Clinical trial NCT02527278: Retrospective Claims Analysis of Hysterectomy After Sterilization
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Contraception
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2015-08-18
Enrollment: 19317
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women aged 18 - 49 at the time of the sterilization procedure from an administrative claims database

Brief summary: 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?


Eligibility criteria: 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

Primary outcomes:
measure: Proportion of women undergoing hysterectomy after hysteroscopic sterilization or laparoscopic tubal ligation
timeFrame: Within 12 months after the procedure
Secondary outcomes:
measure: Proportion of women undergoing salpingectomy after hysteroscopic sterilization or laparoscopic tubal ligation
timeFrame: Within 12 months after the procedure
measure: Proportion of women undergoing salpingostomy after hysteroscopic sterilization or laparoscopic tubal ligation
timeFrame: Within 12 months after the procedure
measure: Proportion of women undergoing hysteroscopy after hysteroscopic sterilization or laparoscopic tubal ligation
timeFrame: Within 12 months after the procedure
measure: Proportion of women who have a diagnosis of pelvic pain after hysteroscopic sterilization or laparoscopic tubal ligation
timeFrame: Within 12 months after the procedure
Other outcomes:
Locations:
city: Whippany
country: United States
state: New Jersey
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: