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A Randomized Controlled Trial of Standard Tubal Ligation Versus Salpingectomy for Sterilization at the Time of Cesarean Delivery (NCT03028623)

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.
  • Procedure: Salpingectomy
    Bilateral salpingectomy will be performed instead of standard tubal ligation as sterilization during cesarean section.
    • Procedure: Tubal ligation
      Standard tubal ligation by either Parkland or Pomeroy technique will be performed at cesarean section
      Ages eligible for Study
      21 Years and older
      Genders eligible for Study
      Female
      Accepts Healthy Volunteers
      Accepts Healthy Volunteers
      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

      1 locations

      United States (1)
      • University of Virginia
        recruiting
        Charlottesville, Virginia, United States, 22908
      Status:
      recruiting
      Type:
      Interventional
      Phase:
      -
      Start:
      30 April, 2017
      Updated:
      01 May, 2017
      Participants:
      36
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