Salpingectomy at Cesarean Delivery for Ovarian Cancer Reduction (SCORE)

NCT02374827 | Completed DMC

• 1 other identifier: F140630003 (ST)
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

To compare the feasibility and surgical outcomes between complete salpingectomy and standard postpartum tubal ligation (partial salpingectomy) at the time of cesarean delivery in women with undesired future fertility. as a possible ovarian cancer risk-reducing procedure.

Conditions

Ovarian Cancer

Keywords

complete salpingectomy; standard tubal ligation; cesarean delivery; feasibility; safety; partial salpingectomy

Outcome Measures

Primary Outcomes (2)

• Time to complete sterilization procedure

  The primary outcome will involve measuring the amount of surgical time required to complete the assigned sterilization procedure

  At time of procedure

• Completion rate of sterilization procedure

  The primary outcome will involve assessing the completion rate of assigned sterilization procedure

  At time of procedure

Secondary Outcomes (3)

• Total operative time

  At time of procedure

• Mean post-operative pain score

  Postpartum admission (3-4 days)

• Perioperative complication rate

  From time of procedure to 6 weeks postpartum

Study Arms (2)

Standard postpartum tubal ligation

ACTIVE COMPARATOR

In this arm, patients will receive the standard postpartum tubal ligation by accepted methods (procedure names are the following: Modified pomeroy technique or Parkland method). These methods are procedures for completing a partial salpingectomy.

Procedure: Standard postpartum tubal ligation

Complete Salpingectomy

EXPERIMENTAL

In this arm, patients will receive a complete salpingectomy by documented accepted methods.

Procedure: Complete Salpingectomy

Interventions

Standard postpartum tubal ligation PROCEDURE

Patients will undergo a standard postpartum tubal ligation by accepted documented surgical procedural methods (Modified Pomeroy or Parkland method)

Standard postpartum tubal ligation

Complete Salpingectomy PROCEDURE

Patients will undergo a complete salpingectomy by a documented surgical protocol established by accepted surgical procedural methods.

Complete Salpingectomy

Eligibility Criteria

• Age: 25 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All pregnant women \> 25 years receiving prenatal care within the UAB Health System, and planning to undergo tubal ligation at the time of their scheduled cesarean delivery (primary or repeat)
• Informed consent obtained

You may not qualify if:

• Inability to obtain informed consent
• Fetal death or anomalies
• Preterm delivery \< 36 weeks gestation
• Immune-compromising disease
• Chronic steroid use
• Chronic prophylactic or therapeutic anti-coagulation
• Patients no followed in our regional health system
• Known BRCA mutation carrier status
• Age \< 25 years

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35249, United States

Location

Related Publications (3)

• Ostby SA, Blanchard CT, Sanjanwala AR, Szychowski JM, Leath CA 3rd, Huh WK, Subramaniam A. Feasibility, Safety, and Provider Perspectives of Bipolar Electrosurgical Cautery Device for (Opportunistic or Complete) Salpingectomy at the Time of Cesarean Delivery. Am J Perinatol. 2024 Apr;41(6):804-813. doi: 10.1055/s-0042-1748525. Epub 2022 Jun 21.

  PMID: 35728603 DERIVED

• 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 DERIVED

• Subramaniam A, Blanchard CT, Erickson BK, Szychowski J, Leath CA, Biggio JR, Huh WK. Feasibility of Complete Salpingectomy Compared With Standard Postpartum Tubal Ligation at Cesarean Delivery: A Randomized Controlled Trial. Obstet Gynecol. 2018 Jul;132(1):20-27. doi: 10.1097/AOG.0000000000002646.

  PMID: 29889762 DERIVED

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Akila Subramaniam, MD, MPH

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

• Britt K Erickson, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Maternal-Fetal Medicine Fellow

Study Record Dates

• First Submitted: February 23, 2015
• First Posted: March 2, 2015
• Study Start: April 1, 2015
• Primary Completion: April 1, 2017
• Study Completion: September 1, 2017
• Last Updated: October 5, 2017

Record last verified: 2017-10

Locations

US (1)