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Recruiting NCT06273683

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

— Observational Permanent Sterilization Pregnancy Related

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Hand-held bipolar energy instrument, Traditional suture ligation.
Who it may be relevant to
Registry conditions: Permanent Sterilization, Pregnancy Related. Basic parameters: from 21 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

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

Primary outcome measures

  • Change in Hemoglobin levels on postoperative day one [Time frame: preoperatively and one day after surgery]
Secondary outcome measures (12)
  • Completion rate of sterilization [Time frame: preoperatively and one day after surgery]
  • Total procedure estimated blood loss [Time frame: intraoperatively]
  • Adjacent organ damage [Time frame: intraoperatively]
  • Need for blood transfusion [Time frame: from day of surgery up to 30 days pospartum]
  • Total operative time [Time frame: intraoperatively]
  • ICU admission [Time frame: from day of surgery up to 7 days postpartum]
  • Length of hospital stay [Time frame: from day of surgery up to 6 weeks postpartum]
  • Hospital readmission postoperatively [Time frame: Day of initial dischage through 6 weeks postpartum]
  • Reoperation rates [Time frame: postoperative day 0 through 6 weeks postpartum]
  • Pain score [Time frame: from day of surgery up to 7 days postparum]
  • Surgical site infection [Time frame: postoperative day 0 through 6 weeks postpartum]
  • Cost [Time frame: intraoperatively]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Inova Fairfax Medical campus — Falls Church

Publications

  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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.
  • 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

Identifiers

NCT: NCT06273683 · INOVA-2023-145

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