The Important Project of Obese Pregnant Women

Overweight and Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05160662
• Other study ID #: 102030
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2021
• Est. completion date: August 1, 2023

Study information

• Verified date: December 2021
• Source: Karolinska Institutet
• Contact: Eva Wiberg-Itzel
• Phone: +46708775346
• Email: eva.itzel[@]telia.comeva[@]itzel.eu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: August 1, 2023
• Est. primary completion date: July 30, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Pregnant women with BMI<35

Related Conditions & MeSH terms

• Overweight
• Overweight and Obesity

Intervention

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

Locations

Country	Name	City	State
Sweden	Eva Wiberg-Itzel	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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