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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Gynuity Health Projects
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 24, 2014
Last verified: March 2014
  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 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:
  • side effects, additional interventions, and acceptability [ Time Frame: immediately after delivery; 3-5 days post delivery ] [ Designated as safety issue: Yes ]

    Observed side effects: perceived severity, additional care provided Correct administration of prophylaxis, correct administration of misoprostol for treatment Any serious adverse outcomes including uterine rupture, hysterectomy, hospitalization, maternal deaths, and neonatal deaths.

    Postpartum Hb, mean difference in postpartum Hb levels between treatment groups, persistent bleeding following study treatment

    # of referrals and transfers Woman's condition at time of referral and at time of transfer Additional interventions Acceptability and management of side effects



Estimated Enrollment: 80
Study Start Date: May 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 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 Names:
  • Gymiso
  • STMOM
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
  • STMOM

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

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

Contacts
Contact: Dina Abbas 2124481230 dabbas@gynuity.org
Contact: Ayisha Diop 2124481230 adiop@gynuity.org

Locations
Pakistan
Home Births Recruiting
Chitral, Khyber Pakhtunkhwa, Pakistan
Principal Investigator: Zafar Ahmed         
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: Rozina Mistry Aga Khan Health Services
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

No publications provided

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 24, 2014
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:
Postpartum Hemorrhage
Puerperal Disorders
Hemorrhage
Obstetric Labor Complications
Pathologic Processes
Pregnancy Complications
Uterine Hemorrhage
Misoprostol
Abortifacient Agents
Abortifacient Agents, Nonsteroidal
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 19, 2014