Misoprostol for term labor induction: a randomized controlled trial

ObjectivesThe aim of this study was to compare the efficacy of vaginal misoprostol with vaginal dinoprostone for term labor induction.Material and MethodsIt was a randomized controlled trial done in the Obstetrics Department, Shifa Community Health Centre, Shifa International Hospital (Teaching Hospital of Shifa College of Medicine, Islamabad). All pregnant women at term pregnancy coming for induction of labor were enrolled. 246 women fulfilled the inclusion criteria. Out of them 208 women consented to be part of the study. These women were then randomized to receive either Treatment A (vaginal misoprostol) or Treatment B (vaginal dinoprostone). Data were completed for 200 women. These included induction labor and induction-delivery interval, fetal and maternal complications, and baby apgar score.ResultsOut of 200 women in the study, 100 were in Group A and 100 in Group B. Labor commenced in a mean of 6.67 hours (±3.63) in Group A whereas it took a mean of 8.41 hours (±5.13) in Group B (p = 0.00). Actual induction to delivery (of the baby) interval was a mean of 11.68 hours (±4.55) for misoprostol and 15.37 hours (±5.30) for dinoprostone group (p = 0.00). There were no cases of uterine rupture in both groups; however, there were 10 cases of uterine hyperstimulation in Group A and 4 in Group B (p = 0.09).ConclusionsIt is time to re-evaluate the role of misoprostol for term labor induction. It is an efficacious and cost-effective alternative to the presently licensed treatment.     

Misoprostol in the treatment of postpartum haemorrhage in addition to routine management: a placebo randomised controlled trial

Postpartum haemorrhage remains a leading cause of maternal mortality, despite treatment with conventional methods. In this randomised controlled trial, we compared misoprostol 600 microg (200 microg orally and 400 microg sublingually) with placebo in the treatment of postpartum haemorrhage in addition to routine treatment. One hundred and sixty consenting women who delivered vaginally with measured blood loss > or =500 mL and for whom inadequate uterine contraction was thought to be a possible factor were given either misoprostol or placebo in addition to normal treatment and after routine active management with uterotonics. Blood loss was measured by collection in a special plastic bedpan and side effects of treatment were recorded. Measured average additional blood loss was 325 mL (95% confidence interval [CI] 265 to 384 mL) with misoprostol and 410 mL (95% CI 323 to 498 mL) with placebo. No severe side effects were noted in the use of misoprostol.     

Misoprostol compared with methylergometrine for the prevention of postpartum haemorrhage: a double-blind randomised trial.

OBJECTIVE: To compare the efficacy and side effects of misoprostol, compared with methylergometrine, for the prevention of postpartum haemorrhage. DESIGN: A double-blind, randomised clinical trial of 200 women with apparently normal pregnancies. SETTING: University teaching hospital. PARTICIPANTS: Two hundred women with apparently normal pregnancies. METHODS: After the baby had been born, all women received two capsules by mouth and the contents of an ampule by intravenous injection. Each woman only received one active product. The capsules contained either a total of 600 microg misoprostol or placebo, and the ampule 200 microg of methylergometrine or placebo. MAIN OUTCOME MEASURES: Need for further oxytocic drugs, blood pressure, the presence of side effects, mean haemoglobin and haematocrit three days after delivery. RESULTS: Two hundred women completed the study (100 received methylergometrine and 100 misoprostol). Postpartum haemorrhage occurred in 4.3% of the methylergometrine group and 8.3% of the misoprostol group (P = 0.57). The need for further oxytocic drugs was 4.4% and 12.8% after methylergometrine and misoprostol, respectively (P = 0.065). One hour after the birth of the baby there was no difference in the mean systolic blood pressure (117 +/- 12 mmHg versus 115 +/- 11 mmHg) (P = 0.26) or the mean diastolic blood pressure (72 +/- 10 mmHg versus 71 +/- 11 mmHg for the groups receiving methylergometrine or misoprostol, respectively) (P = 0.97). The mean temperature in the misoprostol group rose to 37.4 degrees C, compared with 37 degrees C in the methylergometrine group (P < 0.0001). In the misoprostol group 34% developed fever (> 38 degrees C) compared with 3% in the methylergometrine group (P < 0.0001). Shivering (visual analogue score > or = 8) also occurred more often after misoprostol (42%) than after methylergometrine (8.5%) (P < 0.0001). The haemoglobin level (g/dL) on the third postpartum day was similar for both groups ( 11.0 and 11.2 for methylergometrine and misoprostol, respectively) (P = 0.39). CONCLUSIONS: This study suggests that although protection from postpartum haemorrhage using parenteral methylergometrine and oral misoprostol is nearly equal, misoprostol is associated with more side effects.     

Misoprostol vaginal insert compared with dinoprostone vaginal insert: a randomized controlled trial

OBJECTIVE: To compare the 50-microgram (misoprostol vaginal insert 50) and 100-microgram (misoprostol vaginal insert 100) dose reservoirs of the misoprostol vaginal insert to 10-mg dinoprostone vaginal insert for time to vaginal delivery and rate of cesarean delivery. METHODS: A total of 1,308 women requiring cervical ripening (modified Bishop score less than or equal to 4) before induction of labor were randomly assigned to receive misoprostol vaginal insert 100 (n=428), misoprostol vaginal insert 50 (n=443) or 10-mg dinoprostone vaginal insert (n=436). The primary outcomes were time to vaginal delivery and rate of cesarean births. Safety was also assessed by comparing frequency of adverse events. RESULTS: Median time to vaginal delivery was 1,596, 2,127, and 1,650 minutes for misoprostol vaginal insert 100, misoprostol vaginal insert 50, and dinoprostone vaginal insert, respectively (P=.97 and 0.01 compared with dinoprostone vaginal insert, respectively). Of those who delivered in first admission, cesarean deliveries occurred in 119 of 421 (28.3%), 124 of 429 (28.9%), and 115 of 424 (27.1%) of participants treated with misoprostol vaginal insert 100, misoprostol vaginal insert 50, and dinoprostone vaginal inserts, respectively (relative risk 1.04, 95% confidence interval 0.84-1.30 for misoprostol vaginal insert 100 and relative risk 1.06, 95% confidence interval 0.86-1.32 for misoprostol vaginal insert 50 compared with dinoprostone vaginal insert). Medication-related adverse events included hyperstimulation syndrome in 17 of 428 (4.0%), 6 of 443 (1.4%), and 21 of 436 (4.8%); and nonreassuring fetal heart rate patterns in 63 of 428 (14.7%), 54 of 443 (12.2%), and 67 of 436 (15.4%) of participants treated with the misoprostol vaginal insert 100, misoprostol vaginal insert 50, and dinoprostone vaginal inserts, respectively. CONCLUSION: The misoprostol vaginal insert 100 and the dinoprostone vaginal insert had similar median time intervals to vaginal delivery, whereas the misoprostol vaginal insert 50 had a significantly longer time to vaginal delivery. The three products had similar cesarean rates and safety profiles.     

Misoprostol for the prevention and treatment of postpartum haemorrhage

Postpartum haemorrhage (PPH) causes preventable maternal deaths, mainly in low-income countries. Misoprostol has powerful uterotonic effects and, because it is well absorbed orally and sublingually, has the potential to be used more widely than would be possible with injectable uterotonics alone. Misoprostol is clearly less effective than oxytocin. Placebo-controlled studies have had variable results, although two recent trials in low-income communities have shown promising results. The main recognized side effects have been dose-related pyrexia and shivering, including occasional hyperpyrexia. In the randomized trials reported to date, there has been a trend to more deaths with misoprostol than with the control groups. The dose that has been most commonly used in clinical trials for preventing PPH is 600 microg orally. Meta-analysis of direct and adjusted indirect comparisons between 600 and 400 microg showed very similar effectiveness. To date, there is very limited evidence for the effectiveness of misoprostol, the lowest effective dose and the magnitude of adverse effects, both direct and indirect. The need for further research is a matter of great urgency.     

