None listed
Conditions
Brief summary
Induction of labour (IOL) is one of the most common procedures performed in pregnant women, with approximately 35% of labours being induced at the Auckland District Health Board (ADHB). There are multiple induction agents that may be used for IOL, including prostaglandins, catheters and oxytocin infusion. The approach to induction of labour differs internationally and within institutions within the same country. There is no risk-free way to give birth, only interventions that may increase or decrease risks in different populations. Our study aims to assess if there is a way to decrease the risk of labour complications by delaying amniotomy until women are in established labour. We intend to perform a randomised controlled trial to assess labour and birth outcomes in women undergoing oxytocin infusion induction of labour. Participants will be randomised to an early artificial rupture of membranes (ARM) group or a late ARM group. We hypothesize that women in the late ARM group will have a lower rate of intraamniotic infection complicating their labours (chorioamnionitis). Further, we hypothesize that women with late ARM will have a lower rate of caesarean delivery and a lower rate of fetal heart rate abnormalities in labour. Other maternal and neonatal outcomes are also included in our secondary analyses. We intend to survey study participants following their births to assess satisfaction with their inductions.
Interventions
This is a randomised controlled trial comparing women undergoing oxytocin induction of labour to early versus late artificial rupture of membranes (ARM).
Late ARM - Oxytocin infusion is commenced. ARM will not be performed before 6cm dilation unless the oxytocin infusion commenced 12 hours prior and the woman is not yet 6cm dilated. In this case, the ARM will be performed at that time.
The ARM procedure is performed via performing a vaginal examination with a gloved hand and placing a thin pl
This is a randomised controlled trial comparing women undergoing oxytocin induction of labour to early versus late artificial rupture of membranes (ARM). Late ARM - Oxytocin infusion is commenced. ARM will not be performed before 6cm dilation unless the oxytocin infusion commenced 12 hours prior and the woman is not yet 6cm dilated. In this case, the ARM will be performed at that time. The ARM procedure is performed via performing a vaginal examination with a gloved hand and placing a thin plastic device through the cervix of the woman. The examiner then uses the end of the device to create a small hole in the amniotic membrane. This procedure usually takes 1-2 minutes. The procedure is performed by either the midwife or the doctor. Medical records will be audited as the time of ARM is always recorded. Oxytocin induction of labour is the method at the Auckland City Hospital. There is a standard protocol that the midwives follow to administer a sufficient dosage to women undergoing induction. The starting dose is 1-2 milliunits per minute. Oxytocin is administered intravenously via an infusion. There is no maximum duration of administration. However, it would be unusual for an induction of labour to take longer than 72 hours.
Sponsors
Meghan Hill
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
14 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
Pregnant women with a live singleton cephalic presentation Planning IOL at greater than or equal to 37 weeks gestation On admission for IOL, or for after cervical ripening with intact membranes Cardiotocography normal
Exclusion criteria
Previous caesarean delivery Major fetal congenital anomaly or known chromosomal abnormality Fetal growth restriction with Absent or Reverse End Diastolic Flow noted on umbilical artery Doppler (Abnormal pulsatility index of the Middle Cerebral Artery or Umbilical Artery or abnormal CPR are permissible) Participant in OBLIGE Study
Outcome results
None listed