A randomized trial of labour induction using the Foley catheter of different bores (French sizes 16, 22 and 28: 1 French size equals 0.33 mm)

Induction of Labour with 16 F versus 22 F versus 28 F size Foley Catheter: A randomised trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN21224268

Enrollment

147

Registered

2017-12-13

Start date

2017-12-15

Completion date

Unknown

Last updated

2022-11-07

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

Conditions

Induction of labour Pregnancy and Childbirth Induction of labour

Interventions

Randomisation is by the opening of sealed opaque and numbered envelope with lowest available envelope assigned in strict order. Randomization sequence is generated using a random number generator at R

16 F, 22 F and 28 F. Only specified investigator performs the intervention using standardised protocol in all group. Participants are placed in lithotomy position. The provider performs a vaginal exam

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Women with unfavourable cervix undergoing cervical ripening and induction of labour at term in University Malaya Medical Centre, Kuala Lumpur 2. Scheduled induction of labour 3. Aged 18 years and above 4. Gestational age of > 37 weeks at enrolment 5. Unfavourable cervix (Bishop Score = 5) 6. Reassuring pre induction fetal cardiotocography (CTG) 7. Cephalic presentation 8. Singleton pregnancy 9. Intact membranes

Exclusion criteria

Exclusion criteria: 1. Allergic to latex 2. Inability to consent 3. Known gross fetal anomaly 4. Absolute contraindication to vaginal delivery

Design outcomes

Primary

Measure	Time frame
1. Catheter Insertion time (total minutes to successful catheter placement at first attempt) 2. Patient reported pain (VNRS 0 to 10, taken immediately after first attempt with successful insertion) 3. Patient pain score by Insertion failure rates (placement time more than 5 minutes, procedure abandon by provider or requested by participant during insertion, catheter unable to pass through cervical canal or inadvertent amniotomy)	—

Measure

Time frame

1. Catheter Insertion time (total minutes to successful catheter placement at first attempt) 2. Patient reported pain (VNRS 0 to 10, taken immediately after first attempt with successful insertion) 3. Patient pain score by Insertion failure rates (placement time more than 5 minutes, procedure abandon by provider or requested by participant during insertion, catheter unable to pass through cervical canal or inadvertent amniotomy)

—

Secondary

Measure	Time frame
Maternal outcomes: 1. Time of catheter expelled or evacuated 2. Maternal satisfaction with their care since allocation to the intervention until removal of catheter 3. Use of additional prostaglandin for cervical ripening 4. Use of oxytocin for intrapartum augmention 5. Use of regional analgesia in labour 6. Timing from intervention to delivery 7. Mode of delivery and indication/s of caesarean section 8. Estimated postdelivery blood loss 9. Fever (intrapartum and up to patient discharge) Neonatal outcomes: 1. Apgar score at 1 and 5 minutes 2. Arterial cord pH 3. Birth weight 4. Neonatal admission	—

Measure

Time frame

Maternal outcomes: 1. Time of catheter expelled or evacuated 2. Maternal satisfaction with their care since allocation to the intervention until removal of catheter 3. Use of additional prostaglandin for cervical ripening 4. Use of oxytocin for intrapartum augmention 5. Use of regional analgesia in labour 6. Timing from intervention to delivery 7. Mode of delivery and indication/s of caesarean section 8. Estimated postdelivery blood loss 9. Fever (intrapartum and up to patient discharge) Neonatal outcomes: 1. Apgar score at 1 and 5 minutes 2. Arterial cord pH 3. Birth weight 4. Neonatal admission

—

Countries

Malaysia

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 13, 2026