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

Part of paid clinical trials in Falls Church, Virginia.

Sponsor
Inova Health Care Services
Study ID
NCT06273683
Status
Recruiting
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Conditions

  • Permanent Sterilization
  • Pregnancy Related

Eligibility Criteria

Sex
FEMALE
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Hand-held bipolar energy instrument — OTHER
    A bipolar energy instrument is used for complete salpingectomy at the time of cesarean delivery.
  • Traditional suture ligation — OTHER
    Traditional suture ligation technique is used for complete salpingectomy at the time of cesarean delivery.

Study Details

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.

Key Dates

Start date
Mar 11, 2024
Status verified
Mar 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
900 participants (estimated)

Arms

  • Arm: Complete salpingectomy using a hand-held bipolar energy instrument
  • Arm: Complete salpingectomy using traditional suture ligation

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Inova Fairfax Medical campusFalls ChurchVirginia22042
Jean W Thermolice, MD
[email protected]
703-531-3000
Bianca Nguyen, MD
[email protected]
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)

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By research site
Inova Fairfax Medical campus· Falls Church, VA

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