The Collaborative Randomised Amnioinfusion for Meconium project (CRAMP): 2. Zimbabwe

Objective To evaluate transcervical amnioinfusion for meconium stained amniotic fluid during labour.
Design Multicentre randomised controlled trial.
Setting A large urban academic hospital. Electronic fetal heart rate monitoring was not used.
Participants Women in labour at term with moderate or thick meconium staining of the amniotic fluid.
Interventions Transcervical amnioinfusion of 500 mL saline over 30 minutes, then 500 mL at 30 drops per minute. The control group received routine care. Blinding of the intervention was not possible.
Main outcome measures Caesarean section, meconium aspiration syndrome and perinatal mortality.
Results There was no difference in risk for caesarean section in the two groups (amnioinfusion 9.5% vs control 12.3%; RR 0.84, 95% CI 0.53–1.32). Meconium aspiration syndrome was significantly less frequent in the amnioinfusion group (3.1% vs 12.8%; RR 0.24, 95% CI 0.12–0.48), and there was a trend towards fewer perinatal deaths (1.2% vs 3.6%; RR 0.34, 95% CI 0.11–1.06).
Conclusions Amnioinfusion is technically feasible in a developing country situation with limited intrapartum facilities. In this study amnioinfusion for meconium stained amniotic fluid was associated with striking improvements in perinatal outcome.     

Aromatherapy in childbirth: a pilot randomised controlled trial

Objectives  We aimed to determine the feasibility of conducting a randomised controlled trial (RCT) on the use of aromatherapy during labour as a care option that could improve maternal and neonatal outcomes.
Design  RCT comparing aromatherapy with standard care during labour.
Setting  District general maternity unit in Italy.
Sample  Two hundred and fifty-one women randomised to aromatherapy and 262 controls.
Methods  Participants randomly assigned to administration of selected essential oils during labour by midwives specifically trained in their use and modes of application.
Main outcome measures  Intrapartum outcomes were the following: operative delivery, spontaneous delivery, first- and second-stage augmentation, pharmacological pain relief, artificial rupture of membranes, vaginal examinations, episiotomy, labour length, neonatal wellbeing (Apgar scores) and transfer to neonatal intensive care unit (NICU).
Results  There were no significant differences for the following outcomes: caesarean section (relative risk [RR] 0.99, 95% CI: 0.70–1.41), ventouse (RR 1.5, 95% CI: 0.31–7.62), Kristeller manoeuvre (RR 0.97, 95% CI: 0.64–1.48), spontaneous vaginal delivery (RR 0.99, 95% CI: 0.75–1.3), first-stage augmentation (RR 1.01, 95% CI: 0.83–1.4) and second-stage augmentation (RR 1.18, 95% CI: 0.82–1.7). Significantly more babies born to control participants were transferred to NICU, 0 versus 6 (2%), P = 0.017. Pain perception was reduced in aromatherapy group for nulliparae. The study, however, was underpowered.
Conclusion  This study demonstrated that it is possible to undertake an RCT using aromatherapy as an intervention to examine a range of intrapartum outcomes, and it provides useful information for future sample size calculations.     

Titrated oral misoprostol solution for induction of labour: a multi-centre, randomised trial

