Jim Thornton | University of Nottingham (original) (raw)
Papers by Jim Thornton
BMJ (Clinical research ed.), Feb 1, 2018
/Uncertainties-UDCA-in-ICP-revised-prefinalpending-author-queries%20clean%20LCC2%20JGT%20JC%20CW.pdf
BJOG: An International Journal of Obstetrics & Gynaecology, 2017
Changes in anti-m€ ullerian hormone levels as a biomarker for ovarian reserve after ultrasound-gu... more Changes in anti-m€ ullerian hormone levels as a biomarker for ovarian reserve after ultrasound-guided high-intensity focused ultrasound treatment of adenomyosis and uterine fibroid. BJOG 2017;124(Suppl 3):18-22. 4 Lee JS, Hong GY, Park BJ, Kim TE. Ultrasoundguided high-intensity focused ultrasound treatment for uterine fibroid and adenomyosis: a single center experience from the Republic of Korea. Ultrasonics Sonochem 2015;27: 682-7.
BMJ open, Jan 23, 2017
To identify and prioritise important research questions for miscarriage. A priority setting partn... more To identify and prioritise important research questions for miscarriage. A priority setting partnership using prospective surveys and consensus meetings following methods advocated by the James Lind Alliance. UK. Women and those affected by miscarriage working alongside healthcare professionals. In the initial survey, 1093 participants (932 women who have experienced miscarriage, 8 partners, 17 family members, friends or colleagues, 104 healthcare professionals and eight charitable organisations) submitted 3279 questions. A review of existing literature identified a further 64. Non-questions were removed, and the remaining questions were categorised and summarised into 58 questions. In an interim electronic survey, 2122 respondents chose their top 10 priorities from the 58 summary questions. The 25 highest ranked in the survey were prioritised at a final face-to-face workshop. In summary, the top 10 priorities were ranked as follows: research into preventative treatment, emotional a...
Evidence-based medicine, Jan 23, 2017
Context Mothers with big babies tend to have longer labours and more difficult births. They may r... more Context Mothers with big babies tend to have longer labours and more difficult births. They may require caesarean section, or instrumental vaginal delivery. They may also sustain perineal injury or more seriously the head may deliver and the shoulders get stuck, so called shoulder dystocia. This severe complication may cause birth injury, including brachial plexus injury (2-16%) which may be permanent and disabling. Finally the baby may suffer bony fractures or birth asphyxia with risk of neurological damage or death. Obstetricians have wondered whether inducing labour early might make birth easier and reduce injury, but have been cautious to implement this policy due to concerns that induced labour may be longer or increase caesareans, and because the diagnosis of macrosomia, even using ultrasound scan is notoriously inaccurate. Methods
European Journal of Obstetrics & Gynecology and Reproductive Biology, 2016
To compare women's views about blood pressure (BP) control in CHIPS (Control of Hypertension In P... more To compare women's views about blood pressure (BP) control in CHIPS (Control of Hypertension In Pregnancy Study) (NCT01192412). Design: Quantitative and qualitative analysis of questionnaire responses. Setting: International randomised trial (94 sites, 15 countries). Population/sample: 911 (92.9%) women randomised to 'tight' (target diastolic blood pressure, 85 mmHg) or 'less tight' (target diastolic blood pressure, 100 mmHg) who completed questionnaires. Methods: A questionnaire was administered at $6-12 weeks postpartum regarding post-discharge morbidity and views about trial participation. Questionnaires were administered by the site coordinator, and contact was made by phone, home or clinic visit; rarely, data was collected from medical records. Quantitative analyses were Chi-square or Fisher's exact test for categorical variables, mixed effects multinomial logistic regression to adjust for confounders, and p < 0.001 for statistical significance. NVivo software was used for thematic analysis of women's views. Main outcome measures: Satisfaction, measured as willingness to have the same treatment in another pregnancy or recommend that treatment to a friend. Results: Among the 533 women in 'tight' (N = 265) vs. 'less tight' (N = 268) control who provided comments for qualitative analysis, women in 'tight' (vs. 'less tight') control made fewer positive comments about the amount of medication taken (5 vs. 28 women, respectively) and intensity of BP monitoring (7 vs. 17, respectively). However, this did not translate into less willingness to either have the same treatment in another pregnancy (434, 95.8% vs. 423, 92.4%, respectively; p = 0.14) or recommend that treatment to a friend (435, 96.0% and 428, 93.4%, respectively; p = 0.17). Importantly, although
BJOG : an international journal of obstetrics and gynaecology, 2016
Access to and use of the material held within the University of Nottingham's Institutional Reposi... more Access to and use of the material held within the University of Nottingham's Institutional Repository (the Repository) is based on your acceptance of the following terms and conditions:
Hypertension (Dallas, Tex. : 1979), Nov 12, 2016
To determine whether clinical outcomes differed by occurrence of severe hypertension in the inter... more To determine whether clinical outcomes differed by occurrence of severe hypertension in the international CHIPS trial (Control of Hypertension in Pregnancy Study), adjusting for the interventions of "less tight" (target diastolic blood pressure [dBP] 100 mm Hg) versus "tight" control (target dBP 85 mm Hg). In this post-hoc analysis of CHIPS data from 987 women with nonsevere nonproteinuric preexisting or gestational hypertension, mixed effects logistic regression was used to compare the following outcomes according to occurrence of severe hypertension, adjusting for allocated group and the influence of baseline factors: CHIPS primary (perinatal loss or high-level neonatal care for >48 hours) and secondary outcomes (serious maternal complications), birth weight <10th percentile, preeclampsia, delivery at <34 or <37 weeks, platelets <100×10(9)/L, elevated liver enzymes with symptoms, maternal length of stay ≥10 days, and maternal readmission before 6...
Hypertension (Dallas, Tex. : 1979), Oct 22, 2016
The CHIPS randomized controlled trial (Control of Hypertension in Pregnancy Study) found no diffe... more The CHIPS randomized controlled trial (Control of Hypertension in Pregnancy Study) found no difference in the primary perinatal or secondary maternal outcomes between planned "less tight" (target diastolic 100 mm Hg) and "tight" (target diastolic 85 mm Hg) blood pressure management strategies among women with chronic or gestational hypertension. This study examined which of these management strategies is more or less costly from a third-party payer perspective. A total of 981 women with singleton pregnancies and nonsevere, nonproteinuric chronic or gestational hypertension were randomized at 14 to 33 weeks to less tight or tight control. Resources used were collected from 94 centers in 15 countries and costed as if the trial took place in each of 3 Canadian provinces as a cost-sensitivity analysis. Eleven hospital ward and 24 health service costs were obtained from a similar trial and provincial government health insurance schedules of medical benefits. The mean ...
Obstetrics and gynecology, 1996
To obtain estimates of the effects of amniotomy on the risk of cesarean delivery and on other ind... more To obtain estimates of the effects of amniotomy on the risk of cesarean delivery and on other indicators of maternal and neonatal morbidity (Apgar score less than 7 at 5 minutes, admission to neonatal intensive care unit [NICU]). Published studies were identified through manual and computerized searches using Medline and the Cochrane Collaboration Pregnancy and Childbirth Database. Our search identified ten trials, all published in peer-reviewed journals. Trials were assigned a methodological quality score based on a standardized rating system. Three trials were excluded from the analysis for methodological limitations. Data were abstracted by two trained reviewers. Typical odds ratios (OR) were calculated. Amniotomy was associated with a reduction in labor duration varying from 0.8-2.3 hours. There was a nonstatistically significant increase in the risk of cesarean delivery; OR 1.2, 95% confidence interval (CI) 0.9-1.6. The risk of a 5-minute Apgar score less than 7 was reduced in ...
The Cochrane database of systematic reviews, Jan 30, 2014
Endometrial polyps, which are benign growths of the endometrium, may be a factor in female subfer... more Endometrial polyps, which are benign growths of the endometrium, may be a factor in female subfertility. Possible mechanisms include physical interference with gamete transport, alteration of the endometrial milieu and unresponsiveness to the cyclical global endometrial changes. As such polyps remain mostly asymptomatic, their diagnosis is often incidental during routine investigations prior to embarking on assisted reproductive treatment. Transvaginal sonography, hysterosalpingography and saline infusion sonography are the diagnostic tools most commonly employed. However, hysteroscopy remains the gold standard for diagnosis, as well as for treatment. Due to the possible effect of endometrial polyps on fertility, their removal prior to any subfertility treatment is widely practiced. To determine the effectiveness and safety of removal of endometrial polyps in subfertile women. Electronic databases were searched, including the Cochrane Menstrual Disorders and Subfertility Group Speci...
Protocols, 2014
Analysis 1.2. Comparison 1 Test of placental function versus standard care, Outcome 2 Small-for-g... more Analysis 1.2. Comparison 1 Test of placental function versus standard care, Outcome 2 Small-for-gestational age (below 10th centile on customised birthweight chart or as defined by trialists
New England Journal of Medicine, 2015
BACKGROUND The effects of less-tight versus tight control of hypertension on pregnancy complicati... more BACKGROUND The effects of less-tight versus tight control of hypertension on pregnancy complications are unclear. METHODS We performed an open, international, multicenter trial involving women at 14 weeks 0 days to 33 weeks 6 days of gestation who had nonproteinuric preexisting or gestational hypertension, office diastolic blood pressure of 90 to 105 mm Hg (or 85 to 105 mm Hg if the woman was taking antihypertensive medications), and a live fetus. Women were randomly assigned to less-tight control (target diastolic blood pressure, 100 mm Hg) or tight control (target diastolic blood pressure, 85 mm Hg). The composite primary outcome was pregnancy loss or high-level neonatal care for more than 48 hours during the first 28 postnatal days. The secondary outcome was serious maternal complications occurring up to 6 weeks post partum or until hospital discharge, whichever was later. RESULTS Included in the analysis were 987 women; 74.6% had preexisting hypertension. The primary-outcome rates were similar among 493 women assigned to less-tight control and 488 women assigned to tight control (31.4% and 30.7%, respectively; adjusted odds ratio, 1.02; 95% confidence interval [CI], 0.77 to 1.35), as were the rates of serious maternal complications (3.7% and 2.0%, respectively; adjusted odds ratio, 1.74; 95% CI, 0.79 to 3.84), despite a mean diastolic blood pressure that was higher in the less-tight-control group by 4.6 mm Hg (95% CI, 3.7 to 5.4). Severe hypertension (≥160/110 mm Hg) developed in 40.6% of the women in the less-tight-control group and 27.5% of the women in the tight-control group (P<0.001). CONCLUSIONS We found no significant between-group differences in the risk of pregnancy loss, high-level neonatal care, or overall maternal complications, although less-tight control was associated with a significantly higher frequency of severe maternal hypertension. (Funded by the Canadian Institutes of Health Research; CHIPS Current Controlled Trials number, ISRCTN71416914; ClinicalTrials.gov number, NCT01192412.
Analysis 1.21. Comparison 1 Interventionist care versus expectant (delayed delivery) care for sev... more Analysis 1.21. Comparison 1 Interventionist care versus expectant (delayed delivery) care for severe pre-eclampsia, Outcome
Health Technology Assessment, 2014
BackgroundSmoking during pregnancy causes many adverse pregnancy and birth outcomes. Nicotine rep... more BackgroundSmoking during pregnancy causes many adverse pregnancy and birth outcomes. Nicotine replacement therapy (NRT) is effective for cessation outside pregnancy but efficacy and safety in pregnancy are unknown. We hypothesised that NRT would increase smoking cessation in pregnancy without adversely affecting infants.ObjectivesTo compare (1) at delivery, the clinical effectiveness and cost-effectiveness for achieving biochemically validated smoking cessation of NRT patches with placebo patches in pregnancy and (2) in infants at 2 years of age, the effects of maternal NRT patch use with placebo patch use in pregnancy on behaviour, development and disability.DesignRandomised, placebo-controlled, parallel-group trial and economic evaluation with follow-up at 4 weeks after randomisation, delivery and until infants were 2 years old. Randomisation was stratified by centre and a computer-generated sequence was used to allocate participants using a 1 : 1 ratio. Participants, site pharmac...
