Summary Background Previous prospective cohort studies have shown that angiogenic factors have a high diagnostic accuracy in women with suspected pre-eclampsia, but we remain uncertain of the effectiveness of these tests in a real-world setting. We therefore aimed to determine whether knowledge of the circulating concentration of placental growth factor (PlGF), an angiogenic factor, integrated with a clinical management algorithm, decreased the time for clinicians to make a diagnosis in women with suspected pre-eclampsia, and whether this approach reduced subsequent maternal or perinatal adverse outcomes. Methods We did a multicentre, pragmatic, stepped-wedge cluster-randomised controlled trial in 11 maternity units in the UK, which were each responsible for 3000–9000 deliveries per year. Women aged 18 years and older who presented with suspected pre-eclampsia between 20 weeks and 0 days of gestation and 36 weeks and 6 days of gestation, with a live, singleton fetus were invited to participate by the clinical research team. Suspected pre-eclampsia was defined as new-onset or worsening of existing hypertension, dipstick proteinuria, epigastric or right upper-quadrant pain, headache with visual disturbances, fetal growth restriction, or abnormal maternal blood tests that were suggestive of disease (such as thrombocytopenia or hepatic or renal dysfunction). Women were approached individually, they consented for study inclusion, and they were asked to give blood samples. We randomly allocated the maternity units, representing the clusters, to blocks. Blocks represented an intervention initiation time, which occurred at equally spaced 6-week intervals throughout the trial. At the start of the trial, all units had usual care (in which PlGF measurements were also taken but were concealed from clinicians and women). At the initiation time of each successive block, a site began to use the intervention (in which the circulating PlGF measurement was revealed and a clinical management algorithm was used). Enrolment of women continued for the duration of the blocks either to concealed PlGF testing, or after implementation, to revealed PlGF testing. The primary outcome was the time from presentation with suspected pre-eclampsia to documented pre-eclampsia in women enrolled in the trial who received a diagnosis of pre-eclampsia by their treating clinicians. This trial is registered with ISRCTN, number 16842031. Findings Between June 13, 2016, and Oct 27, 2017, we enrolled and assessed 1035 women with suspected pre-eclampsia. 12 (1%) women were found to be ineligible. Of the 1023 eligible women, 576 (56%) women were assigned to the intervention (revealed testing) group, and 447 (44%) women were assigned to receive usual care with additional concealed testing (concealed testing group). Three (1%) women in the revealed testing group were lost to follow-up, so 573 (99%) women in this group were included in the analyses. One (<1%) woman in the co...
Objective To evaluate the reproductive outcome and the mode of delivery in subsequent pregnancies after instrumental vaginal delivery in theatre or caesarean section at full dilatation. Design Prospective cohort study. Setting Two urban hospitals with a combined total of 10 000 deliveries a year. Participants A cohort of 393 women with term, singleton, cephalic pregnancies who needed operative delivery in theatre during the second stage of labour from February 1999 to February 2000. Postal questionnaires were received from 283 women (72%) at three years after the initial delivery. Main outcome measure Mode of delivery in the subsequent pregnancy. Results 140 women (49%) achieved a further pregnancy at three years. 91/283 (32%) women wished to avoid a further pregnancy. Women were more likely to aim for vaginal delivery (87% (47/54) v 33% (18/54); adjusted odds ratio 15.55 (95% confidence interval 5.25 to 46.04)) and more likely to have a vaginal delivery (78% (42/54) v 31% (17/54); 9.50 (3.48 to 25.97)) if they had had a previous instrumental vaginal delivery rather than a caesarean section. There was a high rate of vaginal delivery after caesarean section among women who attempted vaginal delivery 17/18 (94%). In both groups, fear of childbirth was a frequently reported reason for avoiding a further pregnancy (51% after instrumental vaginal delivery, 42% after caesarean section; 1.75 (0.58 to 5.25)). Conclusion Instrumental vaginal delivery offers advantages over caesarean section for future delivery outcomes. The psychological impact of operative delivery requires urgent attention.
