Condition category
Pregnancy and Childbirth
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
13/10/2014
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 Diana Elbourne

ORCID ID

Contact details

Medical Statistics Unit
London School of Hygiene and Tropical Medicine
London
WC1E 7HT
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

This study tested the hypothesis that active management of the third stage of labour lowers the rates of primary postpartum haemorrhage and longer-term consequences compared with expectant management, in a setting where both managements are commonly practised, and that this effect is not mediated by maternal posture.

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

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Pregnancy and childbirth: Childbirth

Intervention

1. Active management of the third stage (prophylactic oxytocic within 2 minutes of baby's birth, immediate cutting and clamping of the cord, delivery of placenta by controlled cord traction or maternal effort)
2. Expectant management (no prophylactic oxytocic, no cord clamping until pulsation ceased, delivery of placenta by maternal effort. Women were also randomly assigned upright or supine position.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Rate of postpartum haemorrhage

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/06/1993

Overall trial end date

01/12/1995

Reason abandoned

Eligibility

Participant inclusion criteria

Women judged to be at low risk of primary postpartum haemorrhage (PPH) (blood loss greater than 500 ml)

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

1512

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/06/1993

Recruitment end date

01/12/1995

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Medical Statistics Unit
London
WC1E 7HT
United Kingdom

Sponsor information

Organisation

NHS R&D Regional Programme Register - Department of Health (UK)

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

NHS Executive Eastern (UK)

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/pubmed/9504513

Publication citations

  1. Results

    Rogers J, Wood J, McCandlish R, Ayers S, Truesdale A, Elbourne D, Active versus expectant management of third stage of labour: the Hinchingbrooke randomised controlled trial., Lancet, 1998, 351, 9104, 693-699, doi: 10.1016/S0140-6736(97)09409-9.

Additional files

Editorial Notes