Metabolic Profile of Users of Hormonal and Non-hormonal Contraceptives, 5-year Follow-up
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 489
- 试验地点
- 1
- 主要终点
- Body Mass Index
研究概览
简要总结
Evaluation of metabolic profile of users of hormonal and non-hormonal contraceptives during five years follow-up
详细描述
Were eligible for the study 489 Women, followed in Federal University of São Paulo Family Planning Service, who used the same contraceptive method during five year of follow-up, According to the service protocol, the patients, after had participated of a orientation group about contraceptives methods, elected one of them. After that, if the choice had been according to the eligibility criteria of World Health Organization, it was approved by a gynecologist.
The contraceptive methods available were the intrauterine device (IUD) oral contraceptives, including combined pills and progestin-only formulations, and depot medroxyprogestereone acetate.
The study consisted in the evaluation of their medical records of weight, BMI, Blood pressure, glycemia, seric levels of cholesterol and triglycerides, during the five years, and in the comparison of the differences of these data between the contraceptive methods.
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 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •women in reproductive age followed in Federal university of Sao Paulo Family Planning Service
- •use of the same contraceptive method during five years
排除标准
- •incomplete data
研究组 & 干预措施
Non-hormonal contraceptive
Users of non- hormonal intrauterine device during the 5 years follow-up
干预措施: Intrauterine device (Device)
Hormonal contraceptives
Users of combined oral contraceptive, progestin-only pills, depot-medroxyprogestereone acetate during 5 years follow-up
干预措施: Combined Oral Contraceptive (Drug)
Hormonal contraceptives
Users of combined oral contraceptive, progestin-only pills, depot-medroxyprogestereone acetate during 5 years follow-up
干预措施: Progestin-only pills (Drug)
Hormonal contraceptives
Users of combined oral contraceptive, progestin-only pills, depot-medroxyprogestereone acetate during 5 years follow-up
干预措施: Depot-Medroxyprogestereone Acetate (Drug)
结局指标
主要结局
Body Mass Index
时间窗: five years follow-up
evaluation of variation of body mass index during the usage of hormonal and non-hormonal contraceptives
次要结局
- glycemia(five years follow-up)
- cholesterol level(five years follow-up)
- triglycerides level(five years follow-up)
研究者
Ana Maria Homem de Mello Bianchi
PhD
Federal University of São Paulo