Antibiotic prophylaxis for prevention of postpartum perineal wound complications: a randomized controlled trial

OBJECTIVE: To estimate whether prophylactic antibiotics at the time of repair of third- or fourth-degree perineal tears after vaginal delivery prevent wound infection and breakdown. METHODS: This was a prospective, randomized, placebo-controlled study. Patients who sustained third- or fourth-degree perineal tears after a vaginal delivery were recruited for the study. Each patient was given a single intravenous dose of a second-generation cephalosporin (cefotetan or cefoxitin) or placebo before repair of third- or fourth-degree perineal tears. Obstetricians and patients were blinded to study drug. The perineum was inspected for evidence of infection or breakdown at discharge from the hospital and at 2 weeks postpartum. Primary end points were gross disruption or purulent discharge at site of perineal repair by 2 weeks postpartum. RESULTS: One hundred forty-seven patients were recruited for the study. Of these, 83 patients received placebo and 64 patients received antibiotics. Forty patients (27.2%) did not return for their 2-week appointment. Of the patients seen at 2 weeks postpartum, 4 of 49 (8.2%) patients who received antibiotics and 14 of 58 (24.1%) patients who received placebo developed a perineal wound complication (P=.037). There were no differences between groups in parity, incidence of diabetes, operative delivery, or third-degree compared with fourth-degree lacerations. CONCLUSION: By 2 weeks postpartum, patients who received prophylactic antibiotics at the time of third- or fourth-degree laceration repair had a lower rate of perineal wound complications than patients who received placebo. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clincaltrials.gov, NCT00186082. LEVEL OF EVIDENCE: I.     

Abbreviated postpartum magnesium sulfate therapy for women with mild preeclampsia: a randomized controlled trial

OBJECTIVE: To determine whether women receiving 12-hour and 24-hour postpartum magnesium sulfate (MgSO4) therapy for mild preeclampsia have differing clinical courses. METHODS: Consenting women with suspected mild preeclampsia were randomly assigned to 12 hours or 24 hours of MgSO4 postpartum therapy. Treatment was continued after the assigned time period if there was evidence of severe preeclampsia. The frequency of progression to severe disease and other outcomes were compared between study groups using the Fisher exact, chi2, and Student t tests where appropriate. RESULTS: Between January 2001 and August 2004, 200 women were enrolled. The 12-hour and 24-hour groups were similar in age, parity, delivered gestational age, anesthesia, and mode of delivery, as well as for proteinuria and blood pressure. In the 12-hour group, MgSO4 treatment was extended in seven women (6.9%) for progression to severe disease versus one (1.1%) in the 24-hour group (P = .07). Women who developed severe disease had higher blood pressures at the first prenatal visit (140/78 versus 122/69, P < or = .02 for systolic and diastolic pressures), at the time of randomization (152/88 versus 135/78, P < or = .03 for systolic and diastolic pressures), and were more likely to have insulin-requiring diabetes (27.3% versus 4.4%, P = .03). No 12-hour patients required treatment beyond 24 hours postpartum. There were no seizures, MgSO4 toxicity, or intolerance in either group. CONCLUSION: Twelve hours of postpartum MgSO4 therapy for mild preeclampsia is associated with infrequent disease progression and a clinical course similar to that with 24-hour therapy. Patients with chronic hypertension and insulin-requiring diabetes are at risk for progression to severe disease postpartum. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00344058 LEVEL OF EVIDENCE: I.     

