Trial Condition(s):
Hysterectomy
Proportion of hysterectomy after female sterilization
Bayer Identifier:
18473
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
The objective of this study is to describe the proportion of hysterectomy in patients that had undergone sterilization through hysteroscopic device placement and the patients that had undergone sterilization through tubal ligation.
Inclusion Criteria
- Age: 18 to 49 years at index date
- Gender: Female
- Diagnosis: Women who underwent hysteroscopic device sterilization procedure
- Diagnosis: Women who underwent tubal ligation sterilization procedure (includes laparoscopic tubal ligation), and salpingectomyExclusion Criteria
- Patients undergoing in-vitro fertilization (IVF) procedures
- Embryo transfer, intrauterine
- Follicle puncture for oocyte retrieval, any methodTrial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site New Jersey, United States | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
A retrospective analysis to describe the proportion of hysterectomy after female sterilization with hysteroscopic device or tubal ligation using Intermountain Healthcare database in the US
Trial Type:
Observational
Intervention Type:
Device
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
2
Primary Outcome
- Percentage of patients having hysterectomy procedure post-sterilization through hysteroscopic device placementThe study will also describe sub-outcomes related to post-sterilization hysterectomy procedure including: i. Average time (in days) from index date (sterilization) to hysterectomy ii. Percentage of patients having hysterectomy (abdominal) iii. Percentage of patients having hysterectomy (vaginal) iv. Percentage of patients having hysterectomy (laproscopically assisted vaginal hysterectomy - LAVH) v. Percentage of patients having hysterectomy (abdominal, vaginal and LAVH)Timeframe: Retrospective analysis of 10 year period
- Percentage of patients having hysterectomy procedure post-sterilization through through tubal ligationThe study will also describe sub-outcomes related to post-sterilization hysterectomy procedure including: i. Average time (in days) from index date (sterilization) to hysterectomy ii. Percentage of patients having hysterectomy (abdominal) iii. Percentage of patients having hysterectomy (vaginal) iv. Percentage of patients having hysterectomy (laproscopically assisted vaginal hysterectomy - LAVH) v. Percentage of patients having hysterectomy (abdominal, vaginal and LAVH)Timeframe: Retrospective analysis of 10 year period
Additional Information
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