Opportunistic Salpingectomy for Permanent Sterilization at the Time of Cesarean Delivery

Mayo Clinic

Status: Completed

Conditions: Contraception

Treatments: Procedure: Bilateral Salpingectomy; Procedure: Bilateral Tubal Ligation

Study type: Interventional

Funder types: Other

Identifiers

NCT03135431

17-000898

Details and patient eligibility

About

The purpose of this study is to compare the safety of performing a bilateral tubal ligation vs. bilateral salpingectomy, two procedures performed for permanent sterilization, at the time of cesarean delivery. The investigators want to determine if performing bilateral salpingectomy at the time of cesarean delivery poses any greater risk for blood loss, as compared to a bilateral tubal ligation.

Full description

A non-inferiority, two-arm randomized controlled trial to evaluate the safety and feasibility of prophylactic salpingectomy at the time of a cesarean delivery will be conducted as an initiative to avoid a missed opportunity in the primary prevention of ovarian cancer. Once enrolled and consented, women will be randomized using a stratified block randomization algorithm according to number of prior cesarean deliveries and BMI to either salpingectomy or bilateral tubal ligation. The data collection will include preoperative CBC, time of procedure, postoperative CBC at 24 hours, standard patient demographics, procedural complications, estimated blood loss, return to the OR, length of stay, pain scores, and postoperative complications, including readmission within 6 weeks.

Enrollment: 40 patients

Sex: Female

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pregnant women
• 21 years of age or older
• Desire permanent sterilization
• Scheduled for a Cesarean delivery

Exclusion criteria

• Body Mass Index > 50
• Emergent, 'alpha' Cesarean delivery
• Single ovary/fallopian tube complex

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Salpingectomy

Experimental group

Description:

Bilateral salpingectomy following cesarean delivery

Treatment:

Procedure: Bilateral Salpingectomy

Tubal Ligation

Active Comparator group

Description:

Bilateral tubal ligation following cesarean delivery via Parkland or modified Pomeroy methods.

Treatment:

Procedure: Bilateral Tubal Ligation