Opportunistic Salpingectomy for Permanent Sterilization at the Time of Cesarean Delivery
Opportunistic Salpingectomy at the Time of Cesarean Delivery: A Randomized Controlled Trial of the Safety of Salpingectomy vs Tubal Ligation
1 other identifier
interventional
40
1 country
1
Brief Summary
The purpose of this study is to compare the safety of performing a bilateral tubal ligation vs. bilateral salpingectomy, two procedures performed for permanent sterilization, at the time of cesarean delivery. The investigators want to determine if performing bilateral salpingectomy at the time of cesarean delivery poses any greater risk for blood loss, as compared to a bilateral tubal ligation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 27, 2017
CompletedFirst Posted
Study publicly available on registry
May 1, 2017
CompletedStudy Start
First participant enrolled
May 17, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 19, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 30, 2018
CompletedResults Posted
Study results publicly available
July 10, 2019
CompletedJuly 10, 2019
July 1, 2019
1 year
April 27, 2017
April 20, 2019
July 9, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Mean Difference Between Pre and Postoperative Hemoglobin (g/dl)
Identify the mean difference in pre and postoperative hemoglobin for patients undergoing salpingectomy for sterilization vs. patients undergoing standard bilateral tubal ligation via mid-segment resection of the fallopian tube at the time of cesarean delivery.
At least 24 but not greater than 48 hours after surgery
Secondary Outcomes (2)
Operative Time
Day of surgery
Estimated Blood Loss
Day of surgery
Study Arms (2)
Salpingectomy
EXPERIMENTALBilateral salpingectomy following cesarean delivery
Tubal Ligation
ACTIVE COMPARATORBilateral tubal ligation following cesarean delivery via Parkland or modified Pomeroy methods.
Interventions
Surgical tying, cutting, or removal of a portion of the fallopian tubes
Eligibility Criteria
You may qualify if:
- Pregnant women
- years of age or older
- Desire permanent sterilization
- Scheduled for a Cesarean delivery
You may not qualify if:
- Body Mass Index \> 50
- Emergent, 'alpha' Cesarean delivery
- Single ovary/fallopian tube complex
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (1)
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
Related Links
Results Point of Contact
- Title
- Vanessa Torbenson, M.D.
- Organization
- Mayo Clinic
Study Officials
- PRINCIPAL INVESTIGATOR
Vanessa E Torbenson, M.D.
Mayo Clinic
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Consultant Obstetrics and Gynecology
Study Record Dates
First Submitted
April 27, 2017
First Posted
May 1, 2017
Study Start
May 17, 2017
Primary Completion
May 19, 2018
Study Completion
July 30, 2018
Last Updated
July 10, 2019
Results First Posted
July 10, 2019
Record last verified: 2019-07
Data Sharing
- IPD Sharing
- Will not share