Comparing two different interventions after balloon catheter induction of labour in women who have not delivered a child before

A randomized controlled trial of two different regimens of outpatient Foley catheter induction of labour in nulliparous women

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN90853814

Enrollment

330

Registered

2020-08-13

Start date

2020-09-01

Completion date

Unknown

Last updated

2023-11-20

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

Conditions

Outpatient Foley catheter induction of labour in nulliparous women Pregnancy and Childbirth

Interventions

All nulliparous women planned for induction of labour by the care provider will be assessed for eligibility and will be counselled regarding this study in the clinic and antenatal ward setting. If the

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Nulliparous 2. Age 18 years and above 3. Gestational age of = 37weeks at enrolment 4. Scheduled induction of labour 5. Viable pregnancy 6. Cephalic presentation 7. Singleton pregnancy 8. Unfavourable cervix (Bishop score = 5) 9. Absence of significant contraction = 2 in 10 minutes 10. Intact membranes 11. Reassuring pre induction fetal cardiotocography (CTG) 12. Patient has motor vehicle 13. Patient stays about 30 minutes distance from University Malaya Medical Centre

Exclusion criteria

Exclusion criteria: 1. Allergic to latex 2. Multiparous 3. Women with ruptured membranes 4. Contraindication to vaginal delivery 5. Known gross fetal anomaly 6. Fetal weight clinically estimated to be = 2 kg and = 4 kg and confirmed by ultrasound 7. Previous uterine scar (caesarean/myomectomy)

Design outcomes

Primary

Measure	Time frame
1. Maternal satisfaction evaluated using a visual numerical scale scored 0-10, assessed within 24 hours of delivery 2. Duration of active labour, defined as amniotomy and oxytocin to delivery interval, measured in hr:min; obtained from patient's medical records at birth	—

Secondary

Measure	Time frame
Maternal outcome measures: 1. Induction to delivery interval (duration measured in hr:min), obtained from patient's medical records at birth 2. Mechanism of membrane rupture (amniotomy or spontaneous rupture of membrane), obtained from patient's medical records at birth 3. Oxytocin augmentation (duration measured in hr:min), obtained from patient's medical records at birth 4. Use of additional method(s) of cervical ripening, obtained from patient's medical records at birth 5. Use of regional analgesia in labour, obtained from patient's medical records at birth 6. Mode of delivery, obtained from patient's medical records at birth 7. Estimated blood loss, obtained from patient's medical records at birth 8. Fever; one or more readings of temperature = 38°C, diagnosis of chorioamnionitis or endometritis, obtained from patient's medical records intrapartum and day 1 postpartum 9. Total duration of hospital stay, obtained from patient's medical records on discharge 10. Date and time of catheter removal/dislodged, obtained from patient's medical records upon admission to hospital Neonatal outcome measures: 1. Apgar score at 1 and 5 minutes measured using the Apgar score chart at 1 and 5 minutes of birth 2. Arterial cord pH: blood drawn into a heparinized syringe taken from the umbilical artery of the umbilical cord after delivery of the baby, measured using a blood gas machine located in the labour ward at time of birth 3. Birth weight measured using a calibrated digital weighing scale located in the labour ward nursery at birth 4. Neonatal admission, taken from the medical records of the baby at birth or before mother's date of hospital discharge	—

Measure

Time frame

Maternal outcome measures: 1. Induction to delivery interval (duration measured in hr:min), obtained from patient's medical records at birth 2. Mechanism of membrane rupture (amniotomy or spontaneous rupture of membrane), obtained from patient's medical records at birth 3. Oxytocin augmentation (duration measured in hr:min), obtained from patient's medical records at birth 4. Use of additional method(s) of cervical ripening, obtained from patient's medical records at birth 5. Use of regional analgesia in labour, obtained from patient's medical records at birth 6. Mode of delivery, obtained from patient's medical records at birth 7. Estimated blood loss, obtained from patient's medical records at birth 8. Fever; one or more readings of temperature = 38°C, diagnosis of chorioamnionitis or endometritis, obtained from patient's medical records intrapartum and day 1 postpartum 9. Total duration of hospital stay, obtained from patient's medical records on discharge 10. Date and time of catheter removal/dislodged, obtained from patient's medical records upon admission to hospital Neonatal outcome measures: 1. Apgar score at 1 and 5 minutes measured using the Apgar score chart at 1 and 5 minutes of birth 2. Arterial cord pH: blood drawn into a heparinized syringe taken from the umbilical artery of the umbilical cord after delivery of the baby, measured using a blood gas machine located in the labour ward at time of birth 3. Birth weight measured using a calibrated digital weighing scale located in the labour ward nursery at birth 4. Neonatal admission, taken from the medical records of the baby at birth or before mother's date of hospital discharge

—

Countries

Malaysia

Contacts

Public ContactTan Peng Chiong

pctan@um.edu.my+60 (0)379494422

Outcome results

None listed

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