GRANT #311 Extending the OBLIGE trial; Outpatient Balloon vs Inpatient Gel for induction of labour

Dr Joy Marriott, Obstetrician and Gynaecologist, Waikato District Health Board.
Senior Lecturer, Department of Obstetrics and Gynaecology, FMHS, University of Auckland.

Abstract:

In New Zealand, one in four pregnant people have labour induced. The OBLIGE trial is a multi-centre randomised controlled trial comparing two common ways of starting induction of labour (IOL). Pregnant women planning IOL at term are randomised to receiving prostaglandin hormones and staying in hospital, or having a balloon catheter placed and being managed as an outpatient for the first 18-24 hours. Their care for the remainder of labour and birth is the same and managed by the participant’s usual clinician. The hypothesis is that outpatient balloon IOL will result in fewer caesarean sections compared to inpatient prostaglandins.

Findings from this study will also evaluate whether this model of outpatient care will be safe for women and their babies, be acceptable to women and hospital staff, and cost less. If so, outpatient balloon induction could become routine practice. Our findings will assist clinicians, managers and policy-makers

to make informed decisions about providing women with choice of IOL methods and settings. Furthermore, they will inform the new national Clinical Practice Guidelines on IOL.

The study started recruitment in October 2017 and there are currently over 500 participants across ten sites. The sample size required is 1552 participants. Monthly recruitment has increased over time as more hospitals have joined the study. Recruitment has now increased to a level that will enable study completion, however, additional funding is essential.

This grant application is specifically to support OBLIGE recruitment at Waikato DHB. Waikato started recruitment in March 2018. Recruitment numbers have been lower than expected for the size of our maternity unit (only three to four per month, but the potential for 25). With extra funding, we expect more efficient recruitment. The funding will be prioritised to more dedicated research midwifery time to spend with both potential participants and with midwives and doctors, and toward transport and accommodation for women who either live rurally or need assistance. Research sites with dedicated research midwives are able to recruit more efficiently. Given a higher proportion of Maori women having IOL in Waikato, local OBLIGE recruitment will ensure Māori are well represented in this national study. Waikato MRF support would be clearly visible on all study promotion at the DHB and at a national level.

OBLIGE is the first multi-centre randomised clinical trial in which the Waikato Obstetrics and Gynaecology department has participated. Historically, there has been a very limited research culture in our department. Currently, our department is actively aspiring to increase research, and local success of the OBLIGE trial is a significant part of the culture change for obstetricians and midwives.


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