What this study is
One in three women of reproductive age utilize tubal sterilization for contraception, and sterilization is often requested at time of cesarean delivery. Complete salpingectomy for the purpose of permanent sterilization at the time of cesarean birth is increasingly being performed worldwide.
A preferred complete salpingectomy technique for the purpose of sterilization at the time of cesarean delivery has not emerged in current practice. The objective is to compare short-term clinical outcomes and cost of salpingectomy using a hand-held bipolar energy instrument with those of traditional suture ligation. This retrospective cohort study will be conducted from 2017-2023 at a single tertiary care hospital. The investigators hypothesize that bipolar energy instrument use will not significantly improve clinical outcomes.
What's being tested
- Hand-held bipolar energy instrument
Intervention · OTHER
A bipolar energy instrument is used for complete salpingectomy at the time of cesarean delivery.
- Traditional suture ligation
Intervention · OTHER
Traditional suture ligation technique is used for complete salpingectomy at the time of cesarean delivery.
Study details
- Sponsor
- Inova Health Care Services
- Conditions
- Permanent Sterilization · Pregnancy Related
- Enrolling
- 900 people
- Starts
- 2024-03-11
- Est. completion
- 2027-12
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 21 Years and overSex FEMALEHealthy volunteers Not acceptedYou may qualify if
- Request for permanent sterilization at the time of cesarean delivery
- 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 can't join if
- Vaginal delivery
- History of prior adnexal surgery (such as prior bilateral tubal ligation or unilateral salpingectomy oophorectomy)
- Placenta accreta spectrum
- Placenta previa
- History of bleeding diathesis.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
Loading treatment details…
Study locations (1)
1 openInova Fairfax Medical campus
Falls Church, Virginia, United States
- Jean W Thermolice, MD · Contact703-531-3000jean.thermolice@inova.org
- Bianca Nguyen, MD · Contactbianca.nguyen@inova.org
- Sofia Girald-Berlingeri, MD · Sub-investigator
- Bianca Nguyen, MD · Sub-investigator
- Catherine Kim, MD · Sub-investigator
- Miranda Newell, MS · Sub-investigator
- Renee Brenner, BS · Sub-investigator
Recruiting
Study team
Sponsor
Inova Health Care Services
Study ID INOVA-2023-145
Principal investigator
Jean W Thermolice, MD
Inova Fairfax Medical Campus
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.