GOT-IT TRIAL

 

 

Project title: A pragmatic group sequential placebo controlled randomised trial to determine the effectiveness of Glyceryl trinitrate for retained placenta.

A retained placenta (RP) is a complication after a normal birth, which affects nearly 11,000 women in the UK a year. This is where the placenta is not delivered straight away after giving birth.  It is a major cause of major loss of blood (postpartum haemorrhage ) which can lead in the most serious cases 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 procedure for the women, involving an additional stay in hospital, and is an additional cost for the NHS. 

 It has been recommended that research is needed into new and more acceptable medical treatments for RP. It is hoped that new effective treatments for RP would dramatically reduce the number of women requiring MROP. The reduction in MROP procedures  will benefit women who will be more satisfied with their care, experience less separation from their baby immediately after birth, and will mean that women will suffer less illness associated with RP as well as having cost benefits for the NHS.

This study will try to prove the effectiveness of a safe treatment for other conditions, called Glyceryl trinitrate (GTN) as an effective treatment for RP.  We will compare GTN against a treatment which looks the same but has no active ingredients (called a placebo) in a trial where women are given one of the treatments and the results between the two groups compared to see which one works the best - this is called a randomised controlled blinded trial.