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

NCT06273683 | Recruiting

• 1 other identifier: INOVA-2023-145
• Study Type: observational
• Target: 900
• Locations: 1 country
• Sites: 1

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

Keywords

Sterilization, salpingectomy, cesarean delivery

Outcome Measures

Primary Outcomes (1)

• Change in Hemoglobin levels on postoperative day one

  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

  preoperatively and one day after surgery

Secondary Outcomes (12)

• Completion rate of sterilization

  preoperatively and one day after surgery

• Total procedure estimated blood loss

  intraoperatively

• Adjacent organ damage

  intraoperatively

• Need for blood transfusion

  from day of surgery up to 30 days pospartum

• Total operative time

  intraoperatively

Study Arms (2)

Complete salpingectomy using a hand-held bipolar energy instrument

Other: Hand-held bipolar energy instrument

Complete salpingectomy using traditional suture ligation

Other: Traditional suture ligation

Interventions

Hand-held bipolar energy instrument OTHER

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

Complete salpingectomy using a hand-held bipolar energy instrument

Traditional suture ligation OTHER

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

Complete salpingectomy using traditional suture ligation

Eligibility Criteria

• Age: 21 Years+
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients aged 21 years or older undergoing permanent sterilization at the time of cesarean delivery at 24 weeks' gestation or beyond, 21 years old and older

You may qualify if:

• request for permanent sterilization at the time of cesarean delivery
• weeks' gestation or beyond
• years old or older
• Medicaid sterilization consent per Virginia Department of Medical Assistance Services regulations (if Medicaid recipient).

You may not qualify 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.

Sponsors & Collaborators

• Inova Health Care Services: lead

Study Sites (1)

Inova Fairfax Medical campus

Falls Church, Virginia, 22042, United States

RECRUITING

Related Publications (9)

• Mandelbaum RS, Matsuzaki S, Sangara RN, Klar M, Matsushima K, Roman LD, Paulson RJ, Wright JD, Matsuo K. Paradigm shift from tubal ligation to opportunistic salpingectomy at cesarean delivery in the United States. Am J Obstet Gynecol. 2021 Oct;225(4):399.e1-399.e32. doi: 10.1016/j.ajog.2021.06.074. Epub 2021 Jun 26.

  PMID: 34181896 BACKGROUND

• Venkatesh KK, Clark LH, Stamilio DM. Cost-effectiveness of opportunistic salpingectomy vs tubal ligation at the time of cesarean delivery. Am J Obstet Gynecol. 2019 Jan;220(1):106.e1-106.e10. doi: 10.1016/j.ajog.2018.08.032. Epub 2018 Aug 28.

  PMID: 30170036 BACKGROUND

• Subramaniam A, Einerson BD, Blanchard CT, Erickson BK, Szychowski J, Leath CA 3rd, Biggio JR, Huh WK. The cost-effectiveness of opportunistic salpingectomy versus standard tubal ligation at the time of cesarean delivery for ovarian cancer risk reduction. Gynecol Oncol. 2019 Jan;152(1):127-132. doi: 10.1016/j.ygyno.2018.11.009. Epub 2018 Nov 23.

  PMID: 30477808 BACKGROUND

• ACOG Committee Opinion No. 774 Summary: Opportunistic Salpingectomy as a Strategy for Epithelial Ovarian Cancer Prevention. Obstet Gynecol. 2019 Apr;133(4):842-843. doi: 10.1097/AOG.0000000000003165.

  PMID: 30913193 BACKGROUND

• Society of Gynecologic Oncology. SGO Clinical Practice Statement: Salpingectomy for Ovarian Cancer. 2013. https://www.sgo.org/clinicalpractice/guidelines/sgo-clinical-practice-statement-salpingectomy-for-ovarian-cancer-prevention

  BACKGROUND

• Walker JL, Powell CB, Chen LM, Carter J, Bae Jump VL, Parker LP, Borowsky ME, Gibb RK. Society of Gynecologic Oncology recommendations for the prevention of ovarian cancer. Cancer. 2015 Jul 1;121(13):2108-20. doi: 10.1002/cncr.29321. Epub 2015 Mar 27.

  PMID: 25820366 BACKGROUND

• Nguyen, N. T., Alabaster, A., Simmons, S., Weintraub, M. L. R., & Powell, C. B. (2019). Opportunistic salpingectomy techniques at the time of cesarean delivery: a retrospective cohort study. Journal of Clinical Gynecology and Obstetrics, 8(3), 70-76.

  BACKGROUND

• Lauterbach R, Gruenwald O, Matanes E, Justman N, Mor O, Vitner D, Avrahami R, Ghanem N, Zipori Y, Weiner Z, Lowenstein L. A randomized controlled trial of 2 techniques of salpingectomy during cesarean delivery. Am J Obstet Gynecol MFM. 2022 Nov;4(6):100690. doi: 10.1016/j.ajogmf.2022.100690. Epub 2022 Jul 16.

  PMID: 35843545 BACKGROUND

• Chan LM, Westhoff CL. Tubal sterilization trends in the United States. Fertil Steril. 2010 Jun;94(1):1-6. doi: 10.1016/j.fertnstert.2010.03.029.

  PMID: 20497790 RESULT

Study Officials

• Jean W Thermolice, MD

  Inova Fairfax Medical Campus

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jean W Thermolice, MD

CONTACT

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

Bianca Nguyen, MD

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2024
• First Posted: February 22, 2024
• Study Start: March 11, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 5, 2026

Record last verified: 2026-03

Locations

US (1)