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

Completed

• Conditions: Iron Deficiency
• Interventions: Other: Data collection (laboratory and obstetric results)

• Registration Number: NCT05262634
• Lead Sponsor: University Hospital, Basel, Switzerland

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-01
• Primary Completion: 2022-01-31
• Study Completion: 2022-01-31
• Status Verified: 2022-02
• Study First Submitted: 2022-02-21
• Study First Submitted QC: 2022-02-21
• Last Update Submitted: 2022-02-21
• Study First Posted: 2022-03-02
• Last Update Posted: 2022-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 713

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
study group: iron deficiency	Data collection (laboratory and obstetric results)	Pregnant women with a documented iron deficiency in the first trimester
control group: normal iron status	Data collection (laboratory and obstetric results)	Pregnant women with normal hematological parameters and iron status in the first trimester

Primary Outcome Measures

Name	Time	Method
Proportion of hemorrhage	one time assessment at baseline	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
Proportion of anemia	one time assessment at baseline	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
Proportion of growth retardation	one time assessment at baseline	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

Trial Locations

Locations (1)

Women's Clinic, University Hospital Basel; 🇨🇭 Basel, Switzerland