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

NCT03028623 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2018-04-10

No results posted yet for this study

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.

Conditions

  • Method of Tubal Ligation at the Time of Cesarean Section

Interventions

PROCEDURE

Salpingectomy

Bilateral salpingectomy will be performed instead of standard tubal ligation as sterilization during cesarean section.

PROCEDURE

Tubal ligation

Standard tubal ligation by either Parkland or Pomeroy technique will be performed at cesarean section

Sponsors & Collaborators

  • University of Virginia

    lead OTHER

Principal Investigators

  • Kate' Pettit, MD · University of Virginia

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-05-01
Primary Completion
2018-03-05
Completion
2018-03-05

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03028623 on ClinicalTrials.gov