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Trial record 8 of 1758 for:    "Mayo Clinic" [Exact]

Opportunistic Salpingectomy for Permanent Sterilization at the Time of Cesarean Delivery

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2017 by Mayo Clinic
Sponsor:
Information provided by (Responsible Party):
Vanessa Torbenson, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT03135431
First received: April 27, 2017
Last updated: April 28, 2017
Last verified: April 2017
  Purpose
The purpose of this study is to compare the safety of performing a bilateral tubal ligation vs. bilateral salpingectomy, two procedures performed for permanent sterilization, at the time of cesarean delivery. The investigators want to determine if performing bilateral salpingectomy at the time of cesarean delivery poses any greater risk for blood loss, as compared to a bilateral tubal ligation.

Condition Intervention
Contraception
Procedure: Bilateral Salpingectomy
Procedure: Bilateral Tubal Ligation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Two-arm randomized controlled trial
Masking: No masking
Primary Purpose: Treatment
Official Title: Opportunistic Salpingectomy at the Time of Cesarean Delivery: A Randomized Controlled Trial of the Safety of Salpingectomy vs Tubal Ligation

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Mean difference between pre and postoperative hemoglobin (g/dl) [ Time Frame: At least 24 but not greater than 48 hours after surgery ]
    Identify the mean difference in pre and postoperative hemoglobin for patients undergoing salpingectomy for sterilization vs. patients undergoing standard bilateral tubal ligation via mid-segment resection of the fallopian tube at the time of cesarean delivery.


Secondary Outcome Measures:
  • Operative time [ Time Frame: Day of surgery ]
    Compare mean difference in length of operative time (in minutes) to perform bilateral salpingectomy as compared to standard bilateral tubal ligation, following cesarean delivery.

  • Estimated blood loss [ Time Frame: Day of surgery ]
    Identify mean difference in estimated total blood loss as a result of standard bilateral tubal ligation surgical procedure and bilateral salpingectomy procedure, following cesarean delivery.


Estimated Enrollment: 120
Anticipated Study Start Date: June 2017
Estimated Study Completion Date: October 2019
Estimated Primary Completion Date: May 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Salpingectomy
Bilateral salpingectomy following cesarean delivery
Procedure: Bilateral Salpingectomy
Surgical removal of entire fallopian tubes
Active Comparator: Tubal Ligation
Bilateral tubal ligation following cesarean delivery via Parkland or modified Pomeroy methods.
Procedure: Bilateral Tubal Ligation
Surgical tying, cutting, or removal of a portion of the fallopian tubes

Detailed Description:
A non-inferiority, two-arm randomized controlled trial to evaluate the safety and feasibility of prophylactic salpingectomy at the time of a cesarean delivery will be conducted as an initiative to avoid a missed opportunity in the primary prevention of ovarian cancer. Once enrolled and consented, women will be randomized using a stratified block randomization algorithm according to number of prior cesarean deliveries and BMI to either salpingectomy or bilateral tubal ligation. The data collection will include preoperative CBC, time of procedure, postoperative CBC at 24 hours, standard patient demographics, procedural complications, estimated blood loss, return to the OR, length of stay, pain scores, and postoperative complications, including readmission within 6 weeks.
  Eligibility

Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pregnant women
  • 21 years of age or older
  • Desire permanent sterilization
  • Scheduled for a Cesarean delivery

Exclusion Criteria:

  • Body Mass Index > 50
  • Emergent, 'alpha' Cesarean delivery
  • Single ovary/fallopian tube complex
  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: NCT03135431

Contacts
Contact: Marnie M Wetzstein, BSN 507-266-4813 wetzstein.marnie@mayo.edu

Locations
United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Vanessa E Torbenson, M.D. Mayo Clinic
  More Information

Responsible Party: Vanessa Torbenson, Consultant Obstetrics and Gynecology, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03135431     History of Changes
Other Study ID Numbers: 17-000898
Study First Received: April 27, 2017
Last Updated: April 28, 2017
Individual Participant Data  
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

ClinicalTrials.gov processed this record on May 22, 2017