Misoprostol to treat Postpartum Haemorrhage (PPH): a randomised controlled trial (Argentina, Egypt, South Africa, Thailand and Viet Nam)

ISRCTN	ISRCTN34455240
DOI	https://doi.org/10.1186/ISRCTN34455240
Secondary identifying numbers	WHO/A35042

Submission date: 06/06/2005
Registration date: 07/06/2005
Last edited: 25/08/2011

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr J Villar
Scientific

World Health Organization
20 Avenue Appia
Geneva-27
CH-1211
Switzerland

Email	villarj@who.int

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title
Study objectives	To assess the effects of misoprostol adjunct to the use of injectable oxytocics in women requiring additional uterotonics following active management of the third stage of labour, on outcomes such as blood loss and side effects.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Postpartum haemorrhage
Intervention	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.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Misoprostol
Primary outcome measure	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 measures	No secondary outcome measures
Overall study start date	01/05/2005
Completion date	31/10/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	1400
Key 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.
Key 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.
Date of first enrolment	01/05/2005
Date of final enrolment	31/10/2006

Locations

Countries of recruitment

Argentina
Egypt
South Africa
Switzerland
Thailand
Viet Nam

Study participating centre

World Health Organization

Geneva-27
CH-1211
Switzerland

Sponsor information

UNDP/UNFPA/WHO/World Bank - Special Programme of Research, Development and Research Training in Human Reproduction
Research organisation

World Health Organisation
20 Avenue Appia
Geneva-27
CH-1211
Switzerland

Website	http://www.who.int/reproductive-health/hrp/
"ROR"	https://ror.org/01f80g185

Funders

Funder type

Research organisation

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)

No information available

Gynuity Health Projects will be responsible for funding and financial oversight of the centres

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	22/05/2010		Yes	No