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

Not Applicable

Completed

• Conditions: Method of Tubal Ligation at the Time of Cesarean Section
• Interventions: Procedure: Salpingectomy; Procedure: Tubal ligation

• Registration Number: NCT03028623
• Lead Sponsor: University of Virginia

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-01-13
• Study First Submitted QC: 2017-01-19
• Study First Posted: 2017-01-23
• Study Start: 2017-05-01
• Primary Completion: 2018-03-05
• Study Completion: 2018-03-05
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-07
• Last Update Posted: 2018-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 44

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental	Salpingectomy	Tubal sterilization will be performed by bilateral salpingectomy using a ligasure device at the time of cesarean section.
Control	Tubal ligation	Tubal sterilization will be performed by standard tubal ligation, either Parkland or Pomeroy technique, at the time of cesarean section

Primary Outcome Measures

Name	Time	Method
Time of tubal ligation	at time of procedure	Primary outcome will be the time it takes to complete the sterilization procedure

Secondary Outcome Measures

Name	Time	Method
Total procedure time	at time of procedure	The total time it takes to complete the cesarean plus sterilization procedure
Estimated blood loss	at time of procedure	Estimated blood loss for the entire procedure
Rate of aborted procedures	at time of procedure	Inability to complete bilateral salpingectomy in the experimental arm

Trial Locations

Locations (1)

University of Virginia; 🇺🇸 Charlottesville, Virginia, United States