Management of Labor in Patients With Previous Cesarian Section

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02196103
• Other study ID #: 0019-14-HYMC
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• First received: July 15, 2014
• Last updated: July 17, 2014
• Start date: September 2014
• Est. completion date: September 2018

Study information

• Verified date: July 2014
• Source: Hillel Yaffe Medical Center
• Contact: Asnat Walfisch, MD
• Phone: 050-4492200
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: September 2018
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Device:
• Double balloon cervical catheter

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hillel Yaffe Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	satisfaction	maternal experience and satisfaction with the method of delivery that was applied	48 hours	No
Primary	vaginal delivery rate	20% higher vaginal delivery rate	48 hours	No
Secondary	safety	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.	48 hours	Yes