Induction of labour at 39 weeks or beyond in multiparous women with a favourable cervix

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2017
INTERVENTION: Participants undergo an internal (vaginal) digital examination to assess the favourability of their cervix. Women with an unfavourable cervix (e.g. cervical opening less than 2 cm dilated) are ineligible for the trial and their usual care continues. Eligible women, after providing written consent to participate, are randomised to one of two groups (labour induced or the control group) through opening the numbered sealed envelope containing their allocation. The randomisation sequence is generated using a computerised random number generator. Group one (labour induced): Women assigned to induction of labour are given a date for their labour induction as soon as practicable upon reaching 39 weeks (if recruited at 39 weeks, as soon as possible). The appointment for labour induction is scheduled for at 8 am on a weekday. As the cervix is favourable, labour induction is expected to be initiated by breaking the water followed by a drip (oxytocin) to start contractions off. Management of labour induction is according to standard practice. Group two (control): Women allocated to standard expectant care have normal care with outpatient follow up. This involves waiting for spontaneous labour and usually with recommendation to induce labour at 41 weeks if they still have not delivered, provided there are no interim issues identified. Management of labour induction is according to standard practice. Participants are followed until their hospital discharge, and their babies are followed until their hospital discharge. CONDITION: Healthy pregnancy at or after 39 weeks gestation ; Pregnancy and Childbirth ; Healthy pregnancy at or after 39 weeks gestation PRIMARY OUTCOME: 1. Delivery time (week day 9 am to 5 pm or other) is assessed from hospital records after hospital discharge; 2. Maternal satisfaction of care is measured using a visual numerical rating score sheet and self‐scored from 0‐10, assessed after delivery ; SECONDARY OUTCOME: Maternal outcomes:; 1. Mode of delivery is assessed from hospital records at hospital discharge; 2. Oxytocin use in labour is assessed from hospital records at hospital discharge; 3. Epidural use in labour is assessed from hospital records at hospital discharge ; 4. Number of antenatal clinic visits is assessed from hospital records at hospital discharge ; 5. Number of non‐birth related hospital admissions after recruitment is assessed from hospital records at hospital discharge ; 6. Presentation at hospital admission for birth (i.e. spontaneous labour, induction of labour, prelabour rupture of membranes, planned caesarean section, and others) is assessed from hospital records at beginning of hospital stay ; 7. Blood loss is estimated using healthcare provider’s standard estimation at delivery; 8. Fever is measured using a single temperature reading = 38 degrees Celsius is extracted from hospital records measured during labour, after delivery and at hospital discharge; 9. Duration of hospital stay for birth admission is assessed from hospital records at hospital discharge; ; Neonatal Outcomes:; 1. Neonatal outcomes are measured by Apgar score at 5 minutes after birth; 2. Neonatal admission to special care nursery or intensive care is assessed from hospital records at infant’s hospital discharge; 3. Birth weight is assessed from hospital records at hospital discharge; 4. Umbilical cord arterial blood pH and base excess is assessed from hospital records at hospital discharge; INCLUSION CRITERIA: 1. Aged over 18 years 2. At least one previous vaginal birth (birth after gestational age of 28 weeks and birth weight of over 1kg) 3. Gestational age of 38 weeks to 40 weeks at enrollment 4. Favourable cervix (Bishop Score = 6 and likely to be suitable for amniotomy)
Epistemonikos ID: 9c2c976307d64bce10d0b36a7552f0a67f1d88e9
First added on: Aug 24, 2024