Medication and Supplement Use During PregnancyNCT02842216
Retrospective Analysis of Hospital Medical Records on Medication and Supplement Use in Pregnant Women
An observational study of Medication and Supplement Use During Pregnancy, run by KU Leuven.
Trial summary
Monocentric study in University Hospitals Leuven (campus Gasthuisberg). Hospital medical records from all pregnant women who delivered between 01/07/2015 and 31/12/2015 in University Hospitals will be analyzed for the presence of medication and supplements. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Medication and Supplement Use During Pregnancy
- How many people
- 1,200 participants
- Where
- No sites listed yet
- Study dates
- Jul 2016to Aug 2017
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Pregnant women who delivered in the University Hospital of Leuven
Who may be able to join
- All pregnant women who delivered in the University Hospital of Leuven between 01/07/2015 and 31/12/2015
Who cannot join
None listed.
About this study
Monocentric study in University Hospitals Leuven (campus Gasthuisberg).
Hospital medical records from all pregnant women who delivered between 01/07/2015 and 31/12/2015 in University Hospitals will be analyzed for the presence of medication and supplements.
Some demographic and obstetric parameters will be collected as well.
The anonymized dataset will be analyzed using descriptive statistics (Excel). There will be no intervention among the selected sample.
- Keywords
- Pharmaceutical preparations, Dietary supplements
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of registered medicines and supplements in hospital medical records of Belgian pregnant women
Measured: Hospital medical records from 11 months before delivery until 1 month postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2016 (estimated)
- Study startJul 2016
- Primary completionAug 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medication and Supplement Use During PregnancyStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 1,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Universitaire Ziekenhuizen KU Leuven
- Responsible party
- Principal investigator, Michael Ceulemans, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02842216
- Sponsor's protocol ID
- MC201601
- Status last verified
- Aug 2017
- First submitted
- 14 Jul 2016
- Last updated
- 22 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Analysis of Hospital Medical Records on Medication and Supplement Use in Pregnant Women
- ClinicalTrials.gov ID
- NCT02842216
- Acronym / sponsor ID
- MC201601
- Keywords
- Pharmaceutical preparations, Dietary supplements
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,200 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Collaborators
- Universitaire Ziekenhuizen KU Leuven
- Study start
- Jul 2016 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 22 Jul 2016 (estimated)
- 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.
Monocentric study in University Hospitals Leuven (campus Gasthuisberg).
Hospital medical records from all pregnant women who delivered between 01/07/2015 and 31/12/2015 in University Hospitals will be analyzed for the presence of medication and supplements.
Some demographic and obstetric parameters will be collected as well.
The anonymized dataset will be analyzed using descriptive statistics (Excel). There will be no intervention among the selected sample.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pregnant women who delivered in the University Hospital of Leuven
Key inclusion criteria (1 listed)
- All pregnant women who delivered in the University Hospital of Leuven between 01/07/2015 and 31/12/2015
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of registered medicines and supplements in hospital medical records of Belgian pregnant women
Time frame: Hospital medical records from 11 months before delivery until 1 month postpartum
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 22 Aug 2017.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Medication and Supplement Use During Pregnancy, run by KU Leuven.
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 0 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 22 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Number of registered medicines and supplements in hospital medical records of Belgian pregnant women (time frame: Hospital medical records from 11 months before delivery until 1 month postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Aug 2017.