GOT-IT Trial: Glyceryl Trinitrate for Retained Placenta (GOT-IT)
Placenta, Retained
About this trial
This is an interventional treatment trial for Placenta, Retained focused on measuring Retained placenta, Manual Removal of Placenta, Glyceryl Trinitrate
Eligibility Criteria
Inclusion Criteria:
- Women with retained placenta.
- Women aged 16 or over.
- Women with vaginal delivery (including women with a previous caesarean section).
- Haemodynamically stable (systolic blood pressure more than 100mg Hg and pulse less than 110 beats per min).
- > 14 weeks gestation.
Exclusion Criteria:
- Unable to give informed consent.
- Suspected placenta accreta/increta/percreta.
- Multiple pregnancy.
- Women having an instrumental vaginal delivery in theatre
- Allergy or hypersensitivity to nitrates or any other constituent of the formulation.
- Taken alcohol in the last 24 hours.
- Concomitant use with phosphodiesterase inhibitors (such as sildenafil, tadalafil, or vardenafil).
- Contra-indication due to one of the following: Severe anaemia, constrictive pericarditis, extreme bradycardia, incipient glaucoma, Glucose-6- phosphatedehydrogenase-deficiency, cerebral haemorrhage and brain trauma, aortic and / or mitral stenosis and angina caused by hypertrophic obstructive cardiomyopathy. Circulatory collapse, cardiogenic shock and toxic pulmonary oedema.
- Currently participating in another CTIMP.
Sites / Locations
- Royal Infirmary of Edinburgh
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Glyceryl Trinitrate
Placebo
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 400μg of glyceryl trinitrate. 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.
Matched placebo formulation (except for active ingredient of Glyceryl Trinitrate) with matched packaging and labelling.