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

This study is currently recruiting participants.
Verified August 2012 by Gynuity Health Projects
Sponsor:
Collaborator:
The Aga Khan Health Services, Afghanistan
Information provided by (Responsible Party):
Gynuity Health Projects
ClinicalTrials.gov Identifier:
NCT01508429
First received: December 1, 2011
Last updated: August 2, 2012
Last verified: August 2012
History of Changes
  Purpose

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.


Condition Intervention
Postpartum Hemorrhage (PPH)
 Other: placebo
Drug: Misoprostol

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Misoprostol for the Treatment of Postpartum Haemorrhage (PPH) Following Self- Administration of Misoprostol Prophylaxis in Home Deliveries.

Resource links provided by NLM:

MedlinePlus related topics: Postpartum Care
Drug Information available for: Misoprostol
U.S. FDA Resources

Further study details as provided by Gynuity Health Projects:

Primary Outcome Measures:
  • Hb of greater than 2 g/dl from pre- to post-delivery [ Time Frame: 3-5 days after delivery ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Side effects [ Time Frame: immediately after delivery; 3-5 days post delivery ] [ Designated as safety issue: Yes ]
    Observed side effects: perceived severity, additional care provided Any serious adverse outcomes including uterine rupture, hysterectomy, hospitalization, maternal deaths, and neonatal deaths.

  • additional interventions [ Time Frame: immediately after delivery; 3-5 days post delivery ] [ Designated as safety issue: Yes ]
    Additional interventions and additional care provided to the woman, # of referrals and transfers

  • Acceptability [ Time Frame: immediately after delivery; 3-5 days post delivery ] [ Designated as safety issue: No ]
    Acceptability and management of side effects, acceptablity of taking the drugs


Estimated Enrollment: 84
Study Start Date: July 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01508429

Contacts
Contact: Dina Abbas 2124481230 dabbas@gynuity.org
Contact: Jill Durocher 2124481230 jdurocher@gynuity.org

Locations
Afghanistan
Home delivery setting Recruiting
Darwaz, Ishkashim, Shugnan, Wakhan districts, Badakshan Province, Afghanistan
Sponsors and Collaborators
Gynuity Health Projects
The Aga Khan Health Services, Afghanistan
Investigators
Principal Investigator: Shafiq Mirzazada Aga Khan University
Study Director: Gijs Walraven Secretariat of His Highness the Aga Khan, Aiglemont
Study Director: Dina Abbas Gynuity Health Projects
Study Director: Jill Durocher Gynuity Health Projects
  More Information

No publications provided

Responsible Party: Gynuity Health Projects
ClinicalTrials.gov Identifier: NCT01508429     History of Changes
Other Study ID Numbers: 2.4.14
Study First Received: December 1, 2011
Last Updated: August 2, 2012
Health Authority: Afghanistan: Ministry of Public Health

Keywords provided by Gynuity Health Projects:
Postpartum hemorrhage
PPH
misoprostol
home deliveries

Additional relevant MeSH terms:
Hemorrhage
Postpartum Hemorrhage
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Puerperal Disorders
Uterine Hemorrhage
Misoprostol
Anti-Ulcer Agents
 Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs
Abortifacient Agents, Nonsteroidal
Abortifacient Agents

ClinicalTrials.gov processed this record on June 17, 2013