Non-invasive Detection of Iron Deficiency in Obstetrics

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorWuerzburg University Hospital

About this trial

Validation of non-invasive measurement of zinc protoporphyrin for detection of iron deficiency in pregnancy.

In addition, the impact of iron deficiency on the incidence of postpartum depression, restless legs syndrome, obstetric complications and quality of life will be examined.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

any timepoint during or up to 3 months after pregnancy

age ≥ 18 years

written informed consent

Disqualifiers

previous participation in this study

refusal of blood sampling

incapacity to give informed consent

Trial population

pregnant women ≥ 18 years

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • non-invasive measurement of zink protoporphyrin

    Diagnostic test

    validation of non-invasive measurement of zink protoporphyrin

Treatment groups

500 Participants
are divided into 1 treatment group
Group A: pregnant women1 intervention

Trial outcomes

Primary outcomes

1

Accuracy of non-invasive zinc protoporphyrin for the detection of iron deficiency in pregnancy

To validate accuracy of non-invasively measured ZnPP for detection of iron deficiency in pregnancy at prespecified timepoints

Time frame
through study completion, up to 3 months postpartum

Secondary outcomes

1

Influence of iron status on quality of life of pregnant women

To evaluate whether iron deficiency has an impact on the risk of impaired quality of life in pregnancy. Questionnaire: Short Form 12 (SF-12)

Time frame
through study completion, up to 3 months postpartum
2

Influence of iron status on incidence of postpartum depression

To evaluate whether iron deficiency has an impact on the risk of postpartum depression. Questionnaire: Edinburgh Postnatal Depression Scala (EPDS)

Time frame
through study completion, up to 3 months postpartum
3

Influence of iron status on incidence of restless legs syndrome among pregnant women

To evaluate whether iron deficiency has an impact on the risk of restless legs syndrome in pregnancy. Questionnaire: International Restless Legs Scale (IRLS)

Time frame
through study completion, up to 3 months postpartum
4

Influence of iron status on incidence of preterm birth

To evaluate whether iron deficiency has an impact on the risk of preterm delivery

Time frame
peripartum ( about 20 weeks of pregnancy until approximately 6 weeks after delivery. )

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.