Prevalence and Consequences of Vitamin D Deficiency in Pregnant Women in Switzerland

Vitamin D Deficiency Clinical Trial

— PCVDDPWS  

Official title:

Prevalence and Consequences of Vitamin D Deficiency in Pregnant Women in Switzerland

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02904720
• Other study ID #: 2015-00063
• Status: Completed
• Phase: N/A
• First received: September 8, 2016
• Last updated: September 13, 2016
• Start date: October 2015
• Est. completion date: February 2016

Study information

• Verified date: September 2016
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1199
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Vitamin D Deficiency

Locations

Country	Name	City	State
Switzerland	University Hospital Bern	Bern

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne	Significantis GmbH

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Association between vitamin D blood level and the mode of delivery at birth	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	Yes
Other	Association between vitamin D blood level and the gestational age at delivery	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	Yes
Other	Association between vitamin D blood level and newborn growth	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	Yes
Primary	Prevalence of vitamin D deficiency	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	Yes
Secondary	BMI as a risk factor for vitamin D deficiency	Presence of an association between the patient's BMI and their vitamin D blood level?	Between the 1th and the 36th week of pregnancy	Yes
Secondary	Ethnicity as a risk factor for vitamin D deficiency	Presence of an association between the patient's ethnicity and their vitamin D blood level?	Between the 1th and the 36th week of pregnancy	Yes
Secondary	Age as risk factor for vitamin D deficiency	Presence of an association between the patient's age and their vitamin D blood level ?	Between the 1th and the 36th week of pregnancy	Yes
Secondary	Period of the year as risk factor for vitamin D deficiency	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	Yes
Secondary	Smoking Status as risk factor for vitamin D deficiency	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	Yes
Secondary	Association between vitamin D blood level and gestational diabetes mellitus	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	Yes
Secondary	Association between vitamin D blood level and gestational hypertension and preeclampsia	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	Yes