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The Important Project of Obese Pregnant Women

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05160662
Enrollment
600
Registered
2021-12-16
Start date
2021-08-01
Completion date
2023-08-01
Last updated
2022-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overweight and Obesity

Keywords

BMI, obesity

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.

Interventions

PROCEDURENew 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

Sponsors

Karolinska Institutet
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

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)

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Pregnant women with BMI\<35

Design outcomes

Primary

MeasureTime frameDescription
Change in unnecessary interventionsthrough study completion, an average of 2 yearsTo 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

Countries

Sweden

Contacts

Primary ContactEva Wiberg-Itzel
eva.itzel@telia.comeva@itzel.eu+46708775346

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026