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

NCT03830502 | Completed

• 1 other identifier: EtfalSalp
• Study Type: observational
• Target: 58
• Locations: 1 country
• Sites: 3

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.

Conditions

Salpingectomy; Sterilization, Tubal

Keywords

Prophylactic salpingectomy; Opportunistic salpingectomy; Risk-reducing

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Salpingectomy

Women who gave consent for opportunistic prophylactic bilateral salpingectomy during cesarean section as a Surgical sterilization procedure

Procedure: Surgical sterilization

Tubal ligation

Women who refused salpingectomy and gave consent for tubal ligation during cesarean section as a Surgical sterilization procedure

Procedure: Surgical sterilization

Interventions

Surgical sterilization PROCEDURE

Surgical sterilization either standard salpingectomy or tubal ligation with Pomeroy technique

Salpingectomy; Tubal ligation

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women who aged over 18 years old and seek for sterilization at the time of cesarean section.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bartin State Hospital: lead

Study Sites (3)

Bartin State Hospital

Bartın, Turkey (Türkiye)

Location

Istanbul Sisli Hamidiye Etfal Training And Research Hospital, Health Sciences University

Istanbul, Turkey (Türkiye)

Location

Medicalpark Gaziosmanpasa Hospital, Istinye University

Istanbul, Turkey (Türkiye)

Location

Related 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. No abstract available.

  PMID: 30591122 BACKGROUND

Study Officials

• Murat Yassa, M.D.

  Specialist

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 3, 2019
• First Posted: February 5, 2019
• Study Start: February 10, 2019
• Primary Completion: December 10, 2019
• Study Completion: February 1, 2020
• Last Updated: April 30, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (3)