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Does 8 hourly vaginal examination interval after amniotomy and cervical ripening with Foley's catheter in women with firstborn baby improve maternal satisfaction during labour?

Randomised controlled trial of 4 hourly versus 8 hourly vaginal examination interval after amniotomy and cervical ripening with Foley's catheter in nulliparas

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN16222339
Enrollment
198
Registered
2021-05-08
Start date
2021-05-10
Completion date
Unknown
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Maternal satisfaction with induction of labor Pregnancy and Childbirth

Interventions

All women who fulfilled the inclusion criteria undergoing induction via Foley catheter insertion are identified by health care providers at the delivery suite and antenatal ward. will be assessed for
(i) cervical os dilatation of = 3cm, (ii) cephalic presentation, (iii) station not higher than -2, (iv) reassuring fetal heart status, randomization will be performed post amniotomy. Titration of intr

Sponsors

University Malaya Medical Centre
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Women who had cervical ripening with Foley catheter only and favourable cervix with cervical dilatation of 3cm or greater (suitable for amniotomy) with contraction <1:5min 2. Nulliparous 3. No prior pregnancy beyond 20 weeks gestation 4. Age 18 years and above 5. Gestational age of =37weeks at enrolment scheduled induction of labour 6. Scheduled induction of labour 7. Viable pregnancy 8. Cephalic presentation 9. Singleton pregnancy 10. Reassuring pre induction fetal cardiotocography (CTG) 11. Intact membrane

Exclusion criteria

Exclusion criteria: 1. Contraindication to vaginal delivery 2. Known gross fetal anomaly 3. Fetal weight clinically estimated to be =2 kg & =4kg and confirmed by ultrasound 4. Previous uterine surgery, ie: myomectomy, hysterotomy and history of iatrogenic uterine perforation

Design outcomes

Primary

MeasureTime frame
1. Maternal satisfaction of labour care measured using a Visual Numerical Rating Score (VNRS) from 0-10, assessed soon after delivery 2. Duration of active labour, defined as amniotomy to delivery interval is assessed from hospital records after hospital discharge

Secondary

MeasureTime frame
Current secondary outcome measures as of 09/06/2021: Maternal outcomes: 1. Mode of delivery 2. Indication for caesarean and operative vaginal delivery 3. Oxytocin induction/augmentation in labour 4. Fever which is defined from as single temperature reading of 38°C or greater 4.1. Intrapartum 4.2. Post-partum 5. Analgesic & epidural used in labour 6. Estimated delivery blood loss 7. Uterine hyperactivity: 7.1. Tachysystole (six of more contractions in 10 minutes over two consecutive 10-minute periods) 7.2. Hypertonus (sustained contraction 2 min or longer) 7.3. Hypertonus with fetal heart rate abnormality 8. CTG abnormality based on NICE guideline 9. Duration of hospital stay from time of induction until discharge *Indication for induction of labour have been removed from secondary outcome but the data will be captured and recorded in the data collection form Neonatal outcomes: 1. Apgar score at 1 and 5 minutes 2. Umbilical cord arterial blood pH and base excess 3. Birth weight 4. Neonatal admission (NICU/Special care nursery/Indication for neonatal admission) _____ Previous secondary outcome measures: Measured using patient records after birth: Maternal outcomes: 1. Caesarean section rate & Indication for caesarean section 2. Operative vagina delivery Indication 3. Oxytocin induction/augmentation in labour 4. Fever which is defined from as single temperature reading of 38°C or greater 5. Analgesic & epidural used in labour 6. Estimated delivery blood loss 7. Uterine hyperactivity: 7.1. Tachysystole (six of more contractions in 10 minutes over two consecutive 10-minute periods) 7.2. Hypertonus (sustained contraction 2 min or longer) 7.3. Hypertonus with fetal heart rate abnormality 8. CTG abnormality based on NICE guideline 9. Duration of hospital stay from time of induction until discharge 10. Indication for induction of labour Neonatal outcomes: 1. Apgar score at 1 and 5 minutes 2. Umbilical cord arterial blood pH and base excess 3. Birth we

Countries

Malaysia

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026