Concurrent Foley catheter and prostaglandin vaginal insert compared to Foley catheter only for induction of labour in first time mothers with obesity

Concurrent Foley catheter and controlled-release dinoprostone vaginal insert versus Foley catheter for labour induction in obese nulliparas: a randomized controlled trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN16808684

Enrollment

324

Registered

2025-09-25

Start date

2025-10-01

Completion date

Unknown

Last updated

2025-10-06

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

Conditions

Obese nulliparas Induction of labour Pregnancy and Childbirth

Interventions

All participants will have a Foley catheter inserted, but participants randomised to the combined regime will have dinoprostone insertion immediately following their Foley catheter insertion. The rand

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Planned induction of labour (irrespective of indication) 2. BMI =30.0kg/m2 3. Nulliparous (no previous pregnancy = 22 weeks) 4. Unfavourable cervix 5. Intact membrane 6. Term =37 weeks 7. Age 18-45 years old 8. Singleton pregnancy 9. Cephalic presentation 10. Normal fetal heart rate tracing on cardiotocograph before induction 11. Absence of significant contractions (= 2 in 10 minutes)

Exclusion criteria

Exclusion criteria: 1. Previous uterine scar 2. Known major fetal anomaly 3. Fetal weight clinically estimated to be less than 2 kg or more than 4 kg 4. Maternal infection 5. Contraindication for vaginal delivery 6. Latex allergy 7. Dinoprostone allergy

Design outcomes

Primary

Measure	Time frame
Caesarean delivery rate measured using data collected in patient medical records at one timepoint	—

Secondary

Measure	Time frame
The secondary outcome measures are measured using data collected in patient medical records at one timepoint, unless stated: Maternal secondary outcomes: 1. Cervical ripeness measured using the Bishop score at removal/retrieval of trial devices 2. Maternal satisfaction with their induction method measured using the 0-10 Numerical Rating Scale (higher score, greater satisfaction) 3. Recommendation of the allocated method of IOL to a friend measured using a 5-grade Likert scale response (Strongly Agree-Agree-Neutral-Disagree-Strongly Disagree) 4. Additional cervical ripening method if needed 5. Intrapartum oxytocin use (excluding use for PPH prophylaxis) 6. Induction to delivery interval 7. Mode of delivery 7.1. Spontaneous 7.2. Vacuum 7.3. Forceps 7.4. Caesarean section 8. Indication for caesarean section 9. Indication for instrumental vaginal delivery 10. Blood loss during delivery 11. Perineal condition after birth (Intact/First/Second/Third/Fourth/Episiotomy) 12. Maternal infection (Temperature =38.0 0C) 13. Epidural in labour 14. Length of hospital stay 15. ICU admission 16. Cardiorespiratory arrest 17. Needing a hysterectomy Neonatal outcomes: 1. Apgar score at 1 and 5 minutes 2. NICU admission 3. Cord pH 4. Neonatal sepsis 5. Birth weight 6. Birth trauma 7. Hypoxic ischaemic encephalopathy/need for therapeutic hypothermia	—

Measure

Time frame

The secondary outcome measures are measured using data collected in patient medical records at one timepoint, unless stated: Maternal secondary outcomes: 1. Cervical ripeness measured using the Bishop score at removal/retrieval of trial devices 2. Maternal satisfaction with their induction method measured using the 0-10 Numerical Rating Scale (higher score, greater satisfaction) 3. Recommendation of the allocated method of IOL to a friend measured using a 5-grade Likert scale response (Strongly Agree-Agree-Neutral-Disagree-Strongly Disagree) 4. Additional cervical ripening method if needed 5. Intrapartum oxytocin use (excluding use for PPH prophylaxis) 6. Induction to delivery interval 7. Mode of delivery 7.1. Spontaneous 7.2. Vacuum 7.3. Forceps 7.4. Caesarean section 8. Indication for caesarean section 9. Indication for instrumental vaginal delivery 10. Blood loss during delivery 11. Perineal condition after birth (Intact/First/Second/Third/Fourth/Episiotomy) 12. Maternal infection (Temperature =38.0 0C) 13. Epidural in labour 14. Length of hospital stay 15. ICU admission 16. Cardiorespiratory arrest 17. Needing a hysterectomy Neonatal outcomes: 1. Apgar score at 1 and 5 minutes 2. NICU admission 3. Cord pH 4. Neonatal sepsis 5. Birth weight 6. Birth trauma 7. Hypoxic ischaemic encephalopathy/need for therapeutic hypothermia

—

Countries

Malaysia

Contacts

Public ContactKhairun Nurlisa ;Peng Chiong Kamal;Tan

;

knk121191@gmail.com;pctan@um.edu.my+60174988313;+603 79492049

Outcome results

None listed

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