Cochrane Database of Systematic Reviews, 2011
Heparin as an adjunct in assisted reproduction (peri-implantation heparin) is given at or after e... more Heparin as an adjunct in assisted reproduction (peri-implantation heparin) is given at or after egg collection or at embryo transfer during assisted reproduction. Heparin has been advocated to improve embryo implantation and clinical outcomes. It has been proposed that heparin enhances the intra-uterine environment by improving decidualisation with an associated activation of growth factors and a cytokine expression profile in the endometrium that is favourable to pregnancy. To investigate whether the administration of heparin around the time of implantation (peri-implantation heparin) improves clinical outcomes in subfertile women undergoing assisted reproduction. A comprehensive and exhaustive search strategy was developed in consultation with the Trials Search Co-ordinator of the Cochrane Menstrual Disorders and Subfertility Group (MDSG). The strategy was used in an attempt to identify all relevant studies regardless of language or publication status (published, unpublished, in press, and in progress). Relevant trials were identified from both electronic databases and other resources (last search 6 May 2013). All randomised controlled trials (RCTs) were included where peri-implantation heparin was given during assisted reproduction. Peri-implantation low molecular weight heparin (LMWH) during IVF/ICSI was given at or after egg collection or at embryo transfer in the included studies. Live birth rate was the primary outcome. Two review authors independently assessed the eligibility and quality of trials and extracted relevant data. The quality of the evidence was evaluated using GRADE methods. Three RCTs (involving 386 women) were included in the review.Peri-implantation LMWH administration during assisted reproduction was associated with a significant improvement in live birth rate compared with placebo or no LMWH (odds ratio (OR) 1.77, 95% confidence interval (CI) 1.07 to 2.90, three studies, 386 women, I(2) = 51%, very low quality evidence with high heterogeneity). There was also a significant improvement in the clinical pregnancy rate with use of LMWH (OR 1.61, 95% CI 1.03 to 2.53, three studies, 386 women, I(2) = 29%, very low quality evidence with low heterogeneity).However these findings should be interpreted with extreme caution as they were dependent upon the choice of statistical method: they were no longer statistically significant when a random-effects model was used.Adverse events were poorly reported in all included studies, with no comparative data available. However, LMWH did cause adverse effects including bruising, ecchymosis, bleeding, thrombocytopenia and allergic reactions. It appeared that these adverse effects were increased if heparin therapy was used over a longer duration. The results of this Cochrane review of three randomised controlled trials with a total of 386 women suggested that peri-implantation LMWH in assisted reproduction treatment (ART) cycles may improve the live birth rate in women undergoing assisted reproduction. However, these results were dependent on small low quality studies with substantial heterogeneity, and were sensitive to the choice of statistical model. There were side effects reported with use of heparin, including bruising and bleeding, and no reliable data on long-term effects. The results do not justify this use of heparin outside well-conducted research trials.These findings need to be further investigated with well-designed, adequately powered, double-blind, randomised, placebo-controlled, multicentre trials. Further investigations could also focus on the effects of the local (uterine) and not systemic application of heparin during ART.
Prenatal Diagnosis, 2007
To compare the attitudes of women from two different ethnic backgrounds to prenatal testing for a... more To compare the attitudes of women from two different ethnic backgrounds to prenatal testing for a range of conditions, and to see if &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;quot;clusters&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;quot; of attitudes to different conditions could be identified, for which prenatal testing might be offered as a package. Four hundred and twenty white and Pakistani women living in the UK were surveyed about their attitudes to prenatal testing and termination for 30 different fetal conditions. All participants had recently had a baby. Pakistani women held more favourable attitudes to prenatal testing, but less favourable attitudes to termination than their white counterparts. Both groups were most in favour of termination for the same four conditions: anencephaly, trisomy 13 or 18, quadriplegia, Duchenne muscular dystrophy. The rank ordering of conditions was also similar. Only 4% of Pakistani and 2% of white women wanted no prenatal testing at all. Fewer than a quarter of participants would consider a termination of pregnancy for 85% of the conditions, but only 25% of Pakistani women and 6% of white women would consider termination for none of the conditions. More advanced statistical analyses were used to measure how closely associated the 30 conditions were in respondents&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;#39; answers. These analyses identified a principal dimension, reflecting the overall perceived seriousness of the conditions, and a cluster of severely disabling conditions-anencephaly, trisomy 13 or 18, quadriplegia, Duchenne muscular dystrophy, and severe learning difficulties-which stood out from the rest. Even within this cluster there remained a considerable amount of individual variation. Women in the study wanted to make up their own minds about the conditions that to them merited testing or termination. These findings have implications for obtaining informed consent.
Journal of Genetic Counseling, 2008
The aim of this study is to explore reasons for and against prenatal testing and termination for ... more The aim of this study is to explore reasons for and against prenatal testing and termination for a range of conditions in women from two different ethnic backgrounds. A total of 19 Pakistani and European women in West Yorkshire, UK, who either had a child with a genetic condition or had terminated a pregnancy for one, completed a questionnaire about their attitudes regarding prenatal testing and termination for 30 different fetal conditions and were interviewed about their reasons for their responses. There were more similarities than differences between the Pakistani and European white women. The most important factor in most women&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;#39;s decisions about termination of pregnancy was their perception of the quality of the life of a child with the genetic condition, in particular, whether the child would be &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;quot;suffering.&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;quot; This was described as either physical suffering, as a result of medical treatment, or as emotional suffering, as a result of psychological and/or social factors. These findings highlight the need for detailed information about the potential quality of life for the child and the child&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;#39;s family to enable parents to make informed choices, particularly the extent to which the child is likely to suffer, the nature of such potential &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;quot;suffering&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;quot; and the extent to which the child could lead a &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;quot;normal&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;quot; life. The findings also challenge stereotypes about cultural differences in attitudes about termination of pregnancy.
