hydroxyprogesterone caproate with that of vaginal progesterone for prevention of recurrent preterm birth. A prospective randomized controlled trial was conducted at a US tertiary care center between June 1, 2007, and April 30, 2010. Women with singleton pregnancies (16-20 weeks) and a history of spontaneous preterm birth were randomly allocated using a computer-generated randomization sequence to receive either a weekly intramuscular injection of hydroxyprogesterone caproate (250 mg) or a daily vaginal progesterone suppository (100 mg). Participants, investigators, and assessors were not masked to group assignment. The primary outcome was birth before 37 weeks of pregnancy. Per-protocol analyses were performed: participants who completed follow-up were included. Analyses included 66 women given intramuscular progesterone and 79 given vaginal progesterone. Delivery before 37 weeks was recorded among 29 (43.9%) women in the intramuscular proges...

Research paper thumbnail of Immediate Compared With Delayed Cord Clamping in the Preterm Neonate

Obstetrics & Gynecology, 2014

The comparative risks and benefits of early compared with delayed cord clamping in the preterm ne... more The comparative risks and benefits of early compared with delayed cord clamping in the preterm neonate remain unclear. Our objective was to evaluate the short-term effects of delayed clamping of the umbilical cord in preterm neonates. METHODS: We conducted a randomized controlled trial comparing immediate with delayed cord clamping among preterm neonates born between 24 and 34 weeks of gestation. The primary study outcome was the need for blood transfusion. To detect a 33% reduction in this outcome (from 65 to 43.5%) with a two-tailed a of 0.5 and b of 0.8 required 178 patients equally divided into two groups.

Research paper thumbnail of Unsuccessful trial of labor in women with and without previous cesarean delivery

Journal of Maternal-Fetal and Neonatal Medicine, 2010

To compare maternal and neonatal outcomes after unsuccessful labor in women with and those withou... more To compare maternal and neonatal outcomes after unsuccessful labor in women with and those without prior cesarean delivery. This was a retrospective cohort study of all women in labor delivered by cesarean section (CS) from November 2004 through December 2006. The study population was dichotomized by previous CS and compared for various maternal and neonatal outcomes. Student t-test, χ² and Fisher exact tests were used for analysis. There was a significantly higher rate of symptomatic uterine rupture [3/100 (3%) vs. 0/449 (0%), p = 0.006], asymptomatic uterine scar dehiscence [6/100 (6%) vs. 0/449 (0%), p = 0.0001], and bladder injury [2/100 (2%) vs. 0/100 (0%), p = 0.001], among women with prior cesarean delivery compared to those without. The rate of respiratory distress syndrome [(6/100) (6%) vs. 10/449 (2.2%), p = 0.05] and meconium aspiration [4/100 (4%) vs. 2/449 (0.4%), p = 0.01] was also significantly higher among neonates of women with prior cesarean delivery. However, the rate of endomyometritis [3/100 (3%) vs. 50/449 (11.1%), p = 0.009] and febrile morbidity [17/100 (17%) vs. 144/449 (32.1%), p = 0.003] was significantly lower among women with prior cesarean delivery compared to those without prior cesarean birth. Compared to laboring women without previous cesarean delivery, women with previous cesarean delivery have increased maternal and neonatal morbidity. Febrile morbidity was, however, lower among women with previous cesarean delivery. These differential findings should further inform our perinatal counseling of women contemplating trial of labor after a previous cesarean delivery.

Research paper thumbnail of A comparison of meningococcal carriage by pregnancy status

Journal of Negative Results in BioMedicine, 2010

Neisseria meningitidis is the second leading cause of invasive meningitis. A prerequisite for inf... more Neisseria meningitidis is the second leading cause of invasive meningitis. A prerequisite for infection is colonization of the nasopharynx, and asymptomatic carrier rates are widely reported in the range of 10-15%. Recent reports have indicated an increased likelihood that a pediatric admission for Neisseria meningitidis will have a mother who is pregnant in the home. We hypothesized that this association may relate to immunologic changes in pregnancy leading to higher carrier rates. We compared the carrier status by performing nasopharyngeal swabs for Neisseria meningitidis in 100 pregnant and 99 non-pregnant women. Average age of the participants was 28.9 +/-6.7 years. The average gestational age at specimen collection was 27.5 +/-9.4 weeks. Non pregnant women were significantly more likely to use tobacco (38% vs 24%, p < 0.0001). In the entire 199 patients, only one pregnant patient tested positive for Neisseria meningitidis (0.5%; 95% CI: 0.01%-2.8%). The meningococcal carrier rate in our population is well below what is widely reported in the literature. Assuming a 1% carrier rate in the pregnant group and a 0.5% carrier rate in the non pregnant group, 4,763 patients would be required to detect a difference of this magnitude, given 80% power and an alpha of 0.05.

Research paper thumbnail of Evaluation of outcomes after transabdominal cervicoisthmic cerclage

Archives of Gynecology and Obstetrics, 2009

Purpose To evaluate maternal and neonatal outcomes after transabdominal cerclage. Methods Retrosp... more Purpose To evaluate maternal and neonatal outcomes after transabdominal cerclage. Methods Retrospective analysis of 15 patients receiving transabdominal cerclage. Using the patient's prior pregnancy as her own control, we assessed the eVect of this procedure on gestational age and neonatal survival. Results All patients had experienced a prior pregnancy loss. Twelve out of the 15 patients (80%) had at least one prior failed vaginal cerclage. The median gestational age at surgery was 14 (range 12-16) weeks. There was one case of surgical site infection. After cerclage, the proportion of women delivered beyond 32 weeks was signiWcantly higher [11/15 (73.3%) vs. 1/15 (6.7%), P = 0.0016], as was neonatal survival [12/15 (80%) vs. 1/15 (6.7%), P = 0.0009]. Conclusions While transabdominal cerclage is a major surgical procedure, subsequent pregnancy outcomes were improved.

