A Phase 4 interventional study of Misoprostol in Postpartum Hemorrhage, sponsored by Gynuity Health Projects. Status unknown. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-08-03.
Sponsored by Gynuity Health Projects · Phase 4, Interventional, and Health services research
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.
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.
445 studies on the registry are indexed under Postpartum Hemorrhage; 76 are open to participants now.
This study's planned enrollment of 4,330 is above the median of 148 across 340 interventional studies indexed under Postpartum Hemorrhage.
Browse Postpartum Hemorrhage studies →Gynuity Health Projects is the lead sponsor of 112 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
800mcg misoprostol taken sublingually
Number of cases identified as having excessive bleeding
Time frame: 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
Time frame: 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
Time frame: Within 1 week after delivery
Acceptability of side effects of misoprostol
Time frame: 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
Time frame: 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
Time frame: Within 1 week after delivery
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
Level of acceptability and satisfaction with using misoprostol as first-aid option to treat excessive bleeding
Time frame: 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
Time frame: Within 1 week after delivery
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.
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Gynuity Health Projects