Trial record 3 of 26 for:    salpingectomy

Salpingectomy at Cesarean Delivery for Ovarian Cancer Reduction (SCORE)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2015 by University of Alabama at Birmingham
Sponsor:
Information provided by (Responsible Party):
Akila Subramaniam, MD, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT02374827
First received: February 23, 2015
Last updated: NA
Last verified: February 2015
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Ovarian Cancer
Procedure: Standard postpartum tubal ligation
Procedure: Complete Salpingectomy
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Complete Salpingectomy Versus Standard Postpartum Tubal Ligation at the Time of Cesarean Delivery- a Randomized Controlled Study

Resource links provided by NLM:


Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • Time to complete sterilization procedure [ Time Frame: At time of procedure ] [ Designated as safety issue: No ]
    The primary outcome will involve measuring the amount of surgical time required to complete the assigned sterilization procedure

  • Completion rate of sterilization procedure [ Time Frame: At time of procedure ] [ Designated as safety issue: No ]
    The primary outcome will involve assessing the completion rate of assigned sterilization procedure


Secondary Outcome Measures:
  • Total operative time [ Time Frame: At time of procedure ] [ Designated as safety issue: No ]
    Includes cesarean delivery and sterilization procedure time

  • Mean post-operative pain score [ Time Frame: Postpartum admission (3-4 days) ] [ Designated as safety issue: No ]
  • Perioperative complication rate [ Time Frame: From time of procedure to 6 weeks postpartum ] [ Designated as safety issue: Yes ]
    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


Estimated Enrollment: 100
Study Start Date: April 2015
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   25 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02374827

Contacts
Contact: Akila Subramaniam, MD, MPH 504-432-3133 asubramaniam@uabmc.edu

Locations
United States, Alabama
University of Alabama at Birmingham Not yet recruiting
Birmingham, Alabama, United States, 35249
Contact: Akila Subramaniam, MD, MPH    205-934-7879    asubramaniam@uabmc.edu   
Principal Investigator: Akila Subramaniam, MD         
Principal Investigator: Britt K Erickson, MD         
Sub-Investigator: Rodney K Edwards, MD         
Sub-Investigator: Charles Leath, MD         
Sub-Investigator: Warner K Huh, MD         
Sub-Investigator: Joseph R Biggio, MD         
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Akila Subramaniam, MD, Maternal-Fetal Medicine Fellow, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT02374827     History of Changes
Other Study ID Numbers: F140630003 (ST)
Study First Received: February 23, 2015
Last Updated: February 23, 2015
Health Authority: United States: Data and Safety Monitoring Board

Keywords provided by University of Alabama at Birmingham:
complete salpingectomy
standard tubal ligation
cesarean delivery
feasibility
safety
partial salpingectomy

Additional relevant MeSH terms:
Ovarian Neoplasms
Adnexal Diseases
Endocrine Gland Neoplasms
Endocrine System Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms
Neoplasms by Site
Ovarian Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on April 23, 2015