Condition category
Pregnancy and Childbirth
Date applied
19/07/2004
Date assigned
20/07/2004
Last edited
10/08/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof G Justus Hofmeyr

ORCID ID

Contact details

P Bag X9047
East London
5201
South Africa
+27 (0)832809402
gjh@global.co.za

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CRHS010215a

Study information

Scientific title

Acronym

Study hypothesis

Not provided at time of registration

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Screening

Patient information sheet

Condition

Postpartum haemorrhage

Intervention

1. Intervention group: Misoprostol 200 µg tablets. Each woman receives 1 tablet orally, 2 tablets sublingually and 2 tablets rectally.
2. Control group: identical placebo tablets. Each woman receives 1 tablet orally, 2 tablets sublingually and 2 tablets rectally.
(All women receive routine accepted treatment for postpartum haemorrhage)

Intervention type

Drug

Phase

Not Specified

Drug names

Misoprostol

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/2002

Overall trial end date

01/12/2003

Reason abandoned

Eligibility

Participant inclusion criteria

Women with postpartum haemorrhage defined as vaginal bleeding after childbirth considered to be excessive, and considered likely to be due to inadequate uterine contraction

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/01/2002

Recruitment end date

01/12/2003

Locations

Countries of recruitment

South Africa

Trial participating centre

P Bag X9047
East London
5201
South Africa

Sponsor information

Organisation

University of the Witwatersrand (South Africa)

Sponsor details

7
York Rd
Parktown
Johannesburg
2193
South Africa
+27 (0)11 717 2000
gjh@global.co.za

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

University of the Witwatersrand (South Africa) - No external funding; this trial was funded from the existing research unit budget, using full-time research staff.

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Results in: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=15298718

Publication citations

  1. Results

    Hofmeyr GJ, Ferreira S, Nikodem VC, Mangesi L, Singata M, Jafta Z, Maholwana B, Mlokoti Z, Walraven G, Gülmezoglu AM, Misoprostol for treating postpartum haemorrhage: a randomized controlled trial [ISRCTN72263357]., BMC Pregnancy Childbirth, 2004, 4, 1, 16, doi: 10.1186/1471-2393-4-16.

Additional files

Editorial Notes