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NCT Number: NCT06273683

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

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.

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Key information

Conditions

Permanent Sterilization Pregnancy Related

Age range

21 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Inova Fairfax Medical campus

Falls Church, Virginia, 22042, United States

Location status: Recruiting

Location contact

Bianca Nguyen, MD

CONTACT

[email protected]

Bianca Nguyen, MD

SUB_INVESTIGATOR

Catherine Kim, MD

SUB_INVESTIGATOR

Jean W Thermolice, MD

CONTACT

[email protected]

703-531-3000

Miranda Newell, MS

SUB_INVESTIGATOR

Renee Brenner, BS

SUB_INVESTIGATOR

Sofia Girald-Berlingeri, MD

SUB_INVESTIGATOR

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hand-held bipolar energy instrument

Other

A bipolar energy instrument is used for complete salpingectomy at the time of cesarean delivery.

Traditional suture ligation

Other

Traditional suture ligation technique is used for complete salpingectomy at the time of cesarean delivery.

Primary outcomes

  1. 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

Secondary outcomes

  1. Completion rate of sterilization

    Time frame: preoperatively and one day after surgery

    Proportion of sterilization procedure completed by postoperative day one

  2. Total procedure estimated blood loss

    Time frame: intraoperatively

    estimated blood loss calculated and documented in milliliters at the end of the procedure

  3. Adjacent organ damage

    Time frame: intraoperatively

    Rate of injury to abdominal/pelvic organs sustained during the procedure

  4. Need for blood transfusion

    Time frame: from day of surgery up to 30 days pospartum

    any need for blood products transfusion intraoperatively through discharge

  5. Total operative time

    Time frame: intraoperatively

    time necessary to complete the surgery from skin incision to end of skin closure

  6. ICU admission

    Time frame: from day of surgery up to 7 days postpartum

    any admission to the intensive care unit for procedure-related complications

  7. Length of hospital stay

    Time frame: from day of surgery up to 6 weeks postpartum

    Duration of hospitalization in days from admission to discharge

  8. Hospital readmission postoperatively

    Time frame: Day of initial dischage through 6 weeks postpartum

    Any admission after initial discharge from the hospital

  9. 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

  10. Pain score

    Time frame: from day of surgery up to 7 days postparum

    pain severity measured on a scale of 0 through 10

  11. 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

  12. Cost

    Time frame: intraoperatively

    cost difference between bipolar instrument and suture

Study contacts

Contact information is provided by the study sponsor or research team.

Bianca Nguyen, MD

CONTACT

[email protected]

512-750-9573

Jean W Thermolice, MD

CONTACT

[email protected]

703-531-3000

Sponsors and collaborators

Lead sponsor

Inova Health Care Services

Other

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Feb 22, 2024
Registry last updated
Mar 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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