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Prevalence and Consequences of Vitamin D Deficiency in Pregnant Women in Switzerland (PCVDDPWS)

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ClinicalTrials.gov Identifier: NCT02904720
Recruitment Status : Completed
First Posted : September 19, 2016
Last Update Posted : September 19, 2016
Sponsor:
Collaborator:
Significantis GmbH
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

Tracking Information
First Submitted Date September 8, 2016
First Posted Date September 19, 2016
Last Update Posted Date September 19, 2016
Study Start Date October 2015
Actual Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 13, 2016)
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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: September 13, 2016)
  • 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?
  • 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?
  • 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 ?
  • 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?
  • 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 ?
  • 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?
  • 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 ?
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: September 13, 2016)
  • 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)?
  • 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)?
  • 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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Prevalence and Consequences of Vitamin D Deficiency in Pregnant Women in Switzerland
Official Title Prevalence and Consequences of Vitamin D Deficiency in Pregnant Women in Switzerland
Brief Summary 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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population All the pregnant women attending prenatal care and giving birth at birth at our clinic
Condition Vitamin D Deficiency
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 13, 2016)
1199
Original Actual Enrollment Same as current
Actual Study Completion Date February 2016
Actual Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: Female
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number NCT02904720
Other Study ID Numbers 2015-00063
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party University Hospital Inselspital, Berne
Study Sponsor University Hospital Inselspital, Berne
Collaborators Significantis GmbH
Investigators
Study Director: Daniel Surbek, Professor University Hospital Inselspital, Berne
PRS Account University Hospital Inselspital, Berne
Verification Date September 2016