Protocol for a randomised controlled trial of a decision aid for the management of pain in labour and childbirth [ISRCTN52287533]

Background  

Women report fear of pain in childbirth and often lack complete information on analgesic options prior to labour. Preferences for pain relief should be discussed before labour begins. A woman's antepartum decision to use pain relief is likely influenced by her cultural background, friends, family, the media, literature and her antenatal caregivers. Pregnant women report that information about analgesia was most commonly derived from hearsay and least commonly from health professionals. Decision aids are emerging as a promising tool to assist practitioners and their patients in evidence-based decision making.     

Haptotherapy as a new intervention for treating fear of childbirth: a randomized controlled trial

Objective: To evaluate the effect of haptotherapy on severe fear of childbirth in pregnant women.

Design: Randomized controlled trial.

Setting: Community midwifery practices and a teaching hospital in the Netherlands.

Population or Sample: Primi- and multigravida, suffering from severe fear of childbirth (N?=?134).

Methods: Haptotherapy, psycho-education via Internet and care as usual were randomly assigned at 20–24?weeks of gestation and the effects were compared at 36?weeks of gestation and 6?weeks and 6?months postpartum. Repeated measurements ANOVA were carried out on the basis of intention to treat. Since there were crossovers from psycho-education via Internet and care as usual to haptotherapy, the analysis was repeated according to the as treated principle.

Main outcome measures: Fear of childbirth score at the Wijma Delivery Expectancy/Experience Questionnaire.

Results: In the intention to treat analysis, only the haptotherapy group showed a significant decrease of fear of childbirth, F(2,99)?=?3.321, p?=?.040. In the as treated analysis, the haptotherapy group showed a greater reduction in fear of childbirth than the other two groups, F(3,83)?=?6.717, p?<?.001.

Conclusion: Haptotherapy appears to be more effective in reducing fear of childbirth than psycho-education via Internet and care as usual.     

A novel protocol for postpartum magnesium sulphate in severe pre-eclampsia: a randomized controlled pilot trial

Objective: Magnesium sulphate is the preferred anticonvulsant used to prevent the development of fits in severe pre-eclampsia; we aim to compare between three different protocols of postpartum magnesium sulphate in the effectiveness of preventing the development of fits in severe pre-eclampsia.

Methods: Double-blind randomized controlled pilot trial, done in Cairo university hospital, Cairo, Egypt during 2013–2014, on 240 women with severe pre-eclampsia. Magnesium sulphate intravenous infusion was given in the postpartum period to all the patients, women were randomly allocated to group I (Single loading dose only), group II (12?h abbreviated protocol) or group III (24?h standard protocol) (n?=?80 in each group).

Results: There were no significant difference between the three groups as regards the incidence of eclampsia, elevated liver enzymes and low platelets syndrome, maternal ICU admission and; however The incidence of flushing was significantly higher in group III than group II and I (24 [30%] versus 12 [15%] versus 4 [5%]; p?<?0.001) respectively.

Conclusion: The pilot study demonstrates that the single-loading dose of postpartum magnesium sulphate is a promising alternative to the standard and the abbreviated protocol in preventing eclampsia; however, a large clinical trial is necessary to prove this.     

The DiAMOND trial protocol: a randomised controlled trial of two decision aids for mode of delivery among women with a previous caesarean section [ISRCTN84367722]

Background  

Caesarean section (CS) has become an increasingly common method of delivery worldwide, rising in the UK from 9% of deliveries in 1980 to over 21% 2001. This increase, and the question of whether CS should be available to women on request, has been the subject of considerable debate, and national reports and guidelines have specifically highlighted the importance of patient choice in the decision making process. For women who have already experienced CS, the UK National Institute of Clinical Excellence recommends that the decision should consider maternal preferences and priorities in addition to general discussion of the overall risks and benefits of CS. Decision aids for many different medical treatment and screening decisions have been developed and evaluated, but there is relatively little evidence for the use of decision aids for choice of mode of delivery among women with a previous CS. The aim of the study is to evaluate two interventions to assist decision making about mode of delivery among pregnant women with one previous CS.