The iHOLDS Trial
Research type
Research Study
Full title
High or low dose Syntocinon for induction of labour in nulliparous women: a double blind, randomised controlled trial
IRAS ID
278209
Contact name
Liz Adey
Contact email
Sponsor organisation
Birmingham Women's and Children's Hospital NHS Foundation Trust
Eudract number
2020-004387-26
ISRCTN Number
ISRCTN79220656
Duration of Study in the UK
2 years, 2 months, 30 days
Research summary
Approximately 34% of first-time mothers have their labour induced each year in the UK. This can be for a number of reasons, most commonly if a woman has gone past her due date, or because her waters have broken but labour contractions have not yet begun.
Some women will go into labour with use of vaginal prostaglandins alone (softening of the cervix using a pessary), whereas others will need to have their water artificially broken. If contractions still do not start, approximately 60% of women will go on to receive intravenous (via a drip in the arm) oxytocin to stimulate contractions. About 30% of these women will then go on to have an unplanned caesarean section to safely deliver their baby.
Caesarean sections generally result in longer hospital stays, increased chances of complications for mother and baby (e.g. infections) and a higher cost to the NHS. We will test the hypothesis that a high dose regimen of oxytocin compared with the standard dose regimen will achieve regular contractions more rapidly and progress labour more quickly (without increasing side effects) leading to vaginal birth and thus reducing the need for a caesarean section.
Over 21 months the iHOLDS trial will recruit 2,400 first time mothers over the age of 16 who require synthetic oxytocin during induction of labour. The research will be conducted in approximately 30 experienced UK NHS/Health Board Delivery Suites. Following consent, women will be randomised to receive either standard or higher dose oxytocin. Neither the participant nor the researchers will be aware which dose is given. Two weeks after the baby is born, the woman will be sent a validated maternal satisfaction questionnaire via her preferred method of choice with six multiple choice questions.
The trial has been commissioned by the NIHR Health Technology Assessment (HTA) programme.
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
21/WM/0034
Date of REC Opinion
1 Mar 2021
REC opinion
Favourable Opinion