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Comparison of Two Salpingectomy Techniques for Sterilization at the Time of Cesarean Delivery

Inova Health Care Services logo

Inova Health Care Services

Status

Enrolling

Conditions

Permanent Sterilization
Pregnancy Related

Treatments

Other: Hand-held bipolar energy instrument
Other: Traditional suture ligation

Study type

Observational

Funder types

Other

Identifiers

NCT06273683
INOVA-2023-145

Details and patient eligibility

About

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.

Enrollment

900 estimated patients

Sex

Female

Ages

21+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

900 participants in 2 patient groups

Complete salpingectomy using a hand-held bipolar energy instrument
Treatment:
Other: Hand-held bipolar energy instrument
Complete salpingectomy using traditional suture ligation
Treatment:
Other: Traditional suture ligation

Trial contacts and locations

1

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Central trial contact

Jean W Thermolice, MD; Bianca Nguyen, MD

Data sourced from clinicaltrials.gov

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