Research paper thumbnail of 35: A randomized controlled trial of immediate versus delayed cord clamping in the preterm neonate

American Journal of Obstetrics and Gynecology, 2013

ration, necrotizing enterocolitis, respiratory distress syndrome or intraventricular hemorrhage) ... more ration, necrotizing enterocolitis, respiratory distress syndrome or intraventricular hemorrhage) were collected using the fetuses-at-risk approach. A moving average (death at specific day ϩ deaths of day before and day after/3) was applied to correct for daily fluctuations. RESULTS: The final study population comprised 985.321 deliveries in Caucasians (89.2%), 94.664 in Mediterraneans (8.6%) and 24.879 deliveries in Africans (2.3%). For Caucasian and Mediterranean women the period of delivery associated with the lowest cumulative risk of perinatal death was between 39ϩ0 and 39ϩ6 weeks. For African women this nadir appears to start earlier around 38ϩ2 weeks. The risk of antenatal stillbirth rises after 39ϩ6 weeks in Mediterranean compared to Caucasian women. Remarkably, neonatal morbidity is increased along all weeks of gestation in African women when compared to the other ethnicities (Figure). CONCLUSION: The nadir of perinatal death in Caucasian and Mediterranean pregnancies is at 39 weeks, for African women already around 38 weeks. The risk of neonatal morbidity is highest in African women regardless of week of gestation. Ethnicity of the mother should be taken into account when making decisions about intervening in a pregnancy or to wait.

Research paper thumbnail of 683: Local anesthesia and pain perception during amniocentesis: a randomized placebo-controlled trial

American Journal of Obstetrics and Gynecology, 2013

did not differ much. The association between the elevated CPP and obesity remained significant af... more did not differ much. The association between the elevated CPP and obesity remained significant after controlling for confounders such as maternal age. CONCLUSION: Maternal obesity is associated with increased cerebral perfusion pressure. The emerging obesity epidemic, coupled with associated increased risk for perinatal complications make this an important finding and underscore the need for further research.

Research paper thumbnail of The effect of digital cervical examination on group B streptococcal culture

American Journal of Obstetrics and Gynecology, 2010

We sought to evaluate whether group B streptococcus (GBS) detection is altered by the digital cer... more We sought to evaluate whether group B streptococcus (GBS) detection is altered by the digital cervical examination. STUDY DESIGN: A total of 302 women undergoing the clinical GBS culture had a digital cervical examination and a repeated GBS culture. Statistical comparison of pre-post culture results were performed with kappa and McNemar tests. RESULTS: The clinical prevalence of GBS was 19.5%. Discordant results were seen in 30/302 (9.9%) paired cultures (ϭ 0.68; 95% confidence interval, 0.568-0.783). An initially negative GBS culture result was positive on repeated testing in 13/243 (5.3%) pairs. Initially positive cultures were negative on repeated testing in 17/59 (28.8%) pairs. Patients with discordant results had similar characteristics as the remainder of the study group. Given the observed proportion of discordant results (9.9%), the study had 80% power to detect a 5% difference between discordant pairs. CONCLUSION: Paired GBS cultures showed a good level of agreement. The 28.8% rate of positive cultures becoming negative is clinically concerning and warrants further study.

Research paper thumbnail of 730: Doppler velocimetry: A comparison of the intrafetal to extrafetal segments of the umbilical artery(UA)

American Journal of Obstetrics and Gynecology, Dec 1, 2007

Insonation of the UA in the amniotic cavity can be challenging in multiple gestations and can be ... more Insonation of the UA in the amniotic cavity can be challenging in multiple gestations and can be influenced by the adjacent umbilical arterial and venous pulsations. Our objectives were to provide normal data for Doppler volicimetry in the intrafetal paravesical segment of the UA and compare doppler indices between the intrafetal paravesical segment with the extrafetal amniotic segment of the UA. STUDY DESIGN: Consecutive consenting women between 18 and 42 weeks of gestation were enrolled. Systolic/diastolic (S/D), resistive index (RI), pulsatility index (PI) were determined by sonographers insonating the UA at the two locations. The segment insonated first was alternated. RESULTS: The median, (10th,90th percentile) of the S/D of the intrafetal segment were significantly higher than the extrafetal segment [3.2(2.31,4.85) vs 2.7(2.10,3.93), Pϭ.0001]. The S/Ds in the intrafetal segment were higher than the extrafetal segment in 80.6% of instances. Similar results were obtained for RI and PI. CONCLUSION: Doppler indices are significantly higher in the intrafetal paravesical segment of the UA than in te extrafetal segment. Our normogram might be clinically useful when the extrafetal UA is difficult to insonate or when obtained indices might be unreliable.

Research paper thumbnail of Evaluating Progestogens for Preventing Preterm birth International Collaborative (EPPPIC): meta-analysis of individual participant data from randomised controlled trials

The Lancet, 2021

Evidence before this study Preterm birth is the most common cause of neonatal morbidity and morta... more Evidence before this study Preterm birth is the most common cause of neonatal morbidity and mortality globally, and it is unclear if giving a progestogen during pregnancy to asymptomatic women at high risk of preterm birth reduces the risk of preterm birth. Previous reviews focused on a single form of progestogen in at-risk subpopulations, and no individual participant data (IPD) meta-analysis of 17-hydroxyprogesterone caproate (17-OHPC) in single gestation pregnancies had been done. We considered published and unpublished trials that completed primary data collection before July 31, 2016, (12 months before data collection began). We searched MEDLINE, Embase, CINAHL, the Maternity and Infant Care Database, and relevant trial registers, with a final search date of July 30, 2019. Trialists were invited to identify additional trials. Received IPD were checked thoroughly and risk of bias was assessed. Added value of this study We included participant-level data from 31 trials, including more than 11,000 women and 16,000 offspring, in the largest IPD meta-analysis of progestogens used to prevent preterm birth to date. Included trials were generally at low risk of bias. For the high-risk population included in trials of singleton pregnancies (predominantly participants with a previous spontaneous preterm birth or sonographic short cervix), analyses showed that both vaginal progesterone and 17-OHPC reduced the risk of preterm birth before 34 weeks compared with control. Evidence of benefit in reducing preterm birth before 34 weeks was more certain for vaginal progesterone, but there was no clear evidence that either vaginal progesterone or 17-OHPC was superior. A consistent direction of benefit was noted for other birth and neonatal outcomes, including preterm birth before 28 weeks, preterm birth before 37 weeks, perinatal mortality, and composite serious neonatal complications. We noted possible variations in the size of treatment effect by risk factor, but there was no conclusive evidence that the relative effect of treatment varied according to participant characteristics within our high-risk dataset. There was no evidence of benefit in unselected multifetal pregnancies, although our dataset included few women with both multifetal gestation and other risk factors, such as short cervix. Implications of all the available evidence Vaginal progesterone and 17-OHPC both reduced birth before 34 weeks in high-risk singleton pregnancies. Given increased underlying risk, absolute risk reduction is greater for women with a short cervix, hence treatment might be most useful for these women. Maternal complications were possibly increased with exposure, indicating a need for further study of safety. Additional evaluation of long-term infant outcomes is also required. Further investigation of women with a previous preterm birth and longer cervical length (>30 mm) might be required to substantiate that the risk-benefit ratio in this group is clinically favourable. Evidence for oral progesterone was insufficient to support clinical decision making. Shared decision making with women with a high-risk singleton pregnancy should discuss individual risk, potential benefits, harms, and practicalities of intervention. Treatment of unselected multifetal pregnancies with a progestogen is not supported by the evidence.

