Heterozygous Haemoglobinopathy Clinical Trial
Official title:
Maternal and Perinatal Pregnancy Outcome in Women With Heterozygous Hemoglobinopathies
| Verified date | June 2021 |
| Source | University Hospital, Basel, Switzerland |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 540 |
| Est. completion date | April 11, 2021 |
| Est. primary completion date | April 11, 2021 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - pregnant women with or without heterozygous hemoglobinopathy Exclusion Criteria: - refusal of study participation |
| Country | Name | City | State |
|---|---|---|---|
| Switzerland | Frauenklinik University Hospital Basel | Basel | |
| Switzerland | Frauenklinik University Hospital Zürich | Zürich |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Basel, Switzerland |
Switzerland,
Kasparek J, Burkhardt T, Hoesli I, Amstad Bencaiova G. Pregnancy outcomes in women with a hemoglobinopathy trait: a multicenter, retrospective study. Arch Gynecol Obstet. 2021 Apr 11. doi: 10.1007/s00404-021-06058-y. [Epub ahead of print] — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | gestational diabetes | number of women developing gestational diabetes in pregnancy | in the course of pregnancy until delivery | |
| Primary | cholestasis in pregnancy | number of women developing cholestasis in pregnancy | in the course of pregnancy until delivery | |
| Primary | urinary tract infection | number of women developing urinary tract infection | in the course of pregnancy until delivery |