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Salpingectomy at Cesarean Delivery for Ovarian Cancer Reduction (SCORE)

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Disease Information

Descriptive Information
Brief Title † 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
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.
Study Phase N/A
Study Type † Interventional
Study Design †
Primary Outcome Measure † Time to complete sterilization procedure
Secondary Outcome Measure † Total operative time
Condition † Ovarian Cancer
Intervention † ProcedureStandard postpartum tubal ligation
Study Arms / Comparison Groups 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. Complete Salpingectomy In this arm, patients will receive a complete salpingectomy by documented accepted methods.
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Procedure
Estimated Enrollment † 80
Start Date † April 2015
Completion Date September 2017
Primary Completion Date April 2017
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
Gender Female
Ages 25 Years - N/A
Accepts Healthy Volunteers Accepts Healthy Volunteers
Contacts ††
Location Countries † United States
Administrative Information
NCT ID † NCT02374827
Organization ID F140630003 (ST)
Secondary IDs ††
Responsible Party Principal Investigator
Study Sponsor † University of Alabama at Birmingham
Collaborators ††
Investigators † Principal Investigator: Akila Subramaniam, MD, MPH, University of Alabama at Birmingham
Information Provided By
Verification Date April 2017
First Received Date † February 23, 2015
Last Updated Date June 8, 2017
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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