The Release Trial: a randomised trial of umbilical vein oxytocin versus placebo for the treatment of retained placenta.
| ISRCTN | ISRCTN13204258 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13204258 |
| Secondary identifying numbers | LWH 0481 |
- Submission date
- 13/09/2004
- Registration date
- 01/10/2004
- Last edited
- 18/12/2009
- 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 Andrew Weeks
Scientific
Scientific
Department of Obstetrics and Gynaecology
Liverpool Women's Hospital
Crown Street
Liverpool
L8 7SS
United Kingdom
| Phone | +44 (0)151 702 4240 |
|---|---|
| aweeks@liv.ac.uk |
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 acronym | RELEASE |
| Study objectives | The injection of oxytocin down the umbilical vein has been proposed as a treatment for retained placenta. It can be performed by midwives in health centres and needs only the drug and a syringe. Its efficacy has been tested in a number of randomised trials with varying results. A recent meta-analysis by the Cochrane collaboration suggests that it is of borderline efficacy. However, the previous trials have used a wide variety of oxytocin doses as well as a method of injection that has been shown to deliver little of the oxytocin to the placental bed. The results of a recent observational study suggests that with higher oxytocin doses delivered through a tube passed up the umbilical vein, high success rates can be obtained. The results of a pilot study of 10 women, suggests that a dose of 50 IU in 30 ml saline may be effective at delivering the placenta. A multi-centre randomised trial of this new method of umbilical vein injection is proposed. It will involve 572 women of over 34 weeks gestation with retained placenta of at least 30 minutes duration. The study centres will initially be Mulago Hospital, Kampala, Liverpool Women's Hospital, Liverpool and the Jessop Wing, Sheffield. The trial will be double-blind and women with retained placenta who are not bleeding excessively will be randomised to receive either oxytocin (50 IU in 30 ml saline) or placebo. Women will be eligible for inclusion from 30 minutes post-delivery and the primary outcome measure will be the incidence of manual removal of placenta. Women will go for immediate manual removal if haemorrhage occurs or at 30 minutes following the oxytocin injection. A study involving 572 women will have 80% power to detect a 20% reduction in the relative risk of manual removal with 95% significance. The hypothesis is that intra-umbilical injection of oxytocin reduces the incidence of manual removal compared with placebo in the treatment of retained placenta. Please note that as of 14/09/2007 the details of this trial were updated by the Principal Investigator (see contact details). Most changes are noted with the date 14/09/2007. The following amendment has also been made: Pakistan has been added to the list of countries of recruitment as of 14/09/2007 |
| Ethics approval(s) | 1. Ethical approval was granted for the RELEASE trial on 24th June 2004 by the London Multi-Centre Research Ethics Committee (reference MREC/03/2/075). 2. Local ethical approval has also been granted by the Pakistan and Uganda institutions involved. |
| Health condition(s) or problem(s) studied | Retained Placenta |
| Intervention | Either 50 IU oxytocin or sterile water in 25 ml saline injected into the umbilical vein. Please note the previous anticipated end date of this trial was 31/12/2007 (see hypothesis for details of this update). |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Oxytocin |
| Primary outcome measure | Manual removal of the placenta following randomisation |
| Secondary outcome measures | Drop in haemoglobin, measured blood loss, need for transfusion, need for surgery |
| Overall study start date | 01/12/2004 |
| Completion date | 31/05/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 600 (572 as of 14/09/2007) |
| Key inclusion criteria | 1. 600 women with retained placenta for over 30 minutes 2. Written informed consent 3. Estimated gestation at least 34 weeks (or birth weight of 2 kg if gestation unknown) 4. Umbilical cord is clamped and cut 5. In the UK participants should be over 18 years of age, or over 16 and Gillick competent 6. In Uganda participants should be over 18 |
| Key exclusion criteria | 1. Vaginal bleeding or maternal haemodynamic instability (Pulse >100 bpm or systolic blood pressure <100 mmHg) necessitating immediate placental removal 2. Torn umbilical cord making catheterisation impossible 3. Completely physiological third stage management (no cord cutting or clamping, no prophylactic oxytocics, no cord traction or fundal pressure) 4. Stillborn baby |
| Date of first enrolment | 01/12/2004 |
| Date of final enrolment | 31/05/2008 |
Locations
Countries of recruitment
- England
- Pakistan
- Uganda
- United Kingdom
Study participating centre
Department of Obstetrics and Gynaecology
Liverpool
L8 7SS
United Kingdom
L8 7SS
United Kingdom
Sponsor information
Liverpool Women's Hospital (UK)
Hospital/treatment centre
Hospital/treatment centre
Crown Street
Liverpool
L8 7SS
England
United Kingdom
| Website | http://www.lwh.org.uk/ |
|---|---|
"ROR" |
https://ror.org/00eysw063 |
Funders
Funder type
Research organisation
WellBeing (UK) (ref: W1/03)
No information available
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) - Ugandan part of the trial (ref: A35026)
No information available
Higher Education Commission of Pakistan (Pakistan) - funding for the Pakistan arm of the trial (added 14/09/2007)
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? |
|---|---|---|---|---|---|
| Protocol article | protocol | 01/10/2005 | Yes | No | |
| Other publications | experiences and lessons for gaining informed consent | 11/05/2006 | Yes | No | |
| Results article | results | 09/01/2010 | Yes | No |
