Clinical trial NCT06273683: Comparison of Two Salpingectomy Techniques for Sterilization at the Time of Cesarean Delivery
Official title: Comparison of Two Salpingectomy Techniques for Sterilization at the Time of Cesarean Delivery
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Permanent Sterilization
Pregnancy Related
Keywords: Sterilization, salpingectomy, cesarean delivery
Lead sponsor: Inova Health Care Services
Sponsor class: OTHER
First posted: 2024-02-22
Enrollment: 900
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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.


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.

Primary outcomes:
measure: Change in Hemoglobin levels on postoperative day one
timeFrame: preoperatively and one day after surgery
Secondary outcomes:
measure: Completion rate of sterilization
timeFrame: preoperatively and one day after surgery
measure: Total procedure estimated blood loss
timeFrame: intraoperatively
measure: Adjacent organ damage
timeFrame: intraoperatively
measure: Need for blood transfusion
timeFrame: from day of surgery up to 30 days pospartum
measure: Total operative time
timeFrame: intraoperatively
measure: ICU admission
timeFrame: from day of surgery up to 7 days postpartum
measure: Length of hospital stay
timeFrame: from day of surgery up to 6 weeks postpartum
measure: Hospital readmission postoperatively
timeFrame: Day of initial dischage through 6 weeks postpartum
measure: Reoperation rates
timeFrame: postoperative day 0 through 6 weeks postpartum
measure: Pain score
timeFrame: from day of surgery up to 7 days postparum
measure: Surgical site infection
timeFrame: postoperative day 0 through 6 weeks postpartum
measure: Cost
timeFrame: intraoperatively
Other outcomes:
Locations:
city: Falls Church
country: United States
facility: Inova Fairfax Medical campus
state: Virginia
Study officials:
affiliation: Inova Fairfax Medical Campus
name: Jean W Thermolice, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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
citation: 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.
citation: 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.
citation: 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.
citation: 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.