Salpingectomy During Cesarean Section
SCS
1 other identifier
interventional
100
1 country
1
Brief Summary
Based on the accumulated literature, salpingectomy may significantly reduce the risk for ovarian cancer. If investigators can prove that there is no increase in surgical complications and morbidity during salpingectomy in CS, compared to tubal ligation, investigators can recommend for women who are interested in sterilization- salpingectomy during cesarean section .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable healthy
Started Sep 2016
Typical duration for not_applicable healthy
1 active site
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 29, 2016
CompletedFirst Posted
Study publicly available on registry
August 26, 2016
CompletedStudy Start
First participant enrolled
September 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2018
CompletedAugust 26, 2016
August 1, 2016
1.8 years
July 29, 2016
August 25, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
intra- operative complications
operation duration,hemorrhage, technical difficulty in performing salpingectomy during CS
5 days
Secondary Outcomes (1)
long term complication
3 months
Study Arms (2)
salpingectomy group I
OTHERsalpingectomy during cesarean section for sterilization
tubal ligation group II
ACTIVE COMPARATORtubal ligation in cesarean section
Interventions
Every woman , who is eligible to enter the study in terms of the above criteria , will receive a detailed explanation of the study and will review the consent form , and then be asked whether she agrees to participate in . If so , the participant will stamped on the informed consent form . The control group will be women who undergo tubal ligation method BTL during cesarean section . All women will be invited to follow up about three months after surgery. The women will answer questionnaire to quantify the symptoms of menopause by NAMS , blood test for AMH and sonar and Doppler examination of both the ovaries
women who agreed to participate in the study and assigned randomly to this group will have salpingectomy during cesarean section for sterilization.
Eligibility Criteria
You may qualify if:
- Women planned for cesarean section , according to medical or obstetric indication , and seek sterilization
- Women aged 30 and older
- Women who are capable to understand , read and sign an informed consent form
You may not qualify if:
- women aged less then 30 years
- women who disagree to participate in the research
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
ISRAEL
Haifa, Israel, 31048, Israel
Study Officials
- STUDY CHAIR
sagi shlomi, md
helsinki bnai zion
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
July 29, 2016
First Posted
August 26, 2016
Study Start
September 1, 2016
Primary Completion
July 1, 2018
Study Completion
July 1, 2018
Last Updated
August 26, 2016
Record last verified: 2016-08
Data Sharing
- IPD Sharing
- Will not share