None listed
Conditions
Brief summary
Around 35% of labours are induced, and the rates are rapidly rising. Most induction start with 'cervical ripening', traditionally an invasive procedure with a balloon device or hormonal medication administered vaginally in hospital. Low-dose oral misoprostol is a promising alternative - less invasive, can be administered in an outpatient setting, and associated with fewer caesarean sections and equivalent rates of uterine stimulation compared to balloon methods. However, limited clinical trials have directly compared it to balloon methods, none within an outpatient setting. Therefore, we will compare low-dose, oral misoprostol with balloon methods for induction of labour to determine intervention feasibility and acceptability within two-discrete randomised controlled trials within the Sunshine Coast University Hospital and Royal Brisbane and Womens' Hospital. As the context of the intervention (inpatient or outpatient) is likely to influence outcomes, an initial study will be used to assess feasibility and ensure safety and acceptability in the inpatient setting and if it meets a priori criteria the second study will be conducted to demonstrate the same measure in an outpatient setting.
Interventions
Interventional care – Low-dose, oral misoprostol protocol.
a) Day 1 Present to hospital in morning for clinical examination, vaginal examination to determine modified Bishop’s score (MBS), fetal surveillance with cardiotocography (CTG) (Induction of Labour clinic). If modified bishops score is greater than or equal to 7, or artificial rupture of membrane (ARM) is deemed able to be performed, proceed with ARM and syntocinon regime when able. If not, then eight doses of 25 µg Misoprostol tabl
Interventional care – Low-dose, oral misoprostol protocol. a) Day 1 Present to hospital in morning for clinical examination, vaginal examination to determine modified Bishop’s score (MBS), fetal surveillance with cardiotocography (CTG) (Induction of Labour clinic). If modified bishops score is greater than or equal to 7, or artificial rupture of membrane (ARM) is deemed able to be performed, proceed with ARM and syntocinon regime when able. If not, then eight doses of 25 µg Misoprostol tablets taken orally two hours apart, with a cardiotocography (CTG) undertaken before the 3rd dose and then another CTG before the 8th dose (before bedtime), whilst an inpatient in the Maternity Inpatient Unit. For the outpatient trial, women who will receive the same dosage of Misoprostol tablets, will be discharged home with educational and support materials, inclusive of contact phone numbers, dosage regime and advice (when to come back or call the hospital). b) Day 2 Repeat clinical examination (if not contracting, no vaginal examination indicated) and cardiotocography (CTG) in morning. If regular contractions have not started then proceed with a further 8 doses of 25 µg Misoprostol tablets taken orally two hours apart, with a cardiotocography (CTG) before the 9th and 14th doses, whilst an inpatient in the Maternity Inpatient Unit. If regular contractions, then would do vaginal examination with potential for artificial rupture of membrane (but ARM may not always be necessary if seeming to be established in labour). If contracting and cervix NOT fully effaced, then continue with drug protocol. For the outpatient trial, women who will receive the same dosage of Misoprostol tablets, will be discharged home with educational and support materials, inclusive of contact phone numbers, dosage regime and advice (when to come back or call the hospital). c) Day 3 Clinical examination and cardiotocography. If regular contractions have not started or artificial rupture of membrane (ARM) is not possible then proceed with a further three doses of 25 µg Misoprostol tablets taken orally two hours apart. For the outpatient trial, women who will receive the same dosage of Misoprostol tablets, will be discharged home with educational and support materials, inclusive of contact phone numbers, dosage regime and advice (when to come back or call the hospital). If regular contractions have not started or artificial rupture of membrane (ARM) is not possible after 3 days, commence alternate/conventional local IOL protocol using mechanical (balloon catheter) cervical dilatation (see conventional care)
Sponsors
Womens' and Childrens' Service, Sunshine Coast Hospital and Health Service
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Live fetus, singleton pregnancy, cephalic presentation, planning a vaginal birth, labour initiated by induction of labour, intact membranes, normal cardiotocography, Modified Bishops Score less than 7 (or ARM not possible), 16 years or older, informed consent to participate (which includes a vaginal examination prior to induction of labour) and intention to follow recommended care. Participants who meet inclusion criteria who are from non-English speaking background and/or culturally diverse backgrounds will be offered interpreters and cultural support during recruitment and consent.
Exclusion criteria
Previous uterine surgery, major fetal congenital anomaly, suspected severe fetal growth restriction, decline to participate, planned caesarean section and non-English speakers without interpreter.
Outcome results
None listed