Effect of Implantable Progestin-only Contraception on the Incidence of Type 2 Diabetes and Metabolic Syndrome in Thai Women With History of Gestational Diabetes
试验速览
- 阶段
- 不适用
- 入组人数
- 260
- 试验地点
- 2
- 主要终点
- Diabetes mellitus
研究概览
简要总结
The purpose of this study is to determine the effect of implantable contraception on the incidence of diabetes mellitus in women with history of gestational diabetes mellitus comparing with those using nonhormonal contraceptives.
详细描述
Gestational diabetes mellitus (GDM) was defined as abnormal glucose tolerance detected for the first time in pregnancy. GDM is a well-known risk factor for developing overt diabetes later in life, especially type 2 diabetes. About 50-60% of woman with prior GDM will develop type 2 diabetes during their lifetime. Recent studies show that women with previous GDM exhibit a markedly increased prevalence of the metabolic syndrome, even when glucose tolerance is normal. For both maternal and future offspring, women with prior GDM need safe, efficient, and acceptable choices for contraceptive methods that do not enhance their already substantial risk to develop either overt diabetes or metabolic syndrome and associated sequelae. The intrauterine device (IUD) is a very effective and reversible contraceptive method without metabolic disturbances and therefore is an ideal contraceptive for women with prior GDM. Progestins do not increase globulin production; thus, they do not increase coagulation factors or blood pressure. A nonrandomized open-label prospective trial of healthy obese, reproductive-age women in California were studied about the metabolic effects of progestin-only long-acting reversible contraception levonorgestrel-releasing intrauterine system (LNG-IUS) and etonogestrel implant (ENG-I)] comparing with nonhormonal contraception (NHC). The changes in fasting glucose and insulin sensitivity were seen among obese at 3 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Postpartum women with diagnosis of gestational diabetes mellitus
- •Want to use implant contraception or nonhormonal contraceptions such as IUD or tubal sterilization
排除标准
- •Age less than 18 years old
- •Diagnosis of diabetes mellitus at post partum period
- •Cardiovascular disease, Liver disease, autoimmune disease
- •The women that reject to continue in the study.
结局指标
主要结局
Diabetes mellitus
时间窗: 5 years
Incidence of type-2 DM in women with history of gestational diabetes using implantable contraception.
次要结局
- metabolic syndrome(5 years)
研究者
Manee Rattanachaiyanont
Department of Obstetrics and Gynecology, Faculty of Medicine Siriraj Hospital
Mahidol University
