None listed
Conditions
Brief summary
Many babies arrive naturally in a timely manner, however, sometimes we need to assist (or ‘induce’) a pregnancy if there are any complications, or if the pregnancy goes well beyond the due date. It is estimated that one in four women have an induced labour. The induction of labour is commonly commenced by placing some hormone gel (called Prostaglandin) in the vagina to make the cervix (the opening of the womb into the vagina) softer and allow it to open. Induction of labour can also be commenced using a small tube with a balloon on the end, inserted through the cervix and then inflated to mechanically stretch the cervix. In Australia, both methods are commonly used to prepare the cervix for labour. Following either method, when the cervix is more open, contractions are brought on by breaking the waters around the baby (called artificial rupture of membranes or ARM) and administering a hormone fluid (called Syntocinon) intravenously (IV; or into a vein). Sometimes, the induction process may be prolonged and it can take many hours, even days, before the cervix is more open. Prostaglandin hormone gel, in particular, can induce contractions. It is common practice that women undergoing induction remain an inpatient over this time. Balloon catheter induction is however very unlikely to induce contractions and there is even some published studies suggesting balloon catheter inductions may be associated with less chance of distress to babies. As such, for some women undergoing induction of labour with a low-risk, uncomplicated pregnancy, it would seem reasonable to go home after placement of the balloon catheter. The primary aim of the study is to demonstrate that going home after commencing an induction of labour using a balloon catheter is just as safe as having prostaglandin gel induction and remaining as an inpatient. We are additionally interested in the duration of labour, mode of birth, length of hospital stay, overall healthcare costs for women undergoing both induction policies, and which method is perceived by women to be more satisfactory.
Interventions
Women randomised to the balloon arm are not admitted to hospital but seen as an ‘occasion of service’ in Birth Suite / Assessment Unit / Antenatal Clinic. A pre-balloon cardiotocograph (CTG) will be placed for a minimum of 30 minutes until assessed to be normal. A cervical ripening balloon (CRB) plus stylet (Cook Medical, Bloomington, US) will be placed by a midwife / doctor by inserting it through the internal cervical os as part of a digital vaginal examination. 80mls of saline will be ins
Women randomised to the balloon arm are not admitted to hospital but seen as an ‘occasion of service’ in Birth Suite / Assessment Unit / Antenatal Clinic. A pre-balloon cardiotocograph (CTG) will be placed for a minimum of 30 minutes until assessed to be normal. A cervical ripening balloon (CRB) plus stylet (Cook Medical, Bloomington, US) will be placed by a midwife / doctor by inserting it through the internal cervical os as part of a digital vaginal examination. 80mls of saline will be instilled into the cervical and vaginal balloons, and the stylet removed. The insertion would typically take less than 60 seconds. A post-balloon CTG is not required, unless the woman was to experience uterine activity following placement of the balloon. Following a period of observation of 30 minutes, and assuming she was not experiencing contractions or needing pain relief beyond simple analgesia, the woman will be allowed home. Women will be provided with written information about when to call and how to call the hospital. In the absence of vaginal bleeding, fluid loss, contractions, expulsion of the balloon, and/or need for pain relief beyond simple analgesia (any of which would necessitate earlier review), the woman will be asked to return to Birth Suites the following morning at 05:30am. At that time, the woman will be assessed by an experienced midwife, credentialed to perform ARM. The midwife will perform a cervical assessment and document the Modified Bishop’s score. An ARM will then be attempted, and once the membranes are ruptured, an oxytocin infusion should be commenced as soon as possible.
Sponsors
Mater Research
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 52 Years
Healthy volunteers
Yes
Inclusion criteria
All women with live singleton pregnancies greater than or equal to 37 weeks 0 days, booked for induction of labour because of post-term and/or social/elective reasons, and requiring cervical priming will be suitable for inclusion in this study
Exclusion criteria
Major congenital abnormality Multiple pregnancy Intrauterine fetal death Clinical suspicion or ultrasound diagnosis of fetal growth restriction Any contraindication to vaginal birth Indication for IOL other than post-term and/or social/elective reasons Modified Bishops score = 7 at commencement of IOL Women <18 years Inability to consent
Outcome results
None listed