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 Overview

• Status: Completed
• Conditions: Postpartum Haemorrhage
• Intervention / Treatment: Drug: Misoprostol; Other: placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Khyber Pakhtunkhwa
    • Chitral, Khyber Pakhtunkhwa, Pakistan
      • Home Births

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Misoprostol; women who experience a PPH will be randomized to receive 800 misoprostol (four tablets of 200 mcg administered sublingually)	Drug: Misoprostol; 4 tablets of 200 mcg misoprostol administered sublingually if the woman experiences a PPH after child birth; Other Names: Gymiso
Placebo Comparator: placebo; women who experience a PPH will be randomized to receive 4 placebo tablets administered sublingually	Other: placebo; 4 tablets, administered sublingually if the woman experiences a PPH; Other Names: Gymiso

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3-5 days after delivery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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.	immediately after delivery; 3-5 days post delivery

Collaborators and Investigators

• Sponsor: Gynuity Health Projects
• Collaborators: Aga Khan Health Services
• Investigators: Principal Investigator: Zafar Khan, Aga Khan Health Services; Study Director: Nadeem Zuberi, Aga Khan University; 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

Publications and helpful links

General Publications

• 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, 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: December 1, 2011
• First Submitted That Met QC Criteria: December 2, 2011
• First Posted (Estimate): December 5, 2011

Study Record Updates

• Last Update Posted (Estimate): March 10, 2016
• Last Update Submitted That Met QC Criteria: March 9, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: treatment; prophylaxis; misoprostol; postpartum haemorrhage; home births
• Additional Relevant MeSH Terms: Pathologic Processes; Pregnancy Complications; Obstetric Labor Complications; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Postpartum Hemorrhage; Physiological Effects of Drugs; Gastrointestinal Agents; Reproductive Control Agents; Anti-Ulcer Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Oxytocics; Misoprostol
• Other Study ID Numbers: 2.4.15