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To compare the feasibility and surgical outcomes between complete salpingectomy and standard postpartum tubal ligation (partial salpingectomy) at the time of cesarean delivery in women with undesired future fertility. as a possible ovarian cancer risk-reducing procedure.
All pregnant women receiving prenatal care within the UAB Health System, and planning to undergo tubal ligation at the time of their scheduled cesarean delivery (primary or repeat) will be approached about the study. Patients will be randomized to receive either the standard tubal ligation practice at our institution (modified Pomeroy procedure or Parkland) or a complete salpingectomy. The objective of this trial is to evaluate if a complete salpingectomy can be performed safely and comparable to a standard postpartum tubal ligation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard postpartum tubal ligation | Active Comparator | In this arm, patients will receive the standard postpartum tubal ligation by accepted methods (procedure names are the following: Modified pomeroy technique or Parkland method). These methods are procedures for completing a partial salpingectomy. |
|
| Complete Salpingectomy | Experimental | In this arm, patients will receive a complete salpingectomy by documented accepted methods. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard postpartum tubal ligation | Procedure | Patients will undergo a standard postpartum tubal ligation by accepted documented surgical procedural methods (Modified Pomeroy or Parkland method) |
| Measure | Description | Time Frame |
|---|---|---|
| Time to complete sterilization procedure | The primary outcome will involve measuring the amount of surgical time required to complete the assigned sterilization procedure | At time of procedure |
| Completion rate of sterilization procedure | The primary outcome will involve assessing the completion rate of assigned sterilization procedure | At time of procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Total operative time | Includes cesarean delivery and sterilization procedure time | At time of procedure |
| Mean post-operative pain score | Postpartum admission (3-4 days) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Akila Subramaniam, MD, MPH | University of Alabama at Birmingham | Principal Investigator |
| Britt K Erickson, MD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35249 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35728603 | Derived | Ostby SA, Blanchard CT, Sanjanwala AR, Szychowski JM, Leath CA 3rd, Huh WK, Subramaniam A. Feasibility, Safety, and Provider Perspectives of Bipolar Electrosurgical Cautery Device for (Opportunistic or Complete) Salpingectomy at the Time of Cesarean Delivery. Am J Perinatol. 2024 Apr;41(6):804-813. doi: 10.1055/s-0042-1748525. Epub 2022 Jun 21. | |
| 30477808 |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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| Complete Salpingectomy | Procedure | Patients will undergo a complete salpingectomy by a documented surgical protocol established by accepted surgical procedural methods. |
|
| Perioperative complication rate | Composite assessment of the following: estimated blood loss, need for blood transfusion, intra-abdominal hemorrhage/hematoma, need for readmission, need for reoperation, need for additional surgical procedure, major post-operative complication | From time of procedure to 6 weeks postpartum |
| Subramaniam A, Einerson BD, Blanchard CT, Erickson BK, Szychowski J, Leath CA 3rd, Biggio JR, Huh WK. The cost-effectiveness of opportunistic salpingectomy versus standard tubal ligation at the time of cesarean delivery for ovarian cancer risk reduction. Gynecol Oncol. 2019 Jan;152(1):127-132. doi: 10.1016/j.ygyno.2018.11.009. Epub 2018 Nov 23. |
| 29889762 | Derived | Subramaniam A, Blanchard CT, Erickson BK, Szychowski J, Leath CA, Biggio JR, Huh WK. Feasibility of Complete Salpingectomy Compared With Standard Postpartum Tubal Ligation at Cesarean Delivery: A Randomized Controlled Trial. Obstet Gynecol. 2018 Jul;132(1):20-27. doi: 10.1097/AOG.0000000000002646. |
| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |