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NCT01487278 Clinical Trial

Comparing Misoprostol and Oxytocin in UnijectTM for Postpartum Hemorrhage (PPH) Prevention in Mali

Postpartum Hemorrhage Clinical Trial

Official title:
Preventing Postpartum Hemorrhage: Examining Two Strategies for PPH Prevention in Communities: Misoprostol and Oxytocin in UnijectTM in Mali

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT01487278
Other study ID # 2.4.8
Secondary ID
Status Withdrawn
Phase N/A
First received December 5, 2011
Last updated January 8, 2014

Study information
Verified date January 2014
Source Gynuity Health Projects
Contact n/a
Is FDA regulated No
Health authority Mali: Ministry of Health
Study type Interventional

Clinical Trial Summary

This is a large, community-based, cluster-randomized trial to compare routine prophylactic use of 600 mcg oral misoprostol and 10 IU oxytocin delivered by UnijectTM intramuscularly during the third stage of labor.

Description:

This study will assess the programmatic implications (including feasibility, acceptability, costs, risks and benefits) at the community level of the introduction of misoprostol and/or oxytocin in UnijectTM for the prevention of PPH and will help to identify the appropriate niche for both drugs.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria:

- women delivering at home with a trained study provider who are able to provide informed consent

Exclusion Criteria:

- women with known contraindications to prostaglandins

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Drug:
• misprostol
600 mcg misoprostol oral
Device:
• UnijectTM
10 IU oxytocin delivered intramuscularly with UnijectTM

Locations
Country Name City State
Mali Villages in Mopti Mopti

Sponsors (3)
Lead Sponsor Collaborator
Gynuity Health Projects Guttmacher Institute, The Aga Khan Foundation

Country where clinical trial is conducted

Mali, 

Outcome
Type Measure Description Time frame Safety issue
Primary Mean change in hemoglobin To establish the comparable effectiveness of two technologies, individual pre- and post-delivery Hb measures will be taken to calculate change in Hb. This will be done using a Hemocue Hemoglobin machine + cuvette (HemoCue, Angelholm, Sweden). The Hemocue is a simple means of collecting Hb measures at the community-level where traditional laboratory techniques are not feasible. during 3rd trimester and 1-3 days postpartum No
Secondary occurrence and management of side effects nausea, vomiting, diarrhea, shivering, fever 1 hour postpartum Yes
Secondary correct timing of drug administration administration of the drug after the birth of the baby and verifying no twin, before the expulsion of the placenta collected immediately following birth, verified 1-3 days postpartum Yes
Secondary change in hemoglobin = 2 g/dL during third trimester and 1-3 days postpartum No
Secondary additional interventions use of additional uterotonics, manual removal of placental fragments, etc during birth and 1-3 days postpartum No
Secondary referrals referral requested, transfers carried out, reasons for incomplete referrals/transfers 1-3 days postpartum No
Secondary acceptability acceptability according to woman of study medication, care received, side effects experienced 1-3 days postpartum No
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
Not yet recruiting NCT02853552 - Misoprostol as First Aid Measure to Address Excessive Postpartum Bleeding Phase 4
Completed NCT02910310 - Introduction of UBT for PPH Management in Three Countries N/A
Completed NCT03344302 - Oxytocin Administration During Cesarean Section Phase 4

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