Back to resultsManagement of Labor in Patients With Previous Cesarian Section
Primary Purpose
Pregnancy, Previous Cesarian Section, Premature Rupture of Membranes (PROM)
Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Double balloon cervical catheter
Sponsored by
About this trial
This is an interventional treatment trial for Pregnancy focused on measuring TOLAC, PROM, Previous Cesarian section, Mechanical cervical ripening
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Expectant management
Arm Description
Outcomes
Primary Outcome Measures
vaginal delivery rate
20% higher vaginal delivery rate
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT02196103
First Posted
July 15, 2014
Last Updated
July 17, 2014
Sponsor
Hillel Yaffe Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02196103
Brief Title
Management of Labor in Patients With Previous Cesarian Section
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Unknown status
Study Start Date
September 2014 (undefined)
Primary Completion Date
September 2015 (Anticipated)
Study Completion Date
September 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hillel Yaffe Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy, Previous Cesarian Section, Premature Rupture of Membranes (PROM)
Keywords
TOLAC, PROM, Previous Cesarian section, Mechanical cervical ripening
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Expectant management
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Double balloon cervical catheter
Primary Outcome Measure Information:
Title
vaginal delivery rate
Description
20% higher vaginal delivery rate
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
safety
Description
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.
Time Frame
48 hours
Other Pre-specified Outcome Measures:
Title
satisfaction
Description
maternal experience and satisfaction with the method of delivery that was applied
Time Frame
48 hours
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Asnat Walfisch, MD
Phone
050-4492200
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Asnat Walfisch, MD
Organizational Affiliation
Hillel Yaffe Medical Center
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Management of Labor in Patients With Previous Cesarian Section
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