Objectives To determine the effects of titrated oral misoprostol solution, compared with vaginal dinoprostone.
Study design Open, randomised clinical trial.
Setting Academic hospitals in South Africa and Liverpool, UK.
Methods Women undergoing induction of labour after 34 weeks of pregnancy were allocated by randomised, sealed opaque envelopes, to induction of labour with titrated oral misoprostol solution, or two doses of vaginal dinoprostone (2mg) administered six hours apart. Failure to deliver within 24 hours of randomisation was the primary outcome on which the sample size was based. The data were analysed by intention-to-treat.
Results Six hundred and ninety-five women were randomly allocated: 346 to oral misoprostol and 349 to vaginal dinoprostone. There were no significant differences in substantive outcomes. Vaginal delivery within 24 hours was not achieved in 38% of women in the oral misoprostol group and 36% in the vaginal dinoprostone group (RR 1.08; 95% CI 0.89-1.31). The caesarean section rates were 16% and 20%, respectively (RR 0.80; 95% CI 0.58-1.11). Hyperstimulation with fetal heart rate changes occurred in 4% of women in the oral misoprostol group and 3% after vaginal dinoprostone (RR 1.32, 95% CI 0.59–2.98). The response to induction of labour in women with unfavourable cervices was somewhat slower with misoprostol when membranes were intact, and with dinoprostone when membranes were ruptured. There were no differences in neonatal outcome between the two groups.
Conclusions This new approach to oral misoprostol administration was successful in minimising the risk of uterine hyperstimulation, which has been a feature of misoprostol use for induction of labour, at the expense of a somewhat slower response in women with intact membranes and unfavourable cervices. Misoprostol is not registered for use in pregnant women, and further research is needed to confirm optimal and safe dosages.     

Sublingual compared with oral misoprostol in term labour induction: a randomised controlled trial

Objective To compare the efficacy and patient acceptability of 50 μg of sublingual misoprostol with 100 μg of oral misoprostol in the induction of labour at term.
Design Non-blinded randomised comparative trial.
Setting Tertiary level UK Hospital.
Sample Two hundred and fifty women at term with indications for labour induction.
Methods Fifty micrograms of sublingual misoprostol or 100 μg of oral misoprostol was administered every four hours after random allocation, to a maximum of five doses.
Main outcome measures Number of patients delivering vaginally within 24 hours of the induction, mode of delivery, neonatal outcomes and patient acceptability.
Results There was no significant difference in the number of women delivering vaginally within 24 hours of the induction in the sublingual group as compared with the oral group (62.8% vs 59%, RR 1.1, 95% CI 0.6–2.1), or in the mean induction to delivery time (21.8 vs 24.1 h, mean difference 2.3 h 95% CI −2.2 to +6.7). There was no difference in the uterine hyperstimulation rates (1.6% in both groups), operative delivery rates or neonatal outcomes. In the sublingual group, 92.6% found the induction acceptable with 15.8% finding the tablets with an unpleasant taste, while in the oral group it was 96.9% and 4%, respectively. More patients in the oral group thought that they would consider the same method of induction again as compared with the sublingual group (58.6% vs 40%, RR 1.4, 95% CI 1.04–1.9).
Conclusion Fifty micrograms of sublingual misoprostol every four hours has the same efficacy and safety profile as compared with 100 μg orally, but the oral route might be preferred by women.     

Randomised trial comparing a policy of early with selective amniotomy in uncomplicated labour at term

Objective To compare two management policies: rupture of the fetal membranes when women are in normal labour or leave them intact as long as feasible.
Setting The labour ward of a city university hospital.
Design Automated randomised clinical trial.
Participants 1540 women in uncomplicated term labour. Data on labour duration, blood loss, oxytocin use and fetal condition were collected from 1132 women. Some data from nulliparous women has been presented earlier by the UK Amniotomy Group.
Main outcome measures Duration of labour, Apgar score, fetal morbidity and maternal morbidity including perineal injury, mode of delivery, epidural rates and the total number of vaginal examinations in the first stage of labour after amniotomy.
Interventions Amniotomy at the next vaginal examination or amniotomy only if indicated. The median cervical dilatation at membrane rupture was 2 cm greater in the first group.
Results A policy of routine amniotomy in labour had no measurable advantage over selective amniotomy for parous women (difference = 4 min) but shortened labour in nulliparous women by 1 h (Mann-Whitney U test:   P < 0.05  ). There was a suggestion of a higher caesarean section rate (OR 1.9; 95% CI 0.9–3.5), and there were more vaginal examinations after membrane rupture in the group allocated routine amniotomy. There were no measurable differences in oxytocin use, fetal condition at birth, retained placenta rates, blood loss, pain or analgesia requirements.
Conclusion Routine amniotomy may shorten the first labour but not subsequent ones. There is a suggestion that routine surgical interference may be harmful by increasing the risk of caesarean section, and this agrees with data from other trials (common odds ratio 1.2; 95% CI 0.92–1.6).     