BMJ (Clinical research ed.), Feb 1, 2018
/Uncertainties-UDCA-in-ICP-revised-prefinalpending-author-queries%20clean%20LCC2%20JGT%20JC%20CW.pdf
BJOG: An International Journal of Obstetrics & Gynaecology, 2017
Changes in anti-m€ ullerian hormone levels as a biomarker for ovarian reserve after ultrasound-gu... more Changes in anti-m€ ullerian hormone levels as a biomarker for ovarian reserve after ultrasound-guided high-intensity focused ultrasound treatment of adenomyosis and uterine fibroid. BJOG 2017;124(Suppl 3):18-22. 4 Lee JS, Hong GY, Park BJ, Kim TE. Ultrasoundguided high-intensity focused ultrasound treatment for uterine fibroid and adenomyosis: a single center experience from the Republic of Korea. Ultrasonics Sonochem 2015;27: 682-7.
BMJ open, Jan 23, 2017
To identify and prioritise important research questions for miscarriage. A priority setting partn... more To identify and prioritise important research questions for miscarriage. A priority setting partnership using prospective surveys and consensus meetings following methods advocated by the James Lind Alliance. UK. Women and those affected by miscarriage working alongside healthcare professionals. In the initial survey, 1093 participants (932 women who have experienced miscarriage, 8 partners, 17 family members, friends or colleagues, 104 healthcare professionals and eight charitable organisations) submitted 3279 questions. A review of existing literature identified a further 64. Non-questions were removed, and the remaining questions were categorised and summarised into 58 questions. In an interim electronic survey, 2122 respondents chose their top 10 priorities from the 58 summary questions. The 25 highest ranked in the survey were prioritised at a final face-to-face workshop. In summary, the top 10 priorities were ranked as follows: research into preventative treatment, emotional a...
Evidence-based medicine, Jan 23, 2017
Context Mothers with big babies tend to have longer labours and more difficult births. They may r... more Context Mothers with big babies tend to have longer labours and more difficult births. They may require caesarean section, or instrumental vaginal delivery. They may also sustain perineal injury or more seriously the head may deliver and the shoulders get stuck, so called shoulder dystocia. This severe complication may cause birth injury, including brachial plexus injury (2-16%) which may be permanent and disabling. Finally the baby may suffer bony fractures or birth asphyxia with risk of neurological damage or death. Obstetricians have wondered whether inducing labour early might make birth easier and reduce injury, but have been cautious to implement this policy due to concerns that induced labour may be longer or increase caesareans, and because the diagnosis of macrosomia, even using ultrasound scan is notoriously inaccurate. Methods
European Journal of Obstetrics & Gynecology and Reproductive Biology, 2016
To compare women's views about blood pressure (BP) control in CHIPS (Control of Hypertension In P... more To compare women's views about blood pressure (BP) control in CHIPS (Control of Hypertension In Pregnancy Study) (NCT01192412). Design: Quantitative and qualitative analysis of questionnaire responses. Setting: International randomised trial (94 sites, 15 countries). Population/sample: 911 (92.9%) women randomised to 'tight' (target diastolic blood pressure, 85 mmHg) or 'less tight' (target diastolic blood pressure, 100 mmHg) who completed questionnaires. Methods: A questionnaire was administered at $6-12 weeks postpartum regarding post-discharge morbidity and views about trial participation. Questionnaires were administered by the site coordinator, and contact was made by phone, home or clinic visit; rarely, data was collected from medical records. Quantitative analyses were Chi-square or Fisher's exact test for categorical variables, mixed effects multinomial logistic regression to adjust for confounders, and p < 0.001 for statistical significance. NVivo software was used for thematic analysis of women's views. Main outcome measures: Satisfaction, measured as willingness to have the same treatment in another pregnancy or recommend that treatment to a friend. Results: Among the 533 women in 'tight' (N = 265) vs. 'less tight' (N = 268) control who provided comments for qualitative analysis, women in 'tight' (vs. 'less tight') control made fewer positive comments about the amount of medication taken (5 vs. 28 women, respectively) and intensity of BP monitoring (7 vs. 17, respectively). However, this did not translate into less willingness to either have the same treatment in another pregnancy (434, 95.8% vs. 423, 92.4%, respectively; p = 0.14) or recommend that treatment to a friend (435, 96.0% and 428, 93.4%, respectively; p = 0.17). Importantly, although
BJOG : an international journal of obstetrics and gynaecology, 2016
Access to and use of the material held within the University of Nottingham's Institutional Reposi... more Access to and use of the material held within the University of Nottingham's Institutional Repository (the Repository) is based on your acceptance of the following terms and conditions:
Hypertension (Dallas, Tex. : 1979), Nov 12, 2016
To determine whether clinical outcomes differed by occurrence of severe hypertension in the inter... more To determine whether clinical outcomes differed by occurrence of severe hypertension in the international CHIPS trial (Control of Hypertension in Pregnancy Study), adjusting for the interventions of "less tight" (target diastolic blood pressure [dBP] 100 mm Hg) versus "tight" control (target dBP 85 mm Hg). In this post-hoc analysis of CHIPS data from 987 women with nonsevere nonproteinuric preexisting or gestational hypertension, mixed effects logistic regression was used to compare the following outcomes according to occurrence of severe hypertension, adjusting for allocated group and the influence of baseline factors: CHIPS primary (perinatal loss or high-level neonatal care for >48 hours) and secondary outcomes (serious maternal complications), birth weight <10th percentile, preeclampsia, delivery at <34 or <37 weeks, platelets <100×10(9)/L, elevated liver enzymes with symptoms, maternal length of stay ≥10 days, and maternal readmission before 6...
