Postpartum Hemorrhage
Conditions
Keywords
Postpartum Haemorrhage, Misoprostol
Brief summary
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.
Interventions
DRUGMisoprostol
600 mcg of sublingual misoprostol
Sponsors
Aga Khan University
Aga Khan Health Services
The Aga Khan Foundation
Family Care International
Gynuity Health Projects
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
* All women delivering vaginally with clinically diagnosed PPH requiring uterotonics
Exclusion criteria
* Refusal to give consent for participation or if the woman is too distressed to give consent * Woman is not entitled to give informed consent (e.g. minors without a guardian) * Woman who had a caesarean section * Delivery is regarded as abortion (gestational age \< 28 weeks)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood loss greater than or equal to 500 mls after enrolment | Blood loss measured for minimum of 1 hour or until active bleeding ceased |
Secondary
| Measure | Time frame |
|---|---|
| Pre-delivery and post-delivery hemoglobin measures | Pre-delivery hemoglobin measured upon admission to hospital (during labor) and measured postpartum 12-24 hours after delivery |
| Side effects | observed or reported following study treatment and prior to discharge |
| Average blood loss | Blood loss measured for minimum of one hour or until active bleeding ceased |
| Clinical complications (need for transfusion, hysterectomy) | After delivery and prior to hospital discharge |
Countries
Pakistan
Outcome results
None listed