Permanent SterilizationNCT06273683
Comparison of Two Salpingectomy Techniques for Sterilization at the Time of Cesarean Delivery
An observational study of Permanent Sterilization and Pregnancy Related, run by Inova Health Care Services at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Permanent Sterilization, Pregnancy Related
- What is being tested?
- Hand-held bipolar energy instrument and Traditional suture ligation
- How many people
- 900 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Mar 2024to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Women only
- Adult, Older adult
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
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Inova Fairfax Medical campus
Falls Church, Virginia, 22042
Jean W Thermolice, MD, 703-531-3000, jean.thermolice@inova.org
Bianca Nguyen, MD, bianca.nguyen@inova.org
About this study
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.
- Conditions
- Permanent Sterilization, Pregnancy Related
- Being tested
- Hand-held bipolar energy instrument, Traditional suture ligation
- Keywords
- Sterilization, salpingectomy, cesarean delivery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hand-held bipolar energy instrumentOther
A bipolar energy instrument is used for complete salpingectomy at the time of cesarean delivery.
Traditional suture ligationOther
Traditional suture ligation technique is used for complete salpingectomy at the time of cesarean delivery.
| Study group | Role | What they receive |
|---|---|---|
| Complete salpingectomy using a hand-held bipolar energy instrument | Not described Receives: Other: Hand-held bipolar energy instrument | |
| Complete salpingectomy using traditional suture ligation | Not described Receives: Other: Traditional suture ligation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hemoglobin levels on postoperative day one
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
Measured: preoperatively and one day after surgery
Secondary outcomes (12)
Completion rate of sterilization
Proportion of sterilization procedure completed by postoperative day one
Measured: preoperatively and one day after surgery
Total procedure estimated blood loss
estimated blood loss calculated and documented in milliliters at the end of the procedure
Measured: intraoperatively
Adjacent organ damage
Rate of injury to abdominal/pelvic organs sustained during the procedure
Measured: intraoperatively
Need for blood transfusion
any need for blood products transfusion intraoperatively through discharge
Measured: from day of surgery up to 30 days pospartum
Total operative time
time necessary to complete the surgery from skin incision to end of skin closure
Measured: intraoperatively
ICU admission
any admission to the intensive care unit for procedure-related complications
Measured: from day of surgery up to 7 days postpartum
Length of hospital stay
Duration of hospitalization in days from admission to discharge
Measured: from day of surgery up to 6 weeks postpartum
Hospital readmission postoperatively
Any admission after initial discharge from the hospital
Measured: Day of initial dischage through 6 weeks postpartum
Reoperation rates
Number of participants who return to the operating room due to initial procedure-related complications
Measured: postoperative day 0 through 6 weeks postpartum
Pain score
pain severity measured on a scale of 0 through 10
Measured: from day of surgery up to 7 days postparum
Surgical site infection
any infection that occurs post-surgery in the abdomen, pelvis, abdominal walls or skin
Measured: postoperative day 0 through 6 weeks postpartum
Cost
cost difference between bipolar instrument and suture
Measured: intraoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2024
- Study start11 Mar 2024
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Permanent SterilizationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inova Health Care Services
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean W Thermolice, MD, Principal investigator, Inova Fairfax Medical Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06273683
- Sponsor's protocol ID
- INOVA-2023-145
- Status last verified
- Mar 2026
- First submitted
- 1 Feb 2024
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Mandelbaum RS, Matsuzaki S, Sangara RN, Klar M, Matsushima K, Roman LD, Paulson RJ, Wright JD, Matsuo K. Paradigm shift from tubal ligation to opportunistic salpingectomy at cesarean delivery in the United States. Am J Obstet Gynecol. 2021 Oct;225(4):399.e1-399.e32. doi: 10.1016/j.ajog.2021.06.074. Epub 2021 Jun 26.
PubMed 34181896Venkatesh KK, Clark LH, Stamilio DM. Cost-effectiveness of opportunistic salpingectomy vs tubal ligation at the time of cesarean delivery. Am J Obstet Gynecol. 2019 Jan;220(1):106.e1-106.e10. doi: 10.1016/j.ajog.2018.08.032. Epub 2018 Aug 28.
