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Misoprostol as First Aid Measure to Address Excessive Postpartum Bleeding

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.
 
ClinicalTrials.gov Identifier: NCT02853552
Recruitment Status : Unknown
Verified July 2016 by Gynuity Health Projects.
Recruitment status was:  Not yet recruiting
First Posted : August 3, 2016
Last Update Posted : August 3, 2016
Sponsor:
Collaborator:
National Committee for Maternal & Neonatal Health
Information provided by (Responsible Party):
Gynuity Health Projects

Brief Summary:
The overall study purpose is to evaluate the safety, feasibility and acceptability of advance distribution of misoprostol to be used as 'first aid treatment' administered by the woman herself or her family to help treat excessive bleeding in home births.

Condition or disease Intervention/treatment Phase
Postpartum Hemorrhage Drug: Misoprostol Phase 4

Detailed Description:

This is a quasi-experimental, pre-post intervention study that will be conducted over a period of 12 months and will span two phases:

Phase 1 (baseline) (6 months): Data on deliveries will be collected for pregnant women who deliver during this phase. Data will also be collected on the treatment administered in any PPH cases. Women will be counseled on and also receive educational materials on how to identify excessive bleeding and the importance of seeking care at a facility if excessive bleeding occurs.

Phase 2 (misoprostol) (6 months): During this phase, the study will pilot the first aid concept. Women will be provided with a single dose of 800 mcg sublingual misoprostol (200 mcg x 4 tablets) during their third trimester to use in the event of excessive postpartum bleeding, as well as the educational materials and counseling provided during the Phase 1. The misoprostol is intended to serve as a first aid treatment measure and although seeking additional care is challenging in this setting, women and families will be advised to have a plan ready to seek immediate care at a health facility as soon as they take the misoprostol.

During both study phases, data will be collected on maternal, clinical, and neonatal outcomes for all deliveries that occur in the study area. If women receive any care related to their delivery, data collectors will document this information.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4330 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Use of Misoprostol by Families and Women as a First Aid Measure to Address Excessive Postpartum Bleeding in Home Deliveries
Study Start Date : October 2016
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : October 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Misoprostol


Intervention Details:
  • Drug: Misoprostol
    800mcg misoprostol taken sublingually


Primary Outcome Measures :
  1. Number of cases identified as having excessive bleeding [ Time Frame: Within 1 week after delivery ]
  2. Proportion of women who administer misoprostol as first aid [ Time Frame: Within 1 week after delivery ]
    Proportion of women who took misoprostol to treat excessive bleeding out of women who self-diagnosed excessive bleeding

  3. Proportion of women who correctly administer misoprostol as first aid [ Time Frame: Within 1 week after delivery ]
    Proportion of women who administer misoprostol by correct route and correct dose for treatment of excessive bleeding out of all women who administer misoprostol for treatment of excessive bleeding

  4. Acceptability of side effects of misoprostol [ Time Frame: Within 1 week after delivery ]
  5. Number of women who are transferred for excessive bleeding [ Time Frame: Within 1 week after delivery ]
    Women who are receive care for heavy bleeding by a skilled provider at home or at a health facility

  6. Proportion of women who experience a serious adverse event due to excessive bleeding [ Time Frame: Within 1 week after delivery ]
    Proportion of women who experience a SAE (defined as laparotomy, surgery, hysterectomy, blood transfusion or death) out of all women who experience excessive bleeding

  7. Proportion of women who receive an additional intervention (e.g. use of additional uterotonic or suturing) for excessive bleeding [ Time Frame: Within 1 week after delivery ]
  8. Level of acceptability and satisfaction with using misoprostol as first-aid option to treat excessive bleeding [ Time Frame: Within 1 week after delivery ]
  9. Correct comprehension of information related to misoprostol and its use for first aid [ Time Frame: Within 1 week after delivery ]
    Proportion of women who correctly answer questions related to use and administration of misoprostol for first aid to treat excessive bleeding



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Pregnant women living in sample districts

Exclusion Criteria:

  • Unable to provide informed consent

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): NCT02853552


Contacts
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Contact: Dina Abbas, MPH 212-448-1230

Sponsors and Collaborators
Gynuity Health Projects
National Committee for Maternal & Neonatal Health
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Responsible Party: Gynuity Health Projects
ClinicalTrials.gov Identifier: NCT02853552    
Other Study ID Numbers: 3007
First Posted: August 3, 2016    Key Record Dates
Last Update Posted: August 3, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Postpartum Hemorrhage
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