Comparison of Two Salpingectomy Techniques for Sterilization at the Time of Cesarean Delivery
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age21+
SponsorInova Health Care Services
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
vaginal delivery
history of prior adnexal surgery (such as prior bilateral tubal ligation or unilateral salpingectomy oophorectomy)
placenta accreta spectrum
placenta previa
Trial 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
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Hand-held bipolar energy instrument
Other interventionA bipolar energy instrument is used for complete salpingectomy at the time of cesarean delivery.
Traditional suture ligation
Other interventionTraditional suture ligation technique is used for complete salpingectomy at the time of cesarean delivery.
Treatment groups
900 Participants
are divided into 2 treatment groupsGroup A: Complete salpingectomy using a hand-held bipolar energy instrument1 intervention
Group B: Complete salpingectomy using traditional suture ligation1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
preoperatively and one day after surgerySecondary outcomes
1
Completion rate of sterilization
Proportion of sterilization procedure completed by postoperative day one
Time frame
preoperatively and one day after surgery2
Total procedure estimated blood loss
estimated blood loss calculated and documented in milliliters at the end of the procedure
Time frame
intraoperatively3
Adjacent organ damage
Rate of injury to abdominal/pelvic organs sustained during the procedure
Time frame
intraoperatively4
Need for blood transfusion
any need for blood products transfusion intraoperatively through discharge
Time frame
from day of surgery up to 30 days pospartumSponsors and contacts
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Source ClinicalTrials.gov