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Salpingectomy at Cesarean Delivery for Ovarian Cancer Reduction (SCORE) (SCORE)

Primary Purpose

Ovarian Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standard postpartum tubal ligation
Complete Salpingectomy
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer focused on measuring complete salpingectomy, standard tubal ligation, cesarean delivery, feasibility, safety, partial salpingectomy

Eligibility Criteria

25 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • University of Alabama at Birmingham

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard postpartum tubal ligation

Complete Salpingectomy

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Time to complete sterilization procedure
The primary outcome will involve measuring the amount of surgical time required to complete the assigned sterilization procedure
Completion rate of sterilization procedure
The primary outcome will involve assessing the completion rate of assigned sterilization procedure

Secondary Outcome Measures

Total operative time
Includes cesarean delivery and sterilization procedure time
Mean post-operative pain score
Perioperative complication rate
Composite assessment of the following: estimated blood loss, need for blood transfusion, intra-abdominal hemorrhage/hematoma, need for readmission, need for reoperation, need for additional surgical procedure, major post-operative complication

Full Information

First Posted
February 23, 2015
Last Updated
October 3, 2017
Sponsor
University of Alabama at Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT02374827
Brief Title
Salpingectomy at Cesarean Delivery for Ovarian Cancer Reduction (SCORE)
Acronym
SCORE
Official Title
Complete Salpingectomy Versus Standard Postpartum Tubal Ligation at the Time of Cesarean Delivery- a Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
April 2015 (Actual)
Primary Completion Date
April 2017 (Actual)
Study Completion Date
September 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer
Keywords
complete salpingectomy, standard tubal ligation, cesarean delivery, feasibility, safety, partial salpingectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard postpartum tubal ligation
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Complete Salpingectomy
Arm Type
Experimental
Arm Description
In this arm, patients will receive a complete salpingectomy by documented accepted methods.
Intervention Type
Procedure
Intervention Name(s)
Standard postpartum tubal ligation
Intervention Description
Patients will undergo a standard postpartum tubal ligation by accepted documented surgical procedural methods (Modified Pomeroy or Parkland method)
Intervention Type
Procedure
Intervention Name(s)
Complete Salpingectomy
Intervention Description
Patients will undergo a complete salpingectomy by a documented surgical protocol established by accepted surgical procedural methods.
Primary Outcome Measure Information:
Title
Time to complete sterilization procedure
Description
The primary outcome will involve measuring the amount of surgical time required to complete the assigned sterilization procedure
Time Frame
At time of procedure
Title
Completion rate of sterilization procedure
Description
The primary outcome will involve assessing the completion rate of assigned sterilization procedure
Time Frame
At time of procedure
Secondary Outcome Measure Information:
Title
Total operative time
Description
Includes cesarean delivery and sterilization procedure time
Time Frame
At time of procedure
Title
Mean post-operative pain score
Time Frame
Postpartum admission (3-4 days)
Title
Perioperative complication rate
Description
Composite assessment of the following: estimated blood loss, need for blood transfusion, intra-abdominal hemorrhage/hematoma, need for readmission, need for reoperation, need for additional surgical procedure, major post-operative complication
Time Frame
From time of procedure to 6 weeks postpartum

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Akila Subramaniam, MD, MPH
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Britt K Erickson, MD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35249
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
30477808
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.
Results Reference
derived
PubMed Identifier
29889762
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.
Results Reference
derived

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Salpingectomy at Cesarean Delivery for Ovarian Cancer Reduction (SCORE)

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