Permanent Sterilization, Pregnancy Related
Conditions
Keywords
Sterilization, salpingectomy, cesarean delivery
Brief 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.
Interventions
OTHERHand-held bipolar energy instrument
A bipolar energy instrument is used for complete salpingectomy at the time of cesarean delivery.
OTHERTraditional suture ligation
Traditional suture ligation technique is used for complete salpingectomy at the time of cesarean delivery.
Sponsors
Inova Health Care Services
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Hemoglobin levels on postoperative day one | 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
| Measure | Time frame | Description |
|---|---|---|
| Completion rate of sterilization | preoperatively and one day after surgery | Proportion of sterilization procedure completed by postoperative day one |
| Total procedure estimated blood loss | intraoperatively | estimated blood loss calculated and documented in milliliters at the end of the procedure |
| Adjacent organ damage | intraoperatively | Rate of injury to abdominal/pelvic organs sustained during the procedure |
| Need for blood transfusion | from day of surgery up to 30 days pospartum | any need for blood products transfusion intraoperatively through discharge |
| Total operative time | intraoperatively | time necessary to complete the surgery from skin incision to end of skin closure |
| ICU admission | from day of surgery up to 7 days postpartum | any admission to the intensive care unit for procedure-related complications |
| Length of hospital stay | from day of surgery up to 6 weeks postpartum | Duration of hospitalization in days from admission to discharge |
| Hospital readmission postoperatively | Day of initial dischage through 6 weeks postpartum | Any admission after initial discharge from the hospital |
| Reoperation rates | postoperative day 0 through 6 weeks postpartum | Number of participants who return to the operating room due to initial procedure-related complications |
| Pain score | from day of surgery up to 7 days postparum | pain severity measured on a scale of 0 through 10 |
| Surgical site infection | postoperative day 0 through 6 weeks postpartum | any infection that occurs post-surgery in the abdomen, pelvis, abdominal walls or skin |
| Cost | intraoperatively | cost difference between bipolar instrument and suture |
Countries
United States
Contacts
CONTACTJean W Thermolice, MD
CONTACTBianca Nguyen, MD
PRINCIPAL_INVESTIGATORJean W Thermolice, MD
Inova Fairfax Medical Campus
Outcome results
None listed