Postpartum Hemorrhage (PPH)
Conditions
Keywords
Postpartum hemorrhage, PPH, misoprostol, home deliveries
Brief summary
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.
Interventions
OTHERplacebo
4 placebo tablets (resembling misoprostol) administered sublingually
DRUGMisoprostol
800mcg misoprostol (4 200mcg tablets administered sublingually)
Sponsors
Aga Khan Health Services
Gynuity Health Projects
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
Inclusion criteria
* Women must be pregnant * Must be able to provide informed consent * Must agree to have a community health worker present at the time of delivery * Must agree to participate in a follow up interview by the study midwife * Must agree to have pre and postpartum haemoglobin taken
Exclusion criteria
* Women who do not meet the inclusion criteria
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hb of greater than or equal to 2 g/dl from pre- to post-delivery | 3-5 days after 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Side effects | immediately after delivery; 3-5 days post delivery | Observed side effects: perceived severity, additional care provided Any serious adverse outcomes including uterine rupture, hysterectomy, hospitalization, maternal deaths, and neonatal deaths. |
| additional interventions | immediately after delivery; 3-5 days post delivery | Additional interventions and additional care provided to the woman, # of referrals and transfers |
| Acceptability | immediately after delivery; 3-5 days post delivery | Acceptability and management of side effects, acceptablity of taking the drugs |
Countries
Afghanistan
Outcome results
None listed