Misoprostol as First Aid Measure to Address Excessive Postpartum Bleeding

NCT02853552 | Unknown Phase 4

• 1 other identifier: 3007
• Study Type: interventional
• Target: 4,330
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Postpartum Hemorrhage

Outcome Measures

Primary Outcomes (9)

• Number of cases identified as having excessive bleeding

  Within 1 week after delivery

• Proportion of women who administer misoprostol as first aid

  Proportion of women who took misoprostol to treat excessive bleeding out of women who self-diagnosed excessive bleeding

  Within 1 week after delivery

• Proportion of women who correctly administer misoprostol as first aid

  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

  Within 1 week after delivery

• Acceptability of side effects of misoprostol

  Within 1 week after delivery

• Number of women who are transferred for excessive bleeding

  Women who are receive care for heavy bleeding by a skilled provider at home or at a health facility

  Within 1 week after delivery

• Proportion of women who experience a serious adverse event due to excessive bleeding

  Proportion of women who experience a SAE (defined as laparotomy, surgery, hysterectomy, blood transfusion or death) out of all women who experience excessive bleeding

  Within 1 week after delivery

• Proportion of women who receive an additional intervention (e.g. use of additional uterotonic or suturing) for excessive bleeding

  Within 1 week after delivery

• Level of acceptability and satisfaction with using misoprostol as first-aid option to treat excessive bleeding

  Within 1 week after delivery

• Correct comprehension of information related to misoprostol and its use for first aid

  Proportion of women who correctly answer questions related to use and administration of misoprostol for first aid to treat excessive bleeding

  Within 1 week after delivery

Interventions

Misoprostol DRUG

800mcg misoprostol taken sublingually

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant women living in sample districts

You may not qualify if:

• Unable to provide informed consent

Sponsors & Collaborators

• Gynuity Health Projects: lead
• National Committee for Maternal & Neonatal Health: collaborator

MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

Misoprostol

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Central Study Contacts

Dina Abbas, MPH

CONTACT

212-448-1230

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2016
• First Posted: August 3, 2016
• Study Start: October 1, 2016
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: August 3, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share