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

October 3, 2017 updated by: Akila Subramaniam, MD, University of Alabama at Birmingham

Complete Salpingectomy Versus Standard Postpartum Tubal Ligation at the Time of Cesarean Delivery- a Randomized Controlled Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35249
        • University of Alabama at Birmingham

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard postpartum tubal ligation
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
Patients will undergo a standard postpartum tubal ligation by accepted documented surgical procedural methods (Modified Pomeroy or Parkland method)
Experimental: Complete Salpingectomy
In this arm, patients will receive a complete salpingectomy by documented accepted methods.
Procedure: Complete Salpingectomy
Patients will undergo a complete salpingectomy by a documented surgical protocol established by accepted surgical procedural methods.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to complete sterilization procedure
Time Frame: At time of 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
Time Frame: At time of procedure
The primary outcome will involve assessing the completion rate of assigned sterilization procedure
At time of procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total operative time
Time Frame: At time of procedure
Includes cesarean delivery and sterilization procedure time
At time of procedure
Mean post-operative pain score
Time Frame: Postpartum admission (3-4 days)
Postpartum admission (3-4 days)
Perioperative complication rate
Time Frame: From time of procedure to 6 weeks postpartum
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
From time of procedure to 6 weeks postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Investigators

  • Principal Investigator: Akila Subramaniam, MD, MPH, University of Alabama at Birmingham
  • Principal Investigator: Britt K Erickson, MD, University of Alabama at Birmingham

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2015

Primary Completion (Actual)

April 1, 2017

Study Completion (Actual)

September 1, 2017

Study Registration Dates

First Submitted

February 23, 2015

First Submitted That Met QC Criteria

February 23, 2015

First Posted (Estimate)

March 2, 2015

Study Record Updates

Last Update Posted (Actual)

October 5, 2017

Last Update Submitted That Met QC Criteria

October 3, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F140630003 (ST)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Ovarian Cancer

Clinical Trials on Standard postpartum tubal ligation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bahrain

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe