Denison 2014.
| Trial name or title | GOT‐IT Trial: Glyceryl Trinitrate for Retained Placenta |
| Methods | This study will try to prove the clinical and cost effectiveness of GTN used to treat retained placenta. 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. |
| Participants | Patients with placenta not delivered for 15 minutes or more after birth. |
| Interventions | Experimental: GTN Nitrolingual Pump Spray [Coro‐Nitro] A liquid within non‐pressurised, red plastic‐coated glass bottle fitted with a pump capable of delivering a metered dose containing 400 μg of GTN. Excipients: the formulation contains fractionated coconut oil, absolute ethanol, medium chain partial glycerides and peppermint oil. The treatment will be self administered (2 puffs) as a single intervention. No second intervention will be given. |
| Outcomes |
Primary outcome measures 1. Need for manual removal of placenta. 2. Blood loss. 3. Net incremental costs (or cost savings) to the National Health Service. Secondary outcome measures 1. Fall in haemoglobin. 2. Time from randomisation to delivery of placenta. 3. Need for manual removal of placenta in theatre. 4. Need for earlier than planned manual removal of placenta on the basis of the clinical condition. 5. Systolic and diastolic blood pressure. 6. Need for blood transfusion. 7. Need for general anaesthesia. 8. Maternal pyrexia. 9. Sustained uterine relaxation. 10. Mean costs for each treatment allocation group. |
| Starting date | September 2014. |
| Contact information | Fiona C Denison, fiona.denison@ed.ac.uk |
| Notes |
NCT02085213 Allocation: randomised. Endpoint classification: intervention model: single group assignment; masking: double blind (participant, investigator, outcomes assessor). |
GTN: glyceryl trinitrate