Misoprostol for the Treatment of Postpartum Hemorrhage

Status Completed

Clinical Trial Summary

The purpose of this study is to test whether misoprostol is as effective as oxytocin for treating primary postpartum hemorrhage (PPH) with uterine atony as the suspected cause in two circumstances: 1) where women have received prophylactic uterotonics in the third stage of labor; and 2) where no prophylactic uterotonics have been given in the third stage of labor.

Clinical Trial Description

Postpartum hemorrhage (PPH) remains a major cause of maternal deaths worldwide. Misoprostol offers several advantages over oxytocin and ergometrine, the drugs currently used to treat PPH. For example, misoprostol is stable at high temperatures and has a shelf life of several years, it is easy to administer, it can be given to hypertensive patients, and it is inexpensive. This randomized, double-blind placebo-controlled trial will test whether misoprostol is as effective as oxytocin in treating primary PPH in hospital births, both when women have received prophylactic uterotonics in the third stage of labor and when they have not.

Blood loss will be measured for all consenting women who deliver vaginally. If PPH occurs and uterine atony is the suspected cause, women will be randomized to receive either: a) four 200 µg pills of misoprostol sublingually and an IV of saline (resembling oxytocin) or b) four placebo tablets resembling misoprostol sublingually and 40 IU oxytocin by IV. This study seeks to answer the following questions:

- Is misoprostol as effective as oxytocin for treatment of primary PPH for women who do and do not receive oxytocin prophylaxis in the third stage of labor?

- Does misoprostol have an acceptable safety profile when given as an 800 µg sublingual dose to treat PPH?

- Is the side effect profile of misoprostol acceptable to women?

This study will take place in hospitals located in Burkina Faso, Ecuador, Egypt, Turkey, and Vietnam. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00116350
Study type	Interventional
Source	Gynuity Health Projects
Contact
Status	Completed
Phase	N/A
Start date	July 2005
Completion date	January 2008

View Details

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
Not yet recruiting	`NCT02319707` - Management of the Third Stage of Labor	Phase 3
Completed	`NCT02163616` - Treatment of Postpartum Hemorrhage With Misoprostol: Fever Study	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
Not yet recruiting	`NCT02853552` - Misoprostol as First Aid Measure to Address Excessive Postpartum Bleeding	Phase 4
Completed	`NCT02805426` - Effectiveness of Tranexamic Acid When Used as an Adjunct to Misoprostol for the Treatment of Postpartum Hemorrhage	Phase 4

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.