Objective: To understand the experiences of women, birth partners and health professionals of verbal followed by retrospective written consent in a prospective cohort study of a device to manage post-partum haemorrhage (PPH). Design: Grounded Theory. Setting: Tertiary facility in the North-West of England, UK. Sample: We used purposive and theoretical sampling to recruit 51 participants; 12 women, 12 birth partners, 16 obstetricians and 11 midwives. Methods: Semi-structured interviews were conducted, using a topic guide for focus, until data saturation was achieved. Data were analysed using framework analysis technique. Results: Most women wanted sufficient information to make a decision at the time of the event, rather than in advance, and preferred not to be overwhelmed with detail. A key factor in making the decision to participate was a positive and trusting relationship with the attending obstetrician. Obtaining consent for research in emergencies was viewed by obstetricians as requiring a different approach and more challenging than consent for standard procedures in an emergency. Conclusions: This is the first study to explore verbal followed by retrospective written consent processes with women, clinicians and observers. This was acceptable to all, however information needs to be appropriate, and consenters require adequate training. (197/200)

Objective: To assess whether, in those requiring ongoing uterine stimulation after cervical ripening with oral misoprostol and membrane rupture, augmentation with low dose oral misoprostol is superior to intravenous oxytocin. Design: Open-label, superiority randomised trial Setting: Government hospitals in India Population: Women induced with oral misoprostol for hypertensive disease in pregnancy and requiring ongoing induction after membrane rupture Methods: Participants received misoprostol (25mcg orally two hourly) or titrated oxytocin through an infusion pump. Main Outcome Measure: Caesarean birth Results: 520 women were randomised and the baseline characteristics were comparable between the groups. The caesarean section rate was not reduced by the use of misoprostol (misoprostol 32.3% vs oxytocin 27.3%; adjusted odds ratio 1.226 (95% CI 0.81-1.85, p=0.33)). There were no differences in rates of hyperstimulation, fetal heart rate abnormalities, or maternal side effects, although the geometric mean time from randomisation to birth was 31 minutes longer with misoprostol. Fewer babies in the misoprostol arm were admitted to the special care unit (10 vs 21 in the oxytocin group) and there were no neonatal deaths in the misoprostol group, compared to 3 in the oxytocin arm. Women’s acceptability ratings were high in both study groups. Conclusion: Following cervical preparation with oral misoprostol and membrane rupture, the use of ongoing oral misoprostol for augmentation did not significantly reduce caesarean rates compared to oxytocin. The method, however, was safe for both mother and baby.

A document by Andrew D Weeks. Click on the document to view its contents.