Active versus expectant management of third stage of labour: the Hinchingbrooke randomised controlled trial
| ISRCTN | ISRCTN63422923 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN63422923 |
| Protocol serial number | N/A |
| Sponsor | NHS R&D Regional Programme Register - Department of Health (UK) |
| Funder | NHS Executive Eastern (UK) |
- Submission date
- 23/01/2004
- Registration date
- 23/01/2004
- Last edited
- 13/10/2014
- 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 Diana Elbourne
Scientific
Scientific
Medical Statistics Unit
London School of Hygiene and Tropical Medicine
London
WC1E 7HT
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
Rate of postpartum haemorrhage |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/12/1995 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 1512 |
| Key inclusion criteria | Women judged to be at low risk of primary postpartum haemorrhage (PPH) (blood loss greater than 500 ml) |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/06/1993 |
| Date of final enrolment | 01/12/1995 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Medical Statistics Unit
London
WC1E 7HT
United Kingdom
WC1E 7HT
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | 07/03/1998 | Yes | No |
