Maternal and Perinatal Pregnancy Outcome in Women With Heterozygous Hemoglobinopathies

Completed

• Conditions: Heterozygous Haemoglobinopathy
• Interventions: Other: pregnancy outcome

• Registration Number: NCT03837119
• Lead Sponsor: University Hospital, Basel, Switzerland

Brief Summary

This retrospective study aims to investigate pregnancy outcome in women with heterozygous hemoglobinopathies (regarding gestational diabetes, cholestasis and urinary tract infections) and to analyze if there are aggravated maternal and/or perinatal risks.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-04-04
• Study First Submitted: 2019-02-08
• Study First Submitted QC: 2019-02-08
• Study First Posted: 2019-02-11
• Primary Completion: 2021-04-11
• Study Completion: 2021-04-11
• Status Verified: 2021-06
• Last Update Submitted: 2024-12-06
• Last Update Posted: 2024-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 540

Inclusion Criteria

• pregnant women with or without heterozygous hemoglobinopathy

Exclusion Criteria

• refusal of study participation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Heterozygous Hemoglobinopathy	pregnancy outcome	pregnancy outcome in women with heterozygous hemoglobinopathy
No Heterozygous Hemoglobinopathy	pregnancy outcome	pregnancy outcome in women without heterozygous hemoglobinopathy

Primary Outcome Measures

Name	Time	Method
gestational diabetes	in the course of pregnancy until delivery	number of women developing gestational diabetes in pregnancy
cholestasis in pregnancy	in the course of pregnancy until delivery	number of women developing cholestasis in pregnancy
urinary tract infection	in the course of pregnancy until delivery	number of women developing urinary tract infection

Trial Locations

Locations (2)

Frauenklinik University Hospital Basel; 🇨🇭 Basel, Switzerland

Frauenklinik University Hospital Zürich; 🇨🇭 Zürich, Switzerland