The Release Trial: a randomised trial of umbilical vein oxytocin versus placebo for the treatment of retained placenta.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN13204258

Enrollment

600

Registered

2004-10-01

Start date

2004-12-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Retained Placenta Pregnancy and Childbirth Retained placenta and membranes, without haemorrhage

Interventions

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

Eligibility

Sex/Gender

Female

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Manual removal of the placenta following randomisation	—

Secondary

Measure	Time frame
Drop in haemoglobin, measured blood loss, need for transfusion, need for surgery	—

Countries

Pakistan, Uganda, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 23, 2026