Vitamin D and Angiogenic Markers in Odense Child Cohort 1: A Prospective Cohort Study on Their Role in Early Pregnancy Adverse Outcome
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 2,874
- 试验地点
- 1
- 主要终点
- Spontaneous Abortion
研究概览
简要总结
The Vitamin D and Angiogenic Marker Study 1:
Vitamin D and angiogenic markers in early pregnancy. Epidemiology and associations to early-pregnancy miscarriage
详细描述
Overall: The Odense Child Cohort Study (OCC) is a population-based cohort study, comprising pregnant women recruited between January 1st 2010 and December 31st 2012. All women who were pregnant in the municipality of Odense during this time were eligible for participation, and 6,707 women were approached directly with recruitment material.
The study complied with the Helsinki declaration and was approved by the Regional Scientific Ethical Committee for Southern Denmark, no. S-20090130. All participants gave informed consent. From a population base of 6,707 pregnant women, 2,874 (42.9%) enrolled in the OCC up to December 31st, 2012. The children will be followed until 18 years of age.
Serum samples were taken in early pregnancy (GA 2-25 weeks), late pregnancy (GA 26-30 weeks), maternal serum and cord blood at birth, and from the children along with general examinations at ages 3 months, 1 year, 3 years.
Questionnaires were completed by the families in early pregnancy, late pregnancy, after birth, and at the times of clinical examination of the children.
Register data on health variables were further available from the Danish registries.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant and residing in the municipality of Odense during 2010-2012
排除标准
- •Not residing in Odense, leaving the municipality
结局指标
主要结局
Spontaneous Abortion
时间窗: Outcome is assessed in gestational weeks 5+0 to 22+0.
Occurrence of spontaneous abortion, as diagnosed by transvaginal ultrasound in medical files. The time from inclusion in cohort to occurrance of spontaneous abortion was on average 13 days.
次要结局
未报告次要终点
研究者
Henrik Christesen
MD, PhD, Associate Professor
Odense University Hospital
