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

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

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.

Study Overview

• Status: Completed
• Conditions: Method of Tubal Ligation at the Time of Cesarean Section
• Intervention / Treatment: Procedure: Tubal ligation; Procedure: Salpingectomy

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reoperation rate	Rate of reoperation within 6 weeks	within 6 weeks
Length of stay	Length of stay in hours	within 1008 hours
Readmission rate	Rate of readmission within 6 weeks	within 6 weeks

Collaborators and Investigators

• Sponsor: University of Virginia
• Investigators: Principal Investigator: Kate' Pettit, MD, University of Virginia

Publications and helpful links

General Publications

• Garcia C, Moskowitz OM, Chisholm CA, Duska LR, Warren AL, Lyons GR, Pettit KE. Salpingectomy Compared With Tubal Ligation at Cesarean Delivery: A Randomized Controlled Trial. Obstet Gynecol. 2018 Jul;132(1):29-34. doi: 10.1097/AOG.0000000000002674.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2017
• Primary Completion (Actual): March 5, 2018
• Study Completion (Actual): March 5, 2018

Study Registration Dates

• First Submitted: January 13, 2017
• First Submitted That Met QC Criteria: January 19, 2017
• First Posted (Estimate): January 23, 2017

Study Record Updates

• Last Update Posted (Actual): April 10, 2018
• Last Update Submitted That Met QC Criteria: April 7, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 19517 (Other Identifier: City of Hope Comprehensive Cancer Center)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No