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

NCT05262634 | Completed

• 1 other identifier: 2020-02033; bb22Hoesli2
• Study Type: observational
• Target: 713
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Iron Deficiency

Keywords

iron deficiency anemia of pregnancy; pregnancy outcome; perinatal risk; maternal risk

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (2)

study group: iron deficiency

Pregnant women with a documented iron deficiency in the first trimester

Other: Data collection (laboratory and obstetric results)

control group: normal iron status

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

Other: Data collection (laboratory and obstetric results)

Interventions

Data collection (laboratory and obstetric results) 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; study group: iron deficiency

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The data comes from the patient files of pregnant women who were treated in the Polyclinic Women's Clinic University Hospital Basel between 2017 and 2019.

You may qualify if:

• 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

You may not qualify if:

• Pregnant women with a documented rejection

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

Women's Clinic, University Hospital Basel

Basel, 4031, Switzerland

Location

MeSH Terms

Conditions

Iron Deficiencies

Interventions

Data Collection; Laboratories

Condition Hierarchy (Ancestors)

Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Non-Medical Public and Private Facilities; Health Facilities; Health Care Facilities Workforce and Services

Study Officials

• Irene Hoesli, Prof. Dr. med.

  Women's Clinic, University Hospital Basel

  STUDY DIRECTOR

• Gabriela Amstad Bencaiova, Dr. med.

  Women's Clinic, University Hospital Basel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2022
• First Posted: March 2, 2022
• Study Start: September 1, 2021
• Primary Completion: January 31, 2022
• Study Completion: January 31, 2022
• Last Updated: March 2, 2022

Record last verified: 2022-02

Locations

CH (1)