Condition category
Pregnancy and Childbirth
Date applied
06/06/2005
Date assigned
07/06/2005
Last edited
25/08/2011
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

Dr J Villar

ORCID ID

Contact details

World Health Organization
20 Avenue Appia
Geneva-27
CH-1211
Switzerland
villarj@who.int

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

WHO/A35042

Study information

Scientific title

Acronym

Study hypothesis

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

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

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Misoprostol

Primary outcome measures

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 trial start date

01/05/2005

Overall trial end date

31/10/2006

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

1400

Participant 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.

Recruitment start date

01/05/2005

Recruitment end date

31/10/2006

Locations

Countries of recruitment

Argentina, Egypt, South Africa, Thailand, Viet Nam

Trial participating centre

World Health Organization
Geneva-27
CH-1211
Switzerland

Sponsor information

Organisation

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

Sponsor details

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

Sponsor type

Research organisation

Website

http://www.who.int/reproductive-health/hrp/

Funders

Funder type

Research organisation

Funder name

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)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

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

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

1. 2001 results in http://www.ncbi.nlm.nih.gov/pubmed/20494730

Publication citations

  1. Results

    Widmer M, Blum J, Hofmeyr GJ, Carroli G, Abdel-Aleem H, Lumbiganon P, Nguyen TN, Wojdyla D, Thinkhamrop J, Singata M, Mignini LE, Abdel-Aleem MA, Tran ST, Winikoff B, Misoprostol as an adjunct to standard uterotonics for treatment of post-partum haemorrhage: a multicentre, double-blind randomised trial., Lancet, 2010, 375, 9728, 1808-1813, doi: 10.1016/S0140-6736(10)60348-0.

Additional files

Editorial Notes