Side effects of oral misoprostol during the first 24 hours after administration in the third stage of labour

Objective To evaluate the side effects of 600 μg misoprostol orally during the first 24 hours after administration in the third stage of labour.
Design Double blind randomised controlled trial.
Setting Tertiary care hospitals in Nigeria and Thailand.
Sample All women participating in the WHO Misoprostol trial in these two hospitals between January 1, 1999 and June 17, 1999.
Methods All women were followed up during the first 24 hours postpartum to evaluate the occurrence of shivering, nausea, vomiting, diarrhoea and other misoprostol-related side effects.
Main outcome measures Rates of shivering, nausea, vomiting, diarrhoea and pyrexia within 1 hour and in the intervals 2–6, 7–12, 13–18 and 19–24 hours after delivery.
Results A total of 1686 women were enrolled. Women who received misoprostol had higher incidence than the oxytocin group of 'any' shivering in the first hour (RR 6.4, 95% CI 3.9 to 10.4) and the period covering 2–6 hours following delivery (RR 4.7, 95% CI 1.9 to 11.2). Pyrexia was also more common in the misoprostol group in both the same time intervals (RR 2.8, 95% CI 1.4 to 5.3 and RR 6.3, 95% CI 3.7 to 10.8, respectively). Diarrhoea was not present in the first hour in either group but appeared in the second time period (2–6 hours) and third time period (7–12 hours) more frequently in the misoprostol group than with oxytocin.
Conclusion The increased incidence of shivering and pyrexia that occurs with postpartum use of misoprostol persists up to 6 hours following delivery. Approximately 5% of women experience diarrhoea that starts after 1 hour and subsides within 12 hours.     

Intra-umbilical vein injection and retained placenta: evidence from a collaborative large randomised controlled trial

Objective To determine whether intra-umbilical vein injection with saline solution, with or without oxytocin, reduces the need for manual removal of placenta compared with expectant management.
Design Multicentre, randomised controlled trial.
Setting Eleven hospitals in four cities of Argentina: Buenos Aires, Corrientes, Rosario, and Salta.
Participants Two hundred and ninety-one women showing no evidence of placental separation thirty minutes after vaginal delivery.
Interventions Three different management strategies: 1. intra-umbilical vein injection of saline solution plus oxytocin; 2. intra-umbilical vein injection of saline solution alone; and 3. expectant management.
Main outcome measures Primary: manual removal of the placenta. Secondary: blood loss after trial entry, haemoglobin level at 24 to 48 hours and at 40 to 45 days after delivery, blood transfusion, curettage, infection, and days of hospital stay.
Results Rates of subsequent manual removal were similar: intra-umbilical vein injection of saline solution plus oxytocin (58%; RR 0.92; 95% CI 0.73–1.15), or saline alone (63%; RR 1.00; 95% CI 0.80–1.24), compared with expectant management (63%). There were also no detectable effects of the active managements on any of the secondary measures of outcome.
Conclusions Based on evidence available from randomised controlled trials, including this trial, it is unlikely that intra-umbilical injection with or without oxytocin, is clinically useful. We recommend that this intervention should not be used in third stage management of labour.     

Serum levels of oestradiol and progesterone during administration of prostaglandin F2alpha for induction of abortion and labour.

Prostaglandin F2alpha was used to induce abortion or labour in 84 women between the 11th and 44th weeks of pregnancy. Three different routes of administration were used, intravenous, extra-amniotic, and intra-amniotic. The extra-amniotic infusion of prostaglandin F2alpha produced a faster response than the other two routes. Less than one-third of the dose used in the intra-amniotic group was required in the extra-amniotic group for a complete evacuation of the uterus. Vomiting and diarrhoea occurred in 40% of the women in the intra- and extra-amniotic group, while the frequency was 88% in the intravenous group. Serum levels of progesterone and oestradiol decreased in accordance with the pattern found during spontaneous deliveries. The effect of prostaglandin F2alpha on the myometrium does not appear to be mediated via changes in the blood levels of progesterone or oestradiol.     

Randomised trial of amnioinfusion during labour with meconium stained amniotic fluid

Objective To assess the effect of amnioinfusion during labour with meconium stained amniotic fluid on caesarean section rate and perinatal outcome.
Design Prospective randomised controlled study.
Setting A tertiary care teaching hospital in India.
Population Women in labour at term with meconium stained amniotic fluid.
Methods Two hundred women in labour with ≥37 weeks gestation, single cephalic presentation with moderate or thick meconium were randomised to control and amnioinfusion groups at a 1:1 ratio. Amnioinfusion was performed using 500mL of normal saline over a period of 30 minutes in a study group. The control group received routine care. Both groups had intermittent auscultation of fetal heart rate during labour.
Main outcome measures The primary outcome measure was caesarean section rate. Secondary outcome measures were meconium aspiration syndrome, 1 minute and 5 minute apgar  <7  , hypoxic ischaemic encephalopathy, neonatal intensive care unit admission, meconium at the level of vocal cords.
Results The caesarean section rate in the amnioinfusion group was less than the control group (RR 0.47; 95% CI 0.24–0.93). Amnioinfusion was associated with a significant decrease in the incidence of meconium at the vocal cords (   P = 0.001  ); improvement in 1 minute apgar scores (   P <0.05  ), respiratory distress (   P = 0.002  ) and fewer admissions to nursery compared with the controls. This sample size was inadequate to study the impact on meconium aspiration syndrome.
Conclusion Amnioinfusion in an under resourced labour ward decreases caesarean section rates and fetal morbidity.     

A randomised trial comparing low dose vaginal misoprostol and dinoprostone for labour induction

Objective   To compare vaginal misoprostol with dinoprostone for induction of labour.
Design   Randomised multicentre trial.
Setting   Labour wards of one university hospital and two teaching hospitals.
Population   Six hundred and eighty-one women with indication for labour induction at ≥36 weeks of gestation, singleton pregnancy and no previous ceasarean section.
Methods   Misoprostol (25 mcg, hospital-prepared capsule) in the posterior vaginal fornix, every four hours, maximum three times daily or dinoprostone gel (1 mg) every four hours. Oxytocin was administered if necessary.
Main outcome measures   Primary: 'adverse neonatal outcome' (5-minute Apgar score <7 and/or umbilical cord pH <7.15). Secondary: labour duration, mode of delivery and patient satisfaction.
Results   Three hundred and forty-one women received misoprostol and 340 dinoprostone. The median induction–delivery interval was longer in the misoprostol group compared with the dinoprostone group (25 versus 19 hours, P = 0.008). The caesarean section rate was lower in the misoprostol group: 16.1% versus 21%, but this difference was not statistically significant RR = 0.8 (95% CI 0.6–1.04). 'Adverse neonatal outcome' was found to be similar in both groups: 21% in the misoprostol and 23% in the dinoprostone groups. Significantly fewer neonates were admitted to NICU in the misoprostol group compared with dinoprostone 19% versus 26% (RR = 0.7, 95% CI 0.5–0.98).
Conclusions   Misoprostol in this dosing regimen is a safe method of labour induction. NICU admission rates were lower in the misoprostol group. No difference could be detected in patient satisfaction between groups.     

Is routine cervical dilatation necessary during elective caesarean section? A randomised controlled trial

Objective: The purpose of this prospective randomised study was to determine the effect of routine cervical dilatation during elective caesarean section on maternal morbidity.
Methods: Participants with indication for elective caesarean section were randomly allocated to two groups. Group A ( n  = 200) women with intraoperative cervical dilatation; group B ( n  = 200) women with no intraoperative cervical dilatation.
Results: No demographic differences were observed between groups. There was no significant difference between groups in infectious morbidity ( P  = 0.87) (relative risk (RR) 1.11, 95% confidence interval (CI) 0.58–2.11), endometritis ( P  = 0.72) (RR 1.68, 95% CI 0.39–7.14), febrile morbidity ( P  = 0.66) (RR 1.21, 95% CI 0.51–2.87), wound infection ( P  = 0.82) (RR 1.11, 95% CI 0.44–2.81), endometritis ( P  = 0.72) (RR 1.68, 95% CI 0.39–7.14) or urinary tract infection ( P  = 1.00) (RR 1.00, 95% CI 0.28–3.50), and estimated blood loss ( P =  0.2). However, group A had longer operative times compared with the group B ( P =  0.01).
Conclusion: Intraoperative digital cervical dilatation during elective caesarean section did not reduce blood loss and postoperative infectious morbidity. The routine digital cervical dilatation during elective caesarean section is not recommended.     

The association between maternal HIV-1 infection and pregnancy outcomes in Dar es Salaam, Tanzania

Objective To examine the association between maternal HIV infection and pregnancy outcomes controlling for potential confounding factors among a cohort of HIV-uninfected and HIV-infected pregnant women in Dar es Salaam, Tanzania.
Design Prospective cohort study.
Methods A cohort of 1078 HIV-infected and 502 HIV-uninfected pregnant women between 12 and 27 weeks of gestation were enrolled and followed up until delivery. Multiple regression models were used to compare the risk of adverse pregnancy outcomes among HIV-uninfected women with those among HIV-infected women overall, and separately among asymptomatic or symptomatic HIV-infected women.
Results No significant differences between HIV-uninfected women and HIV-infected women were observed in risks of fetal loss or low birthweight or in the weight, head circumference and gestational age of infants at birth. HIV-infected women were more likely to have severe immature infants (<34 weeks) than HIV-uninfected women (multivariate RR 1.54 [95% CI 0.90–2.48]; P =0.05). There was a significantly higher risk of low birthweight (RR 2.29, 95% CI 1.34–3.92; P =0.03) and prematurity (<37 weeks) (RR 1.93, 95% CI 1.35–2.77; P =0.0003) among symptomatic HIV-infected women when compared with HIV-uninfected women.
Conclusion HIV-infected women, particularly those who are symptomatic, are at a higher risk of adverse pregnancy outcomes.     

Preterm delivery for maternal or fetal indications: maternal morbidity, neonatal outcome and late sequelae in infants

Objective To assess maternal morbidity, and neonatal outcome and especially long term sequelae in infants born preterm due to maternal or fetal indications.
Design Analysis of retrospective cohort.
Setting Oulu University Central Hospital, Finland.
Population One hundred and three women, who were between the 24th and the 33rd week of pregnancy, delivered by caesarean delivery because of maternal or fetal indications. They were matched with 103 women who had spontaneous preterm delivery at corresponding gestational weeks between 1990–1997.
Main outcome measures Maternal morbidity, reasons for caesarean delivery, neonatal mortality and morbidity rates, and later development of the infants.
Results Pre-eclampsia was diagnosed in 57% of the women in the indicated group and only in one woman in the control group. All infants in the indicated group and almost a third in the control group were born by caesarean birth; the main indication was threatening fetal asphyxia. There was a significant difference in neonatal mortality rates between the groups (175 vs 78 per thousand live births in the indicated vs control infants; RR 2.3, 95% CI 1.02, 4.9) and the main cause of death was respiratory insufficiency: 64% in the indicated group and 22% in the controls; RR 2.9, 95% CI 0.8, 10. Respiratory distress syndrome occurred more often (73% vs 53%, RR 1.4, 95% CI 1.1, 1.7) and it was more severe and more complicated in infants in the indicated group, compared with those in the control group. Symptomatic chronic lung disease at one year of age was more common in infants in the indicated group than in the control group (15% vs 3%; RR 4.6, 95% CI 1.4, 15.9).
Conclusions Not only the risks of neonatal mortality and morbidity but also long term pulmonary consequences, appear to be greater in infants born preterm by indicated delivery than in preterm infants born spontaneously at corresponding weeks.     

