A pilot randomised controlled trial of outpatient balloon catheter priming for induction of labour.

In low risk pregnant women undertaking cervical priming for induction of labour, where there is no evidence of maternal or fetal compromise, will outpatient management, in comparison to inpatient management, result in comparable clinical outcomes, interventions, maternal satisfaction and complications?

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12612001184864

Acronym

COPRA

Enrollment

100

Registered

2012-11-08

Start date

2012-11-12

Completion date

Unknown

Last updated

2020-01-13

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

Conditions

None listed

Brief summary

A study to find out if it is medically appropriate, and acceptable to the woman to use a balloon catheter as an outpatient improve the chances of a successful induction of labour.

Interventions

Women in the experimental group having cervical priming for induction of labour will be allowed to go home after insertion of a balloon catheter, providing that a 20 minute cardiotocography (CTG) monitoring is satisfactory. They will return the next day for induction of labour, or for prostaglandin (PGE2) repriming. If they go into labour overnight or if there are any complications such as bleeding or rupture of membranes, they will return to the hospital overnight. Women in the control group wi

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

Pregnancy is at term (37 completed weeks to 42 completed weeks. Intact membranes. Induction being performed for post-dates or social reason. Singleton, appropriately grown by clinical exam, cephalic presentation. (Clinical suspicion of growth restriction investigated by ultrasound assessment). -Cervical ripening for reasons other than fetal or maternal compromise.

Exclusion criteria

Known intra uterine growth restriction (< 10th percentile for gestational age), suspected intra uterine growth restriction, Gestational Hypertension and Pre-Eclampsia.*Conditions specific to catheter priming including: placenta previa, low placenta, unDx vaginal bleeding, known latex allergy, active vaginal infection, active genital herpes.

Outcome results