Management of Labor in Patients With Previous Cesarian Section

Management of Labor in Patients With Previous Cesarian Section and Premature Rupture of Membranes Who Desire TOLAC: Comparison Between the Use of Standard Expectant Management and the Double-balloon Catheter Device. A Prospective Randomized Study

Status

UNKNOWN

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02196103

Enrollment

200

Registered

2014-07-21

Start date

2014-09-30

Completion date

2018-09-30

Last updated

2014-07-21

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

Conditions

Pregnancy, Premature Rupture of Membranes (PROM), Previous Cesarian Section

Keywords

TOLAC, PROM, Previous Cesarian section, Mechanical cervical ripening

Brief summary

Induction of labor in women desiring TOLAC has long been a topic of controversy. The paucity of published data on mechanical cervical ripening in the setting of TOLAC and term PROM has led us to undertake the present clinical trial.

Interventions

DEVICEDouble balloon cervical catheter

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

Healthy volunteers

Inclusion criteria

* Diagnosed to be pregnant with PROM at \>34 weeks. Rupture of membranes will be determine clinically and confirmed by positive Nitrazine test. * Ruptured membranes have occurred in the last 24 hours prior to inclusion in the study. * Found to have an unripe cervix in a speculum examination. * Singleton pregnancy in a vertex presentation well applied to the cervix and absence of significant and regular uterine contractions (3-5/10 Min) * Previous on cesarian section. * Willingness to comply with the protocol for the duration of the study. * Have signed an informed consent.

Exclusion criteria

Patients having any of the following conditions: * Any contraindication for the vaginal delivery (i.e. placenta previa, non vertex presentation). * Regular uterine contractions (3-5/10 min). * Diagnosis of rupture membranes was made over 24 hours prior the study inclusion. * Evidence of chorio-amnionitis (T 37.6 celsious Degree with uterine tenderness and maternal or fetal tachycardia or purulent discharge or WBC\>/=20,000) * Suspected placental abruption or presence of a significant hemorrhage. * Non-reassuring fetal status (as determined by fetal heart rate monitoring and/or bio-physical profile) necessitating immediate intervention.

Design outcomes

Primary

Measure	Time frame	Description
vaginal delivery rate	48 hours	20% higher vaginal delivery rate

Secondary

Measure	Time frame	Description
safety	48 hours	safety of the double balloon device in women with one previous cesarian section and PROM at \>/=34 weeks by monitoring fetal heart rate, increased uterine hemorrhage, maternal hemodinamic changes, and uterine atony.

Other

Measure	Time frame	Description
satisfaction	48 hours	maternal experience and satisfaction with the method of delivery that was applied

Contacts

Primary ContactAsnat Walfisch, MD

050-4492200

Outcome results

None listed

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