PregnancyNCT07182318
Validation of the FIGO Nutrition Checklist in Pregnant Women
An observational study of Pregnancy and Nutrition, run by Medical University of Lublin at 1 site in Poland.
Trial summary
The aims of this study were to verify the test-retest reproducibility of FIGO Nutrition Checklist as well as evaluate dietary habits of pregnant women in the third trimester. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- What is being tested?
- The FIGO Nutrition Checklist
- How many people
- 120 participants
- Where
- 1 sitePoland
- Study dates
- 1 Mar 2024to 5 May 2025
- How long will I take part?
- 3 Days
- Phase
- Observational
- 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 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Study population: either outpatients attending the obstetrics clinic or inpatients at the Department of Obstetrics and Gynecology at the Independent Public Health Care Facility in Puławy
Who may be able to join
- gestational age was 35 weeks ± 3 days.
Who cannot join
- terminal disease of the baby
- diabetes
- severe hypertension
- IUGR
Trial locations and contacts
1 site in 1 country.
Poland1 site
Samodzielny Publiczny Zakład Opieki Zdrowotnej w Puławach
Puławy, 24-100
About this study
Official title: Validation and Application of the FIGO Nutrition Checklist in the Third Trimester Pregnant Women.
The aims of this study were to verify the test-retest reproducibility of FIGO Nutrition Checklist as well as evaluate dietary habits of pregnant women in the third trimester.
Read the detailed description
The FIGO Nutrition Checklist was developed to evaluate nutrient intake in both the preconception and gestational periods. It allows to identify inadequate diets as well as provides feedback to women on their dietary habits. The questionnaire is available in several lenguages including polish.
The checklist employs a binary response format-"Yes" or "No." Negative responses may indicate potential nutritional deficits requiring further evaluation.
- Being tested
- The FIGO Nutrition Checklist
- Keywords
- pregnancy, nutrition, child health, maternal health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The FIGO Nutrition ChecklistDiagnostic test
Also called The FIGO Nutrition Checklist after 2-3 days
patient fulfilled the questionnaire twice. period of time 2-3 days
| Study group | Role | What they receive |
|---|---|---|
| third trimester pregnant women | ither outpatients attending the obstetrics clinic or inpatients at the Department of Obstetrics and Gynecology at the Independent Public Health Care Facility in Puławy. Receives: Diagnostic Test: The FIGO Nutrition Checklist | |
| At the time of dietary assessment, the mean gestational age was 35 weeks ± 3 days | Not described Receives: Diagnostic Test: The FIGO Nutrition Checklist |
What is being measured
The primary outcome is the main question the study is designed to answer.
test-retest reproducibility
In most questions of the polish version of FIGO Nutrition Checklist the test-retest reproducibility was very good or excellent. Number patients who changed answers between the first and the second asssesment varied from 0 to 12.5%. The minimum-0% and maximum values-100%. The differences were not statistically significant (McNemar's test)
Measured: 2 to 3 days between fulfillment of the questionnaire
Secondary outcomes (1)
An analysis of dietary habits was conducted using the FIGO Nutrition Checklist.
The dietary habits of the pregnant participants were analyzed using the FIGO Nutrition Checklist, with a focus on the consumption of specific food groups. The questionnaire comprises four sections: dietary requirements, anthropometric measurements (including body weight and height), and six questions assessing diet quality. The final section evaluates folic acid supplementation, sunlight exposure, and indicators of anemia among respondents. The checklist uses a binary response format ("Yes" or "No"), where negative responses may indicate potential nutritional deficiencies that warrant further assessment.
Measured: 2-3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2025
- Study start1 Mar 2024
- Primary completion1 Mar 2025
- Study completion5 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
- Target duration
- 3 Days
Sponsor and investigators
- Lead sponsor
- Medical University of Lublin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katarzyna Skorupska, Medical University of Lublin
- Investigators
- Michał Bogusiewicz, Professor, Study director, Medical University of Lublin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07182318
- Sponsor's protocol ID
- 01/2025
- Status last verified
- Sep 2025
- First submitted
- 4 Sep 2025
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: we plan to publish the data
Publications
International Federation of Gynecology and Obstetrics (FIGO). FIGO Nutrition Checklist: A tool for assessing nutrition in women of reproductive age. International Journal of Gynecology & Obstetrics, 2017: 137(2), 218-223
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation and Application of the FIGO Nutrition Checklist in the Third Trimester Pregnant Women.
- ClinicalTrials.gov ID
- NCT07182318
- Acronym / sponsor ID
- 01/2025
- Keywords
- pregnancy, nutrition, child health, maternal health
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Medical University of LublinUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 5 May 2025 (actual)
- First posted
- 19 Sep 2025 (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.
The aims of this study were to verify the test-retest reproducibility of FIGO Nutrition Checklist as well as evaluate dietary habits of pregnant women in the third trimester.
Detailed description
The FIGO Nutrition Checklist was developed to evaluate nutrient intake in both the preconception and gestational periods. It allows to identify inadequate diets as well as provides feedback to women on their dietary habits. The questionnaire is available in several lenguages including polish.
The checklist employs a binary response format-"Yes" or "No." Negative responses may indicate potential nutritional deficits requiring further evaluation.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 3 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| third trimester pregnant women | – | Diagnostic Test: The FIGO Nutrition Checklistither outpatients attending the obstetrics clinic or inpatients at the Department of Obstetrics and Gynecology at the Independent Public Health Care Facility in Puławy. |
| At the time of dietary assessment, the mean gestational age was 35 weeks ± 3 days | – | Diagnostic Test: The FIGO Nutrition Checklist |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- either outpatients attending the obstetrics clinic or inpatients at the Department of Obstetrics and Gynecology at the Independent Public Health Care Facility in Puławy
Key inclusion criteria (1 listed)
- gestational age was 35 weeks ± 3 days.
Key exclusion criteria (4 listed)
- terminal disease of the baby
- diabetes
- severe hypertension
- IUGR
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 |
|---|---|---|
| The FIGO Nutrition ChecklistAlso: The FIGO Nutrition Checklist after 2-3 dayspatient fulfilled the questionnaire twice. period of time 2-3 days | Diagnostic test | At the time of dietary assessment, the mean gestational age was 35 weeks ± 3 days, third trimester pregnant women |
Primary outcome
test-retest reproducibility
Time frame: 2 to 3 days between fulfillment of the questionnaire
In most questions of the polish version of FIGO Nutrition Checklist the test-retest reproducibility was very good or excellent. Number patients who changed answers between the first and the second asssesment varied from 0 to 12.5%. The minimum-0% and maximum values-100%. The differences were not statistically significant (McNemar's test)
1 secondary outcome
An analysis of dietary habits was conducted using the FIGO Nutrition Checklist.
Time frame: 2-3 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
- BackgroundInternational Federation of Gynecology and Obstetrics (FIGO). FIGO Nutrition Checklist: A tool for assessing nutrition in women of reproductive age. International Journal of Gynecology & Obstetrics, 2017: 137(2), 218-223
- Individual participant dataSharing planned: Yes. we plan to publish the data
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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.
Michał Bogusiewicz, Professor study director
Medical University of Lublin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy and Nutrition, run by Medical University of Lublin at 1 site in Poland.
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 4 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: finished, as of the sponsor's last update on 19 Sep 2025. 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 Poland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
test-retest reproducibility (time frame: 2 to 3 days between fulfillment of the questionnaire). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07182318, which also lists 1 linked publication.
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 19 Sep 2025.