- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07814378
Impact of Iron Supplementation During Pregnancy
Impact of Iron Supplementation on Haemoglobin Levels and Quality-of-life in Iron-deficient (Anaemic) Women Before and After Delivery
During pregnancy, iron deficiency is the most common cause of anemia. Anemia is very common during pregnancy and after childbirth. Around half of pregnant women develop anemia, and after delivery, up to 85% of women may be affected.
This study looks at whether iron given through a vein (intravenous iron) can improve blood levels and how women feel and function in everyday life before and after giving birth.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Suma Choorapoikayil, PhD
- Phone Number: 049-069-6301-83169
- Email: Choorapoikayil@med.uni-frankfurt.de
Study Contact Backup
- Name: Patrick Meybohm, MD
- Phone Number: +49 931 201-30001
- Email: meybohm_p@ukw.de
Study Locations
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-
-
Frankfurt, Germany
- University Hospital Frankfurt, Department for Anaesthesiolgy, Intensive Care, and Pain Therapy
-
Contact:
- Kai Zacharowski, MD
- Phone Number: 049-069-6301-5868
- Email: zacharowski@med.uni-frankfurt.de
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Würzburg, Germany
- University Hospital Würzburg, Department of Anaesthesiology, Intensive Care, Emergency and Pain Medicine
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Contact:
- Peter Kranke, MD
- Phone Number: +49 931 201-30001
- Email: kranke_p@ukw.de
-
Contact:
- Patrick Meybohm, MD
- Phone Number: +49 931 201-30001
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Pregnancy
Exclusion Criteria:
- Thalassemia
- Sickle cell disease
- Aplastic anemia
- Hemochromatosis
- Chronic inflammatory diseases associated with anemia of chronic disease
- Severe renal insufficiency
- Intravenous iron administration within 3 months prior to enrollment
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Proportion of patients achieving an increase in hemoglobin concentration of ≥1 g/dL
Time Frame: between iron supplementation and follow-up: 2-4 weeks
|
Proportion of patients with an increase in hemoglobin concentration of ≥1 g/dL from before the first intravenous iron administration to the last available measurement before delivery
|
between iron supplementation and follow-up: 2-4 weeks
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2026-2980
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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