- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02904720
Prevalence and Consequences of Vitamin D Deficiency in Pregnant Women in Switzerland (PCVDDPWS)
September 13, 2016 updated by: University Hospital Inselspital, Berne
The purpose of this study is to determine the prevalence of vitamin D deficiency among the population of pregnant women receiving prenatal care and giving birth at the investigators' clinic.
The further purposes are to identify the population at risk for vitamin D deficiency and to analyse whether vitamin D deficiency is associated with pregnancy complications.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
1199
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
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Bern, Switzerland, 3010
- University Hospital Bern
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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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
All the pregnant women attending prenatal care and giving birth at birth at our clinic
Description
Inclusion Criteria:
- Pregnant women attending prenatal care at our clinic who had a vitamin D blood-testing at admission
Exclusion Criteria:
- Pregnant women lost to follow-up, Birth outside our clinic
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
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prevalence of vitamin D deficiency
Time Frame: Between the 1th and the 36th week of pregnancy
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Number of patients with vitamin D deficiency after testing of vitamin D blood level at admission for prenatal care in our clinic
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Between the 1th and the 36th week of pregnancy
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
BMI as a risk factor for vitamin D deficiency
Time Frame: Between the 1th and the 36th week of pregnancy
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Presence of an association between the patient's BMI and their vitamin D blood level?
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Between the 1th and the 36th week of pregnancy
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Ethnicity as a risk factor for vitamin D deficiency
Time Frame: Between the 1th and the 36th week of pregnancy
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Presence of an association between the patient's ethnicity and their vitamin D blood level?
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Between the 1th and the 36th week of pregnancy
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Age as risk factor for vitamin D deficiency
Time Frame: Between the 1th and the 36th week of pregnancy
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Presence of an association between the patient's age and their vitamin D blood level ?
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Between the 1th and the 36th week of pregnancy
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Period of the year as risk factor for vitamin D deficiency
Time Frame: Between the 1th and the 36th week of pregnancy
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Presence of an association between the period of the year at the time of the blood testing and the vitamin D blood level?
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Between the 1th and the 36th week of pregnancy
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Smoking Status as risk factor for vitamin D deficiency
Time Frame: Between the 1th and the 36th week of pregnancy
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Presence of an association between the patient's smoking status and the vitamin D blood level ?
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Between the 1th and the 36th week of pregnancy
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Association between vitamin D blood level and gestational diabetes mellitus
Time Frame: Between the 1th and the 36th week of pregnancy
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Presence of an association between the vitamin D blood level and the occurrence of gestational diabetes mellitus?
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Between the 1th and the 36th week of pregnancy
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Association between vitamin D blood level and gestational hypertension and preeclampsia
Time Frame: Between the 1th and the 36th week of pregnancy
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Presence of an association between the vitamin D blood level and the occurrence of gestational hypertension and preeclampsia ?
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Between the 1th and the 36th week of pregnancy
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Association between vitamin D blood level and the mode of delivery at birth
Time Frame: At delivery time
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Presence of an association between the vitamin D blood level and the mode of delivery (Vaginal delivery, instrumentalized delivery, primary and secondary cesarean)?
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At delivery time
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Association between vitamin D blood level and the gestational age at delivery
Time Frame: At delivery time
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Presence of an association between the vitamin D blood level and the gestational age at delivery?
Occurrence of preterm birth (before 37W) or postterm birth (after 40W)?
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At delivery time
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Association between vitamin D blood level and newborn growth
Time Frame: From week 1 until birth
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Presence of an association between vitamin D blood level and the occurrence of intrauterin growth retardation or small-for-gestational age child?
With assessment of measure like length, weight, head perimeter.
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From week 1 until birth
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Director: Daniel Surbek, Professor, University Hospital Inselspital, Berne
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.
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
October 1, 2015
Primary Completion (Actual)
February 1, 2016
Study Completion (Actual)
February 1, 2016
Study Registration Dates
First Submitted
September 8, 2016
First Submitted That Met QC Criteria
September 13, 2016
First Posted (Estimate)
September 19, 2016
Study Record Updates
Last Update Posted (Estimate)
September 19, 2016
Last Update Submitted That Met QC Criteria
September 13, 2016
Last Verified
September 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015-00063
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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