RecruitingNot Applicable

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

United States900 participantsStarted 2024-03-11

Plain-language summary

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.

Who can participate

Age range

21 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial compares two different techniques for removing the fallopian tubes during a C-section — can you explain what those two techniques are and how they differ in terms of what would actually be done to me?
2Since the main thing this study is measuring is the change in my hemoglobin level the day after surgery, does that mean there's some uncertainty about whether one technique causes more blood loss than the other, and how does that affect my safety?
3If I participate, would the surgical technique used on me be assigned randomly, or would you as my surgeon have any say in which method is used?
4How does this trial compare to simply having a standard salpingectomy for sterilization during my C-section outside of a research setting — would my care be meaningfully different if I didn't join the study?
5Since this is listed as 'Phase NA' and is still recruiting, what is already known about both techniques, and are there any risks specific to either one that I should weigh before deciding whether to discuss enrollment with you?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Hemoglobin levels on postoperative day one

Timeframe: preoperatively and one day after surgery

Trial details

NCT IDNCT06273683

SponsorInova Health Care Services

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-12

Contact for this trial

Jean W Thermolice, MD

703-531-3000 jean.thermolice@inova.org

View on ClinicalTrials.gov More Permanent Sterilization trials