Maternal and Perinatal Pregnancy Outcome in Women With Heterozygous Hemoglobinopathies

June 30, 2021 updated by: University Hospital, Basel, Switzerland
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

540

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Basel, Switzerland, 4031
        • Frauenklinik University Hospital Basel
      • Zürich, Switzerland, 8091
        • Frauenklinik University Hospital Zürich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

pregnant women being treated at Universitätsspital Basel/ Frauenklinik (from 2015 until 2017) and at Universitätsspital Zürich (from 2004-2006)

Description

Inclusion Criteria:

  • pregnant women with or without heterozygous hemoglobinopathy

Exclusion Criteria:

  • refusal of study participation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Heterozygous Hemoglobinopathy
pregnancy outcome in women with heterozygous hemoglobinopathy
Other: pregnancy outcome
descriptive statistics of variables
No Heterozygous Hemoglobinopathy
pregnancy outcome in women without heterozygous hemoglobinopathy
Other: pregnancy outcome
descriptive statistics of variables

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
gestational diabetes
Time Frame: in the course of pregnancy until delivery
number of women developing gestational diabetes in pregnancy
in the course of pregnancy until delivery
cholestasis in pregnancy
Time Frame: in the course of pregnancy until delivery
number of women developing cholestasis in pregnancy
in the course of pregnancy until delivery
urinary tract infection
Time Frame: in the course of pregnancy until delivery
number of women developing urinary tract infection
in the course of pregnancy until delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Basel, Switzerland

Investigators

  • Principal Investigator: Irene Hoesli, Prof. Dr. MD, Frauenklinik Universitätsspital Basel

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 4, 2018

Primary Completion (Actual)

April 11, 2021

Study Completion (Actual)

April 11, 2021

Study Registration Dates

First Submitted

February 8, 2019

First Submitted That Met QC Criteria

February 8, 2019

First Posted (Actual)

February 11, 2019

Study Record Updates

Last Update Posted (Actual)

July 6, 2021

Last Update Submitted That Met QC Criteria

June 30, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-00101; sp19Hoesli

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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