Clinical Trials Logo

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.


Clinical Trial 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. ;


Study Design

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


Related Conditions & MeSH terms


NCT number NCT02853552
Study type Interventional
Source Gynuity Health Projects
Contact Dina Abbas, MPH
Phone 212-448-1230
Status Not yet recruiting
Phase Phase 4
Start date October 2016
Completion date October 2017

See also
  Status Clinical Trial Phase
Completed NCT03434444 - In Vitro Optimization of Oxytocin-induced Myometrial Contractility by Propranolol N/A
Terminated NCT01980173 - Medico-economic Comparison of Postpartum Hemorrhage Management Using the Bakri Balloon and Standard Care N/A
Not yet recruiting NCT06033170 - Celox™ PPH for Reaching Haemostasis in Patients With Postpartum Hemorrhage N/A
Completed NCT02163616 - Treatment of Postpartum Hemorrhage With Misoprostol: Fever Study Phase 3
Not yet recruiting NCT02319707 - Management of the Third Stage of Labor Phase 3
Recruiting NCT01600612 - Oxytocin, Carbetocin and Misopristol for Treatment of Postpartum Hemorrhage: A Multicentric Randomized Trial N/A
Completed NCT02079558 - Efficacy of Oxytocin vs. Carbetocin in Prevention of Postpartum Hemorrhage After Cesarean Section Phase 2
Withdrawn NCT01108302 - Effectiveness, Safety and Feasibility of Auxiliary Nurse Midwives' (ANM) Use of Oxytocin in Uniject™ to Prevent Postpartum Hemorrhage in India N/A
Completed NCT00097123 - RCT of Misoprostol for Postpartum Hemorrhage in India N/A
Completed NCT02883673 - Safety and Effectiveness of the Jada System in Treating Primary Postpartum Hemorrhage N/A
Completed NCT02542813 - Safety, Tolerability and Pharmacokinetics (PK) Study of Oxytocin (GR121619) Administered Via an Inhaled Route in Healthy Female Volunteers Phase 1
Completed NCT04201665 - EMG for Uterotonic Efficiency Estimation N/A
Terminated NCT03246919 - Ideal Time of Oxytocin Infusion During Cesarean Section Phase 4
Not yet recruiting NCT05501106 - Reducing Postpartum Hemorrhage After Vaginal Delivery N/A
Completed NCT05429580 - Prophylactic Tranexamic Acid Use After Vaginal Delivery N/A
Terminated NCT03064152 - Rotational Thromboelastometry for the Transfusion Management of Postpartum Hemorrhage After Vaginal or Cesarean Delivery N/A
Recruiting NCT05382403 - Novel Vacuum-Induced Hemorrhage Control for Postpartum Hemorrhage N/A
Completed NCT03344302 - Oxytocin Administration During Cesarean Section Phase 4
Completed NCT02910310 - Introduction of UBT for PPH Management in Three Countries N/A
Completed NCT02805426 - Effectiveness of Tranexamic Acid When Used as an Adjunct to Misoprostol for the Treatment of Postpartum Hemorrhage Phase 4