Management of Labor in Patients With Previous Cesarian Section
1 other identifier
interventional
200
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 pregnancy
Started Sep 2014
Longer than P75 for phase_2 pregnancy
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 15, 2014
CompletedFirst Posted
Study publicly available on registry
July 21, 2014
CompletedStudy Start
First participant enrolled
September 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2018
CompletedJuly 21, 2014
July 1, 2014
1 year
July 15, 2014
July 17, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
vaginal delivery rate
20% higher vaginal delivery rate
48 hours
Secondary Outcomes (1)
safety
48 hours
Other Outcomes (1)
satisfaction
48 hours
Study Arms (1)
Expectant management
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Diagnosed to be pregnant with PROM at \>34 weeks. Rupture of membranes will be determine clinically and confirmed by positive Nitrazine test.
- 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.
You may not qualify if:
- Any contraindication for the vaginal delivery (i.e. placenta previa, non vertex presentation).
- Regular uterine contractions (3-5/10 min).
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
de Vaan MD, Ten Eikelder ML, Jozwiak M, Palmer KR, Davies-Tuck M, Bloemenkamp KW, Mol BWJ, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2023 Mar 30;3(3):CD001233. doi: 10.1002/14651858.CD001233.pub4.
PMID: 36996264DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Asnat Walfisch, MD
Hillel Yaffe Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 15, 2014
First Posted
July 21, 2014
Study Start
September 1, 2014
Primary Completion
September 1, 2015
Study Completion
September 1, 2018
Last Updated
July 21, 2014
Record last verified: 2014-07