Postpartum Haemorrhage
Conditions
Keywords
postpartum haemorrhage, misoprostol, treatment, prophylaxis, home births
Brief summary
A double-blind individual randomized controlled study of misoprostol vs. placebo for treatment in homebirths in the Chitral district, in the Khyber Pakhtunkhwa province in Pakistan.
Detailed description
A double-blind individual randomized controlled study of misoprostol vs. placebo for treatment in homebirths in the Chitral district, in the Khyber Pakhtunkhwa province in Pakistan. The purpose of the study is to assess the overall clinical and programmatic effectiveness of Traditional Birth Attendants (TBAs) administering 800 mcg sublingual misoprostol to treat Postpartum Haemorrhage (PPH) at the community level. The study will recruit pregnant women who deliver at home. All women enrolled in the study will receive misoprostol for prevention (600 mcg oral dose). Women diagnosed with PPH will be randomized to receive either a) standard care + 800 mcg sublingual misoprostol (four 200 mcg tablets) or b) standard care + four placebo tablets resembling misoprostol. In this setting, standard care is uterine massage and/or compression and referral to the nearest health facility or attendance by the Lady Health Visitor/ Community Health Nurse.
Interventions
DRUGMisoprostol
4 tablets of 200 mcg misoprostol administered sublingually if the woman experiences a PPH after child birth
OTHERplacebo
4 tablets, administered sublingually if the woman experiences a PPH
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 who deliver at home with a study TBA present. * Women must be willing and able to provide informed consent * Women must agree to participate in a follow up interview * Women must agree to have pre and post-partum haemoglobin taken
Exclusion criteria
* If the woman does not meet any of the above outlined inclusion criteria
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Haemoglobin concentration (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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants who experience side effects | immediately after delivery; 3-5 days post delivery | number of women who experienced side effects and the severity of the side effects as rated on a scale, additional care provided |
| number of participants who received additional interventions | immediately after delivery; 3-5 days post delivery | number of participants who received care by as skilled provider and the type of care provided |
| number of women who found misoprostol treatment to be acceptable | immediately after delivery; 3-5 days post delivery | women will be asked to rate their acceptability with the treatment using a scale |
| number of participants who experience severe adverse events | immediately after delivery; 3-5 days post delivery | serious adverse are defined as uterine rupture, hysterectomy, hospitalization, maternal deaths, and neonatal deaths. |
Countries
Pakistan
Outcome results
None listed