Comparison between early versus delayed breaking of the waterbag (amniotic sac) in terms of labour duration in childbirth

Immediate oxytocin and early amniotomy versus immediate oxytocin and delayed amniotomy following cervical ripening with foley catheter in nulliparous women

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN59705367

Enrollment

140

Registered

2020-09-22

Start date

2020-09-25

Completion date

Unknown

Last updated

2021-02-08

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

Conditions

induction of labour in nulliparous pregnant women Pregnancy and Childbirth

Interventions

All nulliparous women having Foley catheter insertion are recruited in our delivery suite and antenatal ward. Eligible women will be provided with a patient information sheet and written consent will

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Female aged 18 years and above 2. Nulliparous 3. Gestational age of =37 weeks at enrolment Scheduled induction of labour (Gestational age estimations supported by ultrasonographic dating) 4. Planned labour induction 5. Singleton pregnancy 6. Cephalic presentation 7. Women who had a cervical ripening with Foley catheter only and favourable cervix with cervical dilatation of 3 cm or greater (suitable for amniotomy) with contraction every 1 to 5 min 8. Intact membranes 9. Reassuring cardiotocogram

Exclusion criteria

Exclusion criteria: 1. Previous uterine incision/ injury (caesarean delivery, myomectomy, perforation) 2. Gross fetal anomaly 3. Contraindication for vaginal birth 4. Fetal weight clinically estimated to be =2 kg or =4kg before induction and confirmed by ultrasound 5. Ruptured membranes

Design outcomes

Secondary

Measure	Time frame
Maternal outcome: 1. Caesarean rate measured as the percentage of women delivered via caeserean delivery at the end of study using patient records 2. Maternal satisfaction with the birth process using visual numerical rating scale at delivery 3. Intrapartum and postpartum fever (temperature of 38C or greater) reported throughout the process of labour and within 24 hours after delivery 4. Analgesic used in labour that is reported throughout the process of labour and measured at the time of delivery using case report forms 5. Delivery blood loss documented upon delivery and measured at the time of delivery using case report forms 6. Uterine hyperactivity defined as six or more contractions in 10 minutes over two consecutive 10-minute periods or sustained contraction 2 min or longer or association with fetal heart rate abnormality which documented throughout the labour process and measured at delivery using case report forms 7. CTG abnormality defined as suspicious or pathological according to NICE guideline 2017 and documented throughout the labour process and measured after delivery using case report forms 8. Mode of delivery with indication documented upon delivery and measured at the time of delivery using case report forms Neonatal outcome: 1. Apgar score at 1 and 5 min documented upon delivery and measured at the time of delivery using case report forms 2. Arterial cord pH & Base excess documented upon delivery and measured at the time of delivery using case report forms 3. Birth weight measured using weigh scale and documented upon delivery using case report forms 4. Neonatal care admission measured using patient records: 4.1. Admission to NICU after delivery within 24 hours of delivery 4.2. Admission to Paediatric ICU after	—

Measure

Time frame

Maternal outcome: 1. Caesarean rate measured as the percentage of women delivered via caeserean delivery at the end of study using patient records 2. Maternal satisfaction with the birth process using visual numerical rating scale at delivery 3. Intrapartum and postpartum fever (temperature of 38C or greater) reported throughout the process of labour and within 24 hours after delivery 4. Analgesic used in labour that is reported throughout the process of labour and measured at the time of delivery using case report forms 5. Delivery blood loss documented upon delivery and measured at the time of delivery using case report forms 6. Uterine hyperactivity defined as six or more contractions in 10 minutes over two consecutive 10-minute periods or sustained contraction 2 min or longer or association with fetal heart rate abnormality which documented throughout the labour process and measured at delivery using case report forms 7. CTG abnormality defined as suspicious or pathological according to NICE guideline 2017 and documented throughout the labour process and measured after delivery using case report forms 8. Mode of delivery with indication documented upon delivery and measured at the time of delivery using case report forms Neonatal outcome: 1. Apgar score at 1 and 5 min documented upon delivery and measured at the time of delivery using case report forms 2. Arterial cord pH & Base excess documented upon delivery and measured at the time of delivery using case report forms 3. Birth weight measured using weigh scale and documented upon delivery using case report forms 4. Neonatal care admission measured using patient records: 4.1. Admission to NICU after delivery within 24 hours of delivery 4.2. Admission to Paediatric ICU after

—

Primary

Measure	Time frame
Intervention to delivery interval measured as the time (min) from oxytocin initiation to delivery of the baby	—

Countries

Malaysia

Contacts

Public ContactNur Adlyn Hasan

adlyn@ummc.edu.my+60 (0)3 7949 4422

Outcome results

None listed

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