None listed
Conditions
Brief summary
Rationale: The induction of labour rate in New Zealand is high. Mechanical methods of induction in hospital are safe and effective. However, most women in New Zealand have induction using pharmacological methods. Trials are needed to determine the safety and effectiveness of outpatient induction with balloon catheter. Outpatient balloon induction has the potential to give women more choice and improve satisfaction, and to save on health care costs, while maintaining safe outcomes for mothers and their babies. Aim: To compare two management protocols for initial management of induction of labour Objective: To demonstrate safety, clinical effectiveness and cost effectiveness for mothers and babies who are allowed to go home after commencing a balloon induction, versus remaining in hospital after commencing a prostaglandin induction. Design: This will be a multi-centre randomized controlled trial across New Zealand. Women will be identified by clinicians in antenatal clinics when induction of labour is recommended. Women will be included if they have a live singleton cephalic presentation and induction of labour is planned at 37 weeks’ or more gestation, and excluded if monitoring in hospital is necessary. Eligible women will be recruited by a research midwife and provide written consent to participate. The primary outcome is clinical effectiveness as measured by caesarean section rate. Secondary outcomes include safety as measured by rates of adverse events (placental abruption; stillbirth; neonatal admission to intensive care); cost effectiveness; and maternal and staff satisfaction. Implications: If outpatient balloon induction is found to be as safe and effective as inpatient prostaglandin induction in low-risk women, then district health boards can incorporate this protocol into their clinical guidelines. Moreover, this evidence-based recommendation can be added to the Auckland Consensus Guideline (2014) which will hopefully become a national guideline following broad consultation, enabling consistency of practice across the country.
Interventions
Participants will present themselves to the hospital Assessment area on the day of their scheduled induction of labour. The research midwife will confirm their consent to participate in the trial. They will then be randomized to the intervention or control group. Women in the intervention group will then receive an explanation of the balloon insertion procedure from the doctor or midwife on duty and have an opportunity to ask questions. The foley balloon is the device which will be used. It is a
Participants will present themselves to the hospital Assessment area on the day of their scheduled induction of labour. The research midwife will confirm their consent to participate in the trial. They will then be randomized to the intervention or control group. Women in the intervention group will then receive an explanation of the balloon insertion procedure from the doctor or midwife on duty and have an opportunity to ask questions. The foley balloon is the device which will be used. It is a flexible catheter that is threaded up the cervical canal, and the balloon inflated just above the internal os with 50mL sterile water. This requires the woman to be in lithotomy position on a gynaecological procedure table. The procedure takes five minutes and will be performed by the midwife or doctor on duty, Afterwards, the woman will be asked to rate her discomfort during the procedure (VAS score) and will then be discharged from hospital with an information sheet on what to expect, when to return to hospital and a phone number to ring if concerned. If the balloon falls out, or if contractions start, or if she has spontaneous rupture of membranes, she would be instructed to return to hospital. If no concerns, she will return to hospital the following day (18-24 hours) and the balloon will be removed by the midwife on duty. Then the induction will be continued as clinically appropriate.
Sponsors
Department of Obstetrics and Gynaecology, FMHS, University of Auckland
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator)
Eligibility
Sex/Gender
All
Age
16 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
Women with a live singleton cephalic presentation planning induction of labour at 37 weeks’ gestation or more
Exclusion criteria
major congenital anomaly; suspected severe fetal growth restriction (defined as estimated fetal weight less than 10th centile or abdominal circumference less than or equal to 5th centile AND oligohydramnios or abnormal dopplers, OR estimated fetal weight less than 3rd centile); previous caesarean; ruptured membranes; bishop score 7 or more at commencement of induction; maternal risk or fetal compromise that would necessitate monitoring the woman or her baby in hospital; not willing to stay within 60 minutes of hospital; does not speak English or have someone with them who speaks English.
Outcome results
None listed