Contact information
Type
Scientific
Contact name
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/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
CRHS010215a
Study information
Scientific title
Acronym
Study hypothesis
Not provided at time of registration
Ethics approval(s)
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Not specified
Study 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
Pharmaceutical study type(s)
Phase
Not Specified
Drug/device/biological/vaccine name(s)
Misoprostol
Primary outcome measure
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall study start date
01/01/2002
Overall study end date
01/12/2003
Reason abandoned (if study stopped)
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(s)
Patient
Age group
Adult
Sex
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
Study 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
ROR
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
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 06/08/2004 | Yes | No |