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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
80
Patients will undergo a standard postpartum tubal ligation by accepted documented surgical procedural methods (Modified Pomeroy or Parkland method)
Patients will undergo a complete salpingectomy by a documented surgical protocol established by accepted surgical procedural methods.
University of Alabama at Birmingham
Birmingham, Alabama, United States
Time to complete sterilization procedure
The primary outcome will involve measuring the amount of surgical time required to complete the assigned sterilization procedure
Time frame: At time of procedure
Completion rate of sterilization procedure
The primary outcome will involve assessing the completion rate of assigned sterilization procedure
Time frame: At time of procedure
Total operative time
Includes cesarean delivery and sterilization procedure time
Time frame: At time of procedure
Mean post-operative pain score
Time frame: 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
Time frame: From time of procedure to 6 weeks postpartum
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