Research paper thumbnail of An evaluation of nutritional and vasoactive stimulants as risk factors for gastroschisis: a pilot study

The Journal of Maternal-Fetal & Neonatal Medicine, 2018

Objective: To evaluate poor maternal nutrition, environmental exposures and vasoactive stimulants... more Objective: To evaluate poor maternal nutrition, environmental exposures and vasoactive stimulants as potential risk factors for gastroschisis. Methods: A case-control study was conducted among singleton pregnancies diagnosed in a tertiary teaching hospital in a 22-month period. Cases of gastroschisis were matched to controls at the time of diagnosis by race and maternal age. Demographics, periconceptual exposures, nutritional biomarkers and illicit drug hair analysis were evaluated. Analyses were performed using conditional logistic regression. Results-Thirty gastroschisis cases and 76 controls were studied with no associations observed for illicit drug use or serum levels of ferritin, iron, B6, B12, folate or zinc. Neither prescription medication nor over the counter mediation use differed between cases and controls. Following adjustment for insurance, education, low BMI and nulliparity, mothers of gastroschisis cases had an increased odds of alcohol use one month prior and/or during early pregnancy compared to controls, with adjusted OR 3.19 (95% CI 1.01-11.61). Conclusions: Our findings suggest that further investigation of vasoactive stimulants such as alcohol is warranted in the search to identify risk factors for gastroschisis.

Research paper thumbnail of Vaginal progesterone vs intramuscular 17α‐hydroxyprogesterone caproate for prevention of recurrent spontaneous preterm birth in singleton gestations: systematic review and meta‐analysis of randomized controlled trials

Ultrasound in Obstetrics & Gynecology, 2017

ABSTRACTObjectiveRandomized controlled trials (RCTs) have recently compared intramuscular 17α‐hyd... more ABSTRACTObjectiveRandomized controlled trials (RCTs) have recently compared intramuscular 17α‐hydroxyprogesterone caproate (17‐OHPC) with vaginal progesterone for reducing the risk of spontaneous preterm birth (SPTB) in singleton gestations with prior SPTB. The aim of this systematic review and meta‐analysis was to evaluate the efficacy of vaginal progesterone compared with 17‐OHPC in prevention of SPTB in singleton gestations with prior SPTB.MethodsSearches of electronic databases were performed to identify all RCTs of asymptomatic singleton gestations with prior SPTB that were randomized to prophylactic treatment with either vaginal progesterone (intervention group) or intramuscular 17‐OHPC (comparison group). No restrictions for language or geographic location were applied. The primary outcome was SPTB < 34 weeks. Secondary outcomes were SPTB < 37 weeks, < 32 weeks, < 28 weeks and < 24 weeks, maternal adverse drug reaction and neonatal outcomes. The summary measure...

Research paper thumbnail of A randomized controlled trial of intramuscular versus vaginal progesterone for the prevention of recurrent preterm birth

International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics, Jan 18, 2016

To compare the efficacy of intramuscular hydroxyprogesterone caproate with that of vaginal proges... more To compare the efficacy of intramuscular hydroxyprogesterone caproate with that of vaginal progesterone for prevention of recurrent preterm birth. A prospective randomized controlled trial was conducted at a US tertiary care center between June 1, 2007, and April 30, 2010. Women with singleton pregnancies (16-20 weeks) and a history of spontaneous preterm birth were randomly allocated using a computer-generated randomization sequence to receive either a weekly intramuscular injection of hydroxyprogesterone caproate (250 mg) or a daily vaginal progesterone suppository (100 mg). Participants, investigators, and assessors were not masked to group assignment. The primary outcome was birth before 37 weeks of pregnancy. Per-protocol analyses were performed: participants who completed follow-up were included. Analyses included 66 women given intramuscular progesterone and 79 given vaginal progesterone. Delivery before 37 weeks was recorded among 29 (43.9%) women in the intramuscular proges...

Research paper thumbnail of Immediate Compared With Delayed Cord Clamping in the Preterm Neonate

Obstetrics & Gynecology, 2014

The comparative risks and benefits of early compared with delayed cord clamping in the preterm ne... more The comparative risks and benefits of early compared with delayed cord clamping in the preterm neonate remain unclear. Our objective was to evaluate the short-term effects of delayed clamping of the umbilical cord in preterm neonates. METHODS: We conducted a randomized controlled trial comparing immediate with delayed cord clamping among preterm neonates born between 24 and 34 weeks of gestation. The primary study outcome was the need for blood transfusion. To detect a 33% reduction in this outcome (from 65 to 43.5%) with a two-tailed a of 0.5 and b of 0.8 required 178 patients equally divided into two groups.

Research paper thumbnail of Unsuccessful trial of labor in women with and without previous cesarean delivery

Journal of Maternal-Fetal and Neonatal Medicine, 2010

To compare maternal and neonatal outcomes after unsuccessful labor in women with and those withou... more To compare maternal and neonatal outcomes after unsuccessful labor in women with and those without prior cesarean delivery. This was a retrospective cohort study of all women in labor delivered by cesarean section (CS) from November 2004 through December 2006. The study population was dichotomized by previous CS and compared for various maternal and neonatal outcomes. Student t-test, χ² and Fisher exact tests were used for analysis. There was a significantly higher rate of symptomatic uterine rupture [3/100 (3%) vs. 0/449 (0%), p = 0.006], asymptomatic uterine scar dehiscence [6/100 (6%) vs. 0/449 (0%), p = 0.0001], and bladder injury [2/100 (2%) vs. 0/100 (0%), p = 0.001], among women with prior cesarean delivery compared to those without. The rate of respiratory distress syndrome [(6/100) (6%) vs. 10/449 (2.2%), p = 0.05] and meconium aspiration [4/100 (4%) vs. 2/449 (0.4%), p = 0.01] was also significantly higher among neonates of women with prior cesarean delivery. However, the rate of endomyometritis [3/100 (3%) vs. 50/449 (11.1%), p = 0.009] and febrile morbidity [17/100 (17%) vs. 144/449 (32.1%), p = 0.003] was significantly lower among women with prior cesarean delivery compared to those without prior cesarean birth. Compared to laboring women without previous cesarean delivery, women with previous cesarean delivery have increased maternal and neonatal morbidity. Febrile morbidity was, however, lower among women with previous cesarean delivery. These differential findings should further inform our perinatal counseling of women contemplating trial of labor after a previous cesarean delivery.

Research paper thumbnail of A comparison of meningococcal carriage by pregnancy status

Journal of Negative Results in BioMedicine, 2010

Neisseria meningitidis is the second leading cause of invasive meningitis. A prerequisite for inf... more Neisseria meningitidis is the second leading cause of invasive meningitis. A prerequisite for infection is colonization of the nasopharynx, and asymptomatic carrier rates are widely reported in the range of 10-15%. Recent reports have indicated an increased likelihood that a pediatric admission for Neisseria meningitidis will have a mother who is pregnant in the home. We hypothesized that this association may relate to immunologic changes in pregnancy leading to higher carrier rates. We compared the carrier status by performing nasopharyngeal swabs for Neisseria meningitidis in 100 pregnant and 99 non-pregnant women. Average age of the participants was 28.9 +/-6.7 years. The average gestational age at specimen collection was 27.5 +/-9.4 weeks. Non pregnant women were significantly more likely to use tobacco (38% vs 24%, p < 0.0001). In the entire 199 patients, only one pregnant patient tested positive for Neisseria meningitidis (0.5%; 95% CI: 0.01%-2.8%). The meningococcal carrier rate in our population is well below what is widely reported in the literature. Assuming a 1% carrier rate in the pregnant group and a 0.5% carrier rate in the non pregnant group, 4,763 patients would be required to detect a difference of this magnitude, given 80% power and an alpha of 0.05.

Research paper thumbnail of 730: Doppler velocimetry: A comparison of the intrafetal to extrafetal segments of the umbilical artery(UA)

American Journal of Obstetrics and Gynecology, Dec 1, 2007

Insonation of the UA in the amniotic cavity can be challenging in multiple gestations and can be ... more Insonation of the UA in the amniotic cavity can be challenging in multiple gestations and can be influenced by the adjacent umbilical arterial and venous pulsations. Our objectives were to provide normal data for Doppler volicimetry in the intrafetal paravesical segment of the UA and compare doppler indices between the intrafetal paravesical segment with the extrafetal amniotic segment of the UA. STUDY DESIGN: Consecutive consenting women between 18 and 42 weeks of gestation were enrolled. Systolic/diastolic (S/D), resistive index (RI), pulsatility index (PI) were determined by sonographers insonating the UA at the two locations. The segment insonated first was alternated. RESULTS: The median, (10th,90th percentile) of the S/D of the intrafetal segment were significantly higher than the extrafetal segment [3.2(2.31,4.85) vs 2.7(2.10,3.93), Pϭ.0001]. The S/Ds in the intrafetal segment were higher than the extrafetal segment in 80.6% of instances. Similar results were obtained for RI and PI. CONCLUSION: Doppler indices are significantly higher in the intrafetal paravesical segment of the UA than in te extrafetal segment. Our normogram might be clinically useful when the extrafetal UA is difficult to insonate or when obtained indices might be unreliable.

Research paper thumbnail of Evaluating Progestogens for Preventing Preterm birth International Collaborative (EPPPIC): meta-analysis of individual participant data from randomised controlled trials

The Lancet, 2021

Evidence before this study Preterm birth is the most common cause of neonatal morbidity and morta... more Evidence before this study Preterm birth is the most common cause of neonatal morbidity and mortality globally, and it is unclear if giving a progestogen during pregnancy to asymptomatic women at high risk of preterm birth reduces the risk of preterm birth. Previous reviews focused on a single form of progestogen in at-risk subpopulations, and no individual participant data (IPD) meta-analysis of 17-hydroxyprogesterone caproate (17-OHPC) in single gestation pregnancies had been done. We considered published and unpublished trials that completed primary data collection before July 31, 2016, (12 months before data collection began). We searched MEDLINE, Embase, CINAHL, the Maternity and Infant Care Database, and relevant trial registers, with a final search date of July 30, 2019. Trialists were invited to identify additional trials. Received IPD were checked thoroughly and risk of bias was assessed. Added value of this study We included participant-level data from 31 trials, including more than 11,000 women and 16,000 offspring, in the largest IPD meta-analysis of progestogens used to prevent preterm birth to date. Included trials were generally at low risk of bias. For the high-risk population included in trials of singleton pregnancies (predominantly participants with a previous spontaneous preterm birth or sonographic short cervix), analyses showed that both vaginal progesterone and 17-OHPC reduced the risk of preterm birth before 34 weeks compared with control. Evidence of benefit in reducing preterm birth before 34 weeks was more certain for vaginal progesterone, but there was no clear evidence that either vaginal progesterone or 17-OHPC was superior. A consistent direction of benefit was noted for other birth and neonatal outcomes, including preterm birth before 28 weeks, preterm birth before 37 weeks, perinatal mortality, and composite serious neonatal complications. We noted possible variations in the size of treatment effect by risk factor, but there was no conclusive evidence that the relative effect of treatment varied according to participant characteristics within our high-risk dataset. There was no evidence of benefit in unselected multifetal pregnancies, although our dataset included few women with both multifetal gestation and other risk factors, such as short cervix. Implications of all the available evidence Vaginal progesterone and 17-OHPC both reduced birth before 34 weeks in high-risk singleton pregnancies. Given increased underlying risk, absolute risk reduction is greater for women with a short cervix, hence treatment might be most useful for these women. Maternal complications were possibly increased with exposure, indicating a need for further study of safety. Additional evaluation of long-term infant outcomes is also required. Further investigation of women with a previous preterm birth and longer cervical length (>30 mm) might be required to substantiate that the risk-benefit ratio in this group is clinically favourable. Evidence for oral progesterone was insufficient to support clinical decision making. Shared decision making with women with a high-risk singleton pregnancy should discuss individual risk, potential benefits, harms, and practicalities of intervention. Treatment of unselected multifetal pregnancies with a progestogen is not supported by the evidence.

Research paper thumbnail of An evaluation of nutritional and vasoactive stimulants as risk factors for gastroschisis: a pilot study

The Journal of Maternal-Fetal & Neonatal Medicine, 2018

Objective: To evaluate poor maternal nutrition, environmental exposures and vasoactive stimulants... more Objective: To evaluate poor maternal nutrition, environmental exposures and vasoactive stimulants as potential risk factors for gastroschisis. Methods: A case-control study was conducted among singleton pregnancies diagnosed in a tertiary teaching hospital in a 22-month period. Cases of gastroschisis were matched to controls at the time of diagnosis by race and maternal age. Demographics, periconceptual exposures, nutritional biomarkers and illicit drug hair analysis were evaluated. Analyses were performed using conditional logistic regression. Results-Thirty gastroschisis cases and 76 controls were studied with no associations observed for illicit drug use or serum levels of ferritin, iron, B6, B12, folate or zinc. Neither prescription medication nor over the counter mediation use differed between cases and controls. Following adjustment for insurance, education, low BMI and nulliparity, mothers of gastroschisis cases had an increased odds of alcohol use one month prior and/or during early pregnancy compared to controls, with adjusted OR 3.19 (95% CI 1.01-11.61). Conclusions: Our findings suggest that further investigation of vasoactive stimulants such as alcohol is warranted in the search to identify risk factors for gastroschisis.

Research paper thumbnail of Vaginal progesterone vs intramuscular 17α‐hydroxyprogesterone caproate for prevention of recurrent spontaneous preterm birth in singleton gestations: systematic review and meta‐analysis of randomized controlled trials

Ultrasound in Obstetrics & Gynecology, 2017

ABSTRACTObjectiveRandomized controlled trials (RCTs) have recently compared intramuscular 17α‐hyd... more ABSTRACTObjectiveRandomized controlled trials (RCTs) have recently compared intramuscular 17α‐hydroxyprogesterone caproate (17‐OHPC) with vaginal progesterone for reducing the risk of spontaneous preterm birth (SPTB) in singleton gestations with prior SPTB. The aim of this systematic review and meta‐analysis was to evaluate the efficacy of vaginal progesterone compared with 17‐OHPC in prevention of SPTB in singleton gestations with prior SPTB.MethodsSearches of electronic databases were performed to identify all RCTs of asymptomatic singleton gestations with prior SPTB that were randomized to prophylactic treatment with either vaginal progesterone (intervention group) or intramuscular 17‐OHPC (comparison group). No restrictions for language or geographic location were applied. The primary outcome was SPTB < 34 weeks. Secondary outcomes were SPTB < 37 weeks, < 32 weeks, < 28 weeks and < 24 weeks, maternal adverse drug reaction and neonatal outcomes. The summary measure...

Research paper thumbnail of A randomized controlled trial of intramuscular versus vaginal progesterone for the prevention of recurrent preterm birth

International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics, Jan 18, 2016

To compare the efficacy of intramuscular hydroxyprogesterone caproate with that of vaginal proges... more To compare the efficacy of intramuscular hydroxyprogesterone caproate with that of vaginal progesterone for prevention of recurrent preterm birth. A prospective randomized controlled trial was conducted at a US tertiary care center between June 1, 2007, and April 30, 2010. Women with singleton pregnancies (16-20 weeks) and a history of spontaneous preterm birth were randomly allocated using a computer-generated randomization sequence to receive either a weekly intramuscular injection of hydroxyprogesterone caproate (250 mg) or a daily vaginal progesterone suppository (100 mg). Participants, investigators, and assessors were not masked to group assignment. The primary outcome was birth before 37 weeks of pregnancy. Per-protocol analyses were performed: participants who completed follow-up were included. Analyses included 66 women given intramuscular progesterone and 79 given vaginal progesterone. Delivery before 37 weeks was recorded among 29 (43.9%) women in the intramuscular proges...

Research paper thumbnail of Immediate Compared With Delayed Cord Clamping in the Preterm Neonate

Obstetrics & Gynecology, 2014

The comparative risks and benefits of early compared with delayed cord clamping in the preterm ne... more The comparative risks and benefits of early compared with delayed cord clamping in the preterm neonate remain unclear. Our objective was to evaluate the short-term effects of delayed clamping of the umbilical cord in preterm neonates. METHODS: We conducted a randomized controlled trial comparing immediate with delayed cord clamping among preterm neonates born between 24 and 34 weeks of gestation. The primary study outcome was the need for blood transfusion. To detect a 33% reduction in this outcome (from 65 to 43.5%) with a two-tailed a of 0.5 and b of 0.8 required 178 patients equally divided into two groups.

Research paper thumbnail of Unsuccessful trial of labor in women with and without previous cesarean delivery

Journal of Maternal-Fetal and Neonatal Medicine, 2010

To compare maternal and neonatal outcomes after unsuccessful labor in women with and those withou... more To compare maternal and neonatal outcomes after unsuccessful labor in women with and those without prior cesarean delivery. This was a retrospective cohort study of all women in labor delivered by cesarean section (CS) from November 2004 through December 2006. The study population was dichotomized by previous CS and compared for various maternal and neonatal outcomes. Student t-test, χ² and Fisher exact tests were used for analysis. There was a significantly higher rate of symptomatic uterine rupture [3/100 (3%) vs. 0/449 (0%), p = 0.006], asymptomatic uterine scar dehiscence [6/100 (6%) vs. 0/449 (0%), p = 0.0001], and bladder injury [2/100 (2%) vs. 0/100 (0%), p = 0.001], among women with prior cesarean delivery compared to those without. The rate of respiratory distress syndrome [(6/100) (6%) vs. 10/449 (2.2%), p = 0.05] and meconium aspiration [4/100 (4%) vs. 2/449 (0.4%), p = 0.01] was also significantly higher among neonates of women with prior cesarean delivery. However, the rate of endomyometritis [3/100 (3%) vs. 50/449 (11.1%), p = 0.009] and febrile morbidity [17/100 (17%) vs. 144/449 (32.1%), p = 0.003] was significantly lower among women with prior cesarean delivery compared to those without prior cesarean birth. Compared to laboring women without previous cesarean delivery, women with previous cesarean delivery have increased maternal and neonatal morbidity. Febrile morbidity was, however, lower among women with previous cesarean delivery. These differential findings should further inform our perinatal counseling of women contemplating trial of labor after a previous cesarean delivery.

Research paper thumbnail of A comparison of meningococcal carriage by pregnancy status

Journal of Negative Results in BioMedicine, 2010

Neisseria meningitidis is the second leading cause of invasive meningitis. A prerequisite for inf... more Neisseria meningitidis is the second leading cause of invasive meningitis. A prerequisite for infection is colonization of the nasopharynx, and asymptomatic carrier rates are widely reported in the range of 10-15%. Recent reports have indicated an increased likelihood that a pediatric admission for Neisseria meningitidis will have a mother who is pregnant in the home. We hypothesized that this association may relate to immunologic changes in pregnancy leading to higher carrier rates. We compared the carrier status by performing nasopharyngeal swabs for Neisseria meningitidis in 100 pregnant and 99 non-pregnant women. Average age of the participants was 28.9 +/-6.7 years. The average gestational age at specimen collection was 27.5 +/-9.4 weeks. Non pregnant women were significantly more likely to use tobacco (38% vs 24%, p < 0.0001). In the entire 199 patients, only one pregnant patient tested positive for Neisseria meningitidis (0.5%; 95% CI: 0.01%-2.8%). The meningococcal carrier rate in our population is well below what is widely reported in the literature. Assuming a 1% carrier rate in the pregnant group and a 0.5% carrier rate in the non pregnant group, 4,763 patients would be required to detect a difference of this magnitude, given 80% power and an alpha of 0.05.

Research paper thumbnail of Evaluation of outcomes after transabdominal cervicoisthmic cerclage

Archives of Gynecology and Obstetrics, 2009

Purpose To evaluate maternal and neonatal outcomes after transabdominal cerclage. Methods Retrosp... more Purpose To evaluate maternal and neonatal outcomes after transabdominal cerclage. Methods Retrospective analysis of 15 patients receiving transabdominal cerclage. Using the patient's prior pregnancy as her own control, we assessed the eVect of this procedure on gestational age and neonatal survival. Results All patients had experienced a prior pregnancy loss. Twelve out of the 15 patients (80%) had at least one prior failed vaginal cerclage. The median gestational age at surgery was 14 (range 12-16) weeks. There was one case of surgical site infection. After cerclage, the proportion of women delivered beyond 32 weeks was signiWcantly higher [11/15 (73.3%) vs. 1/15 (6.7%), P = 0.0016], as was neonatal survival [12/15 (80%) vs. 1/15 (6.7%), P = 0.0009]. Conclusions While transabdominal cerclage is a major surgical procedure, subsequent pregnancy outcomes were improved.

Research paper thumbnail of 35: A randomized controlled trial of immediate versus delayed cord clamping in the preterm neonate

American Journal of Obstetrics and Gynecology, 2013

ration, necrotizing enterocolitis, respiratory distress syndrome or intraventricular hemorrhage) ... more ration, necrotizing enterocolitis, respiratory distress syndrome or intraventricular hemorrhage) were collected using the fetuses-at-risk approach. A moving average (death at specific day ϩ deaths of day before and day after/3) was applied to correct for daily fluctuations. RESULTS: The final study population comprised 985.321 deliveries in Caucasians (89.2%), 94.664 in Mediterraneans (8.6%) and 24.879 deliveries in Africans (2.3%). For Caucasian and Mediterranean women the period of delivery associated with the lowest cumulative risk of perinatal death was between 39ϩ0 and 39ϩ6 weeks. For African women this nadir appears to start earlier around 38ϩ2 weeks. The risk of antenatal stillbirth rises after 39ϩ6 weeks in Mediterranean compared to Caucasian women. Remarkably, neonatal morbidity is increased along all weeks of gestation in African women when compared to the other ethnicities (Figure). CONCLUSION: The nadir of perinatal death in Caucasian and Mediterranean pregnancies is at 39 weeks, for African women already around 38 weeks. The risk of neonatal morbidity is highest in African women regardless of week of gestation. Ethnicity of the mother should be taken into account when making decisions about intervening in a pregnancy or to wait.

Research paper thumbnail of 683: Local anesthesia and pain perception during amniocentesis: a randomized placebo-controlled trial

American Journal of Obstetrics and Gynecology, 2013

did not differ much. The association between the elevated CPP and obesity remained significant af... more did not differ much. The association between the elevated CPP and obesity remained significant after controlling for confounders such as maternal age. CONCLUSION: Maternal obesity is associated with increased cerebral perfusion pressure. The emerging obesity epidemic, coupled with associated increased risk for perinatal complications make this an important finding and underscore the need for further research.

Research paper thumbnail of The effect of digital cervical examination on group B streptococcal culture

American Journal of Obstetrics and Gynecology, 2010

We sought to evaluate whether group B streptococcus (GBS) detection is altered by the digital cer... more We sought to evaluate whether group B streptococcus (GBS) detection is altered by the digital cervical examination. STUDY DESIGN: A total of 302 women undergoing the clinical GBS culture had a digital cervical examination and a repeated GBS culture. Statistical comparison of pre-post culture results were performed with kappa and McNemar tests. RESULTS: The clinical prevalence of GBS was 19.5%. Discordant results were seen in 30/302 (9.9%) paired cultures (ϭ 0.68; 95% confidence interval, 0.568-0.783). An initially negative GBS culture result was positive on repeated testing in 13/243 (5.3%) pairs. Initially positive cultures were negative on repeated testing in 17/59 (28.8%) pairs. Patients with discordant results had similar characteristics as the remainder of the study group. Given the observed proportion of discordant results (9.9%), the study had 80% power to detect a 5% difference between discordant pairs. CONCLUSION: Paired GBS cultures showed a good level of agreement. The 28.8% rate of positive cultures becoming negative is clinically concerning and warrants further study.

