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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05262634
Other study ID # 2020-02033; bb22Hoesli2
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 1, 2021
Est. completion date January 31, 2022

Study information

Verified date February 2022
Source University Hospital, Basel, Switzerland
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The primary aim of this retrospective, monocentric study with two parallel groups is to investigate pregnancy outcome in women with iron deficiency in the first trimester. It compares the pregnancy outcome between pregnant women with an iron deficiency and those without an iron deficiency in the first trimester. The study group are pregnant women with a diagnosed iron deficiency in the first trimester, a total of 227 pregnant women. The control group consists of 486 pregnant women without first-trimester iron deficiency. Matching criteria include parity and maternal age. Data from patient files of pregnant women who were treated in the Women's Clinic, University Hospital Basel between 2017 and 2019 are analyzed.


Recruitment information / eligibility

Status Completed
Enrollment 713
Est. completion date January 31, 2022
Est. primary completion date January 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria: - Pregnant women with a documented iron deficiency in the first trimester - Pregnant women with normal hematological parameters and iron status in the first trimester - Treated at the Women's Clinic, University Hospital in Basel Exclusion Criteria: - Pregnant women with a documented rejection

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Data collection (laboratory and obstetric results)
Maternal data: age, pregnancy, parity, singleton or multiple pregnancy, BMI, obstetric history data, and ethnicity. Laboratory chemical results: hemoglobin (Hb), number of erythrocytes, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), number of hypochromic erythrocytes (HRC), erythrocyte distribution width (EBW), ferritin, C reactive protein (CRP). Maternal pregnancy outcomes and complications: Hb before and after delivery, mode of delivery, placenta abruption, preeclampsia/eclampsia, gestational diabetes, gestational cholestasis, pregnancy-induced hypertension, bacteriuria or urinary tract infections, peripartum and postpartum hemorrhage, puerperal infections, uterine subinvolution. Perinatal outcomes: gestational age, birth weight, intrauterine growth retardation, preterm birth, macrosomia, premature rupture of membranes, Apgar score, intrauterine fetal death, pH values, admission to neonatology

Locations

Country Name City State
Switzerland Women's Clinic, University Hospital Basel Basel

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of anemia Proportion of anemia in pregnant women with an iron deficiency diagnosed in the first trimester compared to pregnant women with normal hematological parameters and iron status in the first trimester one time assessment at baseline
Primary Proportion of hemorrhage Proportion of hemorrhage in pregnant women with an iron deficiency diagnosed in the first trimester compared to pregnant women with normal hematological parameters and iron status in the first trimester one time assessment at baseline
Primary Proportion of growth retardation Proportion of growth retardation in pregnant women with an iron deficiency diagnosed in the first trimester compared to pregnant women with normal hematological parameters and iron status in the first trimester one time assessment at baseline
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