Objective To compare the maternal and neonatal outcomes of operative vaginal delivery in relation to the use of episiotomy. Design Pilot randomised controlled trial (RCT).Setting Two urban maternity units in Scotland and England.Sample Nulliparous women anticipating a singleton cephalic vaginal delivery were recruited in the antenatal period.Methods If an operative vaginal delivery was required in the second stage of labour, women were randomised to either routine (in all cases) or restrictive (only if tearing apparent) use of episiotomy.Main outcome measures The primary outcome was anal sphincter tearing (third or fourth degree). Secondary outcomes included postpartum haemorrhage (PPH), neonatal trauma and pelvic floor symptoms up until 10 days postpartum.Results In a group of 317 women requiring operative vaginal delivery, 200 were randomised: 99 to routine use of episiotomy and 101 to restrictive use. There were small differences in the rates of anal sphincter tears (8.1% routine versus 10.9% restrictive, OR 0.72, 95% CI 0.28-1.87) and primary PPH (36.4% routine versus 26.7% restrictive, OR 1.57, 95% CI 0.86-2.86). Neonatal trauma was similar between the two groups (45.5% routine versus 43.6% restrictive, OR 1.08, 95% CI 0.62-1.89), as was prolonged catheterisation, urinary incontinence, faecal incontinence, perineal infection and prolonged hospital admission.Conclusions This pilot study does not provide conclusive evidence that a policy of routine episiotomy is better or worse than a restrictive policy. A definitive RCT is feasible but will require a large sample size to inform clinical practice.Keywords Anal sphincter tears, episiotomy, operative vaginal delivery, randomised controlled trial.Please cite this paper as: Murphy D, Macleod M, Bahl R, Goyder K, Howarth L, Strachan B. A randomised controlled trial of routine versus restrictive use of episiotomy at operative vaginal delivery: a multicentre pilot study.
This is a national survey of UK obstetric trainees and consultant labour ward leads designed to investigate current practice and training for impacted fetal head (IFH) at caesarean section (CS). An anonymous, on-line survey was disseminated to trainees via Postgraduate Schools and RCOG trainee representatives, and to labour ward leads via their national network. 345 are using techniques which have not been investigated and are not recommended for managing an IFH. Moreover, this survey is an eye-opener as to the paucity of training, highlighting that UK obstetric trainees are not adequately prepared to manage this emergency. What are the implications of these findings for clinical practice and further research?There is a pressing need to standardize the definition, guidance and training for IFH at CS. Further research should clarify appropriate techniques for IFH and establish consensus for best practice. An evidence-based simulation training package, which allows clinicians to learn and practice recognized disimpaction techniques is urgently required.
Objective To evaluate the maternal and neonatal morbidity of operative vaginal delivery in relation to the use of episiotomy.Design Prospective cohort study.Setting Two urban maternity units in Scotland and England.Population All nonrandomised nulliparous women delivered by forceps or vacuum during the recruitment period of a clinical trial evaluating the use of episiotomy at operative vaginal delivery.Methods Use of episiotomy was compared to no episiotomy for all operative vaginal deliveries with sub-group analyses for forceps or vacuum deliveries.Main outcome measures The primary outcome was anal sphincter tearing (third or fourth degree). Secondary outcomes included postpartum haemorrhage, neonatal trauma and pelvic floor symptoms up until 10 days postpartum.Results A total of 1360 women were included in the study, of whom 294 (21.6%) did not receive an episiotomy. Vacuum delivery was associated with less use of episiotomy than forceps (56.1 versus 89.4%, OR 0.15, 95% CI 0.11-0.20). Anal sphincter tear rates were not statistically different with use of episiotomy compared with no episiotomy (9.9 versus 7.1%, adjusted OR 1.11, 95% CI 0.66-1.87). Episiotomy use was associated with higher rates of postpartum haemorrhage (28.5 versus 18.4%, adjusted OR 1.72, 95% CI 1.21-2.45), need for moderate or strong analgesia (90.5 versus 67.6%, adjusted OR 3.70, 95% CI 2.60-5.27), perineal infection (5.1 versus 1.4%, adjusted OR 4.04, 95% CI 1.44-11.37) and neonatal trauma (38.1 versus 22.0%, adjusted OR 1.65, 95% CI 1.20-2.27). Use of episiotomy did not reduce the risk of shoulder dystocia (3.5 versus 1.7%, adjusted OR 1.42, 95% CI 0.53-3.85).Conclusions The use of episiotomy did not reduce or greatly increase anal sphincter tears and was associated with greater maternal and neonatal morbidity. This may reflect the complexity of deliveries. The role of episiotomy at operative vaginal delivery should be evaluated in a randomised controlled trial.Keywords Anal sphincter tear, episiotomy, operative vaginal delivery, prospective cohort study.
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