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Completed

NCT Number: NCT03135431

Opportunistic Salpingectomy for Permanent Sterilization at the Time of Cesarean Delivery

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.

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Key information

Conditions

Contraception

Age range

21 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bilateral salpingectomy

Procedure

Surgical removal of entire fallopian tubes

Bilateral Tubal Ligation

Procedure

Surgical tying, cutting, or removal of a portion of the fallopian tubes

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Opportunistic Salpingectomy at the Time of Cesarean Delivery: A Randomized Controlled Trial of the Safety of Salpingectomy vs Tubal Ligation

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 1, 2017
Registry last updated
Jul 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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