Misoprostol for Preventing Postpartum Hemorrhage

NCT ID: NCT00124540

Last Updated: 2008-05-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-08-31

Study Completion Date

2007-10-31

Brief Summary

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This hospital-based, multicenter, randomized, placebo-controlled trial will assess the effects of misoprostol as part of active management of the third stage of labor on postpartum blood loss, complications, and side effects. Twelve hundred eligible women will receive routine oxytocics (oxytocin 5-10 IU) plus either 400 mcg sublingual misoprostol or placebo during or immediately after delivery. The primary outcome will be measured blood loss of =\>500 mls within one hour after enrollment.

Detailed Description

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Conditions

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Postpartum Hemorrhage

Keywords

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Misoprostol Active management Postpartum hemorrhage Maternal morbidity Anemia Developing countries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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1

placebo resembling misoprostol

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

placebo resembling misoprosotl

2

misoprostol

Group Type EXPERIMENTAL

misoprostol

Intervention Type DRUG

Interventions

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misoprostol

Intervention Type DRUG

placebo

placebo resembling misoprosotl

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Women who have given birth to 1 or more live-born infants (para 1 or more)
* Vaginal delivery

Exclusion Criteria

* Refusal or inability to give informed consent
* Delivery regarded as abortion according to local gestational age limits
* Inability to take misoprostol sublingually
* Cesarean section
* Assisted vaginal delivery
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Witwatersrand, South Africa

OTHER

Sponsor Role collaborator

Effective Care Research Unit

OTHER

Sponsor Role collaborator

Family Care International

OTHER

Sponsor Role collaborator

Gynuity Health Projects

OTHER

Sponsor Role lead

Responsible Party

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University of Witwatersrand

Principal Investigators

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Lindeka Mangesi

Role: STUDY_DIRECTOR

Effective Care Research Unit, East London Hospital Complex, South Africa

G. J. Hofmeyr, MD

Role: PRINCIPAL_INVESTIGATOR

Effective Care Research Unit, Frere Maternity Hospital, East London Hospital Complex

Locations

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University College Hospital

Ibadan, , Nigeria

Site Status

Tembisa Hospital

Johannesburg, , South Africa

Site Status

Rob Ferreira Hospital

Mbombela, , South Africa

Site Status

Dora Nginza Hospital

Port Elizabeth, , South Africa

Site Status

Mulago Hospital

Kampala, , Uganda

Site Status

Countries

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Nigeria South Africa Uganda

References

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Hofmeyr GJ, Fawole B, Mugerwa K, Godi NP, Blignaut Q, Mangesi L, Singata M, Brady L, Blum J. Administration of 400 mug of misoprostol to augment routine active management of the third stage of labor. Int J Gynaecol Obstet. 2011 Feb;112(2):98-102. doi: 10.1016/j.ijgo.2010.08.019. Epub 2010 Dec 4.

Reference Type DERIVED
PMID: 21130990 (View on PubMed)

Other Identifiers

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2.4.5

Identifier Type: -

Identifier Source: org_study_id