Comparison of Two Salpingectomy Techniques for Sterilization at the Time of Cesarean Delivery

March 19, 2024 updated by: Inova Health Care Services

One in three women of reproductive age utilize tubal sterilization for contraception, and sterilization is often requested at time of cesarean delivery. Complete salpingectomy for the purpose of permanent sterilization at the time of cesarean birth is increasingly being performed worldwide.

A preferred complete salpingectomy technique for the purpose of sterilization at the time of cesarean delivery has not emerged in current practice. The objective is to compare short-term clinical outcomes and cost of salpingectomy using a hand-held bipolar energy instrument with those of traditional suture ligation. This retrospective cohort study will be conducted from 2017-2023 at a single tertiary care hospital. The investigators hypothesize that bipolar energy instrument use will not significantly improve clinical outcomes.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

900

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Virginia
      • Falls Church, Virginia, United States, 22042
        • Recruiting
        • Inova Fairfax Medical Campus
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Sofia Girald-Berlingeri, MD
        • Sub-Investigator:
          • Bianca Nguyen, MD
        • Sub-Investigator:
          • Catherine Kim, MD
        • Sub-Investigator:
          • Miranda Newell, MS
        • Sub-Investigator:
          • Renee Brenner, BS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Patients aged 21 years or older undergoing permanent sterilization at the time of cesarean delivery at 24 weeks' gestation or beyond, 21 years old and older

Description

Inclusion Criteria:

  • request for permanent sterilization at the time of cesarean delivery
  • 24 weeks' gestation or beyond
  • 21 years old or older
  • Medicaid sterilization consent per Virginia Department of Medical Assistance Services regulations (if Medicaid recipient).

Exclusion Criteria:

  • vaginal delivery
  • history of prior adnexal surgery (such as prior bilateral tubal ligation or unilateral salpingectomy oophorectomy)
  • placenta accreta spectrum
  • placenta previa
  • history of bleeding diathesis.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Complete salpingectomy using a hand-held bipolar energy instrument
Other: Hand-held bipolar energy instrument
A bipolar energy instrument is used for complete salpingectomy at the time of cesarean delivery.
Complete salpingectomy using traditional suture ligation
Other: Traditional suture ligation
Traditional suture ligation technique is used for complete salpingectomy at the time of cesarean delivery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Hemoglobin levels on postoperative day one
Time Frame: preoperatively and one day after surgery
Change in hemoglobin levels reported in gram per deciliter on postoperative day one, calculated as the difference between immediate preoperative and postoperative day 1 hemoglobin levels
preoperatively and one day after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Completion rate of sterilization
Time Frame: preoperatively and one day after surgery
Proportion of sterilization procedure completed by postoperative day one
preoperatively and one day after surgery
Total procedure estimated blood loss
Time Frame: intraoperatively
estimated blood loss calculated and documented in milliliters at the end of the procedure
intraoperatively
Adjacent organ damage
Time Frame: intraoperatively
Rate of injury to abdominal/pelvic organs sustained during the procedure
intraoperatively
Need for blood transfusion
Time Frame: from day of surgery up to 30 days pospartum
any need for blood products transfusion intraoperatively through discharge
from day of surgery up to 30 days pospartum
Total operative time
Time Frame: intraoperatively
time necessary to complete the surgery from skin incision to end of skin closure
intraoperatively
ICU admission
Time Frame: from day of surgery up to 7 days postpartum
any admission to the intensive care unit for procedure-related complications
from day of surgery up to 7 days postpartum
Length of hospital stay
Time Frame: from day of surgery up to 6 weeks postpartum
Duration of hospitalization in days from admission to discharge
from day of surgery up to 6 weeks postpartum
Hospital readmission postoperatively
Time Frame: Day of initial dischage through 6 weeks postpartum
Any admission after initial discharge from the hospital
Day of initial dischage through 6 weeks postpartum
Reoperation rates
Time Frame: postoperative day 0 through 6 weeks postpartum
Number of participants who return to the operating room due to initial procedure-related complications
postoperative day 0 through 6 weeks postpartum
Pain score
Time Frame: from day of surgery up to 7 days postparum
pain severity measured on a scale of 0 through 10
from day of surgery up to 7 days postparum
Surgical site infection
Time Frame: postoperative day 0 through 6 weeks postpartum
any infection that occurs post-surgery in the abdomen, pelvis, abdominal walls or skin
postoperative day 0 through 6 weeks postpartum
Cost
Time Frame: intraoperatively
cost difference between bipolar instrument and suture
intraoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Inova Health Care Services

Investigators

  • Principal Investigator: Jean W Thermolice, MD, Inova Fairfax Medical Campus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 11, 2024

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

February 1, 2024

First Submitted That Met QC Criteria

February 14, 2024

First Posted (Actual)

February 22, 2024

Study Record Updates

Last Update Posted (Actual)

March 20, 2024

Last Update Submitted That Met QC Criteria

March 19, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • INOVA-2023-145

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pregnancy Related

Clinical Trials on Hand-held bipolar energy instrument

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Finland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe