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Clinical Trials/NCT01355536
NCT01355536
Completed
Not Applicable

Metabolic and Endocrine Status in Women With Prior Preterm Birth. A Cross Sectional, Case- Control Study

Namsos Hospital1 site in 1 country262 target enrollmentOctober 2006
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ConditionsPolycystic Ovary SyndromePreterm BirthDiabetes Mellitus

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Polycystic Ovary Syndrome
Sponsor
Namsos Hospital
Enrollment
262
Locations
1
Primary Endpoint
The prevalence of Diabetes Mellitus
Status
Completed
Last Updated
14 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

The prevalence of preterm birth is rising in most western countries. The causes of preterm birth is not fully understood and seem to be multifactorial. The endocrine and metabolic aspects are scarcely investigated.The main purpose of this study is to test the hypothesis that endocrine and metabolic factors associate to preterm births.

Registry
clinicaltrials.gov
Start Date
October 2006
End Date
April 2008
Last Updated
14 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
Namsos Hospital

Eligibility Criteria

Inclusion Criteria

  • •One or more preterm birth in the given period of time
  • •Having Namsos Hospital as their local Hospital during pregnancy

Exclusion Criteria

  • •Moved from the region of Mid- Norway at the time of the study
  • •Lack of communication skills in Norwegian or English
  • •Ongoing pregnancy
  • •Ongoing breastfeeding

Outcomes

Primary Outcomes

The prevalence of Diabetes Mellitus

Time Frame: one week after enrollment

The prevalence of Diabetes Mellitus will be assessed in both study groups and the difference between the groups will be reported.

The prevalence of PCOS

Time Frame: one week after enrollment.

The prevalence of PCOS will be assessed in both study groups and the difference between the groups will be reported.

Secondary Outcomes

  • Serum levels of insulin(One year)
  • Ovarian antral follicle count(three years.)
  • Serum levels of androgens(one year)
  • Serum levels of AMH(One year)
  • Difference in quality of life between study groups.(four years)
  • Difference in anxiety between study groups.(four years)
  • Serum levels of glucose(One year)

Study Sites (1)

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