Heterozygous HaemoglobinopathyNCT03837119
Maternal and Perinatal Pregnancy Outcome in Women With Heterozygous Hemoglobinopathies
An observational study of Heterozygous Haemoglobinopathy, run by University Hospital, Basel, Switzerland at 2 sites in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Heterozygous Haemoglobinopathy
- What is being tested?
- pregnancy outcome
- How many people
- 540 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 4 Apr 2018to 11 Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: pregnant women being treated at Universitätsspital Basel/ Frauenklinik (from 2015 until 2017) and at Universitätsspital Zürich (from 2004-2006)
Who may be able to join
- pregnant women with or without heterozygous hemoglobinopathy
Who cannot join
- refusal of study participation
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
Frauenklinik University Hospital Basel
Basel, 4031
Frauenklinik University Hospital Zürich
Zurich, 8091
About this study
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.
- Conditions
- Heterozygous Haemoglobinopathy
- Being tested
- pregnancy outcome
- Keywords
- pregnancy, gestational diabetes, cholestasis in pregnancy, urinary tract infection in pregnancy
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pregnancy outcomeOther
descriptive statistics of variables
| Study group | Role | What they receive |
|---|---|---|
| Heterozygous Hemoglobinopathy | pregnancy outcome in women with heterozygous hemoglobinopathy Receives: Other: pregnancy outcome | |
| No Heterozygous Hemoglobinopathy | pregnancy outcome in women without heterozygous hemoglobinopathy Receives: Other: pregnancy outcome |
What is being measured
The primary outcome is the main question the study is designed to answer.
gestational diabetes
number of women developing gestational diabetes in pregnancy
Measured: in the course of pregnancy until delivery
cholestasis in pregnancy
number of women developing cholestasis in pregnancy
Measured: in the course of pregnancy until delivery
urinary tract infection
number of women developing urinary tract infection
Measured: in the course of pregnancy until delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2019
- Study start4 Apr 2018
- Primary completion11 Apr 2021
- Study completion11 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heterozygous HaemoglobinopathyStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 540 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Irene Hoesli, Prof. Dr. MD, Principal investigator, Frauenklinik Universitätsspital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03837119
- Sponsor's protocol ID
- 2018-00101; sp19Hoesli
- Other IDs
- 2018
- Status last verified
- Jun 2021
- First submitted
- 8 Feb 2019
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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 Nov;304(5):1197-1203. doi: 10.1007/s00404-021-06058-y. Epub 2021 Apr 11.
PubMed 33842991
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal and Perinatal Pregnancy Outcome in Women With Heterozygous Hemoglobinopathies
- ClinicalTrials.gov ID
- NCT03837119
- Acronym / sponsor ID
- 2018-00101; sp19Hoesli
- Conditions
- Heterozygous Haemoglobinopathy
- Keywords
- pregnancy, gestational diabetes, cholestasis in pregnancy, urinary tract infection in pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 540 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 4 Apr 2018 (actual)
- Primary completion
- 11 Apr 2021 (actual)
- Study completion
- 11 Apr 2021 (actual)
- First posted
- 11 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Heterozygous Hemoglobinopathy | – | Other: pregnancy outcomepregnancy outcome in women with heterozygous hemoglobinopathy |
| No Heterozygous Hemoglobinopathy | – | Other: pregnancy outcomepregnancy outcome in women without heterozygous hemoglobinopathy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- pregnant women being treated at Universitätsspital Basel/ Frauenklinik (from 2015 until 2017) and at Universitätsspital Zürich (from 2004-2006)
Key inclusion criteria (1 listed)
- pregnant women with or without heterozygous hemoglobinopathy
Key exclusion criteria (1 listed)
- refusal of study participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pregnancy outcomedescriptive statistics of variables | Other | Heterozygous Hemoglobinopathy, No Heterozygous Hemoglobinopathy |
Primary outcome
gestational diabetes
Time frame: in the course of pregnancy until delivery
number of women developing gestational diabetes in pregnancy
cholestasis in pregnancy
Time frame: in the course of pregnancy until delivery
number of women developing cholestasis in pregnancy
urinary tract infection
Time frame: in the course of pregnancy until delivery
number of women developing urinary tract infection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2024.
- Results publication: PubMed 33842991Kasparek J, Burkhardt T, Hoesli I, Amstad Bencaiova G. Pregnancy outcomes in women with a hemoglobinopathy trait: a multicenter, retrospective study. Arch Gynecol Obstet. 2021 Nov;304(5):1197-1203. doi: 10.1007/s00404-021-06058-y. Epub 2021 Apr 11.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Irene Hoesli, Prof. Dr. MD principal investigator
Frauenklinik Universitätsspital Basel
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heterozygous Haemoglobinopathy, run by University Hospital, Basel, Switzerland at 2 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
gestational diabetes (time frame: in the course of pregnancy until delivery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03837119, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2024.