Salpingectomy at Cesarean Delivery for Ovarian Cancer Reduction (SCORE)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Complete Salpingectomy Versus Standard Postpartum Tubal Ligation at the Time of Cesarean Delivery- a Randomized Controlled Study

Conditions
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Ovarian Cancer

Intervention / Treatment
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* Procedure: Standard postpartum tubal ligation
* Procedure: Complete Salpingectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All pregnant women > 25 years 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) Informed consent obtained Exclusion Criteria: Inability to obtain informed consent Fetal death or anomalies Preterm delivery < 36 weeks gestation Immune-compromising disease Chronic steroid use Chronic prophylactic or therapeutic anti-coagulation Patients no followed in our regional health system Known BRCA mutation carrier status Age < 25 years

Ages Eligible for Study
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Minimum Age: 25 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard postpartum tubal ligation<br>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. | Procedure: Standard postpartum tubal ligation<br>* Patients will undergo a standard postpartum tubal ligation by accepted documented surgical procedural methods (Modified Pomeroy or Parkland method)<br>|
| Experimental: Complete Salpingectomy<br>In this arm, patients will receive a complete salpingectomy by documented accepted methods. | Procedure: Complete Salpingectomy<br>* Patients will undergo a complete salpingectomy by a documented surgical protocol established by accepted surgical procedural methods.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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complete salpingectomy, standard tubal ligation, cesarean delivery, feasibility, safety, partial salpingectomy