Recruiting

Bipolar Energy vs. Suture Ligation

Sponsor:

Inova Health Care Services

Code:

NCT06273683

Conditions

Permanent Sterilization

Pregnancy Related

Eligibility Criteria

Sex: Female

Age: 21+

Healthy Volunteers: Not accepted

Interventions

Hand-held bipolar energy instrument

Traditional suture ligation

Study Details

Brief summary:

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.

Conditions

Permanent Sterilization

Pregnancy Related

Study ID

NCT06273683

Start date

Mar 11, 2024

Status verified date

Mar, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 21+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.

Study Design

Enrollment

900 participants

Anticipated

Interventions and Outcome Measures

Arms

Complete salpingectomy using a hand-held bipolar energy instrument

Complete salpingectomy using traditional suture ligation

Interventions

Hand-held bipolar energy instrument

A bipolar energy instrument is used for complete salpingectomy at the time of cesarean delivery.

Traditional suture ligation

Traditional suture ligation technique is used for complete salpingectomy at the time of cesarean delivery.

Primary outcome measure

  • Change in Hemoglobin levels on postoperative day one [ Time Frame: preoperatively and one day after surgery ]

Central Contacts and Locations

Central contacts

Jean W Thermolice, MD

703-531-3000jean.thermolice@inova.org

Bianca Nguyen, MD

512-750-9573bianca.nguyen@inova.org

Locations

Inova Fairfax Medical campus

Recruiting

Falls Church, Virginia, United States, 22042

Contacts

Jean W Thermolice, MD

703-531-3000jean.thermolice@inova.org

Bianca Nguyen, MD

bianca.nguyen@inova.org

More Information

Sponsor

Inova Health Care Services

Last update posted

Mar 5, 2026

Last verified

Mar, 2026

Keywords

  • Sterilization, salpingectomy, cesarean delivery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Inova Health Care Services on 2026-03-05.