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Vitamin D and Angiogenic Markers in Odense Child Cohort 1 (VITAM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02434900
Recruitment Status : Active, not recruiting
First Posted : May 6, 2015
Last Update Posted : May 6, 2015
Sponsor:
Information provided by (Responsible Party):
Henrik Christesen, Odense University Hospital

Brief Summary:

The Vitamin D and Angiogenic Marker Study 1:

Vitamin D and angiogenic markers in early pregnancy. Epidemiology and associations to early-pregnancy miscarriage


Condition or disease
Abortion, Spontaneous

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Study Type : Observational [Patient Registry]
Actual Enrollment : 2874 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 18 Years
Official Title: Vitamin D and Angiogenic Markers in Odense Child Cohort 1: A Prospective Cohort Study on Their Role in Early Pregnancy Adverse Outcome
Study Start Date : January 2010
Estimated Primary Completion Date : December 2031
Estimated Study Completion Date : December 2031

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Spontaneous Abortion [ Time Frame: Outcome is assessed in gestational weeks 5+0 to 22+0. ]
    Occurrence of spontaneous abortion, as diagnosed by transvaginal ultrasound in medical files. The time from inclusion in cohort to occurrance of spontaneous abortion was on average 13 days.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

The Odense Child Cohort Study (OCC) is a population-based cohort study, comprising pregnant women recruited between January 1st 2010 and December 31st 2012. All women who were pregnant in the municipality of Odense during this time were eligible for participation, and 6,707 women were approached directly with recruitment material.

The study complied with the Helsinki declaration and was approved by the Regional Scientific Ethical Committee for Southern Denmark, no. S-20090130. All participants gave informed consent. From a population base of 6,70 pregnant women, 2,874 (42.9%) enrolled in the OCC up to December 31st, 2012. The children will be followed until 18 years of age.

Criteria

Inclusion Criteria:

  • Pregnant and residing in the municipality of Odense during 2010-2012

Exclusion Criteria:

  • Not residing in Odense, leaving the municipality

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02434900


Locations
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Denmark
HCA Research, Odense University Hospital
Odense, Denmark, 5000
Sponsors and Collaborators
Odense University Hospital
Investigators
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Principal Investigator: Henrik T Christesen, MD, PhD Project leader
Additional Information:

Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Henrik Christesen, MD, PhD, Associate Professor, Odense University Hospital
ClinicalTrials.gov Identifier: NCT02434900    
Other Study ID Numbers: VITAM1
First Posted: May 6, 2015    Key Record Dates
Last Update Posted: May 6, 2015
Last Verified: April 2015
Additional relevant MeSH terms:
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Abortion, Spontaneous
Pregnancy Complications