Clinical Trial: GOT-IT Trial: Glyceryl Trinitrate for Retained Placenta

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: GOT-IT Trial: A Pragmatic Group Sequential Placebo Controlled Randomised Trial to Determine the Effectiveness of Glyceryl Trinitrate for Retained Placenta.

Brief 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.

Detailed Summary:
Sponsor: University of Edinburgh

Current Primary Outcome:

• Need for Manual Removal of Placenta [ Time Frame: From time of randomisation up to 15-minutes post administration of study treatment ]
  Defined as the placenta remaining undelivered 15 minutes post study treatment and/or being required within 15 minutes of treatment due to safety concerns.
• Blood Loss [ Time Frame: From time of administration of treatment to transfer to the postnatal ward or other clinical area (e.g. labour ward high dependency) - up to 24 hours. ]
• Satisfaction with treatment [ Time Frame: 6-weeks ]
  Patient rated satisfaction with treatment collected by postal questionnaire.
• Net incremental costs (or cost savings) to the National Health Service [ Time Frame: 6-weeks ]
  Net incremental costs (or cost savings) to the National Health Service of using GTN versus standard practice. Costs will include GTN (dose and time to administer drug, monitor woman and deliver the placenta if effective), MROP, and further health service resource use to six weeks postnatal (as measured by the health service resource use questionnaire).

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Fall in haemoglobin [ Time Frame: First postnatal day (approximately 24 hours since the birth). ]
  Fall in haemoglobin of more than 15% between recruitment and the first postnatal day.
• Time from randomisation to delivery of placenta. [ Time Frame: From time of randomisation and administration of the study treatment to delivery of placenta (up to approximately 2 hours). ]
• Need for Manual Removal of Placenta in theatre. [ Time Frame: From time of randomisation and administration of the study treatment to delivery of placenta (up to approximately 2 hours). ]
• Need for earlier than planned MROP on the basis of the clinical condition. [ Time Frame: From time of randomisation and administration of the study treatment to delivery of placenta (up to approximately 2 hours). ]
• Systolic and diastolic blood pressure. [ Time Frame: Study treatment to 15 minutes postadministration. ]
  Fall in systolic or diastolic blood pressure of more than 15mmHg and/or increase in pulse of more than 20 beats/minute between baseline and 5 and 15 minutes postadministration of active/placebo treatment.
• Need for blood transfusion [ Time Frame: From the time of delivery of the placenta to time of discharge from hospital (up to 7 days). ]
• Need for general anaesthesia [ Time Frame: From time of randomisation and administration of the study treatment to delivery of placenta (up to approximately 2 hours). ]
• Maternal Pyrexia [ Time Frame: Within 72 hours of delivery or discharge from hospital if discharge occurs sooner ]
  One or more temperature reading of more than 38°C.
• Sustained uterine relaxation. [ Time Frame: Within 24 hours of the time of delivery of the placenta. ]
  Sustained uterine relaxation after removal of placenta requiring uterotonics.
• Mean costs for each treatment allocation group [ Time Frame: 6 weeks. ]
  The mean costs will be summarised by treatment allocation group, and the incremental cost (cost saving) associated with the use of GTN will be estimated using an appropriately specified general linear model. The cost data will be presented alongside the primary and secondary outcome data in a cost-consequence balance sheet, indicating which strategy each outcome favours.

Original Secondary Outcome: Same as current

Information By: University of Edinburgh

Dates:
Date Received: March 4, 2014
Date Started: September 2014
Date Completion: January 2018
Last Updated: May 2, 2017
Last Verified: April 2017