Pregnancy Outcome in Women With an Iron Deficiency in the First Trimester

NCT ID: NCT05262634

Last Updated: 2022-03-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

713 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-01

Study Completion Date

2022-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Iron Deficiency

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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study group: iron deficiency

Pregnant women with a documented iron deficiency in the first trimester

Data collection (laboratory and obstetric results)

Intervention Type OTHER

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

control group: normal iron status

Pregnant women with normal hematological parameters and iron status in the first trimester

Data collection (laboratory and obstetric results)

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Irene Hoesli, Prof. Dr. med.

Role: STUDY_DIRECTOR

Women's Clinic, University Hospital Basel

Gabriela Amstad Bencaiova, Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Women's Clinic, University Hospital Basel

Locations

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Women's Clinic, University Hospital Basel

Basel, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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2020-02033; bb22Hoesli2

Identifier Type: -

Identifier Source: org_study_id

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