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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ISRCTN
Last refreshed on: 13 January 2015
Main ID:  ISRCTN34455240
Date of registration: 07/06/2005
Prospective Registration: Yes
Primary sponsor: UNDP/UNFPA/WHO/World Bank - Special Programme of Research, Development and Research Training in Human Reproduction
Public title: Misoprostol to treat Postpartum Haemorrhage (PPH): a randomised controlled trial (Argentina, Egypt, South Africa, Thailand and Viet Nam)
Scientific title:
Date of first enrolment: 01/05/2005
Target sample size: 1400
Recruitment status: Completed
URL:  http://isrctn.com/ISRCTN34455240
Study type:  Interventional
Study design:  Randomised controlled trial (Treatment)  
Phase: 
Countries of recruitment
Argentina Egypt South Africa Thailand Viet Nam
Contacts
Name:    
Address: 
Telephone:
Email:
Affiliation: 
Name: J    Villar
Address:  World Health Organization 20 Avenue Appia CH-1211 Geneva-27 Switzerland
Telephone:
Email: villarj@who.int
Affiliation: 
Key inclusion & exclusion criteria
Inclusion criteria: All women delivering vaginally with clinically diagnosed PPH thought to be due to or contributed to by atonia requiring additional uterotonics will receive either misoprostol or placebo in addition to routine treatment for PPH.
Exclusion criteria: Refusal to give consent for participation; Too ill or distressed to give consent; The woman is not entitled to give informed consent e.g. minors without a guardian; The delivery is regarded as abortion according to the local gestational age limits; If the woman is delivered by caesarean section; If the woman cannot take misoprostol sub-lingually; If the woman suffers from severe bleeding disorder such as haemophilia; If the woman has a temperature of more than 38.5°C; If the woman has any severe allergic condition; If the woman's placenta is not delivered at the time of randomization.

Age minimum:
Age maximum:
Gender: Female
Health Condition(s) or Problem(s) studied
Postpartum haemorrhage
Pregnancy and Childbirth
Postpartum haemorrhage
Intervention(s)
Women will be provided with information about the trial during antenatal care. At admission for delivery the trial will be explained again and women will be invited to give informed consent. After delivery, women clinically diagnosed with postpartum haemorrhage requiring further uterotonic treatment will be given injectable uterotonics as routinely practised at each centre. Women with PPH who agreed to participate in the trial will be randomized and will be given the trial's treatment (3 tablets of misoprostol 200 µg or placebo). The three tablets will be administered sublingually. The administration of the study medication (misoprostol or placebo) will be as close to the administration of additional injectable uterotonics as possible.
Primary Outcome(s)
The primary outcome will be the incidence of greater than or equal to 500 ml of measured blood loss at 60 minutes after enrolment.

Follow up duration for primary endpoints: approximate duration of involvement in the study for each subject is one follow up visit 10 days post-treatment.
Secondary Outcome(s)
No secondary outcome measures
Secondary ID(s)
WHO/A35042
Source(s) of Monetary Support
United Nations Development Programme (UNDP)/United Nations Population Fund (UNFPA)/World Health Organization (WHO)/World Bank - Special Programme of Research, Development and Research Training in Human Reproduction (HRP), Gynuity Health Projects will be responsible for funding and financial oversight of the centres
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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