Amnioinfusion in very early preterm prelabor rupture of membranes (AMIPROM): pregnancy, neonatal and maternal outcomes in a randomized controlled pilot study.

OBJECTIVE: To assess short- and long-term outcomes of pregnant women with very early rupture of membranes randomized to serial amnioinfusion or expectant management, and to collect data to inform a larger, more definitive clinical trial. METHODS: This was a prospective non-blinded randomized controlled trial with randomization stratified for pregnancies in which the membranes ruptured between 16 + 0 and 19 + 6 weeks' gestation and 20 + 0 and 23 + 6 weeks' gestation to minimize the risk of random imbalance in gestational age distribution between randomized groups. Intention-to-treat analysis was used. The study was conducted in 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). The participants were women with confirmed preterm prelabor rupture of membranes at 16 + 0 to 24 + 0 weeks' gestation. Women with multiple pregnancy, fetal abnormality or obstetric indication for immediate delivery were excluded. Participants were randomly allocated to either serial weekly transabdominal amnioinfusions if the deepest pool of amniotic fluid was < 2 cm or expectant management until 37 weeks' gestation. Short-term maternal, pregnancy and neonatal 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 test at around 12 months of age. Neurodevelopment was assessed using the Bayley Scales of Infant Development, second edition (BSID-II) at corrected age of 2 years. RESULTS: Fifty-eight women were randomized to the study. Two babies were excluded from the analysis because of termination of pregnancy for lethal anomaly, leaving 56 participants (28 assigned to serial amnioinfusion and 28 to expectant management) recruited between 2002 and 2009. There was no significant difference in perinatal mortality (19/28 vs 19/28; relative risk (RR) 1.0 (95% CI, 0.70-1.43)) and maternal or neonatal morbidity. The overall chance of surviving without long-term respiratory or neurodevelopmental disability was 4/56 (7.1%); 4/28 (14.3%) in the amnioinfusion group and 0/28 in the expectant group (RR 9.0 (95% CI, 0.51-159.70)). 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 groups and the number of survivors was too small to draw any conclusions about long-term outcomes. It does, however, signal that a larger definitive study to evaluate amnioinfusion for improvement in healthy survival is needed. The pilot suggests that, with appropriate funding, such a study is feasible.

A re-evaluation of the role of rotational forceps: retrospective comparison of maternal and perinatal outcomes following different methods of birth for malposition in the second stage of labour.

OBJECTIVE: To compare the outcomes of operative cephalic births by Kielland forceps (KF), rotational ventouse (RV), or primary emergency caesarean section (pEMCS) for malposition in the second stage of labour in modern practise. DESIGN: Retrospective observational study. POPULATION: Data were included from 1291 consecutive full-term, singleton cephalic births between 2 November 2006 and 30 November 2010 with malposition of the fetal head during the second stage of labour leading to an attempt to deliver by KF, RV or pEMCS. METHODS: Maternal and neonatal outcomes of all KF births were compared with other methods of operative birth for malposition in the second stage of labour (RV or pEMCS). MAIN OUTCOME MEASURES: Achieving a vaginal birth was the primary outcome and fetal (admission to special care baby unit, low cord pH, low Apgar, shoulder dystocia, Erb's palsy) and maternal (massive obstetric haemorrhage-blood loss of >1500 ml, sphincter injury, length of stay in hospital) safety outcomes were also recorded. RESULTS: Women were more likely to need caesarean section if RV (22.4%) was selected to assist the birth rather than KF (3.7%; adjusted odds ratio 8.20; 95% confidence interval 4.54-14.79). Births by KF had a rate of adverse maternal and neonatal outcomes comparable to those by RV and pEMCS in the second stage for malposition. CONCLUSIONS: Our results suggest that, in experienced hands, assisted vaginal birth by KF is likely to be the most effective and safe method to prevent the ever rising rate of caesarean sections when malposition complicates the second stage of labour.

Standard- or high-dose oxytocin for nulliparous women with confirmed delay in labour: quantitative and qualitative results from a pilot randomised controlled trial.

