Cohort Study of Risk Reducing Salpingectomy

Not Applicable

Completed

• Conditions: Ovary; Sterilization, Tubal; Salpingectomy; Prevention & Control
• Interventions: Procedure: Traditional sterilization; Procedure: Salpingectomy

• Registration Number: NCT02165709
• Lead Sponsor: University of North Carolina, Chapel Hill

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-06-13
• Study First Submitted QC: 2014-06-13
• Study First Posted: 2014-06-17
• Primary Completion: 2015-08
• Study Completion: 2015-09
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-21
• Last Update Posted: 2017-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 18

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Traditional sterilization	Traditional sterilization	Participants will be offered a risk-reducing salpingectomy, and those that choose a traditional sterilization will be in this treatment arm.
Salpingectomy	Salpingectomy	Participants will be offered a risk-reducing salpingectomy, and if they choose this options the surgeon will proceed with a salpingectomy.

Primary Outcome Measures

Name	Time	Method
Percent of women accepting RRS	12 months	Determination of patient demand/interest in pursuing RRS for sterilization during 12-month study period

Secondary Outcome Measures

Name	Time	Method
Percent of women with successful RRS completion	12 months	Feasibility will be defined as number (%) of successful RRS completion when intended

Trial Locations

Locations (1)

University of North Carolina Hosptials; 🇺🇸 Chapel Hill, North Carolina, United States