NCT00124540

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2005

Typical duration for not_applicable

Geographic Reach
3 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 26, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 28, 2005

Completed
4 days until next milestone

Study Start

First participant enrolled

August 1, 2005

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

May 28, 2008

Status Verified

May 1, 2008

Enrollment Period

2.1 years

First QC Date

July 26, 2005

Last Update Submit

May 26, 2008

Conditions

Postpartum Hemorrhage

Keywords

MisoprostolActive managementPostpartum hemorrhageMaternal morbidityAnemiaDeveloping countries

Outcome Measures

Primary Outcomes (1)

  • Blood loss =>500 mls within one hour after enrollment

Secondary Outcomes (6)

  • Blood loss =>1000 mls within one hour after enrollment

  • Mean blood loss after enrollment

  • Blood transfusion

  • Hemoglobin level <8 g/dL 24 hours after delivery

  • Maternal morbidity and mortality

  • +1 more secondary outcomes

Study Arms (2)

1

PLACEBO COMPARATOR

placebo resembling misoprostol

Drug: placebo

2

EXPERIMENTAL

misoprostol

Drug: misoprostol

Interventions

misoprostolDRUG
2
placeboDRUG

placebo resembling misoprosotl

1

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

University College Hospital

Ibadan, Nigeria

Location

Tembisa Hospital

Johannesburg, South Africa

Location

Rob Ferreira Hospital

Mbombela, South Africa

Location

Dora Nginza Hospital

Port Elizabeth, South Africa

Location

Mulago Hospital

Kampala, Uganda

Location

Related Publications (1)

  • 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.

    PMID: 21130990DERIVED

MeSH Terms

Conditions

Postpartum HemorrhageAnemia

Interventions

Misoprostol

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPuerperal DisordersUterine HemorrhageHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins E, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Officials

  • Lindeka Mangesi

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

    STUDY DIRECTOR

  • G. J. Hofmeyr, MD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 26, 2005

First Posted

July 28, 2005

Study Start

August 1, 2005

Primary Completion

September 1, 2007

Study Completion

October 1, 2007

Last Updated

May 28, 2008

Record last verified: 2008-05

Locations

UG(1)NG(1)ZA(3)