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Completed

NCT Number: NCT02165709

Cohort Study of Risk Reducing Salpingectomy

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

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Key information

Conditions

Sterilization, Tubal Ovary Prevention & Control Salpingectomy

Age range

35 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of North Carolina Hosptials

Chapel Hill, North Carolina, 27599, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Salpingectomy

Procedure

Traditional sterilization

Procedure

Primary outcomes

  1. Percent of women accepting RRS

    Time frame: 12 months

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

Secondary outcomes

  1. Percent of women with successful RRS completion

    Time frame: 12 months

    Feasibility will be defined as number (%) of successful RRS completion when intended

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • Medtronic - MITG

Registry information

Official study title

Cohort Study of Risk Reducing Salpingectomy (RRS) Versus Standard Tubal Sterilization Among Women Who Desire Sterilization

Acronym: RRS

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jun 17, 2014
Registry last updated
Apr 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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