PubMed 30170036Subramaniam A, Einerson BD, Blanchard CT, Erickson BK, Szychowski J, Leath CA 3rd, Biggio JR, Huh WK. The cost-effectiveness of opportunistic salpingectomy versus standard tubal ligation at the time of cesarean delivery for ovarian cancer risk reduction. Gynecol Oncol. 2019 Jan;152(1):127-132. doi: 10.1016/j.ygyno.2018.11.009. Epub 2018 Nov 23.
PubMed 30477808ACOG Committee Opinion No. 774 Summary: Opportunistic Salpingectomy as a Strategy for Epithelial Ovarian Cancer Prevention. Obstet Gynecol. 2019 Apr;133(4):842-843. doi: 10.1097/AOG.0000000000003165.
PubMed 30913193Society of Gynecologic Oncology. SGO Clinical Practice Statement: Salpingectomy for Ovarian Cancer. 2013. https://www.sgo.org/clinicalpractice/guidelines/sgo-clinical-practice-statement-salpingectomy-for-ovarian-cancer-prevention
Walker JL, Powell CB, Chen LM, Carter J, Bae Jump VL, Parker LP, Borowsky ME, Gibb RK. Society of Gynecologic Oncology recommendations for the prevention of ovarian cancer. Cancer. 2015 Jul 1;121(13):2108-20. doi: 10.1002/cncr.29321. Epub 2015 Mar 27.
PubMed 25820366Nguyen, N. T., Alabaster, A., Simmons, S., Weintraub, M. L. R., & Powell, C. B. (2019). Opportunistic salpingectomy techniques at the time of cesarean delivery: a retrospective cohort study. Journal of Clinical Gynecology and Obstetrics, 8(3), 70-76.
Lauterbach R, Gruenwald O, Matanes E, Justman N, Mor O, Vitner D, Avrahami R, Ghanem N, Zipori Y, Weiner Z, Lowenstein L. A randomized controlled trial of 2 techniques of salpingectomy during cesarean delivery. Am J Obstet Gynecol MFM. 2022 Nov;4(6):100690. doi: 10.1016/j.ajogmf.2022.100690. Epub 2022 Jul 16.
PubMed 35843545Chan LM, Westhoff CL. Tubal sterilization trends in the United States. Fertil Steril. 2010 Jun;94(1):1-6. doi: 10.1016/j.fertnstert.2010.03.029.
PubMed 20497790
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Salpingectomy Techniques for Sterilization at the Time of Cesarean Delivery
- ClinicalTrials.gov ID
- NCT06273683
- Acronym / sponsor ID
- INOVA-2023-145
- Conditions
- Permanent Sterilization, Pregnancy Related
- Keywords
- Sterilization, salpingectomy, cesarean delivery
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Inova Health Care ServicesUniversity, hospital or other
- Study start
- 11 Mar 2024 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 22 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Complete salpingectomy using a hand-held bipolar energy instrument | – | Other: Hand-held bipolar energy instrument |
| Complete salpingectomy using traditional suture ligation | – | Other: Traditional suture ligation |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hand-held bipolar energy instrumentA bipolar energy instrument is used for complete salpingectomy at the time of cesarean delivery. | Other | Complete salpingectomy using a hand-held bipolar energy instrument |
| Traditional suture ligationTraditional suture ligation technique is used for complete salpingectomy at the time of cesarean delivery. | Other | Complete salpingectomy using traditional suture ligation |
Primary outcome
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
12 secondary outcomes
Completion rate of sterilization
Time frame: preoperatively and one day after surgery
Total procedure estimated blood loss
Time frame: intraoperatively
Adjacent organ damage
Time frame: intraoperatively
Need for blood transfusion
Time frame: from day of surgery up to 30 days pospartum
Total operative time
Time frame: intraoperatively
ICU admission
Time frame: from day of surgery up to 7 days postpartum
Length of hospital stay
Time frame: from day of surgery up to 6 weeks postpartum
Hospital readmission postoperatively
Time frame: Day of initial dischage through 6 weeks postpartum
Reoperation rates
Time frame: postoperative day 0 through 6 weeks postpartum
Pain score
Time frame: from day of surgery up to 7 days postparum
Surgical site infection
Time frame: postoperative day 0 through 6 weeks postpartum
Cost
Time frame: intraoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- Background: PubMed 34181896Mandelbaum RS, Matsuzaki S, Sangara RN, Klar M, Matsushima K, Roman LD, Paulson RJ, Wright JD, Matsuo K. Paradigm shift from tubal ligation to opportunistic salpingectomy at cesarean delivery in the United States. Am J Obstet Gynecol. 2021 Oct;225(4):399.e1-399.e32. doi: 10.1016/j.ajog.2021.06.074. Epub 2021 Jun 26.
