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Metabolic and Endocrine Status in Women With Prior Preterm Birth

This study has been completed.
Sponsor:
Collaborators:
Norwegian University of Science and Technology
The Royal Norwegian Ministry of Health
Information provided by:
Namsos Hospital
ClinicalTrials.gov Identifier:
NCT01355536
First received: May 9, 2011
Last updated: May 17, 2011
Last verified: May 2011
History of Changes
  Purpose

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.


Condition
Polycystic Ovary Syndrome
Preterm Birth
Diabetes Mellitus

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Metabolic and Endocrine Status in Women With Prior Preterm Birth. A Cross Sectional, Case- Control Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Namsos Hospital:

Primary Outcome Measures:
  • The prevalence of PCOS [ Time Frame: one week after enrollment. ] [ Designated as safety issue: Yes ]
    The prevalence of PCOS will be assessed in both study groups and the difference between the groups will be reported.

  • The prevalence of Diabetes Mellitus [ Time Frame: one week after enrollment ] [ Designated as safety issue: Yes ]
    The prevalence of Diabetes Mellitus will be assessed in both study groups and the difference between the groups will be reported.


Secondary Outcome Measures:
  • Ovarian antral follicle count [ Time Frame: three years. ] [ Designated as safety issue: Yes ]
    Difference between study groups.

  • Difference in quality of life between study groups. [ Time Frame: four years ] [ Designated as safety issue: No ]
    Quality of life will be assessed by using Short form 36 Health Survey Questionnaire (SF- 36)

  • Serum levels of androgens [ Time Frame: one year ] [ Designated as safety issue: Yes ]
    Difference between study groups

  • Difference in anxiety between study groups. [ Time Frame: four years ] [ Designated as safety issue: No ]
    Anxiety will be assessed by using Spielberger State Anxiety Inventory Y1 and Y2 (STAI Y1 and Y2).

  • Serum levels of AMH [ Time Frame: One year ] [ Designated as safety issue: Yes ]
    Difference between study groups

  • Serum levels of glucose [ Time Frame: One year ] [ Designated as safety issue: Yes ]
    Difference between study groups

  • Serum levels of insulin [ Time Frame: One year ] [ Designated as safety issue: Yes ]
    Difference between study groups


Biospecimen Retention:   Samples With DNA

Whole blood, serum,endometrial biopsy


Enrollment: 262
Study Start Date: October 2006
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
Preterm birth group
Women with prior preterm birth
Term birth group
Women with prior term birth

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All women in municipalities having Namsos Hospital as their local Hospital and with preterm births from January 1999 to Descember 2006 were identifed by searching birth protocols. These women were invited to participate in the preterm birth study group. As controls we identified the first term birth occuring in time after each preterm birth. These women were invited to participate in the term birth study group.

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01355536

Locations
Norway
Namsos Hospital, Nord- Trøndelag Hospital Trust
Namsos, Nord- Trøndelag, Norway, 7800
Sponsors and Collaborators
Namsos Hospital
Norwegian University of Science and Technology
The Royal Norwegian Ministry of Health
Investigators
Principal Investigator: Tina Eilertsen, MD Namsos Hospital, Nord- Trøndelag Hospital Trust
  More Information

No publications provided by Namsos Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Tina Eilertsen, MD, Hospital of Namsos
ClinicalTrials.gov Identifier: NCT01355536     History of Changes
Other Study ID Numbers: 46011600-57
Study First Received: May 9, 2011
Last Updated: May 17, 2011
Health Authority: Norway: Regional Ethics Commitee
Norway: Norwegian Social Science Data Services

Keywords provided by Namsos Hospital:
Preterm birth
Preterm labour
Polycystic Ovary Syndrome
PCOS
Diabetes Mellitus
 Hyperandrogenism
Hirsutism
Ovarian cysts
Anti Muller Hormone
Hypertension

Additional relevant MeSH terms:
Ovarian Cysts
Cysts
Ovarian Diseases
Diabetes Mellitus
Polycystic Ovary Syndrome
Premature Birth
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Neoplasms
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications

ClinicalTrials.gov processed this record on June 18, 2013