Clinical trial NCT03830502: Driving Factors of Decision Making for Prophylactic Salpingectomy Versus Tubal Ligation at the Time of Cesarean Section
Official title: Driving Factors of Decision Making for Prophylactic Salpingectomy Versus Tubal Ligation at the Time of Cesarean Section
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Salpingectomy
Sterilization, Tubal
Keywords: Prophylactic salpingectomy
Opportunistic salpingectomy
Risk-reducing
Lead sponsor: Bartin State Hospital
Sponsor class: OTHER_GOV
First posted: 2019-02-05
Enrollment: 58
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women who aged over 18 years old and seek for sterilization at the time of cesarean section.

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.

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

Primary outcomes:
measure: Motivators for sterilization type
timeFrame: Evaluation at preoperative 32th gestational weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Bartin
country: Turkey
facility: Bartin State Hospital
city: Istanbul
country: Turkey
facility: Istanbul Sisli Hamidiye Etfal Training And Research Hospital, Health Sciences University
city: Istanbul
country: Turkey
facility: Medicalpark Gaziosmanpasa Hospital, Istinye University
Study officials:
affiliation: Specialist
name: Murat Yassa, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.