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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01508429
First Posted: January 12, 2012
Last Update Posted: July 11, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Aga Khan Health Services
Information provided by (Responsible Party):
Gynuity Health Projects
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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:


Further study details as provided by Gynuity Health Projects:

Primary Outcome Measures:
  • Hb of greater than or equal to 2 g/dl from pre- to post-delivery [ Time Frame: 3-5 days after 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.


Secondary Outcome Measures:
  • Side effects [ Time Frame: immediately after delivery; 3-5 days post delivery ]
    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 ]
    Additional interventions and additional care provided to the woman, # of referrals and transfers

  • Acceptability [ Time Frame: immediately after delivery; 3-5 days post delivery ]
    Acceptability and management of side effects, acceptablity of taking the drugs


Enrollment: 70
Study Start Date: July 2012
Study Completion Date: February 2016
Primary Completion Date: February 2016 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01508429


Locations
Afghanistan
Home delivery setting
Darwaz, Ishkashim, Shugnan, Wakhan districts, Badakshan Province, Afghanistan
Sponsors and Collaborators
Gynuity Health Projects
Aga Khan Health Services
Investigators
Principal Investigator: Shafiq Mirzazada Aga Khan Health Services
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

Responsible Party: Gynuity Health Projects
ClinicalTrials.gov Identifier: NCT01508429     History of Changes
Other Study ID Numbers: 2.4.14
First Submitted: December 1, 2011
First Posted: January 12, 2012
Last Update Posted: July 11, 2016
Last Verified: July 2016

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
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics