Treatment of retained placenta with misoprostol: a randomised controlled trial in a low-resource setting (Tanzania)

Design: Multicentered randomised, double-blind, placebo-controlled trial, to be conducted in 5 hospitals in Tanzania, Africa.Inclusion criteria: Women with retained placenta, at a gestational age of 28 weeks or more and blood loss less than 750 ml, 30 minutes after delivery of the newborn despite active management of third stage of labour.Trial Entry & Randomisation & Study Medication: After obtaining informed consent, eligible women will be allocated randomly to the treatment groups using numbered envelopes that will be randomized in variable blocks containing identical capsules with either 800 microgram of misoprostol or placebo. The drugs will be given sublingually. The women, maternal care providers and researchers will be blinded to treatment allocation.Sample Size: 117 women, to show a 40% reduction in manual removals of the placenta (p = 0.05, 80% power). The randomization will be misoprostol: placebo = 2:1Primary Study Outcome: Expulsion of the placenta without manual removal. Secondary outcome is the number of blood transfusions.This is a protocol for a randomized trial in a low resource setting to assess if medical treatment of women with retained placenta with misoprostol reduces the incidence of manual removal of the placenta.Current Controlled Trials ISRCTN16104753The diagnosis 'retained placenta' (RP) is established when the placenta is not expelled after a certain time period following the delivery of the infant[1,2]. The time period in the definition of RP varies among countries. In our study location Tanzania, like most English speaking countries, RP is defined as lack of expulsion of the placenta 30 minutes after delivery of the infant [3], while in other countries the diagnosis RP is only made after 60 minutes postpartum [4]. Complications of RP are postpartum haemorrhage and infection[5], which may both lead to maternal morbidity and mortality. The need to improve maternal mortality has been recognized at a global level by including it in the Mil