The Important Project of Obese Pregnant Women

December 16, 2021 updated by: Eva Wiberg-Itzel, Karolinska Institutet

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Sweden
      • Stockholm, Sweden, 18239
        • Recruiting
        • Eva Wiberg-Itzel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnant women with BMI<35

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in unnecessary interventions
Time Frame: 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
through study completion, an average of 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2021

Primary Completion (Anticipated)

July 30, 2023

Study Completion (Anticipated)

August 1, 2023

Study Registration Dates

First Submitted

November 21, 2021

First Submitted That Met QC Criteria

December 2, 2021

First Posted (Actual)

December 16, 2021

Study Record Updates

Last Update Posted (Actual)

January 6, 2022

Last Update Submitted That Met QC Criteria

December 16, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 102030

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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