Measuring the clinical effectiveness and healthcare experiences for women undergoing a balloon induction of labour, where the balloon is used for 6 hours compared to 12 hours.

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2018
INTERVENTION: Women randomised to the 6‐hour arm will have a balloon catheter inserted by an experienced clinician (midwife, Registrar or obstetrician) and remain in hospital, Clinical staff will endeavour to review the women at 6‐hours following insertion of the balloon catheter, deflate the balloon, attempt an amniotomy and commence an oxytocin infusion as soon as possible. The induction process for women in the trial will be very similar to usual clinical practice, except that the balloon catheter will be removed at 6 hours. Protocol compliance will be monitored by a research midwife. CONDITION: Induction of labour PRIMARY OUTCOME: Change in cervical favourability (as measured by the modified Bishop's score) SECONDARY OUTCOME: Admission to a neonatal nursery, as recorded in the hospital records Arterial cord blood pH < 7.1, tested using an arterial blood gas analyses Epidural use, as recorded in the hospital records Health status of the baby at time of birth will be assessed using Apgar score at 5 minutes of age, as recorded in the hospital records Healthcare experience (as measured by the Experiences of Induction Tool) Mode of birth, as recorded in the hospital records Time from amniotomy until birth, as recorded in the hospital records Time from insertion of balloon catheter until birth, as recorded in the hospital records Total healthcare costs. Information used to calculate this will be drawn from the hospital record, patient administration system, and operating room data systems,. Where possible, this will be calculated at the patient‐level using a bottom‐up methodology. Where this is not possible, cost will be ascribed using the apportioned cost per minute spent in the various clinical areas. Costs will be calculated from the perspective of the hospital and the time horizon will be from hospital admission until discharge of both mother and baby. INCLUSION CRITERIA: All women with live singleton pregnancies greater than or equal to 37+0 weeks booked for induction of labour and requiring cervical priming (i.e. the cervix to be softer, shorter, dilated)
Epistemonikos ID: 00545315069df01f6142bed214c24f653201693c
First added on: Aug 25, 2024