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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
84
4 tablets of 200 mcg misoprostol administered sublingually if the woman experiences a PPH after child birth
4 tablets, administered sublingually if the woman experiences a PPH
Home Births
Chitral, Khyber Pakhtunkhwa, Pakistan
Haemoglobin concentration (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.
Time frame: 3-5 days after delivery
Number of participants who experience side effects
number of women who experienced side effects and the severity of the side effects as rated on a scale, additional care provided
Time frame: immediately after delivery; 3-5 days post delivery
number of participants who received additional interventions
number of participants who received care by as skilled provider and the type of care provided
Time frame: immediately after delivery; 3-5 days post delivery
number of women who found misoprostol treatment to be acceptable
women will be asked to rate their acceptability with the treatment using a scale
Time frame: immediately after delivery; 3-5 days post delivery
number of participants who experience severe adverse events
serious adverse are defined as uterine rupture, hysterectomy, hospitalization, maternal deaths, and neonatal deaths.
Time frame: immediately after delivery; 3-5 days post delivery
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