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

This study has been completed.
Sponsor:
Collaborator:
Aga Khan Health Services
Information provided by (Responsible Party):
Gynuity Health Projects
ClinicalTrials.gov Identifier:
NCT01485562
First received: December 1, 2011
Last updated: March 9, 2016
Last verified: March 2016
  Purpose
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.

Condition Intervention
Postpartum Haemorrhage
Drug: Misoprostol
Other: placebo

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: Treatment of Postpartum Haemorrhage (PPH) Using Misoprostol in Home Births

Resource links provided by NLM:


Further study details as provided by Gynuity Health Projects:

Primary Outcome Measures:
  • Haemoglobin concentration (Hb) of greater than or equal to 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.


Secondary Outcome Measures:
  • Number of participants who experience side effects [ Time Frame: immediately after delivery; 3-5 days post delivery ] [ Designated as safety issue: Yes ]
    number of women who experienced side effects and the severity of the side effects as rated on a scale, additional care provided

  • number of participants who received additional interventions [ Time Frame: immediately after delivery; 3-5 days post delivery ] [ Designated as safety issue: Yes ]
    number of participants who received care by as skilled provider and the type of care provided

  • number of women who found misoprostol treatment to be acceptable [ Time Frame: immediately after delivery; 3-5 days post delivery ] [ Designated as safety issue: No ]
    women will be asked to rate their acceptability with the treatment using a scale

  • number of participants who experience severe adverse events [ Time Frame: immediately after delivery; 3-5 days post delivery ] [ Designated as safety issue: Yes ]
    serious adverse are defined as uterine rupture, hysterectomy, hospitalization, maternal deaths, and neonatal deaths.


Enrollment: 84
Study Start Date: May 2012
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Gymiso

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

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01485562

Locations
Pakistan
Home Births
Chitral, Khyber Pakhtunkhwa, Pakistan
Sponsors and Collaborators
Gynuity Health Projects
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
  More Information

Responsible Party: Gynuity Health Projects
ClinicalTrials.gov Identifier: NCT01485562     History of Changes
Other Study ID Numbers: 2.4.15 
Study First Received: December 1, 2011
Last Updated: March 9, 2016
Health Authority: Pakistan:Ethical Review Committee, Aga Khan University

Keywords provided by Gynuity Health Projects:
postpartum haemorrhage
misoprostol
treatment
prophylaxis
home births

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

ClinicalTrials.gov processed this record on December 06, 2016