Amnioinfusion in preterm premature rupture of membranes (AMIPROM): a randomised controlled trial of amnioinfusion versus expectant management in very early preterm premature rupture of membranes--a pilot study.

BACKGROUND: Fetal survival is severely compromised when the amniotic membrane ruptures between 16 and 24 weeks of pregnancy. Reduced amniotic fluid levels are associated with poor lung development, whereas adequate levels lead to better perinatal outcomes. Restoring amniotic fluid by means of ultrasound-guided amnioinfusion (AI) may be of benefit in improving perinatal and long-term outcomes in children of pregnancies with this condition. OBJECTIVE: The AI in preterm premature rupture of membranes (AMIPROM) pilot study was conducted to assess the feasibility of recruitment, the methods for conduct and the retention through to long-term follow-up of participants with very early rupture of amniotic membranes (between 16 and 24 weeks of pregnancy). It was also performed to assess outcomes and collect data to inform a larger, more definitive, clinical trial. DESIGN: A prospective, non-blinded randomised controlled trial. A computer-generated random sequence using a 1 : 1 ratio was used. Randomisation was stratified for pregnancies in which the amniotic membrane ruptured between 16(+0) and 19(+6) weeks' gestation and 20(+0) and 24(+0) weeks' gestation. The randomisation sequence was generated in blocks of four. Telephone randomisation and intention-to-treat analysis were used. SETTING: Four UK hospital-based fetal medicine units - Liverpool Women's NHS Trust, St. Mary's Hospital, Manchester, Birmingham Women's NHS Foundation Trust and Wirral University Hospitals Trust. PARTICIPANTS: Women with confirmed preterm prelabour rupture of membranes between 16(+0) and 24(+0) weeks' gestation. Women with multiple pregnancies, resultant fetal abnormalities or obstetric indication for immediate delivery were excluded. INTERVENTIONS: Participants were randomly allocated to either serial weekly transabdominal AI or expectant management (Exp) until 37 weeks of pregnancy, if the deepest pool of amniotic fluid was < 2 cm. MAIN OUTCOME MEASURE: Short-term maternal, pregnancy and neonatal outcomes and long-term outcomes for the child were studied. Long-term respiratory morbidity was assessed using validated respiratory questionnaires at 6, 12 and 18 months of age and infant lung function was assessed at approximately 12 months of age. Neurodevelopment was assessed using Bayley's Scale of Infant Development II at a corrected age of 2 years. RESULTS: Fifty-eight women were randomised and two were excluded from the analysis owing to termination of pregnancy for lethal anomaly, leaving 56 participants (28 serial AI, 28 Exp) recruited between 2002 and 2009, with annual recruitment rates varying between 2 and 14. Recruitment to the study improved significantly from 2007 with National Institute for Health Research (NIHR) funding. There was no significant difference in perinatal mortality [19/28 vs. 19/28; relative risk (RR) 1.0; 95% confidence interval (CI) 0.70 to 1.43], maternal morbidity or neonatal morbidity. The overall chance of surviving without long-term respiratory or neurodevelopmental disability is 4/56 (7.1%): 4/28 (14.3%) in the AI arm and 0/28 in the expectant arm (0%) (RR 9.0; 95% CI 0.51 to 159.70). CONCLUSIONS: This pilot study found no major differences in maternal, perinatal or pregnancy outcomes. The study was not designed to show a difference between the arms and the number of survivors was too small to draw any conclusions about long-term outcomes. It does signal, however, that a larger, definitive, study to evaluate AI for improvement in healthy survival is indicated. The results suggest that, with appropriate funding, such a study is feasible. A larger, definitive, study with full health economic analysis and patient perspective assessment is required to show whether AI can improve the healthy survivor rate.

Women's perceptions of being pregnant and having pregestational diabetes.

OBJECTIVE: to explore the experiences of White British and South East Asian women with type 1 and type 2 diabetes, and the perceived impact of diabetes on their reproductive health. DESIGN: a hermeneutic phenomenological approach was used to explore the perceptions of women with diabetes from two different cultural backgrounds with varied reproductive health experiences. Focus groups and one-to-one interviews were used to elicit women's experiences. An interpretive analytical approach was conducted by two researchers. SETTING: obstetric and diabetes clinics in three hospital sites in the North West of England. PARTICIPANTS: a purposive sample of 22 women with type 1 or type 2 diabetes of different parity and ethnicity. FINDINGS: the main themes were relinquishing personal control, pregnancy overshadowed by diabetes and haphazard preconception care. KEY CONCLUSIONS: strategies should be developed to ensure that whilst safety is maintained, the pregnancy focus is not lost. Women should be supported to optimise their experience as well as clinical outcomes. The convergence of professional roles needs consideration; individual members of multidisciplinary diabetes teams should provide a unique and complementary contribution to care. Preconception care needs to be accessible and responsive to women; this should include recognition of socio-cultural differences.

Control of hypertension in pregnancy.

The hypertensive disorders of pregnancy are a leading cause of maternal mortality and morbidity. Complications are not limited to preeclampsia but also complicate both preexisting hypertension and isolated gestational hypertension. Blood pressure (BP) management is important but is only one aspect of management of the hypertensive disorders of pregnancy, which may be caused or exacerbated by underlying uteroplacental mismatch between maternal supply and fetal demand. BP treatment thresholds and goals vary in international guidelines, largely reflecting differences in opinion rather than differences in published data. Because of short-term maternal risks, there is consensus that BP should be treated when sustained at greater than or equal to 160 to 170 mm Hg systolic and/or 110 mm Hg diastolic. There is no consensus regarding management of nonsevere hypertension, and randomized controlled trials involving just over 3000 women have not clarified the relative maternal and perinatal risks and benefits. Although antihypertensive therapy may decrease transient severe maternal hypertension, therapy may also impair fetal growth and perinatal health and outcomes. The CHIPS Trial (Control of Hypertension In Pregnancy Study) is recruiting to answer this question.

Effect of different partogram action lines on birth outcomes: a randomized controlled trial.

OBJECTIVE: The World Health Organization recommends partograms with a 4-hour action line, denoting the timing of intervention for prolonged labor; others recommend earlier intervention. We assessed the effect of different action line positioning on birth outcomes. METHODS: A randomized trial of primigravid women with uncomplicated pregnancies, in spontaneous labor at term, was conducted in the northwest of England. Women were assigned to have their labors recorded on a partogram with an action line 2 or 4 hours to the right of the alert line. If progress crossed the action line, diagnosis of prolonged labor was made and managed according to standard protocol. Primary outcomes were rate of cesarean delivery and maternal satisfaction. RESULTS: A total of 3,000 women were randomly assigned to groups; 2,975 (99.2%) were available for analysis. Questionnaires were completed by 1,929 (65%) women. There were no differences in cesarean delivery rate (136/1,490 compared with 135/1,485; relative risk [RR] 1, 95% confidence interval [CI] 0.80-1.26) or women dissatisfied with labor experience (72/962 compared with 81/967; RR 0.89, 95% CI 0.66-1.21). More women assigned to the 2-hour arm had labors that crossed the action line (854/1,490 compared with 673/1,485; RR 1.27, 95% CI 1.18-1.37); received more intervention (772/1,490 compared with 624/1,485; RR 1.23, 95% CI 1.14-1.33); and, if admitted to the midwife-led unit, were transferred for consultant-led care (366/674 compared with 285/666; RR 1.26, 95% CI 1.13-1.42). CONCLUSION: In this birth setting, for primigravid women selecting low intervention care, the 2-hour partogram increases the need for intervention without improving maternal or neonatal outcomes, compared with the 4-hour partogram, advocated by the World Health Organization. CLINICAL TRIAL REGISTRATION: Current Controlled Trials, http://www.controlled-trials.com/isrctn/trial/|/0/78346801.html, ISRCTN78346801.

How to repair an anal sphincter injury after vaginal delivery: results of a randomised controlled trial.

OBJECTIVE: To compare two surgical techniques and two types of suture material for anal sphincter repair after childbirth-related injury. DESIGN: Factorial randomised controlled trial. SETTING: Tertiary referral maternity unit. POPULATION: Women with an anal sphincter injury sustained during childbirth. METHOD: Women were randomised into four groups: overlap repair with polyglactin (Vicryl); end-to-end repair with polyglactin (Vicryl); overlap repair with polydioxanone (PDS); and end-to-end repair with PDS. All repairs were completed as a primary procedure by staff trained in both methods. MAIN OUTCOME MEASURES: Suture-related morbidity at six weeks. Bowel symptoms at 3, 6 and 12 months. Anorectal physiology at three months. Quality of life scores at 3 and 12 months. RESULTS: One hundred and fifty women (1.5% of deliveries) were eligible and 112 (75%) were randomised. One hundred and three (92%) attended follow up visit at 6 weeks, 89 (80%) at 3 months, 79 (71%) at 6 months and 60 (54%) at 12 months. At six weeks, there was no difference in suture-related morbidity between groups (P=0.11) and 70% patients were completely asymptomatic. Incidence of bowel symptoms and quality of life disturbances were low, with no differences between the four groups. CONCLUSION: Obstetric anal sphincter repair carried out by appropriately trained staff is associated with low morbidity, irrespective of the suture material and repair method used.

Progress of first stage of labour for multiparous women: an observational study.

As there is no universal definition of 'normal' labour, diagnosing prolonged labour is inherently difficult. Simple charts (partograms) are used to aid this process; however, there are little empirical data on which to base such charts. Therefore, we monitored 403 multiparous women, in the first stage of labour with uncomplicated term pregnancies, in a midwife-led unit. They had vaginal examinations every 2 hours, and we modelled rates of cervical dilatation for all women, either to the end of the first stage of labour or to the point of transfer for intervention. Overall, the median rate of dilatation was 1.9 cm/hour and the 5th percentile was 0.5 cm/hour. There was a weak positive correlation between initial dilatation and rate of dilatation (r= 0.2). Individualised computer-based partograms incorporating some of the factors that affect progress might prove useful in the future.

Pregnancy in women with pre-existing diabetes: management issues.

Despite significantly increased input from multidisciplinary teams during the antenatal period, pregnancy outcomes for women with type 1 and type 2 diabetes remain substantially worse than that of the general obstetric population. Regarding fetal congenital malformations, these are likely to be preventable only by strategies introduced prior to pregnancy. The relationship between fetal macrosomia and glycaemic control is complex, and reducing the incidence of macrosomia may be possible only by novel management strategies that address the wide fluctuations in blood glucose over a 24-hour period. Irrespective of pregnancy diabetes control, the complication of neonatal hypoglycaemia can largely be avoided by tight control of glucose values during labour and delivery. The continued lack of understanding of the pathophysiology of late fetal death in diabetic pregnancies and the shortcomings of current methods of antenatal fetal surveillance make it likely that infants of diabetic mothers will continue to be delivered preterm, with the attendant implications of neonatal morbidity and cost.

Pregnancy outcome in severe placental abruption.

OBJECTIVE: To determine the relationship between decision to delivery interval and perinatal outcome in severe placental abruption. DESIGN: A case-control study. SETTING: Large inner city teaching hospital. METHODS: Retrospective case note review of pregnancies terminated following severe placental aburption and fetal bradycardia. One year paediatric follow up by case note review or postal questionnaire. The differences in outcome (death or cerebral palsy) were examined using non-parametric and univariate analysis for the following time periods--times from onset of symptoms to delivery, onset of symptoms to admission, admission to delivery, onset bradycardia to delivery and decision to delivery interval. MAIN OUTCOME MEASURES: Prenatal death or survival with cerebral palsy. RESULTS: Thirty-three women with singleton pregnancies over 28 weeks of gestation, admitted with clinically overt placental abruption, where delivery was effected for fetal bradycardia. Eleven of the pregnancies had a poor outcome (cases), eight infants died and three surviving infants have cerebral palsy. Twenty-two pregnancies had a good outcome (controls): survival with no developmental delay. No statistically significant relationship was found between maternal age, parity, gestation, or birthweight and a poor outcome. A statistically significant relationship between time from decision to delivery was identified (P = 0.02, Mann-Whitney U test). The results of a univariate logistic regression for this variable suggest that the odds ratio of a poor outcome for delivery at 20 minutes compared with 30 minutes is 0.44 (95% CI 0.22-0.86). Fifty-five percent of infants were delivered within 20 minutes of the decision to deliver. Serious maternal morbidity was rare. CONCLUSION: In this small study of severe placental abruption complicated by fetal bradycardia, a decision to delivery interval of 20 minutes or less was associated with substantially reduced neonatal morbidity and mortality.

Outcomes of pregnancies diagnosed with Klinefelter syndrome: the possible influence of health professionals.

OBJECTIVE: To describe the association between the outcomes of pregnancies diagnosed with Klinefelter syndrome (KS) and the specialty of the health professional providing pre- and post-diagnostic counselling. METHOD: Data were extracted from the case notes of the 111 cases of KS diagnosed prenatally between 1986 and 1997 in eight geographical regions in five European countries. The data extracted included: outcome of pregnancy, maternal age, social class, parity, gestational age at diagnosis, year of diagnosis and specialties of the health professionals conducting pre- and post-diagnosis consultations. RESULTS: The overall termination rate was 44% (49/111: 95% confidence interval: 35 to 54). Using multivariable logistic regression analysis, the only significant predictor of continuation of the pregnancy was the specialties of the health professionals conducting post-diagnosis counselling: the affected pregnancy was more likely to continue when post-diagnosis counselling involved only a genetics specialist (relative risk: 2.42 (1.14 to 5.92)). CONCLUSION: There is an association between whether or not a woman terminates a pregnancy affected by an unfamiliar fetal anomaly and the professional background of the health professional providing post-diagnostic counselling. The causal nature of this association remains to be determined.