Membrane sweeping or no membrane sweeping just prior to transcervical Foley catheter insertion for induction of labour in women with one previous caesarean delivery

Transcervical Foley catheter with and without adjunctive membrane sweeping for induction of labour in women with one previous caesarean delivery: a randomized trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN87387293

Enrollment

110

Registered

2020-06-11

Start date

2020-06-18

Completion date

Unknown

Last updated

2021-12-27

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

Conditions

Induction of labour in women with one previous caesarean delivery and unripe cervix Pregnancy and Childbirth

Interventions

Randomisation will be done with the opening of the lowest available numbered sealed opaque envelopes in strict order. Random blocks of 4 or 8 will be used. Randomisation sequence will be generated usi

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Scheduled for labour induction 2. One previous caesarean section 3. Unripe cervix (Modified Bishop Score = 5) 4. 18 years and above 5. Singleton pregnancy 6. 37 weeks gestation and above 7. Cephalic presentation 8. Reassuring fetal heart rate tracing 9. Absence of significant contraction = 2 in 10 minutes

Exclusion criteria

Exclusion criteria: 1. Contraindication to vaginal delivery 2. Known gross fetal anomaly 3. Ruptured membranes 4. Latex allergy 5. Fetal weight clinically estimated to be = 2 kg or = 4kg, then confirmed by ultrasound 6. Preference for repeat Caesarean delivery

Design outcomes

Primary

Measure	Time frame
1. Induction to delivery interval: the duration from foley catheter insertion to delivery time 2. Maternal satisfaction with the delivery process assessed using a 10 cm visual numerical rating scale (scored from 0 to 10) post-delivery in the postnatal ward before discharge	—

Secondary

Measure	Time frame
Maternal outcome measures, obtained from patients medical record at delivery: 1. Mode of delivery such as spontaneous vaginal delivery/Caesarean delivery and its indication and instrumental delivery (forceps and vacuum) and its indication 2. Use of additional method for cervical ripening e.g. prostaglandin use or repeat Foley catheter 3. Spontaneous rupture of membrane or amniotomy 4. Duration of oxytocin use - from time oxytocin started to stopped in hours and minutes 5. Epidural analgesia in labour - whether used or not 6. Estimated delivery blood loss - in ml 7. Fever - temperature in degree Celcius 8. Major harms e.g. severe postpartum haemorrhage (more than or equal 1500 ml), uterine rupture and admission to the intensive care unit Neonatal outcome measures, obtained from patients medical record at delivery: 1. Apgar score at 1 and 5 minutes 2. Umbilical cord arterial blood pH and base excess 3. Neonatal admission and indication	—

Measure

Time frame

Maternal outcome measures, obtained from patients medical record at delivery: 1. Mode of delivery such as spontaneous vaginal delivery/Caesarean delivery and its indication and instrumental delivery (forceps and vacuum) and its indication 2. Use of additional method for cervical ripening e.g. prostaglandin use or repeat Foley catheter 3. Spontaneous rupture of membrane or amniotomy 4. Duration of oxytocin use - from time oxytocin started to stopped in hours and minutes 5. Epidural analgesia in labour - whether used or not 6. Estimated delivery blood loss - in ml 7. Fever - temperature in degree Celcius 8. Major harms e.g. severe postpartum haemorrhage (more than or equal 1500 ml), uterine rupture and admission to the intensive care unit Neonatal outcome measures, obtained from patients medical record at delivery: 1. Apgar score at 1 and 5 minutes 2. Umbilical cord arterial blood pH and base excess 3. Neonatal admission and indication

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Countries

Malaysia

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 12, 2026