The Important Project of Obese Pregnant Women

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Important Project, a Prospective Cohort Study on Pregnant Women With BMI>=35

Conditions
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Overweight and Obesity

Intervention / Treatment
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* Procedure: New guidlines


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: : Pregnancy where the woman has a BMI>=35 when enrolling to prenatale care Exclusion Criteria: Pregnant women with BMI<35
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: A prospective cohort study involving all women with a BMI >35 who give birth at the women's clinic, between 2019-2023. New guidelines for this group are being developed using NICE guidelines (UK) as a model and will be tested in clinical practice The material will be grouped into: Women with BMI>=35 delivered at the hospital 2019-2020 (control group) Women with BMI>=35 delivered at the hospital 2021-2023 (where new guidelines have been used)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Women with BMI>=35 (2019-2020)<br>Pregnant women with BMI>=35 delivered at the hospital 2019-2020 | |
| Experimental: Women with BMI>=35 (2021-2023)<br>Pregnant women with BMI>=35 delivered at the hospital 2021-2023 | Procedure: New guidlines<br>* New guidelines for this group are being developed using NICE guidelines (evidence-based recommendations for health and care in England) as a model and will be tested in clinical practice<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in unnecessary interventions | 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 | through study completion, an average of 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BMI, obesity