A randomised controlled trial of the use of the Foley catheter balloon for induction of labour to reduce the incidence of caesarean section in diabetic pregnancies: a prospective clinical, economic and psychological evaluation

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN39708525

Enrollment

Registered

2007-09-28

Start date

2003-11-01

Completion date

Unknown

Last updated

2015-01-13

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

Conditions

Pregnancy and Childbirth: Labour induction Pregnancy and Childbirth Labour induction

Interventions

Women consenting to participate in the trial will be randomly allocated to one of two groups: 1. Women will be induced at 38 weeks gestation by means of vaginal prostaglandins according to our curren

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: Not provided at time of registration

Exclusion criteria

Exclusion criteria: Women will be excluded if they are planning an elective caesarean delivery, are multiparae, have co-existing other medical disorders, multiple pregnancy, breech or any presentation other than cephalic.

Design outcomes

Primary

Measure	Time frame
Vaginal delivery versus caesarean section. 1. Clinical: induction success rates, caesarean section rates, length of labour, instrumental delivery, blood loss and neonatal outcomes including Apgar scores, admission to SCBU and blood glucose levels. 2. Psychological: maternal satisfaction rates assessed by a designer questionnaire. 3. Economic: basic costs assessment, including the costs of Foley catheters, additional 24 hour hospital stay, costs of caesarean section etc.	—

Measure

Time frame

Vaginal delivery versus caesarean section. 1. Clinical: induction success rates, caesarean section rates, length of labour, instrumental delivery, blood loss and neonatal outcomes including Apgar scores, admission to SCBU and blood glucose levels. 2. Psychological: maternal satisfaction rates assessed by a designer questionnaire. 3. Economic: basic costs assessment, including the costs of Foley catheters, additional 24 hour hospital stay, costs of caesarean section etc.

—

Secondary

Measure	Time frame
Not provided at time of registration	—

Countries

United Kingdom

Outcome results

None listed

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