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Please cite this paper as: Holzmann M, Cnattingius S, Nordström L. Lactate production as a response to intrapartum hypoxia in the growth-restricted fetus. BJOG 2012;119:1265-1269. Objective To analyse whether the increase in lactate in response to intrapartum hypoxia differs between small- (SGA), appropriate- (AGA) and large-for-gestational-age (LGA) fetuses. Design Observational cohort study. Setting Ten obstetric units in Sweden. Population A cohort of 1496 women. Methods A secondary analysis of a randomised controlled trial, in which 1496 women with fetal heart rate abnormalities, indicating fetal scalp blood sampling, were randomised to lactate analyses. After delivery, the neonates were divided according to birthweight for gestational age into SGA, AGA and LGA groups. Main outcome measure Lactate concentration in fetal scalp blood. Secondary outcome measures Acid-base balance in cord artery blood and Apgar score <7 at 5 minutes. Results Median lactate concentrations in the SGA, AGA and LGA groups were 3.8, 3.0 and 2.2 mmol/l, respectively (SGA versus AGA, P = 0.017; LGA versus AGA, P = 0.009). In the subgroups with scalp lactate >4.8 mmol/l (lactacidaemia), the corresponding median (range) values were 6.2 (4.9-14.6), 5.9 (4.9-15.9) and 5.7 mmol/l (5.0-7.9 mmol/l), respectively (no significant differences between the groups). The proportions of neonates with cord artery pH < 7.00, metabolic acidaemia or Apgar score <7 at 5 minutes were similar in all weight groups. Conclusion SGA fetuses with fetal heart rate abnormalities have the same ability to produce lactate as a response to intrapartum hypoxia as AGA and LGA fetuses. The risk of a poor outcome associated with high lactate concentration is the same in SGA, AGA and LGA fetuses. Scalp blood lactate analysis is therefore a reliable method for intrapartum fetal surveillance of suspected growth-restricted fetuses scheduled for vaginal delivery at ≥34 weeks of gestation. [ABSTRACT FROM AUTHOR]

The article presents the online study on the comparison of intramuscular diamorphine and intramuscular pethidine for labour analgesia based on randomised blinded controlled trial. The study involves women in active labour requesting opioid analgesia for labour pain which found a reduction in pain intensity and over three-hour period after drug administration. The study also revealed that diamorphine was associated with modestly better pain control and was no difference in neonatal outcomes.

Objective: To assess the short- and long-term effects of mindfulness-based stress reduction (MBSR) on the resulting quality of life, sexual functioning, and sexual distress after risk-reducing salpingo-oophorectomy (RRSO).Design: Randomised controlled trial.Setting: A specialised family cancer clinic of the university medical center Groningen.Population: Sixty-six women carriers of the BRCA1/2 mutation who developed at least two moderate-to-severe menopausal symptoms after RRSO.Methods: Women were randomised to an 8-week MBSR training programme or to care as usual (CAU).Main Outcome Measures: Change in the Menopause-Specific Quality of Life Questionnaire (MENQOL), the Female Sexual Function Index, and the Female Sexual Distress Scale, administered from baseline at 3, 6, and 12 months. Linear mixed modelling was applied to compare the effect of MBSR with CAU over time.Results: At 3 and 12 months, there were statistically significant improvements in the MENQOL for the MBSR group compared with the CAU group (both P = 0.04). At 3 months, the mean MENQOL scores were 3.5 (95% confidence interval, 95% CI 3.0-3.9) and 3.8 (95% CI 3.3-4.2) for the MBSR and CAU groups, respectively; at 12 months, the corresponding values were 3.6 (95% CI 3.1-4.0) and 3.9 (95% CI 3.5-4.4). No significant differences were found between the MBSR and CAU groups in the other scores.Conclusion: Mindfulness-based stress reduction was effective at improving quality of life in the short- and long-term for patients with menopausal symptoms after RRSO; however, it was not associated with an improvement in sexual functioning or distress.Tweetable Abstract: Mindfulness improves menopause-related quality of life in women after risk-reducing salpingo-oophorectomy. [ABSTRACT FROM AUTHOR]

Background: There is a substantial body of research evaluating ways to prevent and manage miscarriage, but all studies do not report on the same outcomes.Objective: To review systematically, outcomes reported in existing miscarriage trials.Search Strategy: MEDLINE, Embase, CINAHL, and Cochrane were searched from inception until January 2017.Selection Criteria: Randomised controlled trials (RCTs) reporting prevention or management of miscarriage. Miscarriage was defined as a pregnancy loss in the first trimester.Data Collection and Analysis: Data about the study characteristics, primary, and secondary outcomes were extracted.Main Results: We retrieved 1553 titles and abstracts, from which 208 RCTs were included. For prevention of miscarriage, the most commonly reported primary outcome was live birth and the top four reported outcomes were pregnancy loss/stillbirth (n = 112), gestation of birth (n = 68), birth dimensions (n = 65), and live birth (n = 49). For these four outcomes, 58 specific measures were used for evaluation. For management of miscarriage, the most commonly reported primary outcome was efficacy of treatment. The top four reported outcomes were bleeding (n = 186), efficacy of miscarriage treatment (n = 105), infection (n = 97), and quality of life (n = 90). For these outcomes, 130 specific measures were used for evaluation.Conclusions: Our review found considerable variation in the reporting of primary and secondary outcomes along with the measures used to assess them. There is a need for standardised patient-centred clinical outcomes through the development of a core outcome set; the work from this systematic review will form the foundation of the core outcome set for miscarriage.Tweetable Abstract: There is disparity in the reporting of outcomes and the measures used to assess them in miscarriage trials. [ABSTRACT FROM AUTHOR]

Objective: To determine whether oral clindamycin reduces the risk of preterm birth (PTB) in women with abnormal vaginal microflora as evidenced by a vaginal pH ≥5.0.Design: Randomised double-blind placebo-controlled trial.Setting: Rural southern India.Population: Pregnant women with a singleton fetus between 13+0/7 weeks and 20+6/7 weeks.Methods: Pregnant women were recruited during prenatal visits in Karnataka, India, from October 2013 to July 2015. Women were required to have a singleton fetus between 13+0/7 weeks and 20+6/7 weeks and an elevated vaginal pH (≥5.0) by colorimetric assessment. Participants were randomised to either oral clindamycin 300 mg twice daily for 5 days or an identical-appearing placebo.Main Outcome Measures: The primary outcome was the incidence of PTB, defined as delivery before 37+0/7 weeks.Results: Of the 6476 screened women, 1727 women were randomised (block randomised in groups of six; clindamycin n = 866, placebo n = 861). The demographic, reproductive, and anthropomorphometric characteristics of the study groups were similar. Compliance was high, with over 94% of capsules being taken. The rate of PTB before 37 weeks was comparable between the two groups [clindamycin 115/826 (13.9%) versus placebo 111/806 (13.8%), between-group difference 0.2% (95% CI -3.2 to 3.5%, P = 0.93)], as was PTB at less than 34 weeks [clindamycin 40/826 (4.8%) versus placebo group 37/806 (4.6%), between-group difference 0.3% (95% CI -1.8 to 2.3%, P = 0.81)]. No differences were detected in the incidence of birthweight of<2500 g, <1500 g, miscarriage, stillbirth or neonatal death.Conclusion: In this setting, oral clindamycin did not decrease PTB among women with vaginal pH ≥5.0.Tweetable Abstract: Oral clindamycin between 13+0/7 and 20+6/7 weeks does not prevent preterm birth in women with a vaginal pH ≥5.0. [ABSTRACT FROM AUTHOR]

Background: Gestational diabetes mellitus (GDM) is an increasingly prevalent disorder, associated with low blood vitamin D level.Objectives: To evaluate the relationship between vitamin D and GDM.Search Strategy: EMBASE, MEDLINE, Cochrane Library and China Biology Medicine disc were searched up to May 2017. The references of previous studies were screened.Selection Criteria: Observational studies on the relationship between vitamin D and GDM free from Hawthorne effect and randomised controlled trials of vitamin D supplementation during pregnancy for preventing or treating GDM were included.Data Collection and Analysis: Data and information of included articles were extracted by duplicate using piloted tables. Newcastle-Ottawa Scale and Cochrane Handbook were used for quality assessment. Random-effects models were used for meta-analyses. Heterogeneity tests, sensitivity analysis and analysis of publication bias were conducted.Main Results: Eighty-seven observational studies and 25 randomised controlled trials involving 55 859 and 2445 women, respectively, were included. Low blood vitamin D level during pregnancy was associated with a higher risk of GDM (OR 1.850, 95% CI 1.471-2.328). Blood vitamin D level for women with GDM were lower than in the control women. Blood vitamin D level was associated with fasting plasma glucose (FPG) and homeostasis model of assessment for insulin resistance index (HOMA-IR) (r = -0.100 and r = -0.351), whereas the correlation between blood vitamin D level and fasting insulin (FINS) might be concealed by publication bias. Vitamin D intervention during pregnancy could change the blood levels of vitamin D, FINS, FPG, HOMA-IR, glutathione, C-reactive protein and lipid.Conclusions: Low blood vitamin D level could increase the risk of GDM, and vitamin D supplementation during pregnancy could ameliorate the condition of GDM.Tweetable Abstract: Low blood vitamin D increases gestational diabetes mellitus (GDM) risk. Vitamin D supplementation ameliorates GDM condition. [ABSTRACT FROM AUTHOR]

Background: Randomised trials and their syntheses in meta-analyses offer a unique opportunity to assess the frequency and severity of adverse reactions.Objective: To assess safety reporting in pre-eclampsia trials.Search Strategy: Systematic search using bibliographic databases, including Cochrane Central Register of Controlled Trials, Embase, and MEDLINE, from inception to August 2017.Selection Criteria: Randomised trials evaluating anticonvulsant or antihypertensive medication for pre-eclampsia.Data Collection and Analysis: Descriptive statistics appraising the adequacy of adverse reaction and toxicity reporting.Main Results: We included 60 randomised trials. Six trials (10%) were registered with the International Clinical Trials Registry Platform, two registry records referred to adverse reactions, stating 'safety and toleration' and 'possible side effects' would be collected. Twenty-six trials (43%) stated the frequency of withdrawals within each study arm, and five trials (8%) adequately reported these withdrawals. Adverse reactions were inconsistently reported across eligible trials: 24 (40%) reported no serious adverse reactions and 36 (60%) reported no mild adverse reactions. The methods of definition or measurement of adverse reactions were infrequently reported within published trial reports.Conclusions: Pre-eclampsia trials regularly omit critical information related to safety. Despite the paucity of reporting, randomised trials collect an enormous amount of safety data. Developing and implementing a minimum data set could help to improve safety reporting, permitting a more balanced assessment of interventions by considering the trade-off between the benefits and harms.Funding: National Institute for Health Research (DRF-2014-07-051), UK; Maternity Forum, Royal Society of Medicine, UK.Tweetable Abstract: Developing @coreoutcomes could help to improve safety reporting in #preeclampsia trials. @NIHR_DC. [ABSTRACT FROM AUTHOR]

Background: Standardising outcome collection and reporting in pre-eclampsia trials requires an appraisal of current outcome reporting.Objectives: To map maternal and offspring outcome reporting across randomised trials evaluating therapeutic interventions for pre-eclampsia.Search Strategy: Randomised trials were identified by searching bibliographical databases from inception to January 2016.Selection Criteria: Randomised controlled trials.Data Collection and Analysis: We systematically extracted and categorised outcome reporting.Main Results: Seventy-nine randomised trials, reporting data from 31 615 maternal participants and 28 172 of their offspring, were included. Fifty-five different interventions were evaluated. Included trials reported 119 different outcomes, including 72 maternal outcomes and 47 offspring outcomes. Maternal outcomes were inconsistently reported across included trials; for example, 11 trials (14%) reported maternal mortality, reporting data from 12 422 participants, and 16 trials (20%) reported cardiovascular morbidity, reporting data from 14 963 maternal participants. Forty-three trials (54%) reported fetal outcomes and 23 trials (29%) reported neonatal outcomes. Twenty-eight trials (35%) reported offspring mortality. There was poor reporting of childhood outcomes: six trials (8%) reported neurodevelopmental outcomes. Less than half of included trials reported any relevant information regarding harms for maternal participants and their offspring.Conclusions: Most randomised trials evaluating interventions for pre-eclampsia are missing information on clinically important outcomes, and in particular have neglected to evaluate efficacy and safety in the offspring of participants. Developing and implementing a minimum data set, known as a core outcome set, in future pre-eclampsia trials could help to address these issues.Tweetable Abstract: Future #preeclampsia research requires a core outcome set to reduce #research waste. @coreoutcomes @jamesmnduffy International Prospective Register of Systematic Reviews: CRD42015015529; www.crd.york.ac.uk/PROSPERO/display_record.aspID=CRD42015015529. [ABSTRACT FROM AUTHOR]

Objective: To evaluate maternal and perinatal outcomes after induction of labour versus expectant management in pregnant women with gestational diabetes at term.Design: Multicentre open-label randomised controlled trial.Setting: Eight teaching hospitals in Italy, Slovenia, and Israel.Sample: Singleton pregnancy, diagnosed with gestational diabetes by the International Association of Diabetes and Pregnancy Study Groups criteria (IADPSGC), between 38+0 and 39+0 weeks of gestation, without other maternal or fetal conditions.Methods: Patients were randomly assigned to induction of labour or expectant management and intensive follow-up. Data were analysed by 'intention to treat'.Main Outcome Measures: The primary outcome was incidence of caesarean section. Secondary outcomes were maternal and perinatal mortality and morbidity.Results: A total of 425 women were randomised to the study groups. The incidence of caesarean section was 12.6% in the induction group versus 11.7% in the expectant group. No difference was found between the two groups (relative risk, RR 1.06; 95% confidence interval, 95% CI 0.64-1.77; P = 0.81). The incidence of non-spontaneous delivery, either by caesarean section or by operative vaginal delivery, was 21.0 and 22.3%, respectively (RR 0.94; 95% CI 0.66-1.36; P = 0.76). Neither maternal nor fetal deaths occurred. The few cases of shoulder dystocia were solved without any significant birth trauma.Conclusions: In women with gestational diabetes, without other maternal or fetal conditions, no difference was detected in birth outcomes regardless of the approach used (i.e. active versus expectant management). Although the study was underpowered, the magnitude of the between-group difference was very small and without clinical relevance.Tweetable Abstract: Immediate delivery or expectant management in gestational diabetes at term? [ABSTRACT FROM AUTHOR]

