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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02853552
Other study ID # 3007
Secondary ID
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


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
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