NCT07182318

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 5, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 4, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 19, 2025

Completed
Last Updated

September 19, 2025

Status Verified

September 1, 2025

Enrollment Period

1 year

First QC Date

September 4, 2025

Last Update Submit

September 11, 2025

Conditions

Keywords

pregnancynutritionchild healthmaternal health

Outcome Measures

Primary Outcomes (1)

  • 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)

    2 to 3 days between fulfillment of the questionnaire

Secondary Outcomes (1)

  • An analysis of dietary habits was conducted using the FIGO Nutrition Checklist.

    2-3 days

Study Arms (2)

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.

Diagnostic Test: The FIGO Nutrition Checklist

At the time of dietary assessment, the mean gestational age was 35 weeks ± 3 days

Diagnostic Test: The FIGO Nutrition Checklist

Interventions

patient fulfilled the questionnaire twice. period of time 2-3 days

Also known as: The FIGO Nutrition Checklist after 2-3 days
At the time of dietary assessment, the mean gestational age was 35 weeks ± 3 daysthird trimester pregnant women

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspregnant women
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
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

You may qualify if:

  • gestational age was 35 weeks ± 3 days.

You may not qualify if:

  • terminal disease of the baby
  • diabetes
  • severe hypertension
  • IUGR

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samodzielny Publiczny Zakład Opieki Zdrowotnej w Puławach

Puławy, 24-100, Poland

Location

Related Publications (1)

  • 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

    BACKGROUND

Study Officials

  • Michał Bogusiewicz, Professor

    Medical University of Lublin

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
3 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

September 4, 2025

First Posted

September 19, 2025

Study Start

March 1, 2024

Primary Completion

March 1, 2025

Study Completion

May 5, 2025

Last Updated

September 19, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will share

we plan to publish the data

Shared Documents
STUDY PROTOCOL, CSR
Time Frame
we plan to publish i 2025 year
Access Criteria
everybody who will read the publication

Locations