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The Important Project of Obese Pregnant Women

Primary Purpose

Overweight and Obesity

Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
New guidlines
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Overweight and Obesity focused on measuring BMI, obesity

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnant women with BMI<35

Sites / Locations

  • Eva Wiberg-ItzelRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Women with BMI>=35 (2019-2020)

Women with BMI>=35 (2021-2023)

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
November 21, 2021
Last Updated
December 16, 2021
Sponsor
Karolinska Institutet
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1. Study Identification

Unique Protocol Identification Number
NCT05160662
Brief Title
The Important Project of Obese Pregnant Women
Official Title
"Important Project," a Prospective Cohort Study on Pregnant Women With BMI>=35
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2021 (Actual)
Primary Completion Date
July 30, 2023 (Anticipated)
Study Completion Date
August 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity
Keywords
BMI, obesity

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Women with BMI>=35 (2019-2020)
Arm Type
No Intervention
Arm Description
Pregnant women with BMI>=35 delivered at the hospital 2019-2020
Arm Title
Women with BMI>=35 (2021-2023)
Arm Type
Experimental
Arm Description
Pregnant women with BMI>=35 delivered at the hospital 2021-2023
Intervention Type
Procedure
Intervention Name(s)
New guidlines
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in unnecessary interventions
Description
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
Time Frame
through study completion, an average of 2 years

10. Eligibility

Sex
Female
Gender Based
Yes
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: : Pregnancy where the woman has a BMI>=35 when enrolling to prenatale care Exclusion Criteria: Pregnant women with BMI<35
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eva Wiberg-Itzel
Phone
+46708775346
Email
eva.itzel@telia.comeva@itzel.eu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eva wiberg-itzel
Organizational Affiliation
Karolinska Institute Sodersjukhuset Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eva Wiberg-Itzel
City
Stockholm
ZIP/Postal Code
18239
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eva Wiberg-Itzel, Professor
Phone
+4686163768
Email
eva@itzel.eu
First Name & Middle Initial & Last Name & Degree
Eva Wiberg-Itzel, Professor

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Important Project of Obese Pregnant Women

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