Trial Condition(s):
Contraception
Retrospective Claims Analysis of Hysterectomy after sterilization
Bayer Identifier:
18477
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
The research questions are:
1) What is the proportion of women undergoing hysterectomy after hysteroscopic sterilization or laparoscopic tubal ligation?
2) What is the proportion of women undergoing salpingectomy, salpingostomy, or hysteroscopy after hysteroscopic sterilization or laparoscopic tubal ligation?
3) What is the proportion of women who have a diagnosis of pelvic pain after hysteroscopic sterilization or laparoscopic tubal ligation?
Inclusion Criteria
- Women aged 18 through 49 years at the index date - at least one claim of the hysteroscopic sterilization procedure or interval laparoscopic tubal ligation at any time during January 1, 2010 –December 31, 2012 - Had 6 months of continuous medical and pharmacy benefits pre-index date which is considered the baseline period to capture all patient characteristics prior to the procedure - Had 12 months of continuous medical and pharmacy benefits post-index date (i.e., follow-up period)
Exclusion Criteria
- Women who underwent a postpartum tubal ligation procedure during the entire study period - Women who had claims of a sterilization procedure during the baseline period - Women who had a claim for pregnancy or delivery within 6 weeks prior to the index date - Women who had more than one type of sterilization procedure (i.e., combination of hysteroscopic sterilization, laparoscopic tubal ligation or mini-laparotomy) on the same index date - Women who had concurrent procedures on the same day as the index sterilization procedure that were performed for reasons beyond the purpose of sterilization
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Investigative Site Whippany, United States | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
A Retrospective Claims Analysis to Calculate the Proportion of Women Undergoing Hysterectomy, Salpingectomy, Salpingostomy, Hysteroscopy or Who had a Diagnosis of Pelvic Pain After Hysteroscopic Sterilization or Laparoscopic Tubal Ligation
Trial Type:
Observational
Intervention Type:
Procedure/Surgery
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
4
Primary Outcome
- Proportion of women undergoing hysterectomy after hysteroscopic sterilization or laparoscopic tubal ligationTimeframe: Within 12 months after the procedure
Secondary Outcome
- Proportion of women undergoing salpingectomy after hysteroscopic sterilization or laparoscopic tubal ligationTimeframe: Within 12 months after the procedure
- Proportion of women undergoing salpingostomy after hysteroscopic sterilization or laparoscopic tubal ligationTimeframe: Within 12 months after the procedure
- Proportion of women undergoing hysteroscopy after hysteroscopic sterilization or laparoscopic tubal ligationTimeframe: Within 12 months after the procedure
- Proportion of women who have a diagnosis of pelvic pain after hysteroscopic sterilization or laparoscopic tubal ligationTimeframe: Within 12 months after the procedure
Additional Information
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