Objective: To evaluate the effect of pelvic floor muscle exercises (PFME) for postpartum anal incontinence (AI).Design: A parallel two-armed randomised controlled trial stratified on obstetrical anal sphincter injury with primary sphincter repair and hospital affinity.Setting: Ano-rectal specialist out-patient clinics at two hospitals in Norway.Population: One hundred and nine postpartum women with AI at baseline.Methods: The intervention group received 6 months of individual physiotherapy-led PFME and the control group written information on PFME. Changes in St. Mark's scores and predictors of post-intervention AI were assessed by independent samples t-tests and multiple linear regression analyses, respectively. The study was not blind.Main Outcome Measures: The primary outcome measure was change in AI symptoms on the St. Mark's score from baseline to post-intervention. Secondary outcome measures were manometry measures of anal sphincter length and strength, endoanal ultrasound (EAUS) defect score and voluntary pelvic floor muscle contraction.Results: There was a significant difference in the reduction of St. Mark's scores from baseline to post-intervention in favour of the PFME group (-2.1 versus -0.8 points, P = 0.040). No differences in secondary outcome measures were found between groups. Baseline St. Mark's, PFME group affinity and EAUS defect score predicted post-intervention St. Mark's score in the imputed intention-to-treat analyses. The analysis on un-imputed data showed that women performing weekly PFME improved their AI scores more than women in the control group did.Conclusions: Our results indicate that individually adapted PFME reduces postpartum AI symptoms.Tweetable Abstract: Performing regular pelvic floor muscle exercises may be an effective treatment for postpartum anal incontinence. [ABSTRACT FROM AUTHOR]

Objective To compare the efficacy of fentanyl administered via the subcutaneous (s.c.) or intranasal (i.n.) route with intramuscular (i.m.) pethidine in labouring women requesting analgesia. Design A randomised controlled trial three-armed, parallel-design. Setting A regional hospital and the largest tertiary maternity centre in South Australia. Sample One hundred and fifty-six healthy parturients birthing at term. Methods Women were randomised to receive s.c. fentanyl ( n = 53), i.n. fentanyl ( n = 52), or i.m. pethidine ( n = 51). The outcomes were analysed by intention-to-treat. Main outcome measures Pain scores measured before and 30 minutes after opioid administration. Results All groups reported clinically significant reductions in pain scores (mean range 1.2-1.6; P < 0.001), with no significant differences between groups. Significantly more women in the fentanyl groups reported satisfaction with using the study drug again, compared with women receiving i.m. pethidine (82.9% i.n. fentanyl, 80.6% s.c. fentanyl, and 44.0% i.m. pethidine; P < 0.01). Women in the fentanyl groups experienced less sedation (i.n. fentanyl 7.3%, s.c. fentanyl 2.9%, i.m. pethidine 44%; P ≤ 0.03), shorter labours by at least 2 hours ( P < 0.05), and fewer difficulties establishing breastfeeding (78.8% i.m. pethidine, 39.4% i.n. fentanyl, and 44.0% s.c. fentanyl; P < 0.01). Neonates in the pethidine group were more likely to require nursery admission ( P < 0.02). Conclusions Fentanyl administered by s.c. and i.n. routes is as efficacious in relieving labour pain as i.m. pethidine, but resulted in greater satisfaction, less sedation, shorter labour, fewer nursery admissions, and fewer difficulties in establishing breastfeeding. Fentanyl appears to be a suitable alternative to pethidine when providing parenteral pain relief to labouring women. [ABSTRACT FROM AUTHOR]

Objective To evaluate the effectiveness of 200 mg of daily vaginal natural progesterone to prevent preterm birth in women with preterm labour. Design Multicentre, randomised, double-blind, placebo-controlled trial. Setting Twenty-nine centres in Switzerland and Argentina. Population A total of 385 women with preterm labour (240/7 to 336/7 weeks of gestation) treated with acute tocolysis. Methods Participants were randomly allocated to either 200 mg daily of self-administered vaginal progesterone or placebo within 48 hours of starting acute tocolysis. Main outcome measures Primary outcome was delivery before 37 weeks of gestation. Secondary outcomes were delivery before 32 and 34 weeks, adverse effects, duration of tocolysis, re-admissions for preterm labour, length of hospital stay, and neonatal morbidity and mortality. The study was ended prematurely based on results of the intermediate analysis. Results Preterm birth occurred in 42.5% of women in the progesterone group versus 35.5% in the placebo group (relative risk [ RR] 1.2; 95% confidence interval [95% CI] 0.93-1.5). Delivery at <32 and <34 weeks did not differ between the two groups (12.9 versus 9.7%; [ RR 1.3; 95% CI 0.7-2.5] and 19.7 versus 12.9% [ RR 1.5; 95% CI 0.9-2.4], respectively). The duration of tocolysis, hospitalisation, and recurrence of preterm labour were comparable between groups. Neonatal morbidity occurred in 44 (22.8%) cases on progesterone versus 35 (18.8%) cases on placebo ( RR: 1.2; 95% CI 0.82-1.8), whereas there were 4 (2%) neonatal deaths in each study group. Conclusion There is no evidence that the daily administration of 200 mg vaginal progesterone decreases preterm birth or improves neonatal outcome in women with preterm labour. [ABSTRACT FROM AUTHOR]

Objective To study the effect of aspirin in the prevention of pre-eclampsia in high-risk women. Design Randomised, double-blinded, placebo-controlled trial. Setting Maternity clinics in ten Finnish hospitals participating in the PREDO Project. Sample A total of 152 women with risk factors for pre-eclampsia and abnormal uterine artery Doppler velocimetry. Methods Participants were randomised to start either aspirin 100 mg/day or placebo at 12 + 0 to 13 + 6 weeks + days of gestation. Because of the limited power of this trial, we also conducted a meta-analysis of randomised controlled trials that included data on 346 women with abnormal uterine artery Doppler flow velocimetry, and aspirin 50-150 mg/day started at or before 16 weeks of gestation. Main outcome measure Pre-eclampsia, gestational hypertension and birthweight standard deviation (SD) score. Outcome measures for the meta-analysis were pre-eclampsia, severe pre-eclampsia, preterm (diagnosed <37 + 0 weeks of gestation) and term pre-eclampsia. Results From the 152 randomised women, 121 were included in the final analysis. Low-dose aspirin did not reduce the rate of pre-eclampsia (relative risk [RR] 0.7, 95% CI 0.3-1.7); gestational hypertension (RR 1.6, 95% CI 0.6-4.2); early-onset pre-eclampsia (diagnosed <34 + 0 weeks of gestation) (RR 0.2, 95% CI 0.03-2.1); or severe pre-eclampsia (RR 0.4, 95% CI 0.1-1.3); and the results were not statistically significant in an intention-to-treat analysis. However, our meta-analysis, including the current data, suggested that low-dose aspirin initiated before 16 weeks of gestation reduces the risk of pre-eclampsia (RR 0.6, 95% CI 0.4-0.8) and severe pre-eclampsia (RR 0.3, 95% CI 0.1-0.7). Conclusions Our trial showed no statistically significant effect of aspirin in preventing pre-eclampsia in high-risk women. However, our meta-analysis suggested that aspirin may reduce the incidence of pre-eclampsia. [ABSTRACT FROM AUTHOR]

Objective To compare vaginal repair augmented by mesh with traditional colporrhaphy for the treatment of pelvic organ prolapse. Design Prospective randomised controlled trial. Setting Tertiary teaching hospital. Population One hundred and thirty-nine women with stage ≥2 prolapse according to the pelvic organ prolapse quantification (POP-Q) system requiring both anterior and posterior compartment repair. Methods Subjects were randomised to anterior and posterior vaginal repair with mesh augmentation (mesh group, n = 69) or traditional anterior and posterior colporrhaphy (no mesh group, n = 70). Main outcome measures The primary outcome was the absence of POP-Q stage ≥2 prolapse at 12 months. Secondary outcomes were symptoms, quality-of-life outcomes and satisfaction with surgery. Complications were also reported. Results For subjects attending the 12-month review, success in the mesh group was 81.0% (51 of 63 subjects) compared with 65.6% (40/61) in the no mesh group and was not significantly different ( P-value = 0.07). A high level of satisfaction with surgery and improvements in symptoms and quality-of-life data were observed at 12 months compared to baseline in both groups, but there was no significant difference in these outcomes between the two groups. Vaginal mesh exposure occurred in four women in the mesh group (5.6%). De novo dyspareunia was reported by five of 30 (16.7%) sexually active women in the mesh group and five of 33 (15.2%) in the no mesh group at 12 months. Conclusion In this study, vaginal surgery augmented by mesh did not result in significantly less recurrent prolapse than traditional colporrhaphy 12 months following surgery. [ABSTRACT FROM AUTHOR]

