Comparing length of labour for early and delayed breaking of the waters following induction of labour in women who have previously had a normal vaginal birth

Early amniotomy and immediate oxytocin versus oxytocin and delayed amniotomy following cervical ripening with a Foley catheter in multiparous women

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN87066007

Enrollment

232

Registered

2020-09-29

Start date

2020-10-01

Completion date

Unknown

Last updated

2022-08-29

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

Conditions

Induction of labour in multiparous women Pregnancy and Childbirth

Interventions

All multipara who had a Foley induction are recruited into this study. Eligible women will be provided with a patient information sheet and written consent will be taken. After the removal of Foley or

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Multiparous women (at least one prior vaginal birth at greater than 24 weeks gestation) 2. Aged 18 years and above 3. Planned labour induction 4. Gestational age of >37 weeks at enrolment of scheduled induction of labour. (Gestational age estimations were all supported by ultrasonographic dating.) 5. Cephalic presentation 6. Singleton pregnancy 7. Women who had a cervical riperning with Foley catheter only, and favourable cervix with cervical dilatation of 3 cm or greater (suitable for amniotomy) with contraction frequency <1 in a 5-min period 8. Intact membranes 9. Reassuring fetal heart rate tracing

Exclusion criteria

Exclusion criteria: 1. Previous uterine incision/injury (Caesarean delivery, myomectomy, perforation) 2. Gross fetal anomaly 3. Contraindication for vaginal birth 4. Estimated fetal weight =4.0 kg before induction 5. Low birth weight baby, with birth weight <2.0 kg before induction 6. Ruptured membranes

Design outcomes

Primary

Measure	Time frame
Intervention to delivery interval measured as the time in min from oxytocin initiation to delivery of the baby taken from the mother's medical records.	—

Secondary

Measure	Time frame
Maternal outcome measures: 1. Caesarean rate measured as the percentage of women delivered via Caesarean delivery at the end of the study using patient records 2. Maternal satisfaction with the birth process using a visual numeric scale at delivery 3. Intrapartum and postpartum fever (temperature of 38°C or greater) reported through the process of labour and within 24 h after delivery using patient records 4. Analgesic used in labour that is reported throughout the process of labour and measured at the time of delivery by 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 min over two consecutive 10-min periods or a sustained contraction of 2 min or longer or associated with fetal heart abnormality documented throughout the labour process and measured at delivery using case report forms 7. Cardiotocography (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 measures: 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 blood pH and base excess documented upon delivery and measured at the time of delivery using case report forms 3. Birth weight measured using weighing scale and documented upon delivery and measured at the time of delivery using case report forms 4. Neonatal care admission measured using patient records: 4.1. Admission to Paediatric ICU a	—

Measure

Time frame

Maternal outcome measures: 1. Caesarean rate measured as the percentage of women delivered via Caesarean delivery at the end of the study using patient records 2. Maternal satisfaction with the birth process using a visual numeric scale at delivery 3. Intrapartum and postpartum fever (temperature of 38°C or greater) reported through the process of labour and within 24 h after delivery using patient records 4. Analgesic used in labour that is reported throughout the process of labour and measured at the time of delivery by 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 min over two consecutive 10-min periods or a sustained contraction of 2 min or longer or associated with fetal heart abnormality documented throughout the labour process and measured at delivery using case report forms 7. Cardiotocography (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 measures: 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 blood pH and base excess documented upon delivery and measured at the time of delivery using case report forms 3. Birth weight measured using weighing scale and documented upon delivery and measured at the time of delivery using case report forms 4. Neonatal care admission measured using patient records: 4.1. Admission to Paediatric ICU a

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Countries

Malaysia

Contacts

Public ContactArifah Jamaluddin

drarifahj@gmail.com+60 379494422

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 11, 2026