World Health Organisation multicentre randomised trial of supplementation with vitamins C and E among pregnant women at high risk for pre-eclampsia in populations of low nutritional status from developing countries

Objective  To determine if vitamin C and E supplementation in high-risk pregnant women with low nutritional status reduces pre-eclampsia.
Design  Multicentred, randomised, controlled, double-blinded trial.
Setting  Antenatal care clinics and Hospitals in four countries.
Population  Pregnant women between 14 and 22 weeks' gestation.
Method  Randomised women received 1000 mg vitamin C and 400 iu of vitamin E or placebo daily until delivery.
Main outcome measures  Pre-eclampsia, low birthweight, small for gestational age and perinatal death.
Results  Six hundred and eighty-seven women were randomised to the vitamin group and 678 to the placebo group. Groups had similar gestational ages (18.1; SD 2.4 weeks), socio-economic, clinical and demographical characteristics and blood pressure at trial entry. Risk factors for eligibility were similar, except for multiple pregnancies: placebo group (14.7%), vitamins group (11.8%). Previous pre-eclampsia, or its complications, was the most common risk factor at entry (vitamins 41.6%, placebo 41.3%). Treatment compliance was 87% in the two groups and loss to follow-up was low (vitamins 2.0%, placebo 1.3%). Supplementation was not associated with a reduction of pre-eclampsia (RR: 1.0; 95% CI: 0.9–1.3), eclampsia (RR: 1.5; 95% CI: 0.3–8.9), gestational hypertension (RR: 1.2; 95% CI: 0.9–1.7), nor any other maternal outcome. Low birthweight (RR: 0.9; 95% CI: 0.8–1.1), small for gestational age (RR: 0.9; 95% CI: 0.8–1.1) and perinatal deaths (RR: 0.8; 95% CI: 0.6–1.2) were also unaffected.
Conclusion  Vitamins C and E at the doses used did not prevent pre-eclampsia in these high-risk women.     

High incidence of obstetric interventions after successful external cephalic version

Objective To investigate the delivery outcome after successful external cephalic version (ECV).
Design Case–control study.
Setting University teaching hospital.
Population The study group consisted of 279 consecutive singleton deliveries at term over a six-year period, all of which had had successful ECV performed. The control group included 28,447 singleton term deliveries during the same six-year period.
Methods Between group differences were compared with the Mann–Whitney U test or Student's t test where appropriate. Odds ratio and 95% confidence interval (CI) were calculated for categorical variables.
Main outcome measures Incidence of and indications for obstetric interventions.
Results The risk of instrumental delivery and emergency caesarean section was higher in the ECV group (14.3% vs 12.8%; OR 1.4; 95% CI 1.0–2.0, and 23.3% vs 9.4%; OR 3.1; 95% CI 2.3–4.1, respectively). The higher caesarean rate was due to an increase in all major indications, namely, suspected fetal distress, failure to progress in labour and failed induction. The higher incidence of instrumental delivery was mainly due to an increase in prolonged second stage. The odds ratio for operative delivery remained significant after controlling for potential confounding variables. There were also significantly greater frequencies of labour induction (24.0% vs 13.4%; OR 2.0; 95% CI 1.5–2.7) and use of epidural analgesia (20.4% vs 12.4%; OR 1.8; 95% CI 1.4–2.4) by women in the ECV group. The higher induction rate is mainly due to induction for post term, abnormal cardiotocography (CTG) and antepartum haemorrhage (APH) of unknown origin.
Conclusion The incidence of operative delivery and other obstetric interventions are higher in pregnancies after successful ECV. Women undergoing ECV should be informed about this higher risk of interventions.     

