GraviD-child Follow-up of the Children´s Health, Growth and Development Within the GraviD-study

NCT ID: NCT05228925

Last Updated: 2023-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

172 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-01

Study Completion Date

2023-02-14

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

GraviD is a multi-ethnic population-based pregnancy cohort. Pregnant women were invited to participate in the GraviD study when registering for antenatal care in parts of the region of Västra Götaland in Sweden in 2013-2014. All women registering for antenatal care were eligible for inclusion, as long as the pregnancy had not exceeded 16 gestational weeks. In total, 2125 pregnant women were recruited in gestational week 12 during two time-periods; fall 2013 and spring 2014. Blood sampling was performed in gestational week \<17 and again at gestational week \>31 by midwifes. After delivery, the maternity records were obtained, to collect information on child's gender, birth weight and length and other possible birth outcomes.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

In the GraviD-child study, all healthy singleton children born within the GraviD study will be invited to participate in a single clinical follow up. The follow-up will be conducted when all children are between 7-8 years of age. The study centre is located at the Queen Silvia Children´s hospital in Gothenburg, Sweden. The follow up consist of several parts:

1. Measurement of body weight and height, and waist circumference.
2. A questionnaire regarding health, physical activity, sleeping habits and diet.
3. Endothelial function, a measure of how well the blood vessels dilute.
4. Ultra sound of the thickness of the vessels on the neck, wrist and foot
5. Pulse wave velocity, to measure the elasticity of the vessels on the neck and groin.
6. Body composition using bioelectrical impedance.
7. Blood pressure
8. A venous blood sample of maximum 18 ml will be drawn to analyze markers of cardiovascular health. Blood lipids (total cholesterol, triglycerides, HDL cholesterol, LDL cholesterol), lipoprotein A, apolipoproteins (Apo A1 and Apo B), liver enzymes, glucose, insulin, HbA1c, c-reactive protein, leptin, adiponectin, nutritional biomarkers (such as 25-hydroxyvitamin D) will be analyzed.

The study hypothesis is that a low maternal vitamin D status increase the risk of an unfavorable child cardiometabolic risk profile, vascular health and body composition.

Recruitment start in January 2022 and will run for about a year.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Vitamin D Deficiency Body Composition Vascular Health Cardiometabolic Risk

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Maternal vitamin D status

Maternal vitamin D status (serum 25-hydroxyvitamin D) was collected during the GraviD study, while the woman was pregnant with the child now being followed-up in the GraviD-child study

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Born within the GraviD study
* Healthy
* Singleton

Exclusion Criteria

* Chromosomal abnormality
* Hyper-/Hypothyroidism
Minimum Eligible Age

7 Years

Maximum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Sahlgrenska University Hospital

OTHER

Sponsor Role collaborator

Norwegian Institute of Public Health

OTHER_GOV

Sponsor Role collaborator

Göteborg University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Hanna Augustin, Ass Prof

Role: PRINCIPAL_INVESTIGATOR

Göteborg University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Queen Silvia Children's Hospital

Gothenburg, , Sweden

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Sweden

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2018-00441

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Glycated Albumin in Pregnancy
NCT03372824 COMPLETED