Comparing Misoprostol and Oxytocin in Uniject for Postpartum Hemorrhage (PPH) Prevention in Senegal - Full Text View

Purpose

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

Condition	Intervention
Postpartum Hemorrhage	Drug: Misoprostol Device: UnijectTM


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	Preventing Postpartum Hemorrhage: Examining Two Strategies for PPH Prevention in Communities: Misoprostol and Oxytocin Uniject in Senegal

Resource links provided by NLM:

MedlinePlus related topics: Bleeding Postpartum Care

Drug Information available for: Oxytocin Misoprostol

U.S. FDA Resources

Further study details as provided by Gynuity Health Projects:

Primary Outcome Measures:

Mean change in hemoglobin [ Time Frame: during 3rd trimester and 1-3 days postpartum ] [ Designated as safety issue: No ]
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

Secondary Outcome Measures:

Occurrence and management of side effects [ Time Frame: 1 hour postpartum ] [ Designated as safety issue: Yes ]
nausea, vomiting, diarrhea, shivering, fever
correct timing of drug administration [ Time Frame: collected immediately following birth, verified 1-3 days postpartum ] [ Designated as safety issue: Yes ]
administration of the drug after the birth of the baby and verifying no twin, before the expulsion of the placenta
change in hemoglobin ≥ 2 g/dL [ Time Frame: during third trimester and 1-3 days postpartum ] [ Designated as safety issue: No ]
additional interventions [ Time Frame: during birth ] [ Designated as safety issue: No ]
use of additional uterotonics, manual removal of placental fragments, etc
referrals [ Time Frame: 0-3 days postpartum ] [ Designated as safety issue: No ]
referral requested, transfers carried out, reasons for incomplete referrals/transfers
acceptability [ Time Frame: 1-3 days postpartum ] [ Designated as safety issue: No ]
acceptability according to woman of study medication, care received, side effects experienced


Enrollment:	1365
Study Start Date:	June 2012
Study Completion Date:	January 2014
Primary Completion Date:	January 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Misoprostol 600 mcg oral misoprostol administered during the third stage of labor	Drug: Misoprostol 600 mcg misoprostol oral Other Names: Cytotec Misoclear
Experimental: UnijectTM 10 IU oxytocin delivered IM with UnijectTM during he third stage of labor	Device: UnijectTM 10 IU oxytocin delivered intramuscularly with UnijectTM

Detailed Description:

This study will assess the programmatic implications (including feasibility, acceptability, 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.

Eligibility


Ages Eligible for Study:	Child, Adult, Senior
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

women delivering in community health centers (case de sante) with a trained study provider (matrone) who are able to provide informed consent

Exclusion Criteria:

women with known contraindications to prostaglandins

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01713153

Locations


Senegal
Health huts in the district of Thiadiaye and Kolda
Thiadiay and Kolda, Thiadiaye and Kolda, Senegal

Sponsors and Collaborators

Gynuity Health Projects

ChildFund International

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Diop A, Daff B, Sow M, Blum J, Diagne M, Sloan NL, Winikoff B. Oxytocin via Uniject (a prefilled single-use injection) versus oral misoprostol for prevention of postpartum haemorrhage at the community level: a cluster-randomised controlled trial. Lancet Glob Health. 2016 Jan;4(1):e37-44. doi: 10.1016/S2214-109X(15)00219-3.


Responsible Party:	Gynuity Health Projects
ClinicalTrials.gov Identifier:	NCT01713153 History of Changes
Other Study ID Numbers:	2.4.9
Study First Received:	October 22, 2012
Last Updated:	February 24, 2016
Health Authority:	Senegal: Ministry of Health and Prevention

Keywords provided by Gynuity Health Projects:


postpartum hemorrhage prevention misoprostol Uniject oxytocin

Additional relevant MeSH terms:


Hemorrhage Postpartum Hemorrhage Pathologic Processes Obstetric Labor Complications Pregnancy Complications Puerperal Disorders Uterine Hemorrhage Oxytocin	Misoprostol Oxytocics Reproductive Control Agents Physiological Effects of Drugs Abortifacient Agents, Nonsteroidal Abortifacient Agents Anti-Ulcer Agents Gastrointestinal Agents

ClinicalTrials.gov processed this record on September 26, 2016