Foetal Exposure and Epidemiological Transition: Role of Anaemia in Early Life for Non-communicable Diseases Later
NCT ID: NCT02191683
Last Updated: 2019-09-30
Study Results
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.
COMPLETED
1748 participants
OBSERVATIONAL
2014-07-31
2018-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
1. Anaemia, which is frequent before conception as well as during early pregnancy, affects metabolism and foetal growth trajectories, influencing the risk of NCDs in the offspring.
2. Anaemia from conception till end of 2nd trimester is most detrimental for foetal and newborns' health, compared to 3rd trimester anaemia.
3. Anaemia from conception till end of 2nd trimester affects foetal and newborns health through poor placental development reflected in increased villous branching and changed umbilical and uterine blood flow.
4. Anaemia in early pregnancy disrupts the vascular endothelial growth factor A (VEGF-A)/placental growth factor (PlGF) balance and the insulin-like growth factor (IGF) axis resulting in poor placental development, and poor health of newborns. This may be reflected in specific methylation patterns.
5. Anaemia's impact on the risk for NCDs in the offspring may be mediated via epigenetic mechanisms, including changes in DNA methylation patterns.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Iron Metabolism Parameters At First Trimester and preGnancy outcomE
NCT03176147
Early Detection of Anaemia During the Maternity
NCT00827463
Maternal Iron Deficiency and Childhood Health
NCT06879080
Prevalence Study of the Etiology of Pregnancy Anemia
NCT03448432
The Efficacy of Intermittent Versus Daily Oral Iron Supplementation in Anaemic Pregnant Women.
NCT05278793
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
1. Characterize the health of women aged 18-40 years before conception and during pregnancy, focusing on prevalence of anaemia, infections, nutritional status, and Non-Communicable Diseases (NCDs).
2. Describe how 1st and 2nd trimester anaemia compared to 3rd trimester anaemia alters foetal growth and newborns' body composition.
3. Evaluate how 1st and 2nd trimester anaemia compared to 3rd trimester anaemia affects villous branching in the placenta, as well as uterine and umbilical artery blood flow.
4. Characterize how 1st, 2nd and 3rd trimester anaemia differentially changes the vascular endothelial growth factor A (VEGF-A)/placental growth factor (PlGF) balance and the insulin-like growth factor axis.
5. Determine which markers for foetal programming such as methylation of regulatory genes related to metabolism and haematopoiesis may be discovered early after exposure to anaemia in1st and 2nd trimester compared to 3rd trimester anaemia.
Outcome parameter for the pre-pregnancy study (i.): 1) Prevalence and severity of anaemia among non-pregnant Tanzanian women at fertile age and their nutritional status. 2) Incidence of conception among such women.
Outcome parameter for the pregnancy study (ii.): 1) Foetal growth rate in 2nd and 3rd trimester in offspring of anaemic mothers vs Foetal growth rate in non-anaemic mothers' offspring, 2) Comparison of anaemic mothers' vs non-anaemic mothers' newborn's body composition, placental villous branching, umbilical and uterine blood flow, VEGF-A/PlGF levels, and insulin-like growth factor axis.
For all analyses main exposure variable will be anaemia (Hb\<5mmol/L) in 1st, 2nd and/or3rd trimester of pregnancy. Confounding exposure variables will be chronic health conditions (e.g. HIV), all temporary conditions mentioned above (e.g. malaria) as well as socioeconomic status and paternal characteristics. Regression modelling using both multiple linear and logistic regressions as well as modelling for repeated measures will be used for statistical analyses. For genetic and epigenetic changes, findings in the subgroup of 180 other/newborns, remaining significant after correction for multiple comparisons, will be validated in the remaining cohort. This will enable us within one study to replicate initial findings in one representative and distinct subgroup in another larger comparable study group from an overall homogenous study. Indeed, findings surviving both corrections for multiple testing in the initial hypothesis generating array approaches, as well as being replicated in the remaining study group with single target validation techniques, are highly likely to be biological important. Possible findings from the candidate gene approach will be corrected for multiple testing and the significant results will be compared with previous findings of the same genes from studies in muscle and adipose tissue conducted by Diabetes and Metabolism, Copenhagen University Hospital.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
OTHER
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Health of women before conception
Tanzanian women aged 18-40 years focusing on prevalence of anaemia, infections, nutritional status, and NCDs.
No interventions assigned to this group
480 women during pregnancy
Describe how 1st and 2nd trimester anaemia compared to 3rd trimester anaemia alters foetal growth and newborns' body composition.
Evaluate anaemia's effect on villous branching in placenta, and uterine and umbilical artery blood flow.
Evaluate effect on vascular endothelial growth factor A/placental growth factor balance and insulin-like growth factor axis.
Determine which markers for foetal programming such as methylation of regulatory genes related to metabolism and haematopoiesis may be discovered early after exposure to anaemia.
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* negative pregnancy test
* not using family planning
Exclusion Criteria
* being pregnant
* using family planning
18 Years
40 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Copenhagen University Hospital, Denmark
OTHER
Aarhus University Hospital
OTHER
Lund University
OTHER
National Institute for Medical Research, Tanzania
OTHER_GOV
Department of Clinical Pathology Naestved Hospital Denmark
UNKNOWN
University of Copenhagen
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Ib Christian Bygbjerg
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Mwelecele N Malecela, PHd
Role: STUDY_CHAIR
National Institute for Medical Research, Tanzania
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
National Institute for Medical research
Korogwe, Tanga, Tanzania
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Hatem G, Hjort L, Asplund O, Minja DTR, Msemo OA, Moller SL, Lavstsen T, Groth-Grunnet L, Lusingu JPA, Hansson O, Christensen DL, Vaag AA, Artner I, Theander T, Groop L, Schmiegelow C, Bygbjerg IC, Prasad RB. Mapping the Cord Blood Transcriptome of Pregnancies Affected by Early Maternal Anemia to Identify Signatures of Fetal Programming. J Clin Endocrinol Metab. 2022 Apr 19;107(5):1303-1316. doi: 10.1210/clinem/dgac010.
Paulsen CB, Nielsen BB, Msemo OA, Moller SL, Ekmann JR, Theander TG, Bygbjerg IC, Lusingu JPA, Minja DTR, Schmiegelow C. Anthropometric measurements can identify small for gestational age newborns: a cohort study in rural Tanzania. BMC Pediatr. 2019 Apr 23;19(1):120. doi: 10.1186/s12887-019-1500-0.
Moeller SL, Nyengaard JR, Larsen LG, Nielsen K, Bygbjerg IC, Msemo OA, Lusingu JPA, Minja DTR, Theander TG, Schmiegelow C. Malaria in Early Pregnancy and the Development of the Placental Vasculature. J Infect Dis. 2019 Sep 26;220(9):1425-1434. doi: 10.1093/infdis/jiy735.
Msemo OA, Bygbjerg IC, Moller SL, Nielsen BB, Odum L, Perslev K, Lusingu JPA, Kavishe RA, Minja DTR, Schmiegelow C. Prevalence and risk factors of preconception anemia: A community based cross sectional study of rural women of reproductive age in northeastern Tanzania. PLoS One. 2018 Dec 18;13(12):e0208413. doi: 10.1371/journal.pone.0208413. eCollection 2018.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Strategiske Forskningsråd
Identifier Type: OTHER
Identifier Source: secondary_id
1309-00003B
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.