Standard Tubal Ligation Versus Salpingectomy for Sterilization at the Time of Cesarean Delivery
April 7, 2018 updated by: Kate Pettit, MD, University of Virginia
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
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
44
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Virginia
-
Charlottesville, Virginia, United States, 22908
- University of Virginia
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
17 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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
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
|
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.
|
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
Time Frame: at time of procedure
|
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
Time Frame: at time of procedure
|
The total time it takes to complete the cesarean plus sterilization procedure
|
at time of procedure
|
|
Estimated blood loss
Time Frame: at time of procedure
|
Estimated blood loss for the entire procedure
|
at time of procedure
|
|
Rate of aborted procedures
Time Frame: at time of procedure
|
Inability to complete bilateral salpingectomy in the experimental arm
|
at time of procedure
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Reoperation rate
Time Frame: within 6 weeks
|
Rate of reoperation within 6 weeks
|
within 6 weeks
|
|
Length of stay
Time Frame: within 1008 hours
|
Length of stay in hours
|
within 1008 hours
|
|
Readmission rate
Time Frame: within 6 weeks
|
Rate of readmission within 6 weeks
|
within 6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Kate' Pettit, MD, University of Virginia
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.