Clinical trial NCT02374827: Salpingectomy at Cesarean Delivery for Ovarian Cancer Reduction (SCORE)
Official title: Complete Salpingectomy Versus Standard Postpartum Tubal Ligation at the Time of Cesarean Delivery- a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ovarian Cancer
Keywords: complete salpingectomy
standard tubal ligation
cesarean delivery
feasibility
safety
partial salpingectomy
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2015-03-02
Enrollment: 80
Sex: FEMALE
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: All pregnant women 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) will be approached about the study. Patients will be randomized to receive either the standard tubal ligation practice at our institution (modified Pomeroy procedure or Parkland) or a complete salpingectomy. The objective of this trial is to evaluate if a complete salpingectomy can be performed safely and comparable to a standard postpartum tubal ligation.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Time to complete sterilization procedure
timeFrame: At time of procedure
measure: Completion rate of sterilization procedure
timeFrame: At time of procedure
Secondary outcomes:
measure: Total operative time
timeFrame: At time of procedure
measure: Mean post-operative pain score
timeFrame: Postpartum admission (3-4 days)
measure: Perioperative complication rate
timeFrame: From time of procedure to 6 weeks postpartum
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Akila Subramaniam, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alabama at Birmingham
name: Britt K Erickson, MD
role: PRINCIPAL_INVESTIGATOR
References:
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: 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.