Opportunistic Salpingectomy for Permanent Sterilization at the Time of Cesarean Delivery

NCT ID: NCT03135431

Last Updated: 2019-07-10

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-17

Study Completion Date

2018-07-30

Brief Summary

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The purpose of this study is to compare the safety of performing a bilateral tubal ligation vs. bilateral salpingectomy, two procedures performed for permanent sterilization, at the time of cesarean delivery. The investigators want to determine if performing bilateral salpingectomy at the time of cesarean delivery poses any greater risk for blood loss, as compared to a bilateral tubal ligation.

Detailed Description

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A non-inferiority, two-arm randomized controlled trial to evaluate the safety and feasibility of prophylactic salpingectomy at the time of a cesarean delivery will be conducted as an initiative to avoid a missed opportunity in the primary prevention of ovarian cancer. Once enrolled and consented, women will be randomized using a stratified block randomization algorithm according to number of prior cesarean deliveries and BMI to either salpingectomy or bilateral tubal ligation. The data collection will include preoperative CBC, time of procedure, postoperative CBC at 24 hours, standard patient demographics, procedural complications, estimated blood loss, return to the OR, length of stay, pain scores, and postoperative complications, including readmission within 6 weeks.

Conditions

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Contraception

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Two-arm randomized controlled trial
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Salpingectomy

Bilateral salpingectomy following cesarean delivery

Group Type EXPERIMENTAL

Bilateral Salpingectomy

Intervention Type PROCEDURE

Surgical removal of entire fallopian tubes

Tubal Ligation

Bilateral tubal ligation following cesarean delivery via Parkland or modified Pomeroy methods.

Group Type ACTIVE_COMPARATOR

Bilateral Tubal Ligation

Intervention Type PROCEDURE

Surgical tying, cutting, or removal of a portion of the fallopian tubes

Interventions

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Bilateral Salpingectomy

Surgical removal of entire fallopian tubes

Intervention Type PROCEDURE

Bilateral Tubal Ligation

Surgical tying, cutting, or removal of a portion of the fallopian tubes

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Pregnant women
* 21 years of age or older
* Desire permanent sterilization
* Scheduled for a Cesarean delivery

Exclusion Criteria

* Body Mass Index \> 50
* Emergent, 'alpha' Cesarean delivery
* Single ovary/fallopian tube complex
Minimum Eligible Age

21 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Vanessa Torbenson

Consultant Obstetrics and Gynecology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Vanessa E Torbenson, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Related Links

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Other Identifiers

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17-000898

Identifier Type: -

Identifier Source: org_study_id

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