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GOT-IT Trial: Glyceryl Trinitrate for Retained Placenta

NCT02085213 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1107

Last updated 2018-05-21

No results posted yet for this study

Summary

A retained placenta (RP) is a complication after a normal birth, which affects nearly 11,000 women in the UK per year. This is where the placenta is not delivered spontaneously after giving birth. It is a major cause of postpartum haemorrhage (major loss of blood) which can lead to the death of the mother. The recommended treatment for RP is a surgical procedure - manual removal of placenta (MROP). This is a painful and unpleasant intervention for the women, involving additional hospital stay, and is an expensive outcome for the NHS. It is widely recognised that non-surgical management options for RP are limited and it has been recommended that research is needed into new medical treatments for RP. New effective treatments for RP would dramatically reduce the number of women requiring MROP with the operation being restricted to the small minority of women with particularly stuck placentae. The reduction in operative interventions would have cost benefits for the NHS and also for women in terms of increased satisfaction, less separation of mother and baby immediately after birth, and reduced morbidity.

This study will try to prove the clinical and cost effectiveness of a known treatment for angina, Glyceryl trinitrate (GTN) used to treat RP. The investigators will compare GTN against a placebo (dummy treatment) in a randomised controlled blinded trial (GOT-IT).

The GOT-IT Trial will be conducted in two phases. The first phase will involve an internal pilot study where the aim will be to test out and refine trial procedures in a small number of hospital sites. The second phase will be the main trial where recruitment will be extended to a larger number of hospitals in order to determine clinical and cost effectiveness.

Conditions

  • Placenta, Retained

Interventions

DRUG

Glyceryl Trinitrate

DRUG

Matched Placebo

Matched placebo

Sponsors & Collaborators

  • University of Aberdeen

    collaborator OTHER

  • NHS Lothian

    collaborator OTHER_GOV

  • University of Edinburgh

    lead OTHER

Principal Investigators

  • Fiona C Denison, Dr · University of Edinburgh

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2017-07-26
Completion
2017-10-05

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02085213 on ClinicalTrials.gov