The Important Project of Obese Pregnant Women

Sponsor

Karolinska Institutet (Other)

Overall Status

Recruiting

CT.gov ID

NCT05160662

Collaborator

(none)

600

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Overweight and Obesity	Procedure: New guidlines	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

600 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Intervention 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)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 practiceThe 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)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Aug 1, 2021

Anticipated Primary Completion Date :

Jul 30, 2023

Anticipated Study Completion Date :

Aug 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Women with BMI>=35 (2019-2020) Pregnant women with BMI>=35 delivered at the hospital 2019-2020
Experimental: Women with BMI>=35 (2021-2023) Pregnant women with BMI>=35 delivered at the hospital 2021-2023	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

Arm

Intervention/Treatment

No Intervention: Women with BMI>=35 (2019-2020)

Pregnant women with BMI>=35 delivered at the hospital 2019-2020

Experimental: Women with BMI>=35 (2021-2023)

Pregnant women with BMI>=35 delivered at the hospital 2021-2023

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

Pregnant women with BMI<35

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Eva Wiberg-Itzel	Stockholm		Sweden	18239

Sponsors and Collaborators

Karolinska Institutet

Investigators

Principal Investigator: Eva wiberg-itzel, Karolinska Institute Sodersjukhuset Sweden

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Eva Wiberg-Itzel, Associate professor, Karolinska Institutet

ClinicalTrials.gov Identifier:

NCT05160662

Other Study ID Numbers:

102030

First Posted:

Dec 16, 2021

Last Update Posted:

Jan 6, 2022

Last Verified:

Dec 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Eva Wiberg-Itzel, Associate professor, Karolinska Institutet

BMI, obesity

Additional relevant MeSH terms:

Overweight

Study Results

No Results Posted as of Jan 6, 2022