Misoprostol for Treatment of Postpartum Haemorrhage (PPH) in Home Births
NCT ID: NCT01508429
Last Updated: 2016-07-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
70 participants
INTERVENTIONAL
2012-07-31
2016-02-29
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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misoprostol
800mcg misoprostol (four tablets of 200 mcg administered sublingually)
Misoprostol
800mcg misoprostol (4 200mcg tablets administered sublingually)
placebo
4 placebo tablets (resembling misoprostol) administered sublingually
placebo
4 placebo tablets (resembling misoprostol) administered sublingually
Interventions
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placebo
4 placebo tablets (resembling misoprostol) administered sublingually
Misoprostol
800mcg misoprostol (4 200mcg tablets administered sublingually)
Eligibility Criteria
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Inclusion Criteria
* 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
FEMALE
Yes
Sponsors
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Aga Khan Health Services
OTHER
Gynuity Health Projects
OTHER
Responsible Party
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Principal Investigators
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Shafiq Mirzazada
Role: PRINCIPAL_INVESTIGATOR
Aga Khan Health Services
Gijs Walraven
Role: STUDY_DIRECTOR
Secretariat of His Highness the Aga Khan, Aiglemont
Dina Abbas
Role: STUDY_DIRECTOR
Gynuity Health Projects
Jill Durocher
Role: STUDY_DIRECTOR
Gynuity Health Projects
Locations
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Home delivery setting
Darwaz, Ishkashim, Shugnan, Wakhan Districts, Badakshan Province, Afghanistan
Countries
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References
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Parry Smith WR, Papadopoulou A, Thomas E, Tobias A, Price MJ, Meher S, Alfirevic Z, Weeks AD, Hofmeyr GJ, Gulmezoglu AM, Widmer M, Oladapo OT, Vogel JP, Althabe F, Coomarasamy A, Gallos ID. Uterotonic agents for first-line treatment of postpartum haemorrhage: a network meta-analysis. Cochrane Database Syst Rev. 2020 Nov 24;11(11):CD012754. doi: 10.1002/14651858.CD012754.pub2.
Abbas DF, Mirzazada S, Durocher J, Pamiri S, Byrne ME, Winikoff B. Testing a home-based model of care using misoprostol for prevention and treatment of postpartum hemorrhage: results from a randomized placebo-controlled trial conducted in Badakhshan province, Afghanistan. Reprod Health. 2020 Jun 5;17(1):88. doi: 10.1186/s12978-020-00933-8.
Other Identifiers
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2.4.14
Identifier Type: -
Identifier Source: org_study_id
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