Hypertension (Dallas, Tex. : 1979), Oct 22, 2016
The CHIPS randomized controlled trial (Control of Hypertension in Pregnancy Study) found no diffe... more The CHIPS randomized controlled trial (Control of Hypertension in Pregnancy Study) found no difference in the primary perinatal or secondary maternal outcomes between planned "less tight" (target diastolic 100 mm Hg) and "tight" (target diastolic 85 mm Hg) blood pressure management strategies among women with chronic or gestational hypertension. This study examined which of these management strategies is more or less costly from a third-party payer perspective. A total of 981 women with singleton pregnancies and nonsevere, nonproteinuric chronic or gestational hypertension were randomized at 14 to 33 weeks to less tight or tight control. Resources used were collected from 94 centers in 15 countries and costed as if the trial took place in each of 3 Canadian provinces as a cost-sensitivity analysis. Eleven hospital ward and 24 health service costs were obtained from a similar trial and provincial government health insurance schedules of medical benefits. The mean ...
Obstetrics and gynecology, 1996
To obtain estimates of the effects of amniotomy on the risk of cesarean delivery and on other ind... more To obtain estimates of the effects of amniotomy on the risk of cesarean delivery and on other indicators of maternal and neonatal morbidity (Apgar score less than 7 at 5 minutes, admission to neonatal intensive care unit [NICU]). Published studies were identified through manual and computerized searches using Medline and the Cochrane Collaboration Pregnancy and Childbirth Database. Our search identified ten trials, all published in peer-reviewed journals. Trials were assigned a methodological quality score based on a standardized rating system. Three trials were excluded from the analysis for methodological limitations. Data were abstracted by two trained reviewers. Typical odds ratios (OR) were calculated. Amniotomy was associated with a reduction in labor duration varying from 0.8-2.3 hours. There was a nonstatistically significant increase in the risk of cesarean delivery; OR 1.2, 95% confidence interval (CI) 0.9-1.6. The risk of a 5-minute Apgar score less than 7 was reduced in ...
The Cochrane database of systematic reviews, Jan 30, 2014
Endometrial polyps, which are benign growths of the endometrium, may be a factor in female subfer... more Endometrial polyps, which are benign growths of the endometrium, may be a factor in female subfertility. Possible mechanisms include physical interference with gamete transport, alteration of the endometrial milieu and unresponsiveness to the cyclical global endometrial changes. As such polyps remain mostly asymptomatic, their diagnosis is often incidental during routine investigations prior to embarking on assisted reproductive treatment. Transvaginal sonography, hysterosalpingography and saline infusion sonography are the diagnostic tools most commonly employed. However, hysteroscopy remains the gold standard for diagnosis, as well as for treatment. Due to the possible effect of endometrial polyps on fertility, their removal prior to any subfertility treatment is widely practiced. To determine the effectiveness and safety of removal of endometrial polyps in subfertile women. Electronic databases were searched, including the Cochrane Menstrual Disorders and Subfertility Group Speci...
Protocols, 2014
Analysis 1.2. Comparison 1 Test of placental function versus standard care, Outcome 2 Small-for-g... more Analysis 1.2. Comparison 1 Test of placental function versus standard care, Outcome 2 Small-for-gestational age (below 10th centile on customised birthweight chart or as defined by trialists
New England Journal of Medicine, 2015
BACKGROUND The effects of less-tight versus tight control of hypertension on pregnancy complicati... more BACKGROUND The effects of less-tight versus tight control of hypertension on pregnancy complications are unclear. METHODS We performed an open, international, multicenter trial involving women at 14 weeks 0 days to 33 weeks 6 days of gestation who had nonproteinuric preexisting or gestational hypertension, office diastolic blood pressure of 90 to 105 mm Hg (or 85 to 105 mm Hg if the woman was taking antihypertensive medications), and a live fetus. Women were randomly assigned to less-tight control (target diastolic blood pressure, 100 mm Hg) or tight control (target diastolic blood pressure, 85 mm Hg). The composite primary outcome was pregnancy loss or high-level neonatal care for more than 48 hours during the first 28 postnatal days. The secondary outcome was serious maternal complications occurring up to 6 weeks post partum or until hospital discharge, whichever was later. RESULTS Included in the analysis were 987 women; 74.6% had preexisting hypertension. The primary-outcome rates were similar among 493 women assigned to less-tight control and 488 women assigned to tight control (31.4% and 30.7%, respectively; adjusted odds ratio, 1.02; 95% confidence interval [CI], 0.77 to 1.35), as were the rates of serious maternal complications (3.7% and 2.0%, respectively; adjusted odds ratio, 1.74; 95% CI, 0.79 to 3.84), despite a mean diastolic blood pressure that was higher in the less-tight-control group by 4.6 mm Hg (95% CI, 3.7 to 5.4). Severe hypertension (≥160/110 mm Hg) developed in 40.6% of the women in the less-tight-control group and 27.5% of the women in the tight-control group (P<0.001). CONCLUSIONS We found no significant between-group differences in the risk of pregnancy loss, high-level neonatal care, or overall maternal complications, although less-tight control was associated with a significantly higher frequency of severe maternal hypertension. (Funded by the Canadian Institutes of Health Research; CHIPS Current Controlled Trials number, ISRCTN71416914; ClinicalTrials.gov number, NCT01192412.
Analysis 1.21. Comparison 1 Interventionist care versus expectant (delayed delivery) care for sev... more Analysis 1.21. Comparison 1 Interventionist care versus expectant (delayed delivery) care for severe pre-eclampsia, Outcome
Health Technology Assessment, 2014
BackgroundSmoking during pregnancy causes many adverse pregnancy and birth outcomes. Nicotine rep... more BackgroundSmoking during pregnancy causes many adverse pregnancy and birth outcomes. Nicotine replacement therapy (NRT) is effective for cessation outside pregnancy but efficacy and safety in pregnancy are unknown. We hypothesised that NRT would increase smoking cessation in pregnancy without adversely affecting infants.ObjectivesTo compare (1) at delivery, the clinical effectiveness and cost-effectiveness for achieving biochemically validated smoking cessation of NRT patches with placebo patches in pregnancy and (2) in infants at 2 years of age, the effects of maternal NRT patch use with placebo patch use in pregnancy on behaviour, development and disability.DesignRandomised, placebo-controlled, parallel-group trial and economic evaluation with follow-up at 4 weeks after randomisation, delivery and until infants were 2 years old. Randomisation was stratified by centre and a computer-generated sequence was used to allocate participants using a 1 : 1 ratio. Participants, site pharmac...
Cochrane Database of Systematic Reviews, 2011
Heparin as an adjunct in assisted reproduction (peri-implantation heparin) is given at or after e... more Heparin as an adjunct in assisted reproduction (peri-implantation heparin) is given at or after egg collection or at embryo transfer during assisted reproduction. Heparin has been advocated to improve embryo implantation and clinical outcomes. It has been proposed that heparin enhances the intra-uterine environment by improving decidualisation with an associated activation of growth factors and a cytokine expression profile in the endometrium that is favourable to pregnancy. To investigate whether the administration of heparin around the time of implantation (peri-implantation heparin) improves clinical outcomes in subfertile women undergoing assisted reproduction. A comprehensive and exhaustive search strategy was developed in consultation with the Trials Search Co-ordinator of the Cochrane Menstrual Disorders and Subfertility Group (MDSG). The strategy was used in an attempt to identify all relevant studies regardless of language or publication status (published, unpublished, in press, and in progress). Relevant trials were identified from both electronic databases and other resources (last search 6 May 2013). All randomised controlled trials (RCTs) were included where peri-implantation heparin was given during assisted reproduction. Peri-implantation low molecular weight heparin (LMWH) during IVF/ICSI was given at or after egg collection or at embryo transfer in the included studies. Live birth rate was the primary outcome. Two review authors independently assessed the eligibility and quality of trials and extracted relevant data. The quality of the evidence was evaluated using GRADE methods. Three RCTs (involving 386 women) were included in the review.Peri-implantation LMWH administration during assisted reproduction was associated with a significant improvement in live birth rate compared with placebo or no LMWH (odds ratio (OR) 1.77, 95% confidence interval (CI) 1.07 to 2.90, three studies, 386 women, I(2) = 51%, very low quality evidence with high heterogeneity). There was also a significant improvement in the clinical pregnancy rate with use of LMWH (OR 1.61, 95% CI 1.03 to 2.53, three studies, 386 women, I(2) = 29%, very low quality evidence with low heterogeneity).However these findings should be interpreted with extreme caution as they were dependent upon the choice of statistical method: they were no longer statistically significant when a random-effects model was used.Adverse events were poorly reported in all included studies, with no comparative data available. However, LMWH did cause adverse effects including bruising, ecchymosis, bleeding, thrombocytopenia and allergic reactions. It appeared that these adverse effects were increased if heparin therapy was used over a longer duration. The results of this Cochrane review of three randomised controlled trials with a total of 386 women suggested that peri-implantation LMWH in assisted reproduction treatment (ART) cycles may improve the live birth rate in women undergoing assisted reproduction. However, these results were dependent on small low quality studies with substantial heterogeneity, and were sensitive to the choice of statistical model. There were side effects reported with use of heparin, including bruising and bleeding, and no reliable data on long-term effects. The results do not justify this use of heparin outside well-conducted research trials.These findings need to be further investigated with well-designed, adequately powered, double-blind, randomised, placebo-controlled, multicentre trials. Further investigations could also focus on the effects of the local (uterine) and not systemic application of heparin during ART.
Prenatal Diagnosis, 2007
To compare the attitudes of women from two different ethnic backgrounds to prenatal testing for a... more To compare the attitudes of women from two different ethnic backgrounds to prenatal testing for a range of conditions, and to see if &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;quot;clusters&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;quot; of attitudes to different conditions could be identified, for which prenatal testing might be offered as a package. Four hundred and twenty white and Pakistani women living in the UK were surveyed about their attitudes to prenatal testing and termination for 30 different fetal conditions. All participants had recently had a baby. Pakistani women held more favourable attitudes to prenatal testing, but less favourable attitudes to termination than their white counterparts. Both groups were most in favour of termination for the same four conditions: anencephaly, trisomy 13 or 18, quadriplegia, Duchenne muscular dystrophy. The rank ordering of conditions was also similar. Only 4% of Pakistani and 2% of white women wanted no prenatal testing at all. Fewer than a quarter of participants would consider a termination of pregnancy for 85% of the conditions, but only 25% of Pakistani women and 6% of white women would consider termination for none of the conditions. More advanced statistical analyses were used to measure how closely associated the 30 conditions were in respondents&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;#39; answers. These analyses identified a principal dimension, reflecting the overall perceived seriousness of the conditions, and a cluster of severely disabling conditions-anencephaly, trisomy 13 or 18, quadriplegia, Duchenne muscular dystrophy, and severe learning difficulties-which stood out from the rest. Even within this cluster there remained a considerable amount of individual variation. Women in the study wanted to make up their own minds about the conditions that to them merited testing or termination. These findings have implications for obtaining informed consent.
Journal of Genetic Counseling, 2008
The aim of this study is to explore reasons for and against prenatal testing and termination for ... more The aim of this study is to explore reasons for and against prenatal testing and termination for a range of conditions in women from two different ethnic backgrounds. A total of 19 Pakistani and European women in West Yorkshire, UK, who either had a child with a genetic condition or had terminated a pregnancy for one, completed a questionnaire about their attitudes regarding prenatal testing and termination for 30 different fetal conditions and were interviewed about their reasons for their responses. There were more similarities than differences between the Pakistani and European white women. The most important factor in most women&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;#39;s decisions about termination of pregnancy was their perception of the quality of the life of a child with the genetic condition, in particular, whether the child would be &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;quot;suffering.&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;quot; This was described as either physical suffering, as a result of medical treatment, or as emotional suffering, as a result of psychological and/or social factors. These findings highlight the need for detailed information about the potential quality of life for the child and the child&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;#39;s family to enable parents to make informed choices, particularly the extent to which the child is likely to suffer, the nature of such potential &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;quot;suffering&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;quot; and the extent to which the child could lead a &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;quot;normal&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;quot; life. The findings also challenge stereotypes about cultural differences in attitudes about termination of pregnancy.