Prostaglandin insert (Propess) versus trans-cervical balloon catheter for out-patient labour induction: A randomised controlled trial of feasibility (PROBIT-F)

Phase 1

• Conditions: Induction of Labour; Therapeutic area: Body processes [G] - Reproductive physiologi cal processes [G08]

• Registration Number: EUCTR2017-001914-27-GB
• Lead Sponsor: St George's University Hospitals NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-05-10
• Study Completion: 2019-03-31
• Last Update Posted: 18 March 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 84

Inclusion Criteria

1. Pregnant women aged 18 years or over with a single fetus and uncomplicated pregnancy, who were at a Gestational age > 37 completed weeks, needing induction of labour.
2. No medical risk factors.
3. Able to provide informed consent
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 120
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

1. Unsuitable for outpatient management
2. Unsuitable for randomisation to either PGE2 (e.g. previous Caesarean section/hypersensitivity to Prostaglandins) or catheter use (e.g. latex allergy), or prior attempted IOL in this pregnancy.
3. Had ruptured membranes, or evidence of regular uterine contractions at time of booked induction.
4. Multiple pregnancy or non-vertex presentation;
5. Placenta praevia.
6. Lethal fetal congenital anomaly.
7. Non-vertex presentation.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified