Metabolic and Endocrine Status in Women With Prior Preterm Birth

May 17, 2011 updated by: Namsos Hospital

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

262

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
    • Nord- Trøndelag
      • Namsos, Nord- Trøndelag, Norway, 7800
        • Namsos Hospital, Nord- Trøndelag Hospital Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Preterm birth group
Women with prior preterm birth
Term birth group
Women with prior term birth

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
one week after enrollment.
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.
one week after enrollment

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Namsos Hospital

Collaborators

Norwegian University of Science and Technology
The Royal Norwegian Ministry of Health

Investigators

  • Principal Investigator: Tina Eilertsen, MD, Namsos Hospital, Nord- Trøndelag Hospital Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Primary Completion (Actual)

April 1, 2008

Study Registration Dates

First Submitted

May 9, 2011

First Submitted That Met QC Criteria

May 17, 2011

First Posted (Estimate)

May 18, 2011

Study Record Updates

Last Update Posted (Estimate)

May 18, 2011

Last Update Submitted That Met QC Criteria

May 17, 2011

Last Verified

May 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 46011600-57

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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