Opportunistic Salpingectomy for Permanent Sterilization at the Time of Cesarean Delivery
- Conditions
- Contraception
- Interventions
- Procedure: Bilateral SalpingectomyProcedure: Bilateral Tubal Ligation
- Registration Number
- NCT03135431
- Lead Sponsor
- Mayo Clinic
- Brief Summary
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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 40
- Pregnant women
- 21 years of age or older
- Desire permanent sterilization
- Scheduled for a Cesarean delivery
- Body Mass Index > 50
- Emergent, 'alpha' Cesarean delivery
- Single ovary/fallopian tube complex
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Salpingectomy Bilateral Salpingectomy Bilateral salpingectomy following cesarean delivery Tubal Ligation Bilateral Tubal Ligation Bilateral tubal ligation following cesarean delivery via Parkland or modified Pomeroy methods.
- Primary Outcome Measures
Name Time Method Mean Difference Between Pre and Postoperative Hemoglobin (g/dl) At least 24 but not greater than 48 hours after surgery Identify the mean difference in pre and postoperative hemoglobin for patients undergoing salpingectomy for sterilization vs. patients undergoing standard bilateral tubal ligation via mid-segment resection of the fallopian tube at the time of cesarean delivery.
- Secondary Outcome Measures
Name Time Method Operative Time Day of surgery Compare mean difference in length of operative time (in minutes) to perform bilateral salpingectomy as compared to standard bilateral tubal ligation, following cesarean delivery.
Estimated Blood Loss Day of surgery Identify mean difference in estimated total blood loss as a result of standard bilateral tubal ligation surgical procedure and bilateral salpingectomy procedure, following cesarean delivery.
Trial Locations
- Locations (1)
Mayo Clinic in Rochester
🇺🇸Rochester, Minnesota, United States