Paradigm shift from tubal ligation to opportunistic salpingectomy at cesarean delivery in the United States.
Rachel S Mandelbaum, Shinya Matsuzaki, Rauvynne N Sangara...
https://pubmed.ncbi.nlm.nih.gov/34181896Actively Recruiting
Age: 21Years +
FEMALE
ID06273683
Comparison of Two Salpingectomy Techniques for Sterilization at the Time of Cesarean Delivery
Led by Inova Health Care Services · Updated on 2026-03-05
900
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying permanent sterilization in women requesting tubal sterilization at the time of cesarean delivery. This study compares two techniques for complete salpingectomy: using a hand-held bipolar energy instrument versus traditional suture ligation. The goal is to evaluate short-term clinical outcomes and cost differences, as no preferred technique has yet emerged in current practice. The study involves women who are at least 21 years old, at 24 weeks' gestation or beyond, requesting permanent sterilization during cesarean delivery. Two groups are compared retrospectively: one using a hand-held bipolar energy instrument for salpingectomy, and the other using traditional suture ligation. Data collection covers the surgical procedure and immediate postpartum period. Participants' outcomes include changes in hemoglobin levels one day after surgery, procedure completion rates, blood loss during surgery, adjacent organ damage, need for blood transfusion, operative time, ICU admissions, length of hospital stay, readmissions, reoperation rates, pain scores, surgical site infections, and hospital costs. Monitoring occurs from surgery day up to six weeks postpartum, providing comprehensive clinical and economic data related to each technique.
CONDITIONS
Brief Title
Comparison of Two Salpingectomy Techniques for Sterilization at the Time of Cesarean Delivery
Who Can Participate
Age: 21Years +
FEMALE
Eligibility Criteria
You may qualify if you...
- Request for permanent sterilization at the time of cesarean delivery
- Pregnancy at 24 weeks' gestation or beyond
- 21 years old or older
- Medicaid sterilization consent per Virginia Department of Medical Assistance Services regulations (if Medicaid recipient)
You will not qualify if you...
- Vaginal delivery
- History of prior adnexal surgery such as bilateral tubal ligation or unilateral salpingectomy oophorectomy
- Placenta accreta spectrum
- Placenta previa
- History of bleeding diathesis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Surgery and Immediate Post-operative Care
Duration - Day of surgery
Participants undergo complete salpingectomy using either a hand-held bipolar energy instrument or traditional suture ligation at the time of cesarean delivery. Immediate post-operative assessments are conducted.
1 surgical visit and assessments on postoperative day one
Post-operative Follow-up
Duration - Up to 6 weeks postpartum
Participants are monitored for recovery and possible complications such as blood transfusion need, ICU admission, surgical site infection, and hospital readmission up to 6 weeks postpartum.
Follow-up visits as needed up to 6 weeks postpartum
Trial Site Locations
Total: 1 location
1
Inova Fairfax Medical campus
Falls Church, Virginia, United States, 22042
Actively Recruiting
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Research Team
J
Jean W Thermolice, MD
B
Bianca Nguyen, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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Published Research Related To This Trial
Cost-effectiveness of opportunistic salpingectomy vs tubal ligation at the time of cesarean delivery.
Kartik K Venkatesh, Leslie H Clark, David M Stamilio
https://pubmed.ncbi.nlm.nih.gov/30170036The cost-effectiveness of opportunistic salpingectomy versus standard tubal ligation at the time of cesarean delivery for ovarian cancer risk reduction.
Akila Subramaniam, Brett D Einerson, Christina T Blanchard...
https://pubmed.ncbi.nlm.nih.gov/30477808ACOG Committee Opinion No. 774 Summary: Opportunistic Salpingectomy as a Strategy for Epithelial Ovarian Cancer Prevention.
https://pubmed.ncbi.nlm.nih.gov/30913193Society of Gynecologic Oncology recommendations for the prevention of ovarian cancer.
Joan L Walker, C Bethan Powell, Lee-May Chen...
https://pubmed.ncbi.nlm.nih.gov/25820366A randomized controlled trial of 2 techniques of salpingectomy during cesarean delivery.
Roy Lauterbach, Oren Gruenwald, Emad Matanes...
https://pubmed.ncbi.nlm.nih.gov/35843545Tubal sterilization trends in the United States.
Lolita M Chan, Carolyn L Westhoff
https://pubmed.ncbi.nlm.nih.gov/20497790