Overweight and ObesityNCT05160662
The Important Project of Obese Pregnant Women
A study testing New guidlines in people with Overweight and Obesity, run by Karolinska Institutet at 1 site in Sweden.
Trial 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%. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- New guidlines
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteSweden
- Study dates
- 1 Aug 2021to 1 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- : Pregnancy where the woman has a BMI>=35 when enrolling to prenatale care
Who cannot join
- Pregnant women with BMI<35
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Eva Wiberg-Itzel
Stockholm, 18239
Eva Wiberg-Itzel, Professor, +4686163768, eva@itzel.eu
Eva Wiberg-Itzel, Professor
About this study
Official title: "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.
Read the 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.
- Conditions
- Overweight and Obesity
- Being tested
- New guidlines
- Keywords
- BMI, obesity
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New guidlinesProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: New guidlines |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2021
- Study start1 Aug 2021
- Primary completion30 Jul 2023 (estimated)
- Study completion1 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- 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)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eva Wiberg-Itzel, Karolinska Institutet
- Investigators
- Eva wiberg-itzel, Principal investigator, Karolinska Institute Sodersjukhuset Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05160662
- Sponsor's protocol ID
- 102030
- Status last verified
- Dec 2021
- First submitted
- 21 Nov 2021
- Last updated
- 6 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Important Project," a Prospective Cohort Study on Pregnant Women With BMI>=35
- ClinicalTrials.gov ID
- NCT05160662
- Acronym / sponsor ID
- 102030
- Conditions
- Overweight and Obesity
- Keywords
- BMI, obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 30 Jul 2023 (estimated)
- Study completion
- 1 Aug 2023 (estimated)
- First posted
- 16 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- 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)
| Arm | Type | Receives |
|---|---|---|
| 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 | Procedure: New guidlinesPregnant women with BMI>=35 delivered at the hospital 2021-2023 |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- : Pregnancy where the woman has a BMI>=35 when enrolling to prenatale care
Key exclusion criteria (1 listed)
- Pregnant women with BMI<35
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| New guidlinesNew 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 | Procedure or surgery | Women with BMI>=35 (2021-2023) |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eva wiberg-itzel principal investigator
Karolinska Institute Sodersjukhuset Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing New guidlines in people with Overweight and Obesity, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eva Wiberg-Itzel (+46708775346, eva.itzel@telia.comeva@itzel.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in unnecessary interventions (time frame: through study completion, an average of 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2022.