Standard Tubal Ligation Versus Salpingectomy for Sterilization at the Time of Cesarean Delivery

University of Virginia

Status: Completed

Conditions: Method of Tubal Ligation at the Time of Cesarean Section

Treatments: Procedure: Tubal ligation; Procedure: Salpingectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT03028623

19517

Details and patient eligibility

About

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.

Enrollment: 44 patients

Sex: Female

Ages: 21+ years old

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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44 participants in 2 patient groups

Control

Other group

Description:

Tubal sterilization will be performed by standard tubal ligation, either Parkland or Pomeroy technique, at the time of cesarean section

Treatment:

Procedure: Tubal ligation

Experimental

Experimental group

Description:

Tubal sterilization will be performed by bilateral salpingectomy using a ligasure device at the time of cesarean section.

Treatment:

Procedure: Salpingectomy