Opportunistic Salpingectomy for Permanent Sterilization at the Time of Cesarean Delivery

Study Overview
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Brief Summary
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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
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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.

Official Title
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Opportunistic Salpingectomy at the Time of Cesarean Delivery: A Randomized Controlled Trial of the Safety of Salpingectomy vs Tubal Ligation

Conditions
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Contraception

Intervention / Treatment
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* Procedure: Bilateral Salpingectomy
* Procedure: Bilateral Tubal Ligation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two-arm randomized controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Salpingectomy<br>Bilateral salpingectomy following cesarean delivery | Procedure: Bilateral Salpingectomy<br>* Surgical removal of entire fallopian tubes<br>|
| Active Comparator: Tubal Ligation<br>Bilateral tubal ligation following cesarean delivery via Parkland or modified Pomeroy methods. | Procedure: Bilateral Tubal Ligation<br>* Surgical tying, cutting, or removal of a portion of the fallopian tubes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Difference Between Pre and Postoperative Hemoglobin (g/dl) | 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. | At least 24 but not greater than 48 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operative Time | Compare mean difference in length of operative time (in minutes) to perform bilateral salpingectomy as compared to standard bilateral tubal ligation, following cesarean delivery. | Day of surgery | 
| Estimated Blood Loss | 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. | Day of surgery |