Method of Tubal Ligation at the Time of Cesarean Section
Conditions
Brief summary
The objective of this study is to evaluate the feasibility and safety of salpingectomy versus standard tubal ligation in women undergoing surgical sterilization at the time of a planned cesarean delivery. Salpingectomy is currently being investigated as a potential strategy for ovarian cancer prevention. While this procedure is currently performed during hysterectomies, its feasibility at the time of cesarean delivery is not well established. This randomized, prospective clinical trial will compare the two sterilization methods to demonstrate that salpingectomy compared with standard tubal ligation at the time of cesarean delivery will not result in increased operative time, blood loss or other complications. This study is necessary to promote salpingectomy as a standard sterilization method during cesarean deliveries.
Interventions
PROCEDURESalpingectomy
Bilateral salpingectomy will be performed instead of standard tubal ligation as sterilization during cesarean section.
PROCEDURETubal ligation
Standard tubal ligation by either Parkland or Pomeroy technique will be performed at cesarean section
Sponsors
University of Virginia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Subjects must have planned cesarean delivery and desire sterilization * Subjects must be able to read and provide written informed consent * Subjects must be English or Spanish speaking
Exclusion criteria
* Subjects with known hereditary cancer syndromes * Subjects with a history of prior tubal surgery * Subjects with a placenta accreta * Subjects undergoing trial of labor after cesarean delivery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time of tubal ligation | at time of procedure | Primary outcome will be the time it takes to complete the sterilization procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total procedure time | at time of procedure | The total time it takes to complete the cesarean plus sterilization procedure |
| Estimated blood loss | at time of procedure | Estimated blood loss for the entire procedure |
| Rate of aborted procedures | at time of procedure | Inability to complete bilateral salpingectomy in the experimental arm |
Other
| Measure | Time frame | Description |
|---|---|---|
| Length of stay | within 1008 hours | Length of stay in hours |
| Readmission rate | within 6 weeks | Rate of readmission within 6 weeks |
| Reoperation rate | within 6 weeks | Rate of reoperation within 6 weeks |
Countries
United States
Outcome results
None listed