Skip to main content

Table 1 The Got-it trial

From: The role of therapeutic optimism in recruitment to a clinical trial in a peripartum setting: balancing hope and uncertainty

“The Got-it trial is a randomised placebo controlled double blind pragmatic UK-wide RCT involving women who have a retained placenta (RP) recruited from delivery wards in UK maternity hospitals. RP is a major cause of postpartum haemorrhage and affects around 2 % of vaginal deliveries in the UK. It is diagnosed when the placenta is not delivered within 30 minutes following active management or 60 minutes after physiological followed by active management of the third stage of labour after delivery of the baby [26]. Although some placentas can still be delivered vaginally after a RP is diagnosed, the chance of this happening is low and decreases the longer the placenta remains in situ. The definitive management of RP is, therefore, manual removal of the placenta which is a surgical procedure requiring trained personnel and an operating theatre. The aim of the Got-it trial is to determine whether use of glyceryl trinitrate (GTN) spray, as compared to a placebo, can facilitate delivery of the placenta without having to undertake manual or surgical delivery in theatre. GTN is a drug that was originally developed for the prevention and relief of angina attacks. Its side-effects include headache, dizziness, flushing/feeling hot, a drop in blood pressure or a rise in pulse. In the clinical context of RP, it could also affect blood loss due to its primary mode of action as a muscle relaxant. For the trial’s inclusion and exclusion criteria see Lawton et al. [17].
The trial comprises an internal pilot followed by a substantive RCT. The pilot commenced in October 2014 and involved eight sites that entered the pilot in a staggered way. During the pilot, once a diagnosis of RP had been made, a delegated and trained member of the clinical or research team approached potential recruits. These women were given written information in the form of a one page summary leaflet accompanied by a detailed participant information sheet. Women were also given a verbal explanation of the trial that covered all the elements in the participant information sheet and consent form. Women who gave their consent were randomized to receive GTN or a placebo spray, which they self-administered under their tongue (two puffs). The placebo spray was designed to be identical in taste and appearance to GTN so neither participants nor staff could determine the outcome of randomization. Women who did not deliver their placentas within 15 minutes were taken to theatre for manual removal of the placenta under regional or general anaesthesia, with the method of anaesthetic being determined by the clinical team and being dependent on the urgency of need for placental delivery.”
Excerpts from Lawton et al. [17]