NCT05160662

The Important Project of Obese Pregnant Women

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: Karolinska Institutet · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Overweight and Obesity

Interventions

Type	Name	Description
PROCEDURE	New guidlines	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

Timeline

• Start date: 2021-08-01
• Primary completion: 2023-07-30
• Completion: 2023-08-01
• First posted: 2021-12-16
• Last updated: 2022-01-06

Locations

1 site across 1 country: Sweden