Postpartum haemorrhage (PPH) remains a leading cause of maternal mortality, despite treatment with conventional methods. Uncontrolled reports and three small randomised controlled trials have suggested that misoprostol may have an additive effect to routine treatment, and there is a serious danger that this method will be used widely without research to document the effectiveness or risks of this method. In this randomised controlled trial (RCT), we propose to test whether 600 μg of sublingually administered misoprostol in women requiring additional uterotonics after delivery, and after routine syntocinon to all women during or after delivery, has additional effects above the additional conventional uterotonics in reducing PPH. Women with measured blood loss greater than or equal to 500 mls in 4 Karachi hospitals who give consent will be given locally routine treatment for PPH. In addition, they will be enrolled by drawing the next of a series of randomised treatment packs containing misoprostol or placebo. The primary outcome measure will be blood loss greater than or equal to 500 mls after enrolment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
61
600 mcg of sublingual misoprostol
Aga Khan University Hospital
Karachi, Pakistan
The Aga Khan Health Services
Karachi, Pakistan
Blood loss greater than or equal to 500 mls after enrolment
Time frame: Blood loss measured for minimum of 1 hour or until active bleeding ceased
Average blood loss
Time frame: Blood loss measured for minimum of one hour or until active bleeding ceased
Clinical complications (need for transfusion, hysterectomy)
Time frame: After delivery and prior to hospital discharge
Pre-delivery and post-delivery hemoglobin measures
Time frame: Pre-delivery hemoglobin measured upon admission to hospital (during labor) and measured postpartum 12-24 hours after delivery
Side effects
Time frame: observed or reported following study treatment and prior to discharge
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