GOT-IT Trial: Glyceryl Trinitrate for Retained Placenta
Status:
Completed
Trial end date:
2017-10-05
Target enrollment:
Participant gender:
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.