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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Other | Tubal sterilization will be performed by standard tubal ligation, either Parkland or Pomeroy technique, at the time of cesarean section |
|
| Experimental | Experimental | Tubal sterilization will be performed by bilateral salpingectomy using a ligasure device at the time of cesarean section. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Salpingectomy | Procedure | Bilateral salpingectomy will be performed instead of standard tubal ligation as sterilization during cesarean section. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time of tubal ligation | Primary outcome will be the time it takes to complete the sterilization procedure | at time of procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Total procedure time | The total time it takes to complete the cesarean plus sterilization procedure | at time of procedure |
| Estimated blood loss | Estimated blood loss for the entire procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Reoperation rate | Rate of reoperation within 6 weeks | within 6 weeks |
| Length of stay | Length of stay in hours | within 1008 hours |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kate' Pettit, MD | University of Virginia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Virginia | Charlottesville | Virginia | 22908 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29889755 | Derived | Garcia C, Moskowitz OM, Chisholm CA, Duska LR, Warren AL, Lyons GR, Pettit KE. Salpingectomy Compared With Tubal Ligation at Cesarean Delivery: A Randomized Controlled Trial. Obstet Gynecol. 2018 Jul;132(1):29-34. doi: 10.1097/AOG.0000000000002674. |
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| ID | Term |
|---|---|
| D058994 | Salpingectomy |
| D013246 | Sterilization, Tubal |
| ID | Term |
|---|---|
| D013509 | Gynecologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D013245 | Sterilization, Reproductive |
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| Tubal ligation | Procedure | Standard tubal ligation by either Parkland or Pomeroy technique will be performed at cesarean section |
|
| at time of procedure |
| Rate of aborted procedures | Inability to complete bilateral salpingectomy in the experimental arm | at time of procedure |
| Readmission rate | Rate of readmission within 6 weeks | within 6 weeks |