OBJECTIVE: Evidence suggests that a high dose of oxytocin for nulliparous women at 37-42 weeks of gestation with confirmed delay in labour increases spontaneous vaginal birth. We undertook a pilot study to test the feasibility of this treatment. DESIGN: Pilot double-blind randomised controlled trial. SETTING: Three teaching hospitals in the UK. POPULATION: A total of 94 consenting nulliparous women at term with confirmed delay in labour were recruited, and 18 were interviewed. METHODS: Women were assigned to either a standard (2 mU/min, increasing every 30 minutes to 32 mU/minute) or a high-dose regimen (4 mU/minute, increasing every 30 minutes to 64 mU/minutes) oxytocin by computer-generated randomisation. Simple descriptive statistics were used, as the sample size was insufficient to evaluate clinical outcomes. The constant comparative method was used to analyse the interviews. MAIN OUTCOMES MEASURES: The main outcome measures: number of women eligible; maternal and neonatal birth; safety; maternal psychological outcomes and experiences; health-related quality of life outcomes using validated tools and data on health service resource use; incidence of suspected delay of labour (cervical dilatation of <2 cm after 4 hours, once labour is established); and incidence of confirmed delay of labour (progress of <1 cm on repeat vaginal examination after a period of 2 hours). RESULTS: We successfully developed systems to recruit eligible women in labour and to collect data. Rates of spontaneous vaginal birth (10/47 versus 12/47, RR 1.2, 95% CI 0.6-2.5) and caesarean section (15/47 versus 17/47, RR 1.1, 95% CI 0.6-2.0) were increased, and rates of instrumental birth were reduced (21/47 versus 17/47, RR 0.8, 95% CI 0.5-1.3). No evidence of increased harm for either mother or baby was found. The incidences of suspected delay (14%) and confirmed delay (11%) in labour were less than anticipated. Of those who did not go on to have delayed labour confirmed, all except one woman gave birth vaginally. CONCLUSIONS: A pilot trial assessing the efficacy of high-dose oxytocin was feasible, but uncertainty remains, highlighting the need for a large definitive trial. The implementation of national guidance of suspected and confirmed delay in labour is likely to reduce intervention.

Pregnancies complicated by preeclampsia and non-preeclampsia-related nephrotic range proteinuria.

OBJECTIVE: To examine the impact of nephrotic range proteinuria during pregnancy on renal, maternal and fetal outcomes. METHODS: A retrospective study of pregnant women with proteinuria greater than 3 g/24 h. Outcome measures included: gestation and mode of delivery, maternal high dependency unit admission, birth weight, maternal blood pressure and proteinuria at time of last follow-up, renal biopsy. RESULTS: Two hundred and sixty four pregnancies in 262 women were reviewed. Postnatal data were available in 180; of these 104 (57%) had urinary protein quantified postnatally. Sixty three (60%) were pure preeclampsia and nine (9%) super-imposed preeclampsia. Biopsy-proven renal disease was newly diagnosed in nine (9%). Sixty three per cent required caesarean section and 34% required high dependency unit admission. There were no maternal deaths. Birth weight corrected for gestation was below the fifth centile in 33%. CONCLUSIONS: The incidence of underlying renal pathology in this cohort is significant and highlights the importance of careful follow-up.

A successful pregnancy in a Turner syndrome with oocyte donation.

Advances in reproductive medicine using oocyte donation have made it possible for women with Turner syndrome (TS) to achieve successful pregnancies. These pregnancies carry substantial fetal and maternal risks, with hypertensive disorders or pregnancy and fetal growth restriction common, and an increased risk of aortic dissection, sometimes fatal, for the woman. Careful prepregnancy assessment and fetal and maternal vigilance during pregnancy is a necessary prerequisite for a successful outcome. We present a case of a woman with Turner syndrome achieving a successful pregnancy from donor oocyte and review the relevant literature.

Substance abuse during pregnancy: effect on pregnancy outcomes.

