Metabolic and Endocrine Status in Women With Prior Preterm Birth

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01355536
• Other study ID #: 46011600-57
• Status: Completed
• Phase: N/A
• First received: May 9, 2011
• Last updated: May 17, 2011
• Start date: October 2006

Study information

• Verified date: May 2011
• Source: Namsos Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Regional Ethics CommiteeNorway: Norwegian Social Science Data Services
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 262
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Diabetes Mellitus
• Polycystic Ovary Syndrome
• Premature Birth
• Preterm Birth

Locations

Country	Name	City	State
Norway	Namsos Hospital, Nord- Trøndelag Hospital Trust	Namsos	Nord- Trøndelag

Sponsors (3)

Lead Sponsor	Collaborator
Namsos Hospital	Norwegian University of Science and Technology, The Royal Norwegian Ministry of Health

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The prevalence of PCOS	The prevalence of PCOS will be assessed in both study groups and the difference between the groups will be reported.	one week after enrollment.	Yes
Primary	The prevalence of Diabetes Mellitus	The prevalence of Diabetes Mellitus will be assessed in both study groups and the difference between the groups will be reported.	one week after enrollment	Yes
Secondary	Ovarian antral follicle count	Difference between study groups.	three years.	Yes
Secondary	Difference in quality of life between study groups.	Quality of life will be assessed by using Short form 36 Health Survey Questionnaire (SF- 36)	four years	No
Secondary	Serum levels of androgens	Difference between study groups	one year	Yes
Secondary	Difference in anxiety between study groups.	Anxiety will be assessed by using Spielberger State Anxiety Inventory Y1 and Y2 (STAI Y1 and Y2).	four years	No
Secondary	Serum levels of AMH	Difference between study groups	One year	Yes
Secondary	Serum levels of glucose	Difference between study groups	One year	Yes
Secondary	Serum levels of insulin	Difference between study groups	One year	Yes