"Important Project," a Prospective Cohort Study on Pregnant Women With BMI>=35
试验速览
- 阶段
- 不适用
- 入组人数
- 600
- 试验地点
- 2
- 主要终点
- Change in unnecessary interventions
研究概览
简要总结
Obesity is a globally growing public health problem. In 1993, about 25% of women in Sweden were overweight (BMI over 25) or obese (BMI over 30) on the first visit to maternal health care. Twenty years later, in 2013, the corresponding proportion was 38%. Being fat increases the risk of several severe complications during pregnancy and childbirth, such as miscarriage, premature birth, congenital disabilities, intrauterine fetal death, thromboembolism, gestational diabetes, pregnancy-induced hypertension.
Purpose of the project: To assess whether the introduction of new guidelines for overweight pregnant women (BMI>35) affects the outcome of pregnancy and childbirth, such as the frequency of cesarean sections or labor inductions.
详细描述
A prospective cohort study involving all women with a BMI >35 who give birth at the women's clinic, Soder Hospital, Stockholm, between 2019-2023. New guidelines for this group are being developed using NICEguidelines (UK) as a model and will be tested in clinical practice.
Information from births will be collected from medical files. The information will be handled on a group basis.
Internationally, there are guidelines for how pregnancy should be handled when a woman has a high BMI. This is currently lacking in Swedish maternity care. These international guidelines have now been translated and adapted to Swedish conditions and will be tested for a 2 year period at the women's clinic.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •: Pregnancy where the woman has a BMI>=35 when enrolling to prenatale care
排除标准
- •Pregnant women with BMI<35
结局指标
主要结局
Change in unnecessary interventions
时间窗: through study completion, an average of 2 years
To assess whether the introduction of new guidelines for the group of overweight pregnant women (BMI\>35) affects outcomes such as the frequency of cesareans sections or induction of labor
次要结局
未报告次要终点
研究者
Eva Wiberg-Itzel
Associate professor
Karolinska Institutet