Metabolic and Endocrine Status in Women With Prior Preterm Birth

Completed

• Conditions: Preterm Birth; Diabetes Mellitus; Polycystic Ovary Syndrome

• Registration Number: NCT01355536
• Lead Sponsor: Namsos Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-10
• Primary Completion: 2008-04
• Status Verified: 2011-05
• Study First Submitted: 2011-05-09
• Study First Submitted QC: 2011-05-17
• Last Update Submitted: 2011-05-17
• Study First Posted: 2011-05-18
• Last Update Posted: 2011-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 262

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The prevalence of Diabetes Mellitus	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	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 Outcome Measures

Name	Time	Method
Serum levels of insulin	One year	Difference between study groups
Ovarian antral follicle count	three years.	Difference between study groups.
Serum levels of androgens	one year	Difference between study groups
Serum levels of AMH	One year	Difference between study groups
Difference in quality of life between study groups.	four years	Quality of life will be assessed by using Short form 36 Health Survey Questionnaire (SF- 36)
Difference in anxiety between study groups.	four years	Anxiety will be assessed by using Spielberger State Anxiety Inventory Y1 and Y2 (STAI Y1 and Y2).
Serum levels of glucose	One year	Difference between study groups

Trial Locations

Locations (1)

Namsos Hospital, Nord- Trøndelag Hospital Trust; 🇳🇴 Namsos, Nord- Trøndelag, Norway