High Or Low Dose Syntocinon for delay in labour (HOLDS)
Record ID 32016000660
Authors' objectives: We currently do not know the best care for first time mothers with delayed progress in the first stage of labour and this topic is a research priority for the Royal College of Obstetricians and Gynaecologists. Delayed labour is a relatively common occurrence, affecting between 11- 30% (equivalent to between one and three in ten) of first time mothers. The only recommended treatment for women delayed in the first stage of labour is artificial oxytocin (Syntocinon®) which is given intravenously to stimulate contractions. A standard regimen (concentration and rate of administration) is recommended by NICE Guidelines 2014 and is widely used in the UK. Information from studies looking at different dose regimens of Syntocinon® in delayed labour suggest that a high dose regimen may reduce the chance of caesarean section but the available evidence is not conclusive. Syntocinon® may cause the uterus to contract too much and the baby to become distressed so both mother and baby are carefully monitored and the dose adjusted in relation to the number of contractions and how the baby is. Research shows currently around 32% (equivalent to about three in ten) of the women who need Syntocinon® for delayed labour have an unplanned caesarean section, which we know is related to a longer hospital stay, higher risk of infection, bleeding and blood clots and to increase risk of caesarean section in future pregnancies. By reducing caesarean section we can reduce these risks to women. A reduction in the Caesarean section rate of 5-8% (equivalent to nearly one in ten) in these women could save the NHS nearly £1M per year, as well as possible annual savings of £2.6M from the impact of avoiding caesarean section in future pregnancies. Our proposed trial will randomise 1500 women to standard or high dose regimens of Syntocinon® and measure differences in rates of caesarean section as well as collecting information about the birth and safety of mother and baby. Clinicians will not be aware of which regimen of Syntocinon® is being given, and care will be the same for either group. Serious adverse events are more likely in this high risk group of women and these will be reviewed by an independent group (Data Monitoring Committee). Recruiting women to clinical trials in labour is challenging, and in our pilot study we showed that informing all potentially eligible women about the study in late pregnancy, and approaching them during labour to discuss the study is acceptable. We have set a realistic target for recruitment of about 20% (equivalent to one in five) eligible women, based on the pilot and realise the importance of training staff so they can explain the study and answer any questions women and their partners may have. This application brings together a multidisciplinary team of experts-academics, clinicians, statisticians, and a service user, who together have successfully undertaken the pilot study. Information from this study will directly influence care of future women with delayed labour.
Project Status: Ongoing
URL for project: http://www.nets.nihr.ac.uk/projects/hta/1414044
Anticipated Publish Date: 2021
English language abstract: An English language summary is available
Publication Type: Not Assigned
- Labor, Obstetric
Organisation Name: NIHR Health Technology Assessment programme
Contact Address: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK
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