Anemia and PregnancyFOETALforNCDNCT02191683
Foetal Exposure and Epidemiological Transition: Role of Anaemia in Early Life for Non-communicable Diseases Later
An observational study of Anemia and Pregnancy and Metabolism and Foetal Growth, run by University of Copenhagen at 1 site in Tanzania.
Trial summary
Study Hypotheses: 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anemia and Pregnancy, Metabolism and Foetal Growth, Epigenetics
- How many people
- 1,748 participants
- Where
- 1 siteTanzania
- Study dates
- Jul 2014to Oct 2018
- How long will I take part?
- 21 Months
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Amendment October 2014: replacement of two-phase case-control study by two sub-projects, running in parallel, and following two distinct groups of women, 1) a cohort of 1500 non-pregnant women, disregarding Hb level, of whom 270 followed throughout pregnancy disregarding Hb level and gestational age at first contact, and 2) a case control study of 480 pregnant women followed from 1st trimester with a 160:160:160 ratio of women with Hb≤8g/dL: 8.1-10.9g/dL: ≥11g/dL. The Danish Council for Strategic Research notified and accepted in November 2014.
Who may be able to join
- wishing to get pregnant
- negative pregnancy test
- not using family planning
Who cannot join
- not wishing to get pregnant
- being pregnant
- using family planning
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Foetal Exposure and Epidemiological Transition: the Role of Anaemia in Early Life for Non-communicable Diseases in Later Life
Study Hypotheses:
- 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.
- Anaemia from conception till end of 2nd trimester is most detrimental for foetal and newborns' health, compared to 3rd trimester anaemia.
- 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.
- 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.
- Anaemia's impact on the risk for NCDs in the offspring may be mediated via epigenetic mechanisms, including changes in DNA methylation patterns.
Read the detailed description
Specific objectives are:
- 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).
- Describe how 1st and 2nd trimester anaemia compared to 3rd trimester anaemia alters foetal growth and newborns' body composition.
- 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.
- 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.
- 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.
- Keywords
- Anaemia, Pregnancy, Foetal programming, Epigenetics, Non-communicable diseases, Tanzania
- Medical subject headings
- Anemia, Noncommunicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Health of women before conception | Tanzanian women aged 18-40 years focusing on prevalence of anaemia, infections, nutritional status, and NCDs. | |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Outcome parameter for the pre-pregnancy study (i.):
Prevalence and severity of anaemia among non-pregnant Tanzanian women at fertile age and their nutritional status.
Measured: 12 months from start
Outcome parameter for the pregnancy study (ii.):
Anemia's effect on foetal growth rate in 2nd and 3rd trimester measured as a) discrepancy in estimated and predicted gestational age (GA) between inclusion and antenatal visit at GA 20 weeks \& 30, b) change in z-score for foetal weight/body weight and c) gain in g/week26 at GA of 26, 32 and 37 and delivery. Newborn's body composition, placental villous branching, umbilical and uterine blood flow, VEGF-A/PlGF levels, and GFaxis. For all analyses main exposure variable are anaemia in 1st, 2nd and/or3rd trimester of pregnancy. Confounding exposure variables are chronic health conditions, temporary conditions mentioned above (e.g. malaria) and socioeconomic status and paternal characteristics. Regression modelling using multiple linear and logistic regressions and modelling for repeated measures are used for statistical analyses. Genetic and epigenetic significant changes in subgroup of 180 mother/newborns, after correction for multiple comparisons, will be validated in remaining cohort.
Measured: 31 months
Incidence of conception among non-pregnant Tanzanian women.
Number of women screened, with and without anaemia, respectively, who actually become pregnant within the observation period
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionDec 2017
- Study completionOct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Anemia and PregnancyStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1,748 participants (actual)
- Target duration
- 21 Months
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Denmark, Aarhus University Hospital, Lund University, National Institute for Medical Research, Tanzania, Department of Clinical Pathology Naestved Hospital Denmark
- Responsible party
- Principal investigator, Ib Christian Bygbjerg, University of Copenhagen
- Investigators
- Mwelecele N Malecela, PHd, Study chair, National Institute for Medical Research, Tanzania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02191683
- Sponsor's protocol ID
- 1309-00003B
- Other IDs
- Strategiske Forskningsråd
- Acronym
- FOETALforNCD
- Status last verified
- Sep 2019
- First submitted
- 2 Jul 2014
- Last updated
- 30 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Hatem G, Andersson J, Hjort L, Minja DTR, Catellani F, Moller SL, Asplund O, Christensen DL, Nielsen BB, Theander TG, Artner I, Shaat N, Lusingu JPA, Vaag A, Bygbjerg IC, Schmiegelow C, Grunnet LG, Prasad RB. Sex-specific signatures of fetal programming for gestational diabetes mellitus in umbilical cord: A cohort study from Tanzania. BMC Med. 2026 Aug 21;24(1):457. doi: 10.1186/s12916-026-05158-3.
PubMed 42629565Hatem 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.
