Tugging the Foley catheter (a balloon inflated inside the womb) every three hours in the labour induction of women in their first birth

Tugging the foley catheter every three hours in the labour induction of nulliparous women: a randomised trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN11140013

Enrollment

260

Registered

2023-03-02

Start date

2023-03-06

Completion date

Unknown

Last updated

2025-03-17

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

Conditions

Nulliparous women undergoing induction of labour with Foley catheter Pregnancy and Childbirth

Interventions

Women randomised to : 3 hourly tugging, care providers will be instructed to “tug” the external end of the foley’s catheter to a level of just below patient discomfort and to sustain the tug for at le

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Nulliparous 2. Age =18 years 3. Gestational age of =37 weeks 4. Singleton pregnancy 5. Cephalic presentation 6. Intact membrane 7. Reassuring fetal heart rate tracing 8. Absence of significant contraction =2 in 10 minutes 9. Successful Foley insertion for induction of labour

Exclusion criteria

Exclusion criteria: 1. History of uterine perforation/ previous myomectomy 2. Latex Allergy 3. Estimated fetal weight 4 kg 4. Known major fetal malformations 5. Contraindication for vaginal delivery 6. Patient who is suspected COVID 19 infection or COVID 19 positive

Design outcomes

Primary

Measure	Time frame
Measured after birth: 1. Foley’s catheter insertion to delivery interval (min) using patient records 2. Maternal satisfaction with the labour induction process (using an 11-point 0 to 10 visual numerical rating scale)	—

Secondary

Measure	Time frame
Measured using patient records: Maternal outcomes: 1. Bishop score before and after intervention 2. Use of additional method for cervical ripening 3. Time to delivery after Foley’s catheter removal 4. Mode of delivery 5. Indication for caesarean section 6. Blood loss during delivery 7 Third -or fourth-degree tear 8. Maternal infection before hospital discharge 9 Use of regional analgesia in labour 10. Length of hospital stay (days) 11. ICU admission before hospital discharge 12. Cardiorespiratory arrest before hospital discharge 13. Hysterectomy before hospital discharge Neonatal outcomes: 1. Apgar score at 1 and 5 minutes 2. NICU admission before hospital discharge 3. Cord pH 4. Neonatal sepsis before hospital discharge 5. Birth weight (kg) 6. Birth trauma 7. Hypoxic ischaemic encephalopathy/need for therapeutic hypothermia before hospital discharge	—

Measure

Time frame

Measured using patient records: Maternal outcomes: 1. Bishop score before and after intervention 2. Use of additional method for cervical ripening 3. Time to delivery after Foley’s catheter removal 4. Mode of delivery 5. Indication for caesarean section 6. Blood loss during delivery 7 Third -or fourth-degree tear 8. Maternal infection before hospital discharge 9 Use of regional analgesia in labour 10. Length of hospital stay (days) 11. ICU admission before hospital discharge 12. Cardiorespiratory arrest before hospital discharge 13. Hysterectomy before hospital discharge Neonatal outcomes: 1. Apgar score at 1 and 5 minutes 2. NICU admission before hospital discharge 3. Cord pH 4. Neonatal sepsis before hospital discharge 5. Birth weight (kg) 6. Birth trauma 7. Hypoxic ischaemic encephalopathy/need for therapeutic hypothermia before hospital discharge

—

Countries

Malaysia

Outcome results

None listed

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