Opportunistic Salpingectomy at the Time of Cesarean Delivery: A Randomized Controlled Trial of the Safety of Salpingectomy vs Tubal Ligation
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Contraception
- Sponsor
- Mayo Clinic
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Mean Difference Between Pre and Postoperative Hemoglobin (g/dl)
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
Vanessa Torbenson
Consultant Obstetrics and Gynecology
Mayo Clinic
Eligibility Criteria
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
Outcomes
Primary Outcomes
Mean Difference Between Pre and Postoperative Hemoglobin (g/dl)
Time Frame: 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 Outcomes
- Operative Time(Day of surgery)
- Estimated Blood Loss(Day of surgery)