Clinical trial NCT01485562: Treatment of Postpartum Haemorrhage (PPH) Using Misoprostol in Home Births
Official title: Treatment of Postpartum Haemorrhage (PPH) Using Misoprostol in Home Births
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postpartum Haemorrhage
Keywords: postpartum haemorrhage
misoprostol
treatment
prophylaxis
home births
Lead sponsor: Gynuity Health Projects
Sponsor class: OTHER
Collaborators: name: Aga Khan Health Services
First posted: 2011-12-05
Enrollment: 84
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Haemoglobin concentration (Hb) of greater than or equal to 2 g/dl from pre- to post-delivery
timeFrame: 3-5 days after delivery
Secondary outcomes:
measure: Number of participants who experience side effects
timeFrame: immediately after delivery; 3-5 days post delivery
measure: number of participants who received additional interventions
timeFrame: immediately after delivery; 3-5 days post delivery
measure: number of women who found misoprostol treatment to be acceptable
timeFrame: immediately after delivery; 3-5 days post delivery
measure: number of participants who experience severe adverse events
timeFrame: immediately after delivery; 3-5 days post delivery
Other outcomes:
Locations:
city: Chitral
country: Pakistan
facility: Home Births
state: Khyber Pakhtunkhwa
Study officials:
affiliation: Aga Khan Health Services
name: Zafar Khan
role: PRINCIPAL_INVESTIGATOR
affiliation: Aga Khan University
name: Nadeem Zuberi
role: STUDY_DIRECTOR
affiliation: Secretariat of His Highness the Aga Khan, Aiglemont
name: Gijs Walraven
role: STUDY_DIRECTOR
affiliation: Gynuity Health Projects
name: Ayisha Diop
role: STUDY_DIRECTOR
affiliation: Gynuity Health Projects
name: Dina Abbas
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, Jehan N, Diop A, Durocher J, Byrne ME, Zuberi N, Ahmed Z, Walraven G, Winikoff B. Using misoprostol to treat postpartum hemorrhage in home deliveries attended by traditional birth attendants. Int J Gynaecol Obstet. 2019 Mar;144(3):290-296. doi: 10.1002/ijgo.12756. Epub 2019 Jan 24.