PubMed 35021220Paulsen 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.
PubMed 31014291Moeller 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.
PubMed 30590576Msemo 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.
PubMed 30562390
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Foetal Exposure and Epidemiological Transition: the Role of Anaemia in Early Life for Non-communicable Diseases in Later Life
- ClinicalTrials.gov ID
- NCT02191683
- Acronym / sponsor ID
- FOETALforNCD / 1309-00003B
- Keywords
- Anaemia, Pregnancy, Foetal programming, Epigenetics, Non-communicable diseases, Tanzania
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,748 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Denmark, Aarhus University Hospital, Lund University, National Institute for Medical Research, Tanzania, Department of Clinical Pathology Naestved Hospital Denmark
- Study start
- Jul 2014 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 16 Jul 2014 (estimated)
- 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.
Study Hypotheses:
- 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.
- Anaemia from conception till end of 2nd trimester is most detrimental for foetal and newborns' health, compared to 3rd trimester anaemia.
- 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.
- 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.
- Anaemia's impact on the risk for NCDs in the offspring may be mediated via epigenetic mechanisms, including changes in DNA methylation patterns.
Detailed description
Specific objectives are:
- 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).
- Describe how 1st and 2nd trimester anaemia compared to 3rd trimester anaemia alters foetal growth and newborns' body composition.
- 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.
- 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.
- 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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 21 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Health of women before conception | – | –Tanzanian women aged 18-40 years focusing on prevalence of anaemia, infections, nutritional status, and NCDs. |
| 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Amendment October 2014: replacement of two-phase case-control study by two sub-projects, running in parallel, and following two distinct groups of women, 1) a cohort of 1500 non-pregnant women, disregarding Hb level, of whom 270 followed throughout pregnancy disregarding Hb level and gestational age at first contact, and 2) a case control study of 480 pregnant women followed from 1st trimester with a 160:160:160 ratio of women with Hb≤8g/dL: 8.1-10.9g/dL: ≥11g/dL. The Danish Council for Strategic Research notified and accepted in November 2014.
Key inclusion criteria (3 listed)
- wishing to get pregnant
- negative pregnancy test
- not using family planning
Key exclusion criteria (3 listed)
- not wishing to get pregnant
- being pregnant
- using family planning
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Outcome parameter for the pre-pregnancy study (i.):
Time frame: 12 months from start
Prevalence and severity of anaemia among non-pregnant Tanzanian women at fertile age and their nutritional status.
Outcome parameter for the pregnancy study (ii.):
Time frame: 31 months
Anemia's effect on foetal growth rate in 2nd and 3rd trimester measured as a) discrepancy in estimated and predicted gestational age (GA) between inclusion and antenatal visit at GA 20 weeks \& 30, b) change in z-score for foetal weight/body weight and c) gain in g/week26 at GA of 26, 32 and 37 and delivery. Newborn's body composition, placental villous branching, umbilical and uterine blood flow, VEGF-A/PlGF levels, and GFaxis. For all analyses main exposure variable are anaemia in 1st, 2nd and/or3rd trimester of pregnancy. Confounding exposure variables are chronic health conditions, temporary conditions mentioned above (e.g. malaria) and socioeconomic status and paternal characteristics. Regression modelling using multiple linear and logistic regressions and modelling for repeated measures are used for statistical analyses. Genetic and epigenetic significant changes in subgroup of 180 mother/newborns, after correction for multiple comparisons, will be validated in remaining cohort.
Incidence of conception among non-pregnant Tanzanian women.
Time frame: 12 months
Number of women screened, with and without anaemia, respectively, who actually become pregnant within the observation period
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 30 Sep 2019.
- Derived from this study: PubMed 42629565Hatem G, Andersson J, Hjort L, Minja DTR, Catellani F, Moller SL, Asplund O, Christensen DL, Nielsen BB, Theander TG, Artner I, Shaat N, Lusingu JPA, Vaag A, Bygbjerg IC, Schmiegelow C, Grunnet LG, Prasad RB. Sex-specific signatures of fetal programming for gestational diabetes mellitus in umbilical cord: A cohort study from Tanzania. BMC Med. 2026 Aug 21;24(1):457. doi: 10.1186/s12916-026-05158-3.
- Derived from this study: PubMed 35021220Hatem 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.
- Derived from this study: PubMed 31014291Paulsen 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.
- Derived from this study: PubMed 30590576Moeller 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.
- Derived from this study: PubMed 30562390Msemo 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.
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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.
Mwelecele N Malecela, PHd study chair
National Institute for Medical Research, Tanzania
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 Anemia and Pregnancy and Metabolism and Foetal Growth, run by University of Copenhagen at 1 site in Tanzania.
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 3 inclusion and 3 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 30 Sep 2019. 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 Tanzania. 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?
Outcome parameter for the pre-pregnancy study (i.): (time frame: 12 months from start). The study lists 3 primary outcomes in all. 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 NCT02191683, which also lists 5 linked publications.
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 30 Sep 2019.