Study Completed

Contraception

Bayer Identifier:

19275

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

Not Available

EU CT Number:

Not Available

A Retrospective Analysis of the Medicaid Population to Compare the Frequency of Women Undergoing Hysterectomy or Diagnosed with Pelvic Pain or Abnormal Menstrual Bleeding after Hysteroscopic Sterilization or Laparoscopic Tubal Ligation

Trial purpose

The primary research objective was:
•   To compare the frequency of women undergoing hysterectomy, diagnosed with pelvic pain, or abnormal menstrual bleeding within 24 months after hysteroscopic sterilization or laparoscopic tubal ligation
The secondary research objectives were:
•   To explore the impact of hysteroscopic sterilization versus tubal ligation on the likelihood of hysterectomy, abnormal menstrual bleeding, and pelvic pain after the sterilization procedure.
•   To explore the association of baseline pain condition on the pelvic pain diagnosis in the follow-up period regardless of type of sterilization procedure
•   To explore the association of baseline abnormal menstrual bleeding on abnormal menstrual bleeding diagnosis in the follow-up period regardless of type of sterilization procedure

Key Participants Requirements

Sex

Female

Age

18 - 49 Years

Inclusion Criteria
Patients will be included in the study if they:
- had ≥1 claim for a hysteroscopic sterilization procedure or interval laparoscopic tubal ligation during the identification period (01JUL2009–31DEC2010). The index date will be designated as the first procedure claim date during the identification period for interval laparoscopic tubal ligation or hysteroscopic sterilization procedure;
- were aged 18 through 49 years on the index date;
- had 6 months of continuous medical and pharmacy benefits pre-index date (baseline period) to capture all patient characteristics prior to the procedure; and
- had 24 months of continuous medical and pharmacy benefits post-index date (follow-up period).
Exclusion Criteria
Women will be excluded from the study if they:
- underwent a postpartum tubal ligation procedure during the entire study period;
- had claims of sterilization procedures during the baseline period;
- had a claim for pregnancy or delivery within 6 weeks prior to the index date;
- had ≥1 type of sterilization procedure (ie, a combination of hysteroscopic sterilization, laparoscopic tubal ligation, or mini-laparotomy) on the same index date;
- had concurrent procedures on the same day as the index sterilization procedure that were performed for reasons beyond the purpose of sterilization.
- had modifier code 53 (indicating a failed index procedure only present in the Medicaid dataset) next to the procedure code on index date.

Trial summary

Enrollment Goal

14804

Trial Dates

November 2016 - January 2017

Phase

N/A

Could I Receive a placebo

N/A

Products

Essure (ESS305, BAY1454032)

Accepts Healthy Volunteer

N/A

Primary Outcome

Proportion of women undergoing hysterectomy within 24 months post-index
Time Frame:
Within 24 months post-index
Proportion of women diagnosed with pelvic pain within 24 months post-index
Time Frame:
Within 24 months post-index
Proportion of women diagnosed with abnormal menstrual bleeding within 24 months post-index
Time Frame:
Within 24 months post-index

Secondary Outcome

Odds ratio (OR) of those who had hysterectomy, abnormal menstrual bleeding, and pelvic pain
Time Frame:
At 12-month and 24-month follow-up periods
Association of baseline pain condition on pelvic pain diagnosis in the follow-up period regardless of type of sterilization procedure
Time Frame:
At baseline and follow-up period
Association of baseline abnormal menstrual bleeding on abnormal menstrual bleeding diagnosis in the follow-up period regardless of type of sterilization procedure
Time Frame:
At baseline and follow-up period

Trial design

Trial Type

Observational

Intervention Type

N/A

Trial Purpose

N/A

Allocation

N/A

Blinding

N/A

Assignment

N/A

Trial Arms

N/A

Additional Information

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