A comparison of vaginally administered misoprostol with extra-amniotic saline solution infusion for cervical ripening and labor induction

OBJECTIVE: The purpose of this study was to compare intravaginal misoprostol with extra-amniotic saline solution infusion with concomitant oxytocin for cervical ripening and labor induction in viable pregnancies. STUDY DESIGN: Two hundred women with indications for labor induction and unfavorable cervices were assigned randomly to vaginal misoprostol or extra-amniotic saline solution infusion. Twenty-five micrograms of misoprostol was administered every 4 hours up to six doses, followed by intravenous oxytocin administration. Patients who had received extra-amniotic saline solution infusion also received intravenous oxytocin along with a maximum 12-hour saline solution infusion through Foley catheters that were placed above the internal cervical os. RESULTS: One hundred women were randomly assigned to misoprostol, and 100 women were assigned randomly to extra-amniotic saline solution infusion. The average interval from start of induction to vaginal delivery was longer in the misoprostol group (1323.3 +/- 700.3 minutes) than in the extra-amniotic saline solution infusion group (970.4 +/- 502.7 minutes; P =.006, log transformed data). Abnormal fetal heart rate tracings were found in 30% of the patients who received misoprostol and in 19% of the patients who received extra-amniotic saline solution infusion (relative risk, 1.6; 95% CI, 1.0-2.4; P =.05). There was more tachysystole in the misoprostol group (8%) than in the extra-amniotic saline solution infusion group (1%; P =.02). There were no differences in the routes of deliveries or neonatal outcomes between groups. CONCLUSION: Extra-amniotic saline solution infusion with oxytocin administration appears more effective and is associated with fewer maternal complications than misoprostol for cervical ripening and labor induction.     

A randomized comparison of extra-amniotic saline infusion and intracervical dinoprostone gel for cervical ripening

Objective: To compare extra-amniotic saline infusion to intracervical dinoprostone gel for preinduction cervical ripening.Methods: Women with Bishop scores less than 5 were assigned randomly to either extra-amniotic saline infusion (n = 26) or intracervical dinoprostone gel (n = 26) for preinduction cervical ripening. A sample size of 50 would have 80% power to detect a 10-hour difference in the mean time from start of cervical ripening to delivery for the two methods of intervention, with a type I error of .05.Results: The study populations were similar in age, gestational age, and initial Bishop score. They differed in parity, with 22 nulliparas in the extra-amniotic saline infusion group versus 13 in the dinoprostone gel group (relative risk [RR] 1.69, 95% confidence interval [CI] 1.11, 2.57). The number of women achieving a favorable Bishop score at 6 hours was greater with extra-amniotic saline infusion (n = 20) than dinoprostone gel (n = 9) (RR 2.14, 95% CI 1.22, 3.75). Mean time from start of ripening to delivery was 25.9 hours with extra-amniotic saline infusion and 30.2 hours with dinoprostone gel (P = .25). Birth weight, Apgar scores, umbilical artery pH, and infectious morbidity were similar between groups.Conclusion: More women achieved a favorable Bishop score at 6 and 12 hours after the start of cervical ripening with extra-amniotic saline infusion compared with dinoprostone gel. Saline infusion is as safe as dinoprostone gel for preinduction cervical ripening.     

A randomised controlled trial of early versus delayed oxytocin augmentation to treat primary dysfunctional labour in nulliparous women

Background  Oxytocin is widely used to speed up slow labour, especially in nulliparous women, but randomised trials, apart from one reported only in abstract, have been too small to exclude important effects.
Objective  To test the hypothesis that early use of oxytocin reduces the need for caesarean delivery.
Design  A randomised controlled trial.
Setting  Twelve obstetric units within the Northern and Yorkshire regions in the North East of England.
Participants  A total of 412 low-risk nulliparous women in spontaneous labour at term, who had been diagnosed with primary dysfunctional labour were recruited from January 1999 to December 2001.
Intervention  Immediate oxytocin administration (active group) or oxytocin withheld for up to 8 hours (conservative group).
Main outcome measures  Caesarean section and operative vaginal delivery rates. The length of labour measured from the time of randomisation to delivery. The rate of maternal Edinburgh Postnatal Depression Scale (EPDS) greater than 12 (major depression) within 48 hours of delivery.
Results  The caesarean section rates were 13.5% active versus 13.7% controls (OR 0.98, 95% CI 0.6–1.7). Operative delivery, 24.5% versus 30.9% (OR 0.73, 95% CI 0.5–1.1). The median (interquartile range) randomisation to delivery interval in the active group was 5 hours 52 minutes (3:57–8:28) and in the conservative group 9 hours 8 minutes (5:06–13:16) ( P < 0.001). The rate of EPDS >12 was 20% in the active arm versus 15% among controls (OR 1.26, 95% CI 0.7–2.2). There was one perinatal death in each group and no major differences in perinatal outcomes.
Conclusions  Among nulliparous women with primary dysfunctional labour, early use of oxytocin does not reduce caesarean section or short-term postnatal depression. However, it shortens labour considerably and may reduce operative vaginal deliveries.     

The Collaborative Randomised Amnioinfusion for Meconium Project (CRAMP): 1. South Africa

Objective To evaluate transcervical amnioinfusion for meconium stained amniotic fluid during labout.
Design Multicentre randomised controlled trial.
Setting Four urban academic hospitals in South Africa. Obstetric surveillance included the use of electronic fetal heart rate monitoring in most cases.
Participants Women in labour at term with moderate or thick meconium staining of the amniotic fluid.
Interventions Transcervical amnioinfusion of 800 mL saline at 15 mL per minute, followed by a maintenance infusion at 3 mL per minute. The control group received routine care. Blinding of the intervention was not possible.
Main outcome measures Caesarean section, meconium aspiration syndrome and perinatal mortality.
Results Caesarean section rates were similar (amnioinfusion group 70/167 vs control group 68/159; RR 0.98, 95% CI 0.76–1.26). The incidence of meconium aspiration syndrome was lower than expected on the basis of previous studies (4/162 vs 6/163; RR 0.67, 95% CI 0.19–2.33). There were no perinatal deaths. There were no significant differences between any of the subsidiary outcomes.
Conclusions This study concurred with three previous trials which found no effect of amnioinfusion for meconium stained amniotic fluid on caesarean section rate, though the pooled data from all identified trials to date show a significant reduction. The findings with respect to meconium aspiration syndrome were inconclusive in this study alone because of the small number of babies affected, but the point estimate of the relative risk was consistent with the finding of a significant reduction in previous studies and with the Zimbabwe arm (CRAMP 2) of this study. Pooled data clearly support the use of amnioinfusion for meconium stained amniotic fluid to reduce the incidence of meconium aspiration syndrome.     

A prospective cohort study of oxytocin plus ergometrine compared with oxytocin alone for prevention of postpartum haemorrhage

Objective To determine the safety and efficacy of intramuscular oxytocin plus ergometrine compared to intravenous oxytocin for prevention of postpartum haemorrhage, and the significance of administration at the end of the second stage of labour compared with that after the third stage.
Design A prospective cohort study.
Setting A university affiliated tertiary medical centre.
Participants Two thousand one hundred and eighty–nine women delivering singletons during 40 consecutive weeks.
Main outcome measures Postpartum haemorrhage (> 500 ml), prolonged third stage (> 30 min), retained placenta (>60min), elevated blood pressure (systolic > 150 mmHg, diastolic > 100 mmHg).
Results The rate of postpartum haemorrhage was not significantly different for oxytocinergometrine compared with oxytocin, when administered at the end of the second stage of labour (odds ratio 1.10, 95% confidence interval (CI) 0.75–1.61) or after the third stage (odds ratio 0.95, 95% CI 0.68–1.34). The patients receiving oxytocics at the end of the second stage of labour had significantly lower rates of postparturn haemorrhage, for both oxytocinergometrine (odds ratio 0.69, 95% CI 0.49–0.98) and oxytocin (odds ratio 0.60, 95% CI 0.41–0.87), compared with those treated after the third stage.
Conclusion Administration of oxytocin alone is as effective as the use of oxytocin plus ergometrine in the prevention of postpartum haemorrhage, but associated with a significantly lower rate of unpleasant maternal side effects. Oxytocics administered after delivery of the fetal head compared with after the placental expulsion are associated with a significantly lower rate of postpartum haemorrhage.