HOLDS

• Research type

  Research Study

• Full title

  High or Low Dose Syntocinon (Oxytocin) for delay in labour

• IRAS ID

  17527

• Contact name

  Sara Kenyon

• Sponsor organisation

  University of Birmingham

• Eudract number

  2009-012752-24

• ISRCTN Number

  Pending

• Research summary

  About a third of women become delayed in their first labours and are given a drug (oxytocin) 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 has challenged the use of standard dose of oxytocin by finding it is associated with shorter labour but no change in the mode of birth. The Guideline also found that high dose oxytocin increases the numbers of women having a SVB but not enough is known about the effect on the baby and on women??s birth experience. We have designed a RCT to compare standard and high dose oxytocin for women with recognised delay in labour (HOLDS). This application is for a pilot study which will test all systems for a bigger main trial. It will take place in 3 maternity units similar to those which will take part in the main trial. It will evaluate numbers of women both eligible and recruited and the amount of support required by the units. Interviews will explore women??s understanding and experiences of the trial, the consent processes and their decision to take part. This information will be used to ensure that staff and trial leaflets explain the trial as clearly as possible. Data collection tools and systems will be developed for use in hospital and at 6 weeks after birth to collect data on clinical and psychological outcomes as well as health service use. If effective this relatively inexpensive intervention has potential to increase SVB and reduce resource and health implications associated with CSs and instrumental births.

• REC name

  East Midlands - Leicester Central Research Ethics Committee

• REC reference

  10/H0406/30

• Date of REC Opinion

  23 Jun 2010

• REC opinion

  Further Information Favourable Opinion