Metabolic and Endocrine Status in Women With Prior Preterm Birth

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01355536

Enrollment

262

Registered

2011-05-18

Start date

2006-10-31

Completion date

Unknown

Last updated

2011-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Polycystic Ovary Syndrome, Preterm Birth

Keywords

Preterm birth, Preterm labour, Polycystic Ovary Syndrome, PCOS, Diabetes Mellitus, Hyperandrogenism, Hirsutism, Ovarian cysts, Anti Muller Hormone, Hypertension

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.
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.

Secondary

Measure	Time frame	Description
Serum levels of androgens	one year	Difference between study groups
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).
Ovarian antral follicle count	three years.	Difference between study groups.
Serum levels of glucose	One year	Difference between study groups
Serum levels of insulin	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)

Countries

Norway

Outcome results