Cohort Study of Risk Reducing Salpingectomy (RRS)

University of North Carolina (UNC)

Status: Completed

Conditions: Prevention & Control; Sterilization, Tubal; Ovary; Salpingectomy

Treatments: Procedure: Traditional sterilization; Procedure: Salpingectomy

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02165709

14-0337

Details and patient eligibility

About

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

Enrollment: 18 patients

Sex: Female

Ages: 35 to 60 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 2 patient groups

Salpingectomy

Experimental group

Description:

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

Treatment:

Procedure: Salpingectomy

Traditional sterilization

Active Comparator group

Description:

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

Treatment:

Procedure: Traditional sterilization