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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-01

Study Completion Date

2018-03-05

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.

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Detailed Description

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Conditions

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Method of Tubal Ligation at the Time of Cesarean Section

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Control

Tubal sterilization will be performed by standard tubal ligation, either Parkland or Pomeroy technique, at the time of cesarean section

Group Type OTHER

Tubal ligation

Intervention Type PROCEDURE

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

Experimental

Tubal sterilization will be performed by bilateral salpingectomy using a ligasure device at the time of cesarean section.

Group Type EXPERIMENTAL

Salpingectomy

Intervention Type PROCEDURE

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

Interventions

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Salpingectomy

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

Intervention Type PROCEDURE

Tubal ligation

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

Intervention Type PROCEDURE

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

Minimum Eligible Age

21 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes