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Clinical Trial Details — Status: Withdrawn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
• Status: Withdrawn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• Status: Withdrawn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
• 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

• Hemorrhage
• Postpartum Hemorrhage

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

External Links

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