Standard Tubal Ligation Versus Salpingectomy for Sterilization at the Time of Cesarean Delivery

NCT03028623 | Completed

• 1 other identifier: 19517
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to evaluate the feasibility and safety of salpingectomy versus standard tubal ligation in women undergoing surgical sterilization at the time of a planned cesarean delivery. Salpingectomy is currently being investigated as a potential strategy for ovarian cancer prevention. While this procedure is currently performed during hysterectomies, its feasibility at the time of cesarean delivery is not well established. This randomized, prospective clinical trial will compare the two sterilization methods to demonstrate that salpingectomy compared with standard tubal ligation at the time of cesarean delivery will not result in increased operative time, blood loss or other complications. This study is necessary to promote salpingectomy as a standard sterilization method during cesarean deliveries.

Conditions

Method of Tubal Ligation at the Time of Cesarean Section

Outcome Measures

Primary Outcomes (1)

• Time of tubal ligation

  Primary outcome will be the time it takes to complete the sterilization procedure

  at time of procedure

Secondary Outcomes (3)

• Total procedure time

  at time of procedure

• Estimated blood loss

  at time of procedure

• Rate of aborted procedures

  at time of procedure

Other Outcomes (3)

• Reoperation rate

  within 6 weeks

• Length of stay

  within 1008 hours

• Readmission rate

  within 6 weeks

Study Arms (2)

Control

OTHER

Tubal sterilization will be performed by standard tubal ligation, either Parkland or Pomeroy technique, at the time of cesarean section

Procedure: Tubal ligation

Experimental

EXPERIMENTAL

Tubal sterilization will be performed by bilateral salpingectomy using a ligasure device at the time of cesarean section.

Procedure: Salpingectomy

Interventions

Salpingectomy PROCEDURE

Bilateral salpingectomy will be performed instead of standard tubal ligation as sterilization during cesarean section.

Experimental

Tubal ligation PROCEDURE

Standard tubal ligation by either Parkland or Pomeroy technique will be performed at cesarean section

Control

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must have planned cesarean delivery and desire sterilization
• Subjects must be able to read and provide written informed consent
• Subjects must be English or Spanish speaking

You may not qualify if:

• Subjects with known hereditary cancer syndromes
• Subjects with a history of prior tubal surgery
• Subjects with a placenta accreta
• Subjects undergoing trial of labor after cesarean delivery

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Related Publications (1)

• Garcia C, Moskowitz OM, Chisholm CA, Duska LR, Warren AL, Lyons GR, Pettit KE. Salpingectomy Compared With Tubal Ligation at Cesarean Delivery: A Randomized Controlled Trial. Obstet Gynecol. 2018 Jul;132(1):29-34. doi: 10.1097/AOG.0000000000002674.

  PMID: 29889755 DERIVED

MeSH Terms

Interventions

Salpingectomy; Sterilization, Tubal

Intervention Hierarchy (Ancestors)

Gynecologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative; Sterilization, Reproductive

Study Officials

• Kate' Pettit, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Division of Maternal Fetal Medicine

Study Record Dates

• First Submitted: January 13, 2017
• First Posted: January 23, 2017
• Study Start: May 1, 2017
• Primary Completion: March 5, 2018
• Study Completion: March 5, 2018
• Last Updated: April 10, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)