The Important Project of Obese Pregnant Women

Not Applicable

• Conditions: Overweight and Obesity
• Interventions: Procedure: New guidlines

• Registration Number: NCT05160662
• Lead Sponsor: Karolinska Institutet

Brief 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.

Study Timeline

• Study Start: 2021-08-01
• Study First Submitted: 2021-11-21
• Status Verified: 2021-12
• Study First Submitted QC: 2021-12-02
• Study First Posted: 2021-12-16
• Last Update Submitted: 2021-12-16
• Last Update Posted: 2022-01-06
• Primary Completion: 2023-07-30
• Study Completion: 2023-08-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 600

Inclusion Criteria

• : Pregnancy where the woman has a BMI>=35 when enrolling to prenatale care

Exclusion Criteria

• Pregnant women with BMI<35

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Women with BMI>=35 (2021-2023)	New guidlines	Pregnant women with BMI\>=35 delivered at the hospital 2021-2023

Primary Outcome Measures

Name	Time	Method
Change in unnecessary interventions	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

Trial Locations

Locations (1)

Eva Wiberg-Itzel; 🇸🇪 Stockholm, Sweden