Foley Catheter Latex versus Silicone for Cervical Ripening Prior to Term Induction of Labour: a randomized controlled trial

Not Applicable

• Conditions: Pregnancy; Pregnant Women Requiring Induction of Labour; Reproductive Health and Childbirth - Childbirth and postnatal care

• Registration Number: ACTRN12615000795594
• Lead Sponsor: Westmead Department of Obstetrics and Gynaecology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-07-31
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Stopped early
• Sex: Female
• Target Recruitment: 1740

Inclusion Criteria

All women 16 years and over booked for cervical ripening with a Foley catheter before term induction of labour will be asked to participate in the study. Those who decline participation will have a Foley catheter material of the obstetrician’s choosing.

Exclusion Criteria

1.Latex allergy
2.Bishop score greater than 7
3.Ruptured membranes
4.Placenta closer than 2cm from internal os or undiagnosed vaginal bleeding
5.Abnormal pre-ripening CTG
6.Prior use of prostaglandin gel or Foley catheter for ripening in the current pregnancy
7.Active or purulent infection of the lower genital tract
8.Lethal congenital anomaly or fetal demise
9.Age less than 16 years
10.Unable to consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified