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
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
-
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.