Intracervical Catheters for Induction of Labour in Women With Prelabour Rupture of Membranes at Term

Intracervical Catheters for Induction of Labour in Women With Prelabour Rupture of Membranes at Term: A Pilot Study.

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00890630

Acronym

IC-PROM

Enrollment

Registered

2009-04-30

Start date

2010-04-30

Completion date

2011-07-31

Last updated

2011-07-20

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

Conditions

Fetal Membranes, Premature Rupture, Induced Labor

Brief summary

The purpose of this study is to examine the feasibility of using intracervical balloon catheters for cervical ripening as part of labour induction in healthy, GBS-negative women with prelabour rupture of membranes at term.

Detailed description

This is a randomized controlled trial comparing two methods of induction of labour for pregnant, GBS-negative women presenting with prelabour rupture of membranes at term. The intervention consists of the insertion of a double-balloon intracervical catheter at the time of induction, followed immediately by oxytocin infusion. The control consists of standard therapy: oxytocin induction. Our primary outcome is feasibility, and our secondary outcomes are length of first and second stages of labour, rate of vaginal delivery, intrapartum fever, chorioamnionitis, NICU admission, suspected or proven neonatal sepsis, or serious neonatal complication.

Interventions

PROCEDUREIntracervical Balloon Catheter

Intracervical insertion of an 80cc Double-Balloon Catheter.

DRUGOxytocin

IV Oxytocin infusion, dose dependent on patient response. Start at 2mIU/min, increasing every 30 minutes by 2mIU/min, to max 24mIU/min.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

Inclusion criteria

* Singleton Pregnancy * 37.0 and 41.0 gestational age * Confirmed Rupture of Membranes * Group B Streptococcus Negative * Cephalic Presentation * Absence of contractions for at least 60 minutes following rupture * Absence of contractions at time of enrolment

Exclusion criteria

* Contraindication to Vaginal Delivery * Previous Uterine Surgery, including Caesarean Section * Previous Cerclage, Cone Biopsy, LEEP, or Cervical Surgery * Documented history of cervical incompetence * High Grade intraepithelial lesion, adenocarcinoma in situ, or invasive cervical cancer. * Immunosuppressed State * Active Vaginal Infection

Design outcomes

Primary

Measure	Time frame
Feasibility	48 hours

Secondary

Measure	Time frame
Intrapartum Fever	48 Hours
Duration of Labour	48 hours
NICU Admission	0-7 days postpartum
Chorioamnionitis	48 Hours
Patient Satisfaction	0-6 weeks Postpartum

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026