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Clinical Trials/NCT03830502
NCT03830502
Completed
Not Applicable

Driving Factors of Decision Making for Prophylactic Salpingectomy Versus Tubal Ligation at the Time of Cesarean Section

Bartin State Hospital3 sites in 1 country58 target enrollmentFebruary 10, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Salpingectomy
Sponsor
Bartin State Hospital
Enrollment
58
Locations
3
Primary Endpoint
Motivators for sterilization type
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

Prophylactic (Opportunistic) salpingectomy is a cost-effective strategy recommended for reducing the risk of ovarian cancer at the time of gynecologic surgery in women who have completed childbearing. Similar evidence for cesarean section is growing. However, salpingectomy refers to the surgical removal of a female reproductive organ. Some women may have hesitations about salpingectomy with regard to religious concerns, reduced self-image, tubal reanastomosis or lack of knowledge.

The investigators aimed to explore the underlying factors that motivate women for either decisions.

Detailed Description

Prophylactic and opportunistic bilateral salpingectomy is an increasing trend among surgeons and also proven as an effective risk-reducing method for ovarian cancer. The investigators have experienced denials among women who were seeking tubal ligation as a sterilization procedure during cesarean section after a comprehensive counseling for prophylactic salpingectomy. Therefore, the investigators aimed to assess the driving factors of decision making for prophylactic salpingectomy or tubal ligation. It is planned to preoperatively have a non-validated questionnaire for the women after a detailed briefing.

Registry
clinicaltrials.gov
Start Date
February 10, 2019
End Date
February 1, 2020
Last Updated
6 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
Bartin State Hospital
Responsible Party
Principal Investigator
Principal Investigator

Murat Yassa

Principal Investigator

Bartin State Hospital

Eligibility Criteria

Inclusion Criteria

  • Women seeking for surgical sterilization during their cesarean section
  • Elective and Category 2 or more planned cesarean sections

Exclusion Criteria

  • Clinical conditions that lead to planned cesarean hysterectomy such as placenta percreata
  • History of ovarian cancer, previous chemotherapy or radiation
  • Women who previously underwent sterilization

Outcomes

Primary Outcomes

Motivators for sterilization type

Time Frame: Evaluation at preoperative 32th gestational weeks

A non-validated data collection tool with open-ended questions assessing the factors behind the decision of salpingectomy or tubal ligation. Data collection tool questions why patients choosed or refused salpingectomy in detail. It is not a scale and does not have a range.

Study Sites (3)

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