Research paper thumbnail of 730: Doppler velocimetry: A comparison of the intrafetal to extrafetal segments of the umbilical artery(UA)

American Journal of Obstetrics and Gynecology, Dec 1, 2007

Insonation of the UA in the amniotic cavity can be challenging in multiple gestations and can be ... more Insonation of the UA in the amniotic cavity can be challenging in multiple gestations and can be influenced by the adjacent umbilical arterial and venous pulsations. Our objectives were to provide normal data for Doppler volicimetry in the intrafetal paravesical segment of the UA and compare doppler indices between the intrafetal paravesical segment with the extrafetal amniotic segment of the UA. STUDY DESIGN: Consecutive consenting women between 18 and 42 weeks of gestation were enrolled. Systolic/diastolic (S/D), resistive index (RI), pulsatility index (PI) were determined by sonographers insonating the UA at the two locations. The segment insonated first was alternated. RESULTS: The median, (10th,90th percentile) of the S/D of the intrafetal segment were significantly higher than the extrafetal segment [3.2(2.31,4.85) vs 2.7(2.10,3.93), Pϭ.0001]. The S/Ds in the intrafetal segment were higher than the extrafetal segment in 80.6% of instances. Similar results were obtained for RI and PI. CONCLUSION: Doppler indices are significantly higher in the intrafetal paravesical segment of the UA than in te extrafetal segment. Our normogram might be clinically useful when the extrafetal UA is difficult to insonate or when obtained indices might be unreliable.

Research paper thumbnail of Evaluating Progestogens for Preventing Preterm birth International Collaborative (EPPPIC): meta-analysis of individual participant data from randomised controlled trials

The Lancet, 2021

Evidence before this study Preterm birth is the most common cause of neonatal morbidity and morta... more Evidence before this study Preterm birth is the most common cause of neonatal morbidity and mortality globally, and it is unclear if giving a progestogen during pregnancy to asymptomatic women at high risk of preterm birth reduces the risk of preterm birth. Previous reviews focused on a single form of progestogen in at-risk subpopulations, and no individual participant data (IPD) meta-analysis of 17-hydroxyprogesterone caproate (17-OHPC) in single gestation pregnancies had been done. We considered published and unpublished trials that completed primary data collection before July 31, 2016, (12 months before data collection began). We searched MEDLINE, Embase, CINAHL, the Maternity and Infant Care Database, and relevant trial registers, with a final search date of July 30, 2019. Trialists were invited to identify additional trials. Received IPD were checked thoroughly and risk of bias was assessed. Added value of this study We included participant-level data from 31 trials, including more than 11,000 women and 16,000 offspring, in the largest IPD meta-analysis of progestogens used to prevent preterm birth to date. Included trials were generally at low risk of bias. For the high-risk population included in trials of singleton pregnancies (predominantly participants with a previous spontaneous preterm birth or sonographic short cervix), analyses showed that both vaginal progesterone and 17-OHPC reduced the risk of preterm birth before 34 weeks compared with control. Evidence of benefit in reducing preterm birth before 34 weeks was more certain for vaginal progesterone, but there was no clear evidence that either vaginal progesterone or 17-OHPC was superior. A consistent direction of benefit was noted for other birth and neonatal outcomes, including preterm birth before 28 weeks, preterm birth before 37 weeks, perinatal mortality, and composite serious neonatal complications. We noted possible variations in the size of treatment effect by risk factor, but there was no conclusive evidence that the relative effect of treatment varied according to participant characteristics within our high-risk dataset. There was no evidence of benefit in unselected multifetal pregnancies, although our dataset included few women with both multifetal gestation and other risk factors, such as short cervix. Implications of all the available evidence Vaginal progesterone and 17-OHPC both reduced birth before 34 weeks in high-risk singleton pregnancies. Given increased underlying risk, absolute risk reduction is greater for women with a short cervix, hence treatment might be most useful for these women. Maternal complications were possibly increased with exposure, indicating a need for further study of safety. Additional evaluation of long-term infant outcomes is also required. Further investigation of women with a previous preterm birth and longer cervical length (>30 mm) might be required to substantiate that the risk-benefit ratio in this group is clinically favourable. Evidence for oral progesterone was insufficient to support clinical decision making. Shared decision making with women with a high-risk singleton pregnancy should discuss individual risk, potential benefits, harms, and practicalities of intervention. Treatment of unselected multifetal pregnancies with a progestogen is not supported by the evidence.

Research paper thumbnail of An evaluation of nutritional and vasoactive stimulants as risk factors for gastroschisis: a pilot study

The Journal of Maternal-Fetal & Neonatal Medicine, 2018

Objective: To evaluate poor maternal nutrition, environmental exposures and vasoactive stimulants... more Objective: To evaluate poor maternal nutrition, environmental exposures and vasoactive stimulants as potential risk factors for gastroschisis. Methods: A case-control study was conducted among singleton pregnancies diagnosed in a tertiary teaching hospital in a 22-month period. Cases of gastroschisis were matched to controls at the time of diagnosis by race and maternal age. Demographics, periconceptual exposures, nutritional biomarkers and illicit drug hair analysis were evaluated. Analyses were performed using conditional logistic regression. Results-Thirty gastroschisis cases and 76 controls were studied with no associations observed for illicit drug use or serum levels of ferritin, iron, B6, B12, folate or zinc. Neither prescription medication nor over the counter mediation use differed between cases and controls. Following adjustment for insurance, education, low BMI and nulliparity, mothers of gastroschisis cases had an increased odds of alcohol use one month prior and/or during early pregnancy compared to controls, with adjusted OR 3.19 (95% CI 1.01-11.61). Conclusions: Our findings suggest that further investigation of vasoactive stimulants such as alcohol is warranted in the search to identify risk factors for gastroschisis.

Research paper thumbnail of Vaginal progesterone vs intramuscular 17α‐hydroxyprogesterone caproate for prevention of recurrent spontaneous preterm birth in singleton gestations: systematic review and meta‐analysis of randomized controlled trials

Ultrasound in Obstetrics & Gynecology, 2017

ABSTRACTObjectiveRandomized controlled trials (RCTs) have recently compared intramuscular 17α‐hyd... more ABSTRACTObjectiveRandomized controlled trials (RCTs) have recently compared intramuscular 17α‐hydroxyprogesterone caproate (17‐OHPC) with vaginal progesterone for reducing the risk of spontaneous preterm birth (SPTB) in singleton gestations with prior SPTB. The aim of this systematic review and meta‐analysis was to evaluate the efficacy of vaginal progesterone compared with 17‐OHPC in prevention of SPTB in singleton gestations with prior SPTB.MethodsSearches of electronic databases were performed to identify all RCTs of asymptomatic singleton gestations with prior SPTB that were randomized to prophylactic treatment with either vaginal progesterone (intervention group) or intramuscular 17‐OHPC (comparison group). No restrictions for language or geographic location were applied. The primary outcome was SPTB < 34 weeks. Secondary outcomes were SPTB < 37 weeks, < 32 weeks, < 28 weeks and < 24 weeks, maternal adverse drug reaction and neonatal outcomes. The summary measure...

Research paper thumbnail of A randomized controlled trial of intramuscular versus vaginal progesterone for the prevention of recurrent preterm birth

International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics, Jan 18, 2016

To compare the efficacy of intramuscular hydroxyprogesterone caproate with that of vaginal proges... more To compare the efficacy of intramuscular hydroxyprogesterone caproate with that of vaginal progesterone for prevention of recurrent preterm birth. A prospective randomized controlled trial was conducted at a US tertiary care center between June 1, 2007, and April 30, 2010. Women with singleton pregnancies (16-20 weeks) and a history of spontaneous preterm birth were randomly allocated using a computer-generated randomization sequence to receive either a weekly intramuscular injection of hydroxyprogesterone caproate (250 mg) or a daily vaginal progesterone suppository (100 mg). Participants, investigators, and assessors were not masked to group assignment. The primary outcome was birth before 37 weeks of pregnancy. Per-protocol analyses were performed: participants who completed follow-up were included. Analyses included 66 women given intramuscular progesterone and 79 given vaginal progesterone. Delivery before 37 weeks was recorded among 29 (43.9%) women in the intramuscular proges...

Research paper thumbnail of Immediate Compared With Delayed Cord Clamping in the Preterm Neonate

Obstetrics & Gynecology, 2014

The comparative risks and benefits of early compared with delayed cord clamping in the preterm ne... more The comparative risks and benefits of early compared with delayed cord clamping in the preterm neonate remain unclear. Our objective was to evaluate the short-term effects of delayed clamping of the umbilical cord in preterm neonates. METHODS: We conducted a randomized controlled trial comparing immediate with delayed cord clamping among preterm neonates born between 24 and 34 weeks of gestation. The primary study outcome was the need for blood transfusion. To detect a 33% reduction in this outcome (from 65 to 43.5%) with a two-tailed a of 0.5 and b of 0.8 required 178 patients equally divided into two groups.

Research paper thumbnail of Unsuccessful trial of labor in women with and without previous cesarean delivery

Journal of Maternal-Fetal and Neonatal Medicine, 2010

To compare maternal and neonatal outcomes after unsuccessful labor in women with and those withou... more To compare maternal and neonatal outcomes after unsuccessful labor in women with and those without prior cesarean delivery. This was a retrospective cohort study of all women in labor delivered by cesarean section (CS) from November 2004 through December 2006. The study population was dichotomized by previous CS and compared for various maternal and neonatal outcomes. Student t-test, χ² and Fisher exact tests were used for analysis. There was a significantly higher rate of symptomatic uterine rupture [3/100 (3%) vs. 0/449 (0%), p = 0.006], asymptomatic uterine scar dehiscence [6/100 (6%) vs. 0/449 (0%), p = 0.0001], and bladder injury [2/100 (2%) vs. 0/100 (0%), p = 0.001], among women with prior cesarean delivery compared to those without. The rate of respiratory distress syndrome [(6/100) (6%) vs. 10/449 (2.2%), p = 0.05] and meconium aspiration [4/100 (4%) vs. 2/449 (0.4%), p = 0.01] was also significantly higher among neonates of women with prior cesarean delivery. However, the rate of endomyometritis [3/100 (3%) vs. 50/449 (11.1%), p = 0.009] and febrile morbidity [17/100 (17%) vs. 144/449 (32.1%), p = 0.003] was significantly lower among women with prior cesarean delivery compared to those without prior cesarean birth. Compared to laboring women without previous cesarean delivery, women with previous cesarean delivery have increased maternal and neonatal morbidity. Febrile morbidity was, however, lower among women with previous cesarean delivery. These differential findings should further inform our perinatal counseling of women contemplating trial of labor after a previous cesarean delivery.

Research paper thumbnail of A comparison of meningococcal carriage by pregnancy status

Journal of Negative Results in BioMedicine, 2010

Neisseria meningitidis is the second leading cause of invasive meningitis. A prerequisite for inf... more Neisseria meningitidis is the second leading cause of invasive meningitis. A prerequisite for infection is colonization of the nasopharynx, and asymptomatic carrier rates are widely reported in the range of 10-15%. Recent reports have indicated an increased likelihood that a pediatric admission for Neisseria meningitidis will have a mother who is pregnant in the home. We hypothesized that this association may relate to immunologic changes in pregnancy leading to higher carrier rates. We compared the carrier status by performing nasopharyngeal swabs for Neisseria meningitidis in 100 pregnant and 99 non-pregnant women. Average age of the participants was 28.9 +/-6.7 years. The average gestational age at specimen collection was 27.5 +/-9.4 weeks. Non pregnant women were significantly more likely to use tobacco (38% vs 24%, p < 0.0001). In the entire 199 patients, only one pregnant patient tested positive for Neisseria meningitidis (0.5%; 95% CI: 0.01%-2.8%). The meningococcal carrier rate in our population is well below what is widely reported in the literature. Assuming a 1% carrier rate in the pregnant group and a 0.5% carrier rate in the non pregnant group, 4,763 patients would be required to detect a difference of this magnitude, given 80% power and an alpha of 0.05.