- Background: PubMed 30170036Venkatesh KK, Clark LH, Stamilio DM. Cost-effectiveness of opportunistic salpingectomy vs tubal ligation at the time of cesarean delivery. Am J Obstet Gynecol. 2019 Jan;220(1):106.e1-106.e10. doi: 10.1016/j.ajog.2018.08.032. Epub 2018 Aug 28.
- Background: PubMed 30477808Subramaniam A, Einerson BD, Blanchard CT, Erickson BK, Szychowski J, Leath CA 3rd, Biggio JR, Huh WK. The cost-effectiveness of opportunistic salpingectomy versus standard tubal ligation at the time of cesarean delivery for ovarian cancer risk reduction. Gynecol Oncol. 2019 Jan;152(1):127-132. doi: 10.1016/j.ygyno.2018.11.009. Epub 2018 Nov 23.
- Background: PubMed 30913193ACOG Committee Opinion No. 774 Summary: Opportunistic Salpingectomy as a Strategy for Epithelial Ovarian Cancer Prevention. Obstet Gynecol. 2019 Apr;133(4):842-843. doi: 10.1097/AOG.0000000000003165.
- BackgroundSociety of Gynecologic Oncology. SGO Clinical Practice Statement: Salpingectomy for Ovarian Cancer. 2013. https://www.sgo.org/clinicalpractice/guidelines/sgo-clinical-practice-statement-salpingectomy-for-ovarian-cancer-prevention
- Background: PubMed 25820366Walker JL, Powell CB, Chen LM, Carter J, Bae Jump VL, Parker LP, Borowsky ME, Gibb RK. Society of Gynecologic Oncology recommendations for the prevention of ovarian cancer. Cancer. 2015 Jul 1;121(13):2108-20. doi: 10.1002/cncr.29321. Epub 2015 Mar 27.
- BackgroundNguyen, N. T., Alabaster, A., Simmons, S., Weintraub, M. L. R., & Powell, C. B. (2019). Opportunistic salpingectomy techniques at the time of cesarean delivery: a retrospective cohort study. Journal of Clinical Gynecology and Obstetrics, 8(3), 70-76.
- Background: PubMed 35843545Lauterbach R, Gruenwald O, Matanes E, Justman N, Mor O, Vitner D, Avrahami R, Ghanem N, Zipori Y, Weiner Z, Lowenstein L. A randomized controlled trial of 2 techniques of salpingectomy during cesarean delivery. Am J Obstet Gynecol MFM. 2022 Nov;4(6):100690. doi: 10.1016/j.ajogmf.2022.100690. Epub 2022 Jul 16.
- Results publication: PubMed 20497790Chan LM, Westhoff CL. Tubal sterilization trends in the United States. Fertil Steril. 2010 Jun;94(1):1-6. doi: 10.1016/j.fertnstert.2010.03.029.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jean W Thermolice, MD principal investigator
Inova Fairfax Medical Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Permanent Sterilization and Pregnancy Related, run by Inova Health Care Services at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jean W Thermolice, MD (703-531-3000, jean.thermolice@inova.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Hemoglobin levels on postoperative day one (time frame: preoperatively and one day after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06273683, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.