Cohort Study of Risk Reducing Salpingectomy

NCT ID: NCT02165709

Last Updated: 2017-04-25

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

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2015-09-30

Brief Summary

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Women undergoing surgical sterilization will be interested in risk reducing salpingectomy, and surgeons performing the procedure will be able to successfully complete the salpingectomy.

Detailed Description

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Conditions

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Sterilization, Tubal Salpingectomy Ovary Prevention & Control

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Salpingectomy

Participants will be offered a risk-reducing salpingectomy, and if they choose this options the surgeon will proceed with a salpingectomy.

Group Type EXPERIMENTAL

Salpingectomy

Intervention Type PROCEDURE

Traditional sterilization

Participants will be offered a risk-reducing salpingectomy, and those that choose a traditional sterilization will be in this treatment arm.

Group Type ACTIVE_COMPARATOR

Traditional sterilization

Intervention Type PROCEDURE

Interventions

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Salpingectomy

Intervention Type PROCEDURE

Traditional sterilization

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Women \> 35 years requesting sterilization as interval procedure OR at time of cesarean delivery
* At least one living child
* English or Spanish speaking
* Sterilization planned as interval (laparoscopic) procedure via Family Planning Clinic services or at time of delivery
* Delivery by cesarean section (planned or following labor)

Exclusion Criteria

* Age \< 30
* Medical complications that increase risk for surgical bleeding (e.g. Idiopathic thrombocytopenic purpura (ITP); von Willebrand disease (vWD); need for prophylactic or therapeutic anticoagulation)
Minimum Eligible Age

35 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Medtronic - MITG

INDUSTRY

Sponsor Role collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Matthew L Zerden, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

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University of North Carolina Hosptials

Chapel Hill, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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14-0337

Identifier Type: -

Identifier Source: org_study_id

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