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

Not Applicable

Completed

• Conditions: Outpatient Foley catheter induction of labour in nulliparous women; Pregnancy and Childbirth

• Registration Number: ISRCTN90853814
• Lead Sponsor: niversity Malaya Medical Centre

Brief Summary

2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37846154/ (added 09/11/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-08-13
• Study Completion: 2021-12-31
• Last Update Posted: 20 November 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 330

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

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified