Salpingectomy at Cesarean Delivery for Ovarian Cancer Reduction (SCORE)

Not Applicable

Completed

• Conditions: Ovarian Cancer
• Interventions: Procedure: Standard postpartum tubal ligation; Procedure: Complete Salpingectomy

• Registration Number: NCT02374827
• Lead Sponsor: University of Alabama at Birmingham

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2015-02-23
• Study First Submitted QC: 2015-02-23
• Study First Posted: 2015-03-02
• Study Start: 2015-04
• Primary Completion: 2017-04
• Study Completion: 2017-09
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-03
• Last Update Posted: 2017-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 80

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard postpartum tubal ligation	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	Complete Salpingectomy	In this arm, patients will receive a complete salpingectomy by documented accepted methods.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Total operative time	At time of procedure	Includes cesarean delivery and sterilization procedure time
Mean post-operative pain score	Postpartum admission (3-4 days)
Perioperative complication rate	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

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States