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OpenTrials
Completed

NCT Number: NCT03830502

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Bartin State Hospital, Bartın, Turkey (Türkiye)

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Surgical sterilization

Procedure

Surgical sterilization either standard salpingectomy or tubal ligation with Pomeroy technique

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Bartin State Hospital

Other Gov

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Feb 5, 2019
Registry last updated
Apr 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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