Historical trends in the timing of informed consent for research into intrapartum complications.

Obtaining informed consent for clinical trials involving the management of intrapartum complications is complex. This article describes the strategies used to obtain consent over the last 60 years using data from the Cochrane Library. Of 138 intrapartum randomised studies, 37% had no record of the consent procedures. Of the remainder, 74% sought consent only when the complication developed, 11% sought consent from all women in early labour, and 13% gave all women antenatal information and then sought written consent when the complication arose. Despite the existence of ethics guidelines for intrapartum consent, many studies fail to follow their advice.

The effect of misoprostol on postpartum contractions: a randomised comparison of three sublingual doses.

OBJECTIVE: To compare the postpartum uterine activity and side effects of various doses of sublingual misoprostol and intramuscular oxytocin. DESIGN: Single centre, randomised trial. SETTING: Zliten Teaching Hospital in Libya. POPULATION: Forty-nine women who did not receive oxytocics in labour and who delivered vaginally. METHODS: Thirty-five women were randomised to receive 200, 400 or 600 mcg of sublingual misoprostol PPH prophylaxis immediately following delivery. These were compared with 14 consecutive women given 10 IU of intramuscular oxytocin. Immediately after placental delivery, a Koala intra uterine pressure catheter was inserted transcervically into the uterine cavity. MAIN OUTCOMES MEASURES: Main outcomes measures are the uterine pressure (in Montevideo units) measured over 120 minutes. Other outcomes included temperature and measured blood loss. RESULTS: Women's age, parity, gestational age and neonatal birth weight were not significantly different between the four groups. There was no difference in intrauterine pressure between the three misoprostol doses. However, the uterine pressure was significantly lower than oxytocin with all three doses for the first 10 minutes (P < 0.008) and significantly higher than oxytocin from 50 to 120 minutes (P < 0.008). A dose-related rise in the body temperature and chills was observed in the misoprostol groups, with 8.3%, 8.3% and 45% of women experiencing a fever >39 °C with the 200, 400, and 600 mcg doses respectively. CONCLUSION: Intramuscular oxytocin has the highest immediate post partum uterine activity. Lower doses of misoprostol may be as effective as high doses and with fewer side effects. Clinical outcomes with low-dose misoprostol should be further explored (ISRCTN97277056).

The use of misoprostol in obstetrics and gynaecology.

Misoprostol, although originally introduced as a therapy for gastric ulcers, is now widely used in reproductive health. For some indications it is now the optimal choice, whilst for others it provides an important alternative, especially in low-resource settings. The optimal dose varies widely from 20 to 600 mcg depending on the indication and gestation. Use of the correct dose is important, too low a dose will be ineffective and overdosage can be dangerous for mother and baby. Evidence-based information about the safest regimens for multiple pregnancy indications are therefore provided in this review.