Ovary, Prevention & Control, Salpingectomy, Sterilization, Tubal
Conditions
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.
Interventions
PROCEDURESalpingectomy
PROCEDURETraditional sterilization
Sponsors
Medtronic - MITG
University of North Carolina, Chapel Hill
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
35 Years to 60 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of women accepting RRS | 12 months | Determination of patient demand/interest in pursuing RRS for sterilization during 12-month study period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent of women with successful RRS completion | 12 months | Feasibility will be defined as number (%) of successful RRS completion when intended |
Countries
United States
Outcome results
None listed