OBJECTIVE: To determine the contribution of drug use to maternal and perinatal complications, controlling for social confounders. STUDY DESIGN: This is a retrospective cohort study of 247 drug-using women and 741 controls over a 4-year period from 1997 to 2000. Cases were identified from the drug dependency register. Three controls for each woman with substance abuse were selected from the delivery suite records, with calliper matching by year of delivery (any control patient who delivered within 6 months before or after the date of delivery of a drug-using woman was considered as a potential match) and district of residence (post code). The primary outcomes of interest were preterm birth, abruption, pre-eclampsia, intrauterine growth restriction and low birth weight. RESULTS: There were statistically significantly more preterm births amongst drug-using women (relative risk (RR) 2.5, 95% confidence interval (CI) 1.6-3.8), with preterm births complicating 25% of births amongst drug users. The incidence of low birth weight was 30.8% amongst drug-using women compared to 8% in control women (RR 3.6, CI 2.4-5.4), and the incidence of growth restriction was 25%, significantly higher than the control group (RR 3.82, CI 2.4-6.1). The risk of abruption was also higher (RR 2.74, CI 1.1-7.0). Of note is the extremely low incidence of pre-eclampsia among drug users, even after controlling for the confounder effects of parity and smoking. CONCLUSIONS: Despite multidisciplinary co-ordinated antenatal care, women with substance abuse during pregnancy are at significant risk of adverse obstetric and perinatal outcome, controlling for social confounders. A limitation of the study is that the sample size was not large enough to clearly assess individual drugs. This is the first study to highlight low incidence of pre-eclampsia among drug users over and above the effect of smoking. Further research is needed to elucidate the underlying biological reason for the lack of pre-eclampsia in women with substance abuse during pregnancy.

WITHDRAWN: Dietary regulation for 'gestational diabetes'.

BACKGROUND: Impaired glucose metabolism in pregnancy may be associated with adverse pregnancy outcomes. Primary dietary therapy is used in the management of diabetes, including gestational diabetes. OBJECTIVES: The objective of this review was to assess the effects of primary dietary therapy in women identified as having gestational diabetes on fetal growth and neonatal outcomes. SEARCH STRATEGY: I searched the Cochrane Pregnancy and Childbirth Group trials register. SELECTION CRITERIA: Randomised trials of primary dietary therapy compared with no specific treatment in pregnant women with abnormal glucose tolerance test results. DATA COLLECTION AND ANALYSIS: Trial quality was assessed. MAIN RESULTS: Four studies involving 612 women were included. Trials were small and of variable quality. No differences were detected between primary dietary therapy and no primary dietary therapy for birthweight greater than 4000 grams (odds ratio 0.78, 95% confidence interval 0.45 to 1.35) or caesarean deliveries (odds ratio 0.97, 95% confidence interval 0.65 to 1.44). AUTHORS' CONCLUSIONS: There is not enough evidence to evaluate the use of primary dietary therapy for women who show impaired glucose metabolism during pregnancy.

WITHDRAWN: Very tight versus tight control for diabetes in pregnancy.

BACKGROUND: Pregnancies complicated by pre-existing insulin dependent diabetes are high risk for a number of poor pregnancy and neonatal outcomes. OBJECTIVES: The objective of this review was to assess the effects of very tight glycaemic control in established insulin dependence. SEARCH STRATEGY: The Cochrane Pregnancy and Childbirth Group trials register was searched. SELECTION CRITERIA: Randomised trials comparing very tight with tight control of diabetes in pregnancy. DATA COLLECTION AND ANALYSIS: One reviewer assessed trial quality and extracted data. MAIN RESULTS: Two trials involving 182 women were involved. The two trials were difficult to compare. Maternal hypoglycaemia was more common among women whose diabetic control was very tight compared to tight control (odds ratio 25.96, 95% confidence interval 4.91 to 137.26) based on one trial. There was no difference detected in perinatal outcome between the groups. AUTHORS' CONCLUSIONS: There appears to be no clear evidence of benefit from very tight glycaemic control for pregnant diabetic women. Since very strict control may have a substantial impact on lifestyle, this suggests caution in advising such a degree of control.

Treatments for gestational diabetes and impaired glucose tolerance in pregnancy.

BACKGROUND: Gestational diabetes and impaired glucose tolerance (IGT) in pregnancy affects between 3 and 6% of all pregnancies and both have been associated with pregnancy complications. A lack of conclusive evidence has led clinicians to equate the risk of adverse perinatal outcome with pre-existing diabetes. Consequently, women are often intensively managed with increased obstetric monitoring, dietary regulation, and in some cases insulin therapy. However, there has been no sound evidence base to support intensive treatment. The key issue for clinicians and consumers is whether treatment of gestational diabetes and IGT will improve perinatal outcome. OBJECTIVES: The objective of this review was to compare alternative policies of care for women with gestational diabetes and IGT in pregnancy. SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group trials register (12 September 2002) and the bibliographies of relevant papers. The Cochrane Central Register of Controlled Trials was also searched (The Cochrane Library, Issue 3, 2002). SELECTION CRITERIA: Randomised controlled trials comparing alternative management strategies for women with gestational diabetes and IGT in pregnancy. DATA COLLECTION AND ANALYSIS: Quality was assessed according to the criteria defined by the Cochrane Reviewers' Handbook. Data were extracted and checked independently by two reviewers. Any disagreements were resolved through discussion with the third reviewer. MAIN RESULTS: Three studies with a total of 223 women were included. All three included studies involved women with IGT. No trials reporting treatments for gestational diabetes met the criteria. There are insufficient data for any reliable conclusions about the effect of treatments for IGT on perinatal outcome. The difference in abdominal operative delivery rates is not statistically significant (relative risk (RR) 0.86, 95% confidence interval 0.51 to 1.45) and the effect on special care baby unit admission is also not significant (RR 0.49, 95% confidence interval (CI) 0.19 to 1.24). Reduction in birthweight greater than 90th centile (RR 0.55, 95% CI 0.19 to 1.61) was not found to be significant. This review suggests that an interventionist policy of treatment may be associated with a reduced risk of neonatal hypoglycaemia (RR 0.25, 95% CI 0.07 to 0.86). No other statistically significant differences were detected. A number of outcomes are only reported by one study resulting in a small sample and wide confidence intervals. REVIEWER'S CONCLUSIONS: There are insufficient data for any reliable conclusions about the effects of treatments for impaired glucose tolerance on perinatal outcome.

Serious perinatal complications of non-proteinuric hypertension: an international, multicentre, retrospective cohort study.

OBJECTIVE: To determine the proportion of births complicated by either a pre-existing or a gestational non-proteinuric hypertension, presenting at <34 weeks' gestation, and the associated incidence with 1 or more serious perinatal complications or birth weight <3rd centile for gestational age. METHODS: A retrospective chart review was conducted in 5 international centres, from 1998 to 2002, where "tight" control (normalization) of blood pressure (BP) is the norm. International Classification of Diseases (ICD) codes were used to identify women who delivered at > or =20 weeks' gestation, with any hypertensive disorder of pregnancy. Women were included if they had a diastolic blood pressure (dBP) of 90 to 109 mm Hg, due to either a pre-existing or a gestational non-proteinuric hypertension, presenting at <34 weeks' gestation. Women were excluded if they had ongoing severe hypertension, or if at presentation with dBP of 90 to 109 mm Hg, they had 1 or more of the following: proteinuria, an indication for "tight" control of BP or imminent delivery, or a known intrauterine fetal death or lethal fetal anomaly. Data were collected on paper forms, scanned into an electronic database, and summarized descriptively by type of hypertension. RESULTS: There were 305 eligible women (0.7% deliveries, 12.8% hypertensive deliveries) identified with non-proteinuric hypertension that was either pre-existing (133 [43.6%]) or gestational (172 [56.4%]). Regardless of hypertension type, 16.4% (n = 50) of pregnancies were complicated by birth weight <3rd centile or 1 or more serious perinatal complications, 34.3% (n = 100) by preterm birth, 30.8% (n = 94) by preeclampsia, and 2.0% (n = 6) by serious maternal complications. CONCLUSION: Non-proteinuric pre-existing or gestational hypertension, presenting before 34 weeks' gestation, identifies a subpopulation of hypertensive pregnant women at both substantial perinatal risk and maternal risk. The CHIPS (Control of Hypertension In Pregnancy Study) trial is designed to determine how best to manage the hypertension of such women in order to optimize perinatal outcome.

St Vincent's Declaration 10 years on: outcomes of diabetic pregnancies.

AIMS: To monitor pregnancies in women with pregestational Type 1 diabetes for pregnancy loss, congenital malformations and fetal growth parameters, in a geographically defined area in the north west of England. METHODS: Population cohort study of 547 pregnancies in women with Type 1 diabetes from maternity clinics in 10 centres over a 5-year period (1995-1999 inclusive). Main outcome measures were numbers and rates of miscarriages, stillbirths, neonatal and post-neonatal deaths; prevalence of congenital malformations; birth weight in relation to gestational age. RESULTS: Among 547 pregnancies, there were six (1.1%) pairs of liveborn twins, 439 (80.3%) liveborn singletons; 72 (13.2%) spontaneous abortions, 14 (2.6%) stillbirths and 16 (2.9%) terminations. Four of the terminations were performed because of congenital malformations. Both the stillbirth rate (30.1/1000 total births (95% confidence interval (CI) 16.6-50.0)), and prevalence of congenital malformations (84.3/1000 live births (95% CI 60.3-113.8)) were significantly higher than the local population (P < 0.001). When corrected for gestational age, mean birth weight in the sample was 1.3 sd greater than that of infants of non-diabetic mothers (P = 0.12). Infants with congenital malformations weighed less than those without. CONCLUSION: In an unselected population, the infants of women with pregestational Type 1 diabetes mellitus have 6.4 times the reported risk of a congenital malformation and 5.1 times the reported risk of perinatal mortality than infants in the general population. Further improvements in the management of diabetes and pregnancy in these women are needed if the St Vincent's Declaration target is to be met.

Major postpartum haemorrhage.

Postpartum haemorrhage remains in the top five causes of maternal deaths in both developed and developing countries. Persistent blood loss of more than 1000 ml should prompt predetermined measures to achieve resuscitation and haemostasis. A protocol including guidelines is given and volume replacement is discussed. The range of medical and surgical interventions that may be considered for the modern management of major haemorrhage unresponsive to oxytocin and ergometrine are presented. The review discusses in depth the use of misoprostol, recombinant activated factor VII, the uterine tamponade procedures, artery ligation, and uterine haemostatic suturing techniques. It also evaluates the place of interventional radiology and hysterectomy in modern obstetrics.

Extracranial vascular malformation: value of antenatal and postnatal MRI in management.

We report a case where fetal MRI using a low-field-strength magnet (0.5 T) accurately confirmed a large extracranial vascular malformation, which was suspected on antenatal US. Fetal MRI enabled better counselling of the parents and allowed suitable plans to be made regarding method of delivery and early management of the neonate. To our knowledge this is the first case of an extracranial vascular malformation imaged using fetal MRI.

Computerised analysis of fetal heart rate recordings in maternal type I diabetes mellitus.

OBJECTIVE: 1. To study computerised cardiotocograph parameters from women with type I diabetes; 2. to examine the significance of observed differences from the expected normal values. DESIGN: Prospective observational study in the third trimester of pregnancy. SETTING: The medical antenatal clinic of a tertiary referral centre. POPULATION: Twenty-six women with type I diabetes mellitus with a singleton pregnancy. METHODS: Computerised cardiotocograph recordings were made weekly from 28 to 39 weeks. Derived parameters were compared with the published figures for uncomplicated singleton pregnancies. Details of maternal blood sugar, labour and delivery and neonatal outcome were recorded. Data were compared between groups according to the computerised analysis of the antenatal CTGs. RESULTS: One-hundred and thirty-one recordings were made with a median of five per patient (range 1-12). 1 1.3% showed absent episodes of high variation compared with the expected value of 0.8%, a difference of 9.5% (95% CI 4.5-15.3). Differences in short term variation, basal heart rate, frequency of fetal movements and heart rate accelerations were also found which changed with gestation. Overall these changes represented a more immature form of fetal heart rate than that which would be expected. No relationship between the changes and adverse fetal outcome could be identified. CONCLUSIONS: Significant differences exist in cardiotocographs in maternal type I diabetes compared with normal fetuses. The changes may represent a delay in fetal maturation. The analysis mode of the computer will register these as abnormal features, but there is no evidence that they are pathological. We would recommend that computerised analysis is not used to assess pregnancies complicated by maternal type I diabetes mellitus.

Computerised antenatal fetal heart rate recordings between 24 and 28 weeks of gestation.

OBJECTIVE: To assess computerised fetal heart rate recordings between 24 and 28 weeks of gestation for gestation related differences. DESIGN: Prospective, cross sectional observational study. SETTING: Liverpool Women's Hospital. POPULATION: 112 women: 28 at 27 weeks, 30 at 26 weeks, 27 at 25 weeks and 27 at 24 weeks of gestation, respectively. METHODS: Fetal heart recordings of 60 minutes duration were performed once in each pregnancy using the System 8000 fetal heart rate programme (System 8000, Oxford Sonicaid Ltd, Chichester, UK). For each gestational age, records were analysed for short term variation, basal heart rate, accelerations and time spent in high episodes. RESULTS: The mean short term variation increased with gestation (P = 0.05). No record had a short term variation <4 msecs. There was no relationship between heart rate and increasing gestation. The mean number of accelerations per record increased with increasing gestation (P < 0.01). 20% of recordings showed no accelerations > 15 bpm. The mean duration spent in episodes of high variation increased with gestation (P = 0.05). 13% of recordings showed no time spent in high episodes. All fetuses had normal outcomes at delivery. CONCLUSIONS: Absence of episodes of high variation or absence of accelerations is not an abnormal finding at lower gestations. The standard threshold of 4 msecs for short term variation appears to remain valid at lower gestations. These differences should be considered when using computerised CTG analysis at early gestations.

Reducing postnatal pain from perineal tears by using lignocaine gel: a double-blind randomized trial.

BACKGROUND: Perineal pain is one of the most common causes of maternal morbidity in the early puerperium. Several randomized trials have shown that topical application of local anesthetics is effective in reducing postepisiotomy pain, but no randomized study has assessed the efficacy of local anesthetics for other perineal trauma. This study investigated if topically applied 2 percent lignocaine gel was an effective treatment for this group of women. METHODS: A double-blind placebo controlled trial was conducted in a regional teaching hospital in the northwest of England. One hundred and forty-nine women who had sustained a first- or second-degree tear were allocated by sealed envelopes to the lignocaine gel or placebo group. The primary outcome was self-reported pain at 24 hours postdelivery as measured on a numerical rating scale (pain score). Secondary outcomes included pain scores at 48 hours, the need for oral analgesia, and maternal satisfaction. Based on a pilot study, we calculated that 128 women were required to detect a 25 percent difference in pain scores between the two groups with 80 percent power (alpha = 0.05). The pain scores of women in each trial arm were compared using the unpaired t test and 95 percent confidence intervals. RESULTS: Women using lignocaine gel had lower average pain scores, although this only reached statistical significance at 48 hours after delivery (p = 0.023). In general, women liked using the study gel. No difference was found in consumption of oral analgesia. CONCLUSIONS: This study suggested that lignocaine gel may be effective on the second postnatal day. Further research is required to assess the optimum timing of this intervention and the population that would most benefit from its use.

Congenital cystic adenomatoid malformation of the lung coexisting with recombinant chromosome 18. A case report.

OBJECTIVE: Diagnosis of congenital cystic adenomatoid malformation of the lung (CCAM) in association with recombinant chromosome 18. METHOD: Ultrasound diagnosis of a CCAM and hydrops was made. The mother was known to have a pericentric inversion of chromosome 18 and had a previous pregnancy with a recombinant chromosome 18 (partial deletion of 18p and partial duplication of 18q). Cordocentesis for karyotype was therefore performed. RESULT: Fetal karyotype revealed a recombinant chromosome 18, this time with partial deletion of 18q and partial duplication of 18p. Postmortem confirmed a type III CCAM and a septum primum atrial defect. CONCLUSIONS: Although deletion/duplication of chromosome 18 is commonly associated with a wide variety of anomalies, the association with CCAM is an unusual one. Fetal and parental karyotyping should be considered in cases of CCAM, because fetal therapy is increasingly being considered in these pregnancies. Current management of parents with pericentric inversions must rely on invasive diagnostic testing in the second trimester because predicting the likelihood of an unbalanced karyotype and phenotype in a fetus is difficult.