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

Pregnancy Related Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06273683
• Other study ID #: INOVA-2023-145
• Status: Recruiting
• Start date: March 11, 2024
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: Inova Health Care Services
• Contact: Jean W Thermolice, MD
• Phone: 703-531-3000
• Email: jean.thermolice[@]inova.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 900
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Gender: Female
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pregnancy Related

Intervention

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

Locations

Country	Name	City	State
United States	Inova Fairfax Medical campus	Falls Church	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Inova Health Care Services

Country where clinical trial is conducted

United States, 

References & Publications (9)

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. — View 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. — View 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. — View 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. — View 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.

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

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. — View 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. — View 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. — View Citation

Outcome

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