Objective To evaluate whether magnesium sulphate (MgSO4) given to women at risk of very-preterm birth would be neuroprotective in preterm newborns and would prevent neonatal mortality and severe white-matter injury (WMI). Design A randomised study. Setting Eighteen French tertiary hospitals. Population Women with fetuses of gestational age < 33 weeks whose birth was planned or expected within 24 hours were enrolled from July 1997 to July 2003 with follow up of infants until hospital discharge. Methods Five hundred and seventy-three mothers were randomly assigned to receive a single 40-ml infusion of 0.1 g/ml of MgSO4 (4 g) solution or isotonic 0.9% saline (placebo) over 30 minutes. This study is registered as an International Standard Randomised Controlled Trial, number 00120588. Main outcome measures The primary endpoints were rates of severe WMI or total mortality before hospital discharge, and their combined outcome. Analyses were based on intention to treat. Results After 6 years of enrolment, the trial was stopped. Data from 688 infants were analysed. Comparing infants who received MgSO4 or placebo, respectively, total mortality (9.4 versus 10.4%; OR: 0.79, 95% CI 0.44–1.44), severe WMI (10.0 versus 11.7%; OR: 0.78, 95% CI 0.47–1.31) and their combined outcomes (16.5 versus 17.9%; OR: 0.86, 95% CI 0.55–1.34) were less frequent for the former, but these differences were not statistically significant. No major maternal adverse effects were observed in the MgSO4 group. Conclusion Although our results are inconclusive, improvements of neonatal outcome obtained with MgSO4 are of potential clinical significance. More research is needed to assess the protective effect of MgSO4 alone or in combination with other neuroprotective molecules. [ABSTRACT FROM AUTHOR]

Objective To assess the long-term effects of in utero exposure to magnesium sulphate for children whose mothers had pre-eclampsia. Design Assessment at 18 months of age for children whose mothers were recruited to the Magpie Trial (recruitment 1998–2001 ISRCTN 86938761), which compared magnesium sulphate with placebo. Setting Follow-up of children born at 125 centres in 19 countries across five continents. Population A total of 6922 children were born to women randomised before delivery at follow-up centres. Of these, 2271 were not included for logistic reasons and 168 were excluded (101 at a centre where <20% were contacted, 40 whose death or disability was due to a problem at conception or embryogenesis and 27 whose parent/s opted out). Therefore, 4483 children were included in follow-up, of whom 3283 (73%) were contacted. Methods Assessment by questionnaire, with interview and neurodevelopmental testing of selected children. Main outcome measures Death or neurosensory disability at age of 18 months. Results Of those allocated magnesium sulphate, 245/1635 (15.0%) were dead or had neurosensory disability at 18 months compared with 233/1648 (14.1%) allocated placebo (relative risk [RR] 1.06, 95% CI 0.90–1.25), and of survivors, 19/1409 (1.3%) had neurosensory disability at 18 months compared with 27/1442 (1.9%) (RR 0.72, 95% CI 0.40–1.29). There were no substantial differences in causes of death or in the risk of individual impairments or disabilities. Conclusions The lower risk of eclampsia following prophylaxis with magnesium sulphate was not associated with a clear difference in the risk of death or disability for children at 18 months. [ABSTRACT FROM AUTHOR]

Objective The aim of this study was to assess long-term effects for women following the use of magnesium sulphate for pre-eclampsia. Design Assessment at 2–3 years after delivery for women recruited to the Magpie Trial (recruitment in 1998–2001, ISRCTN 86938761), which compared magnesium sulphate with placebo for pre-eclampsia. Setting Follow up after discharge from hospital at 125 centres in 19 countries across five continents. Population A total of 7927 women were randomised at the follow-up centres. Of these women, 2544 were not included for logistic reasons and 601 excluded (109 at a centre where <20% of women were contacted, 466 discharged without a surviving child and 26 opted out). Therefore, 4782 women were selected for follow-up, of whom 3375 (71%) were traced. Methods Questionnaire assessment was administered largely by post or in a dedicated clinic. Interview assessment of selected women was performed. Main outcome measures Death or serious morbidity potentially related to pre-eclampsia at follow up, other morbidity and use of health service resources. Results Median time from delivery to follow up was 26 months (interquartile range 19–36). Fifty-eight of 1650 (3.5%) women allocated magnesium sulphate died or had serious morbidity potentially related to pre-eclampsia compared with 72 of 1725 (4.2%) women allocated placebo (relative risk 0.84, 95% CI 0.60–1.18). Conclusions The reduction in the risk of eclampsia following prophylaxis with magnesium sulphate was not associated with an excess of death or disability for the women after 2 years. [ABSTRACT FROM AUTHOR]

Objective To determine the efficacy of oral mifepristone followed by vaginal misoprostol 6 hours later compared with the standard 36- to 48-hour regimen for medical termination of pregnancy. Design Single centre, two arm, parallel, open randomised controlled trial. Setting Medical termination service at a teaching hospital. Sample Four hundred and fifty women undergoing medical termination of pregnancy at up to 63 days of gestation. Methods Eligible women were randomised to receive mifepristone 200 mg orally followed by vaginal misoprostol 800 micrograms either 6 hours ( n= 225) or 36–48 hours ( n= 225) later. All participants were invited to attend for a follow-up pelvic ultrasound scan within 7 days following the misoprostol administration. For those women in whom products of conception remained at the follow-up ultrasound scan, expectant management ensued with weekly follow-up ultrasound scans until the termination was complete. They could elect to undergo an evacuation of uterus at any stage following the scan. Those women with a nonviable gestation sac at the follow-up scan were offered a further dose of vaginal misoprostol 800 micrograms or suction termination of pregnancy. Women with a continuing pregnancy were managed with surgical termination. Main outcome measure Successful medical abortion defined as no requirement for medical or surgical intervention beyond the initial dose of misoprostol. Results One hundred and sixty-five women (79%) in the 6-hour group and 197 women (92%) in the 36- to 48-hour group had a successful termination at first follow-up ultrasound or presumed on the basis of other considerations (those not seen for ultrasound but deemed successful by negative pregnancy test, products passed on ward or long-term assessment of notes). Twenty-two women (10%) in the 6-hour regimen required up to three further ultrasound scans after 7 days following the mifepristone administration in order to ensure that the termination process was complete. None of these women required a suction evacuation of uterus. In the 36- to 48-hour regimen, ten (5%) women had up to two further ultrasound scans to confirm a complete termination without the need for a surgical evacuation of uterus. Therefore, the overall successful termination rate in the 6-hour regimen was 89% (187/210) compared with 96% (207/215) in the 36- to 48-hour regimen (relative risk = 0.92, 95% CI 0.84–0.98). Repeat administration of misoprostol or surgical treatment was required in 23 women (11%) in the 6-hour group and 8 women (4%) in the 36- to 48-hour group. A viable pregnancy was found in five women (2%) in the 6-hour group and in three women (1%) in the 36- to 48-hour group. Conclusions Oral mifepristone 200 mg followed by vaginal misoprostol 800 micrograms after 6 hours is not as effective at achieving a complete abortion compared with the 36- to 48-hour protocol. [ABSTRACT FROM AUTHOR]