Treatment of Postpartum Haemorrhage (PPH) Using Misoprostol in Home Births
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Treatment of Postpartum Haemorrhage (PPH) Using Misoprostol in Home Births|
- haemoglobin concentration (Hb) of greater than 2 g/dl from pre- to post-delivery [ Time Frame: 3-5 days after delivery ] [ Designated as safety issue: No ]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.
- side effects, additional interventions, and acceptability [ Time Frame: immediately after delivery; 3-5 days post delivery ] [ Designated as safety issue: Yes ]
Observed side effects: perceived severity, additional care provided Correct administration of prophylaxis, correct administration of misoprostol for treatment Any serious adverse outcomes including uterine rupture, hysterectomy, hospitalization, maternal deaths, and neonatal deaths.
Postpartum Hb, mean difference in postpartum Hb levels between treatment groups, persistent bleeding following study treatment
# of referrals and transfers Woman's condition at time of referral and at time of transfer Additional interventions Acceptability and management of side effects
|Study Start Date:||May 2012|
|Estimated Study Completion Date:||September 2014|
|Estimated Primary Completion Date:||September 2014 (Final data collection date for primary outcome measure)|
Active Comparator: Misoprostol
women who experience a PPH will be randomized to receive 800 misoprostol (four tablets of 200 mcg administered sublingually)
4 tablets of 200 mcg misoprostol administered sublingually if the woman experiences a PPH after child birth
Placebo Comparator: placebo
women who experience a PPH will be randomized to receive 4 placebo tablets administered sublingually
4 tablets, administered sublingually if the woman experiences a PPH
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01485562
|Contact: Dina Abbasfirstname.lastname@example.org|
|Contact: Ayisha Diopemail@example.com|
|Chitral, Khyber Pakhtunkhwa, Pakistan|
|Principal Investigator: Zafar Ahmed|
|Principal Investigator:||Zafar Khan||Aga Khan Health Services|
|Study Director:||Nadeem Zuberi||Aga Khan University|
|Study Director:||Rozina Mistry||Aga Khan Health Services|
|Study Director:||Gijs Walraven||Secretariat of His Highness the Aga Khan, Aiglemont|
|Study Director:||Ayisha Diop||Gynuity Health Projects|
|Study Director:||Dina Abbas||Gynuity Health Projects|