Maternal and Perinatal Pregnancy Outcome in Women With Heterozygous Hemoglobinopathies
Sponsor
University Hospital, Basel, Switzerland (Other)
Overall Status
Completed
CT.gov ID
NCT03837119
Collaborator
(none)
540
2
36.2
270
7.5
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Actual Enrollment
:
540 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Maternal and Perinatal Pregnancy Outcome in Women With Heterozygous Hemoglobinopathies
Actual Study Start Date
:
Apr 4, 2018
Actual Primary Completion Date
:
Apr 11, 2021
Actual Study Completion Date
:
Apr 11, 2021
Arms and Interventions
| Arm | 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
|
Outcome Measures
Primary Outcome Measures
- 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
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- pregnant women with or without heterozygous hemoglobinopathy
Exclusion Criteria:
- refusal of study participation
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Frauenklinik University Hospital Basel | Basel | Switzerland | 4031 | |
| 2 | Frauenklinik University Hospital Zürich | Zürich | Switzerland | 8091 |
Sponsors and Collaborators
- University Hospital, Basel, Switzerland
Investigators
- Principal Investigator: Irene Hoesli, Prof. Dr. MD, Frauenklinik Universitätsspital Basel
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT03837119
Other Study ID Numbers:
- 2018-00101; sp19Hoesli
First Posted:
Feb 11, 2019
Last Update Posted:
Jul 6, 2021
Last Verified:
Jun 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Hospital, Basel, Switzerland
Additional relevant MeSH terms: