Intensive Lifestyle Intervention on Gestational Weight Gain and Development of Gestational Diabetes Mellitus in Overweight/Obese Pregnant Women With a History of Polycystic Ovarian Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 296
- 试验地点
- 2
- 主要终点
- Gestational weight gain
研究概览
简要总结
Polycystic ovarian syndrome (PCOS) is the most common reproductive disorder in women of childbearing age and is also associated with metabolic abnormalities including obesity, type 2 diabetes, dyslipidemia, etc. Importantly, a number of adverse outcome are seen in pregnancies complicated by PCOS, including gestational diabetes mellitus (GDM), preeclampsia and miscarriage. However, optimal management of PCOS complicated pregnancy is not known. This study seeks to explore whether healthy lifestyle intervention in overweight/obese pregnant women with PCOS could reduce gestational weight gain (GWG) and incidence of GDM.
详细描述
A randomized controlled trial in PCOS pregnant women will be initiated at 8-12 weeks of gestation util delivery. Participants will be randomly assigned to the control group (standard care) or the intervention group (intensive lifestyle intervention). The intervention will focus on restricting energy intake combined with behavioral lifestyle modification through participation in group sessions and individual counseling. The primary outcome will be GWG and secondary outcome will be the incidence of GDM.
Our hypothesis is that intensive lifestyle intervention in overweight/obese pregnant women with PCOS will decrease GWG and reduce the incidence of GDM.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •gestational age between 8 and 12 weeks of gestation, pre-pregnancy BMI≥25 (kg/m2)
- •age ≥18 years, and a singleton pregnancy.
排除标准
- •patients with prediabetes and diabetes, hypertension, chronic renal disease, thyroid disorder
- •gestational weeks ≥ 13
- •age <18 years
- •multiple pregnancy
- •uterine malformation
- •or physical restriction that prevents exercise.
结局指标
主要结局
Gestational weight gain
时间窗: From date of randomization until the date of delivery, assessed up to 9 months
次要结局
- Incidence of Gestational Diabetes Mellitus(From enrollment to 24-28 weeks of gestation)
研究者
Guanghui Li
Associate Professor
Capital Medical University