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Retrospective Claims Analysis of Hysterectomy After Sterilization

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02527278
Enrollment
19317
Registered
2015-08-18
Start date
2015-07-30
Completion date
2016-02-09
Last updated
2017-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Contraception

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?

Interventions

Female permanent birth control method performed via a surgical procedure

PROCEDUREHysteroscopic sterilization

Female permanent birth control method performed via placement of a device

Sponsors

Bayer
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 49 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Proportion of women undergoing hysterectomy after hysteroscopic sterilization or laparoscopic tubal ligationWithin 12 months after the procedure

Secondary

MeasureTime frame
Proportion of women undergoing salpingectomy after hysteroscopic sterilization or laparoscopic tubal ligationWithin 12 months after the procedure
Proportion of women undergoing salpingostomy after hysteroscopic sterilization or laparoscopic tubal ligationWithin 12 months after the procedure
Proportion of women undergoing hysteroscopy after hysteroscopic sterilization or laparoscopic tubal ligationWithin 12 months after the procedure
Proportion of women who have a diagnosis of pelvic pain after hysteroscopic sterilization or laparoscopic tubal ligationWithin 12 months after the procedure

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026