The Important Project of Obese Pregnant Women

NCT05160662 | Unknown

• 1 other identifier: 102030
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight and Obesity

Keywords

BMI, obesity

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Women with BMI>=35 (2019-2020)

NO INTERVENTION

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

Women with BMI>=35 (2021-2023)

EXPERIMENTAL

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

Procedure: New guidlines

Interventions

New guidlines PROCEDURE

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

Women with BMI>=35 (2021-2023)

Eligibility Criteria

• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Pregnant women with BMI\<35

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Eva Wiberg-Itzel

Stockholm, 18239, Sweden

RECRUITING

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Eva wiberg-itzel

  Karolinska Institute Sodersjukhuset Sweden

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eva Wiberg-Itzel

CONTACT

+46708775346; eva.itzel@telia.comeva@itzel.eu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: 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)

Study Record Dates

• First Submitted: November 21, 2021
• First Posted: December 16, 2021
• Study Start: August 1, 2021
• Primary Completion: July 30, 2023
• Study Completion: August 1, 2023
• Last Updated: January 6, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)