CompletedPhase 4ACTRN12609000420246

Outpatient Foley catheter Vs inpatient Prostin gel for induction of labour

An evaluation of Outpatient Foley (intracervical) catheter versus Inpatient Prostaglandin Vaginal Gel (PGE2) on the induction of labour at term.


Sponsor

Royal Hospital for Women

Enrollment

100 participants

Start Date

Jul 1, 2009

Study Type

Interventional

Conditions

Summary

Aims of study are 1) To compare: a) Clinical effectiveness b) Patient acceptability c) Safety of the use of Foley catheter in the outpatient setting with intravaginal PGE2 (Prostin) gel in the inpatient setting for induction of labour. 2) To assess the cost-effectiveness of intracervical Foley catheter in the outpatient setting to intravaginal PGE2 (Prostin) gel in the inpatient setting for use in induction of labour. The hypothesis is that for induction of labour in women with an unfavourable cervix, use of the catheter on an outpatient basis (women have catheter inserted, then go home until the following morning) will be at least as clinically effective and safe as use of gel as an inpatient (staying in hospital), and that outpatient catheter use will be both acceptable to women and cost-effective. Currently, most pregnant women who need cervical ripening as part of an induction of labour stay in hospital from the time the gel or catheter is inserted until the cervix is ready for the rest of the induction. This means many women stay 12-24 hours in hospital while they are not in labour, but are waiting for the gel or catheter to work. Most women and their babies needing cervical ripening are otherwise very well, and could stay at home during this time if a safe and effective way to do this was available.


Eligibility

Sex: FemalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study compares two methods used to prepare the cervix for labour induction in pregnant women at 37 weeks or more: a Foley catheter (used as an outpatient) versus prostaglandin gel (used in hospital). The goal is to see which approach is safer and more effective for inducing labour.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Foley catheter placed intracervically (with 30mL inflation of balloon) in women requiring cervical ripening procedure as part of induction of labour. Catheter placement procedure takes approximately

Foley catheter placed intracervically (with 30mL inflation of balloon) in women requiring cervical ripening procedure as part of induction of labour. Catheter placement procedure takes approximately 5 minutes. Women then return home while cervical ripening occurs (expected duration of catheter in situ 12-18 hours, maximum 24 hours) and return to hospital for induction the following day.


Locations(1)

Royal Hospital for Women - Randwick

NSW, Australia

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ACTRN12609000420246


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