Clinical trial NCT01508429: Misoprostol for Treatment of Postpartum Haemorrhage (PPH) in Home Births
Official title: Misoprostol for the Treatment of Postpartum Haemorrhage (PPH) Following Self- Administration of Misoprostol Prophylaxis in Home Deliveries.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postpartum Hemorrhage (PPH)
Keywords: Postpartum hemorrhage
PPH
misoprostol
home deliveries
Lead sponsor: Gynuity Health Projects
Sponsor class: OTHER
Collaborators: name: Aga Khan Health Services
First posted: 2012-01-12
Enrollment: 70
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Hb of greater than or equal to 2 g/dl from pre- to post-delivery
timeFrame: 3-5 days after delivery
Secondary outcomes:
measure: Side effects
timeFrame: immediately after delivery; 3-5 days post delivery
measure: additional interventions
timeFrame: immediately after delivery; 3-5 days post delivery
measure: Acceptability
timeFrame: immediately after delivery; 3-5 days post delivery
Other outcomes:
Locations:
city: Darwaz, Ishkashim, Shugnan, Wakhan districts
country: Afghanistan
facility: Home delivery setting
state: Badakshan Province
Study officials:
affiliation: Aga Khan Health Services
name: Shafiq Mirzazada
role: PRINCIPAL_INVESTIGATOR
affiliation: Secretariat of His Highness the Aga Khan, Aiglemont
name: Gijs Walraven
role: STUDY_DIRECTOR
affiliation: Gynuity Health Projects
name: Dina Abbas
role: STUDY_DIRECTOR
affiliation: Gynuity Health Projects
name: Jill Durocher
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.