Placenta, Retained Clinical Trial
Official title:
GOT-IT Trial: 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 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.
Although a growing body of evidence supports a use for GTN for treatment of RP, much of this evidence is based on anecdotal case-reports or clinical "trials" which are non-randomised, do not include a placebo arm and are underpowered. Further, in the context of constrained maternity resources in a publicly funded health system, it is important to quantify the costs associated with the use of GTN (including any subsequent monitoring costs and costs associated with complications) in relation to its effectiveness and any subsequent cost savings it may deliver over standard practice. There is therefore an urgent need for a pragmatic clinical trial of GTN for RP to determine whether GTN is efficacious, safe, acceptable and cost-effective as a treatment for RP before a treatment which may (or may not) work is embedded within routine clinical practice. Our proposed randomised placebo controlled double blind pragmatic UK wide GOT-IT trial RCT (with internal pilot study) will definitively determine whether sublingual GTN is (or is not) clinically and cost effective for management of RP. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00120042 -
Optimisation of the Management of Placental Delivery in Second Trimester Pregnancy Interruption
|
N/A | |
| Completed |
NCT04720885 -
Management of Large Retained Products of Conception (> 4 cm): Need for an Standardized Procedure.
|