NCT02165709

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

June 13, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 17, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

April 25, 2017

Status Verified

April 1, 2017

Enrollment Period

1.2 years

First QC Date

June 13, 2014

Last Update Submit

April 21, 2017

Conditions

Sterilization, TubalSalpingectomyOvaryPrevention & Control

Outcome Measures

Primary Outcomes (1)

  • Percent of women accepting RRS

    Determination of patient demand/interest in pursuing RRS for sterilization during 12-month study period

    12 months

Secondary Outcomes (1)

  • Percent of women with successful RRS completion

    12 months

Study Arms (2)

Salpingectomy

EXPERIMENTAL

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

Procedure: Salpingectomy

Traditional sterilization

ACTIVE COMPARATOR

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

Procedure: Traditional sterilization

Interventions

SalpingectomyPROCEDURE
Salpingectomy
Traditional sterilizationPROCEDURE
Traditional sterilization

Eligibility Criteria

Age35 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of North Carolina Hosptials

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Interventions

Salpingectomy

Intervention Hierarchy (Ancestors)

Gynecologic Surgical ProceduresUrogenital Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Matthew L Zerden, MD, MPH

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2014

First Posted

June 17, 2014

Study Start

June 1, 2014

Primary Completion

August 1, 2015

Study Completion

September 1, 2015

Last Updated

April 25, 2017

Record last verified: 2017-04

Locations

US(1)