HOLDS
Research type
Research Study
Full title
High Or Low Dose Syntocinon® for delay in labour: the HOLDS trial
IRAS ID
193293
Contact name
Sara Kenyon
Contact email
Sponsor organisation
Birmingham Women's & Children's Hospital
Eudract number
2015-005537-50
Duration of Study in the UK
3 years, 2 months, 31 days
Research summary
About a third of women become delayed in their first labours and are given a drug (oxytocin) widely used in maternity care in the belief that it increases the number of spontaneous vaginal births(SVB). Currently about 40% of these women will have a SVB, 40% will have an instrumental birth and 20% a caesarean section(CS). The latter two are associated with more health related problems and health service costs.
The NICE Intrapartum Care Guideline challenged the use of standard dose regimen of oxytocin by finding it was associated with shorter labour but no change in the mode of birth. The recent Cochrane systematic review suggested that high dose regimen of oxytocin decreases the numbers of women having a CS but not enough is known about the effect on the baby and on women’s birth experience for it to be recommended.
We have designed a randomised controlled trial to compare standard and high dose regimens of oxytocin for women with confirmed delay in the first stage of labour. This application is for a definitive trial, following on from a pilot study undertaken in 2009/10.
Our proposed trial will randomise 1500 women across approximately 30 maternity units to standard or high dose regimens of oxytocin, and measure differences in rates of CS, as well as collecting information about the birth and safety of mother and baby.
This trial will provide best evidence to answer this important clinical question. If effective this relatively inexpensive intervention has potential to reduce resource and health implications associated with CSs.
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
16/WM/0014
Date of REC Opinion
24 Feb 2016
REC opinion
Further Information Favourable Opinion