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

Recruiting

• Conditions: Pregnancy Related; Permanent Sterilization
• Interventions: Other: Hand-held bipolar energy instrument; Other: Traditional suture ligation

• Registration Number: NCT06273683
• Lead Sponsor: Inova Health Care Services

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-01
• Study First Submitted QC: 2024-02-14
• Study First Posted: 2024-02-22
• Study Start: 2024-03-11
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-13
• Last Update Posted: 2025-03-18
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 900

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Complete salpingectomy using a hand-held bipolar energy instrument	Hand-held bipolar energy instrument	-
Complete salpingectomy using traditional suture ligation	Traditional suture ligation	-

Primary Outcome Measures

Name	Time	Method
Change in Hemoglobin levels on postoperative day one	preoperatively and one day after surgery	Change in hemoglobin levels reported in gram per deciliter on postoperative day one, calculated as the difference between immediate preoperative and postoperative day 1 hemoglobin levels

Secondary Outcome Measures

Name	Time	Method
Completion rate of sterilization	preoperatively and one day after surgery	Proportion of sterilization procedure completed by postoperative day one
Total procedure estimated blood loss	intraoperatively	estimated blood loss calculated and documented in milliliters at the end of the procedure
Total operative time	intraoperatively	time necessary to complete the surgery from skin incision to end of skin closure
ICU admission	from day of surgery up to 7 days postpartum	any admission to the intensive care unit for procedure-related complications
Hospital readmission postoperatively	Day of initial dischage through 6 weeks postpartum	Any admission after initial discharge from the hospital
Cost	intraoperatively	cost difference between bipolar instrument and suture
Adjacent organ damage	intraoperatively	Rate of injury to abdominal/pelvic organs sustained during the procedure
Need for blood transfusion	from day of surgery up to 30 days pospartum	any need for blood products transfusion intraoperatively through discharge
Length of hospital stay	from day of surgery up to 6 weeks postpartum	Duration of hospitalization in days from admission to discharge
Reoperation rates	postoperative day 0 through 6 weeks postpartum	Number of participants who return to the operating room due to initial procedure-related complications
Pain score	from day of surgery up to 7 days postparum	pain severity measured on a scale of 0 through 10
Surgical site infection	postoperative day 0 through 6 weeks postpartum	any infection that occurs post-surgery in the abdomen, pelvis, abdominal walls or skin

Trial Locations

Locations (1)

Inova Fairfax Medical campus; 🇺🇸 Falls Church, Virginia, United States