Misoprostol as First Aid Measure to Address Excessive Postpartum Bleeding

Postpartum Hemorrhage Clinical Trial

Official title:

Use of Misoprostol by Families and Women as a First Aid Measure to Address Excessive Postpartum Bleeding in Home Deliveries

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02853552
• Other study ID #: 3007
• Status: Not yet recruiting
• Phase: Phase 4
• First received: July 29, 2016
• Last updated: July 29, 2016
• Start date: October 2016
• Est. completion date: October 2017

Study information

• Verified date: July 2016
• Source: Gynuity Health Projects
• Contact: Dina Abbas, MPH
• Phone: 212-448-1230
• Is FDA regulated: No
• Health authority: Pakistan: Ziauddin University Ethical Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 4330
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Pregnant women living in sample districts

Exclusion Criteria:

• Unable to provide informed consent

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Hemorrhage
• Postpartum Hemorrhage

Intervention

Drug:
• Misoprostol
800mcg misoprostol taken sublingually

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Gynuity Health Projects	National Committee for Maternal & Neonatal Health

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of cases identified as having excessive bleeding		Within 1 week after delivery	No
Primary	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	No
Primary	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	Yes
Primary	Acceptability of side effects of misoprostol		Within 1 week after delivery	No
Primary	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	No
Primary	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	Yes
Primary	Proportion of women who receive an additional intervention (e.g. use of additional uterotonic or suturing) for excessive bleeding		Within 1 week after delivery	Yes
Primary	Level of acceptability and satisfaction with using misoprostol as first-aid option to treat excessive bleeding		Within 1 week after delivery	No
Primary	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	No