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

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

      • Bern, Switzerland, 3010
        • University Hospital Bern

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
Number of patients with vitamin D deficiency after testing of vitamin D blood level at admission for prenatal care in our clinic
Between the 1th and the 36th week of pregnancy

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
Presence of an association between the patient's BMI and their vitamin D blood level?
Between the 1th and the 36th week of pregnancy
Ethnicity as a risk factor for vitamin D deficiency
Time Frame: Between the 1th and the 36th week of pregnancy
Presence of an association between the patient's ethnicity and their vitamin D blood level?
Between the 1th and the 36th week of pregnancy
Age as risk factor for vitamin D deficiency
Time Frame: Between the 1th and the 36th week of pregnancy
Presence of an association between the patient's age and their vitamin D blood level ?
Between the 1th and the 36th week of pregnancy
Period of the year as risk factor for vitamin D deficiency
Time Frame: Between the 1th and the 36th week of pregnancy
Presence of an association between the period of the year at the time of the blood testing and the vitamin D blood level?
Between the 1th and the 36th week of pregnancy
Smoking Status as risk factor for vitamin D deficiency
Time Frame: Between the 1th and the 36th week of pregnancy
Presence of an association between the patient's smoking status and the vitamin D blood level ?
Between the 1th and the 36th week of pregnancy
Association between vitamin D blood level and gestational diabetes mellitus
Time Frame: Between the 1th and the 36th week of pregnancy
Presence of an association between the vitamin D blood level and the occurrence of gestational diabetes mellitus?
Between the 1th and the 36th week of pregnancy
Association between vitamin D blood level and gestational hypertension and preeclampsia
Time Frame: Between the 1th and the 36th week of pregnancy
Presence of an association between the vitamin D blood level and the occurrence of gestational hypertension and preeclampsia ?
Between the 1th and the 36th week of pregnancy

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
Presence of an association between the vitamin D blood level and the mode of delivery (Vaginal delivery, instrumentalized delivery, primary and secondary cesarean)?
At delivery time
Association between vitamin D blood level and the gestational age at delivery
Time Frame: At delivery time
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)?
At delivery time
Association between vitamin D blood level and newborn growth
Time Frame: From week 1 until birth
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.
From week 1 until birth

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

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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