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NCT Number: NCT01355536

Metabolic and Endocrine Status in Women With Prior Preterm Birth

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.

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Key information

Conditions

Polycystic Ovary Syndrome 46, XX Disorders of Sex Development Adnexal Diseases Adrenogenital Syndrome Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cysts Diabetes Mellitus Disorders of Sex Development Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Glucose Metabolism Disorders Gonadal Disorders Hair Diseases Hirsutism Hyperandrogenism Hypertension Male Urogenital Diseases Metabolic Diseases Neoplasms Nutritional and Metabolic Diseases Obstetric Labor Complications Obstetric Labor, Premature Ovarian Cysts Ovarian Diseases Pathological Conditions, Signs and Symptoms Pregnancy Complications Premature Birth Preterm Birth Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases Urogenital Abnormalities Urogenital Diseases Vascular Diseases Virilism

Sex eligibility

Female

Study type

Observational

Primary location

Namsos Hospital, Nord- Trøndelag Hospital Trust

Namsos, Nord- Trøndelag, 7800, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Ovarian antral follicle count

    Time frame: three years.

    Difference between study groups.

  2. 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)

  3. Serum levels of androgens

    Time frame: one year

    Difference between study groups

  4. 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).

  5. Serum levels of AMH

    Time frame: One year

    Difference between study groups

  6. Serum levels of glucose

    Time frame: One year

    Difference between study groups

  7. Serum levels of insulin

    Time frame: One year

    Difference between study groups

Sponsors and collaborators

Lead sponsor

Namsos Hospital

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2008
First posted
May 18, 2011
Registry last updated
May 18, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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