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

Abstract

HYPOTHESIS:

Intraumbilical injection of oxytocin reduces the incidence of manual removal compared with placebo in the treatment of retained placenta. ENTRY CRITERIA: The women recruited will be stable haemodynamically, not bleeding vaginally, over 34 weeks of gestation and with a retained placenta for at least 30 minutes. TREATMENT ARMS: Oxytocin (50 IU) or sterile water (in identical vials) in 25 mL saline injected through an intraumbilical venous catheter.

SAMPLE SIZE:

Five hundred seventy-two women.

PRIMARY ENDPOINT:

Need for manual removal of placenta. CENTRES: Initially, there will be two study sites in the UK (Liverpool and Sheffield) and five in Uganda (Mulago, Nsambia, Mengo, Rubaga and Arua).

FUNDING:

World Health Organization and WellBeing of Women.

• Authors: Andrew Weeks, Florence Mirembe, Zarko Alfirevic
• Journal: BJOG : an international journal of obstetrics and gynaecology (BJOG) Vol. 112 Issue 10 Pg. 1458 (Oct 2005) ISSN: 1470-0328 [Print] England
• PMID: 16167963 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Oxytocics
• Oxytocin

Topics

• Adult
• Female
• Humans
• Injections, Intravenous
• Oxytocics (administration & dosage)
• Oxytocin (administration & dosage)
• Patient Satisfaction
• Physical Therapy Modalities
• Placenta, Retained (drug therapy)
• Pregnancy
• Treatment Outcome
• Umbilical Veins