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

Bayer0 个研究点目标入组 19,317 人开始时间: 2015年7月30日最近更新: 2017年3月21日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: Bayer
入组人数: 19,317
主要终点: Proportion of women undergoing hysterectomy after hysteroscopic sterilization or laparoscopic tubal ligation

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

The research questions are:

What is the proportion of women undergoing hysterectomy after hysteroscopic sterilization or laparoscopic tubal ligation?
What is the proportion of women undergoing salpingectomy, salpingostomy, or hysteroscopy after hysteroscopic sterilization or laparoscopic tubal ligation?
What is the proportion of women who have a diagnosis of pelvic pain after hysteroscopic sterilization or laparoscopic tubal ligation?

研究设计

研究类型: Observational
观察模型: Cohort
时间视角: Retrospective

入排标准

年龄范围: 18 Years 至 49 Years（Adult）
性别: Female
接受健康志愿者: 否

入选标准

•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)

排除标准

•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

结局指标

主要结局

Proportion of women undergoing hysterectomy after hysteroscopic sterilization or laparoscopic tubal ligation

时间窗: Within 12 months after the procedure

次要结局

Proportion of women undergoing salpingectomy after hysteroscopic sterilization or laparoscopic tubal ligation(Within 12 months after the procedure)
Proportion of women undergoing hysteroscopy after hysteroscopic sterilization or laparoscopic tubal ligation(Within 12 months after the procedure)
Proportion of women undergoing salpingostomy after hysteroscopic sterilization or laparoscopic tubal ligation(Within 12 months after the procedure)
Proportion of women who have a diagnosis of pelvic pain after hysteroscopic sterilization or laparoscopic tubal ligation(Within 12 months after the procedure)

研究者

发起方

Bayer

申办方类型

Industry

责任方

Sponsor

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