Standard Tubal Ligation Versus Salpingectomy for Sterilization at the Time of Cesarean Delivery

Study Overview
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Brief Summary
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The objective of this study is to evaluate the feasibility and safety of salpingectomy versus standard tubal ligation in women undergoing surgical sterilization at the time of a planned cesarean delivery. Salpingectomy is currently being investigated as a potential strategy for ovarian cancer prevention. While this procedure is currently performed during hysterectomies, its feasibility at the time of cesarean delivery is not well established. This randomized, prospective clinical trial will compare the two sterilization methods to demonstrate that salpingectomy compared with standard tubal ligation at the time of cesarean delivery will not result in increased operative time, blood loss or other complications. This study is necessary to promote salpingectomy as a standard sterilization method during cesarean deliveries.

Official Title
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A Randomized Controlled Trial of Standard Tubal Ligation Versus Salpingectomy for Sterilization at the Time of Cesarean Delivery

Conditions
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Method of Tubal Ligation at the Time of Cesarean Section

Intervention / Treatment
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* Procedure: Salpingectomy
* Procedure: Tubal ligation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects must have planned cesarean delivery and desire sterilization Subjects must be able to read and provide written informed consent Subjects must be English or Spanish speaking Exclusion Criteria: Subjects with known hereditary cancer syndromes Subjects with a history of prior tubal surgery Subjects with a placenta accreta Subjects undergoing trial of labor after cesarean delivery

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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Control<br>Tubal sterilization will be performed by standard tubal ligation, either Parkland or Pomeroy technique, at the time of cesarean section | Procedure: Tubal ligation<br>* Standard tubal ligation by either Parkland or Pomeroy technique will be performed at cesarean section<br>|
| Experimental: Experimental<br>Tubal sterilization will be performed by bilateral salpingectomy using a ligasure device at the time of cesarean section. | Procedure: Salpingectomy<br>* Bilateral salpingectomy will be performed instead of standard tubal ligation as sterilization during cesarean section.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of tubal ligation | Primary outcome will be the time it takes to complete the sterilization procedure | at time of procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total procedure time | The total time it takes to complete the cesarean plus sterilization procedure | at time of procedure | 
| Estimated blood loss | Estimated blood loss for the entire procedure | at time of procedure | 
| Rate of aborted procedures | Inability to complete bilateral salpingectomy in the experimental arm | at time of procedure |