Misoprostol for Treatment of Postpartum Haemorrhage (PPH) in Home Births

Misoprostol for the Treatment of Postpartum Haemorrhage (PPH) Following Self- Administration of Misoprostol Prophylaxis in Home Deliveries.

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.

Study Overview

• Status: Completed
• Conditions: Postpartum Hemorrhage (PPH)
• Intervention / Treatment: Drug: Misoprostol; Other: placebo

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Afghanistan
  • Badakshan Province
    • Darwaz, Ishkashim, Shugnan, Wakhan districts, Badakshan Province, Afghanistan
      • Home delivery setting

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 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

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; 800mcg misoprostol (four tablets of 200 mcg administered sublingually)	Drug: Misoprostol; 800mcg misoprostol (4 200mcg tablets administered sublingually)
Placebo Comparator: placebo; 4 placebo tablets (resembling misoprostol) administered sublingually	Other: placebo; 4 placebo tablets (resembling misoprostol) administered sublingually

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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. The outcome will be compared between the two treatment groups.	3-5 days after delivery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Side effects	Observed side effects: perceived severity, additional care provided Any serious adverse outcomes including uterine rupture, hysterectomy, hospitalization, maternal deaths, and neonatal deaths.	immediately after delivery; 3-5 days post delivery
additional interventions	Additional interventions and additional care provided to the woman, # of referrals and transfers	immediately after delivery; 3-5 days post delivery
Acceptability	Acceptability and management of side effects, acceptablity of taking the drugs	immediately after delivery; 3-5 days post delivery

Collaborators and Investigators

• Sponsor: Gynuity Health Projects
• Collaborators: Aga Khan Health Services
• Investigators: Study Director: Gijs Walraven, Secretariat of His Highness the Aga Khan, Aiglemont; Study Director: Dina Abbas, Gynuity Health Projects; Principal Investigator: Shafiq Mirzazada, Aga Khan Health Services

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, 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): February 1, 2016
• Study Completion (Actual): February 1, 2016

Study Registration Dates

• First Submitted: December 1, 2011
• First Submitted That Met QC Criteria: January 9, 2012
• First Posted (Estimate): January 12, 2012

Study Record Updates

• Last Update Posted (Estimate): July 11, 2016
• Last Update Submitted That Met QC Criteria: July 6, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: misoprostol; Postpartum hemorrhage; PPH; home deliveries
• 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: 2.4.14