Misoprostol, a prostaglandin E1 that induces uterine contractions, has been proposed as a low cost, easy-to-use option for prevention and treatment of Postpartum Haemorrhage (PPH), especially in settings where injectable uterotonics are not yet available or feasible to use. A double-blinded individual randomized controlled study of misoprostol versus placebo in home deliveries in four districts in the Badakshan Province in Afghanistan. The study will recruit pregnant women who are likely to deliver at home. All women enrolled in the study will receive 600 mcg misoprostol to be self-administered as prophylaxis for PPH after delivery of their baby (ies) and before delivery of the placenta. Women who experience a PPH will be randomized to receive either: a) standard of care + 800 mcg misoprostol (four 200 mcg tablets) or b) standard of care + four placebo tablets resembling misoprostol. In this setting, standard of care is referral.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
70
4 placebo tablets (resembling misoprostol) administered sublingually
800mcg misoprostol (4 200mcg tablets administered sublingually)
Home delivery setting
Darwaz, Ishkashim, Shugnan, Wakhan Districts, Badakshan Province, Afghanistan
Hb of greater than or equal to 2 g/dl from pre- to post-delivery
The primary outcome will measure the proportion of women who experience a drop in their haemoglobin concentration (Hb) of greater than 2 g/dl from pre- to post-delivery. The outcome will be compared between the two treatment groups.
Time frame: 3-5 days after delivery
Side effects
Observed side effects: perceived severity, additional care provided Any serious adverse outcomes including uterine rupture, hysterectomy, hospitalization, maternal deaths, and neonatal deaths.
Time frame: immediately after delivery; 3-5 days post delivery
additional interventions
Additional interventions and additional care provided to the woman, # of referrals and transfers
Time frame: immediately after delivery; 3-5 days post delivery
Acceptability
Acceptability and management of side effects, acceptablity of taking the drugs
Time frame: immediately after delivery; 3-5 days post delivery
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