Opportunistic Salpingectomy for Permanent Sterilization at the Time of Cesarean Delivery

Contraception Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03135431
• Other study ID #: 17-000898
• Status: Completed
• Phase: N/A
• Start date: May 17, 2017
• Est. completion date: July 30, 2018

Study information

• Verified date: July 2019
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 30, 2018
• Est. primary completion date: May 19, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Contraception

Intervention

Procedure:
• Bilateral Salpingectomy
Surgical removal of entire fallopian tubes
• Bilateral Tubal Ligation
Surgical tying, cutting, or removal of a portion of the fallopian tubes

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Difference Between Pre and Postoperative Hemoglobin (g/dl)	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.	At least 24 but not greater than 48 hours after surgery
Secondary	Operative Time	Compare mean difference in length of operative time (in minutes) to perform bilateral salpingectomy as compared to standard bilateral tubal ligation, following cesarean delivery.	Day of surgery
Secondary	Estimated Blood Loss	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.	Day of surgery

External Links

•   Mayo Clinic Clinical Trials