Comparing two techniques for permanent sterilization during cesarean delivery
Comparison of Two Salpingectomy Techniques for Sterilization at the Time of Cesarean Delivery
Inova Health Care Services · NCT06273683
This study is testing whether using a special tool for permanent sterilization during cesarean deliveries is better or just as good as the traditional method for women who choose this option.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 900 (estimated) |
| Ages | 21 Years and up |
| Sex | Female |
| Sponsor | Inova Health Care Services (other) |
| Locations | 1 site (Falls Church, Virginia) |
| Trial ID | NCT06273683 on ClinicalTrials.gov |
What this trial studies
This observational study aims to compare the short-term clinical outcomes and costs associated with two techniques for salpingectomy performed during cesarean deliveries: a hand-held bipolar energy instrument and traditional suture ligation. Conducted at Inova Fairfax Medical campus, the study will analyze data from women who requested permanent sterilization at the time of their cesarean delivery from 2017 to 2023. The researchers hypothesize that the use of the bipolar energy instrument will not lead to significant improvements in clinical outcomes compared to the traditional method.
Who should consider this trial
Good fit: Ideal candidates are women aged 21 and older, at least 24 weeks pregnant, who are requesting permanent sterilization during a cesarean delivery.
Not a fit: Patients who have had prior adnexal surgery, are experiencing vaginal delivery, or have certain pregnancy complications will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help determine the most effective and cost-efficient technique for permanent sterilization during cesarean deliveries.
How similar studies have performed: While there is ongoing research in sterilization techniques, this specific comparison of bipolar energy instruments versus traditional methods during cesarean delivery is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Falls Church, Virginia
- Inova Fairfax Medical campus — Falls Church, Virginia, United States (RECRUITING)
Study contacts
- Principal investigator: Jean W Thermolice, MD — Inova Fairfax Medical Campus
- Study coordinator: Jean W Thermolice, MD
- Email: jean.thermolice@inova.org
- Phone: 703-531-3000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Permanent Sterilization, Pregnancy Related, Sterilization, salpingectomy, cesarean delivery