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

Salpingectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03830502
• Other study ID #: EtfalSalp
• Status: Completed
• Start date: February 10, 2019
• Est. completion date: February 1, 2020

Study information

• Verified date: April 2020
• Source: Bartin State Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: February 1, 2020
• Est. primary completion date: December 10, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Salpingectomy
• Sterilization, Tubal

Intervention

Procedure:
• Surgical sterilization
Surgical sterilization either standard salpingectomy or tubal ligation with Pomeroy technique

Locations

Country	Name	City	State
Turkey	Bartin State Hospital	Bartin
Turkey	Istanbul Sisli Hamidiye Etfal Training And Research Hospital, Health Sciences University	Istanbul
Turkey	Medicalpark Gaziosmanpasa Hospital, Istinye University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Bartin State Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Zamorano AS, Mutch DG. Postpartum salpingectomy: a procedure whose time has come. Am J Obstet Gynecol. 2019 Jan;220(1):8-9. doi: 10.1016/j.ajog.2018.09.041. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Motivators for sterilization type	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.	Evaluation at preoperative 32th gestational weeks