None listed
Conditions
Brief summary
The caesarean section (CS) rate has risen to the point where a third of all mothers in Australia give birth by this method [1]. CS is a major contributing factor to maternal mortality and morbidity following childbirth in developed countries and reducing the overall CS rate is a major policy goal for NSW Health [2]. The highest risk of adverse outcomes associated with CS occurs when it is performed during labour which is 40% of all CSs[1, 3]. Most of these are due to failure to progress (FTP) which accounts for around 8% of all births[3]. Induction of labour (IOL) reduces the risk of CS, particularly when there is a low risk of fetal distress [4, 5], but it is not feasible to offer this intervention to all women because given time, most women will labour naturally. To date, there is no method of prospectively identifying women who are most likely to benefit from IOL. Predictive models could identify women who might benefit from preventative measures such as induction of labour. We have created a model which will be used to screen for women at high risk of caesarean section in labour. This model incorporates maternal age, body mass index (BMI), height, gestational diabetes, estimated fetal weight, amniotic fluid index, and parity. We will be investigating if induction of labour compared with routine antenatal care at 39 weeks of gestation in women with a cephalic presenting fetus reduces the risk of caesarean section for abnormal progress in labour. References: 1.Hilder, L., et al., Australia's mothers and babies 2012. Perinatal statistics series no. 30. Canberra: AIHW, in Australia's mothers and babies 2012. 2. Health, N., Maternity - Towards normal birth in NSW, N. Ministry of Health, Editor. 2010. 3. Zhang, J., et al., Contemporary cesarean delivery practice in the United States. Am J Obstet Gynecol, 2010. 203(4): p. 326 e1-326 e10. 4. Gülmezoglu, A.M., et al., Induction of labour for improving birth outcomes for women at or beyond term. Cochrane Database of Systematic Reviews, 2012(6). 5. Boers, K.E., et al., Induction versus expectant monitoring for intrauterine growth restriction at term: randomised equivalence trial (DIGITAT). BMJ, 2010. 341: p. c7087.
Interventions
Women eligible for randomisation who screen high risk of caesarean section for slow progress in labour will be offered randomisation for two arms: induction of labour at 39 week's vs continuation of normal pregnancy care.
The intervention is induction of labour in the 39th week of pregnancy. The consent for induction will be undertaken by the research team (doctor or midwife) and the induction process will be undertaken as per local health policy guidelines by clinical midwives or doctors with c
Women eligible for randomisation who screen high risk of caesarean section for slow progress in labour will be offered randomisation for two arms: induction of labour at 39 week's vs continuation of normal pregnancy care. The intervention is induction of labour in the 39th week of pregnancy. The consent for induction will be undertaken by the research team (doctor or midwife) and the induction process will be undertaken as per local health policy guidelines by clinical midwives or doctors with cervical ripening using Prostoglandin E2 and/or cook's balloon catheter (if Bishop score <7) with appropriate external fetal monitoring followed by artificial rupture of membranes and syntocinon with appropriate fetal monitoring (as needed). There are one to two slots per week allocated for this pilot which are seperate to the normal induction bookings as not to interfere with normal induction booking process. The day of labour induction in the 39th week will be decided based on both participant preference as well as labour ward acuity (including other booked indicated induction, staffing allowances, preferred weekday slots and emergencies) to ensure that patient safety is not compromised. Given this is a pilot study to assess feasibility, intervention fidelity (ie induction in the 39th week) will be assessed both qualitatively with a patient satisfaction questionnaire and quantitatively through audit of medical records.
Sponsors
Royal Prince Alfred Hospital Women and Babies
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
- Pregnant - Female - Greater than 18 years - Planned vaginal birth - Cephalic presentation - Screening ultrasound at 36+0 to 37+6 weeks gestation for fetal biometry, amniotic fluid index and metal Doppler studies - Positive screen risk for caesarean section for failure to progress in labour - Potential participants with a risk of caesarean section for abnormal progress in labour of >= 28% will be eligible to participate
Exclusion criteria
- Planned induction of labour before the estimated date of confinement - Previous caesarean section or uterine incision - Any indication for elective caesarean section - Known major anatomic fetal abnormality - Any contraindication for induction of labour
Outcome results
None listed