Clinical trial NCT01355536: Metabolic and Endocrine Status in Women With Prior Preterm Birth
Official title: Metabolic and Endocrine Status in Women With Prior Preterm Birth. A Cross Sectional, Case- Control Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Polycystic Ovary Syndrome
Preterm Birth
Diabetes Mellitus
Keywords: Preterm birth
Preterm labour
Polycystic Ovary Syndrome
PCOS
Diabetes Mellitus
Hyperandrogenism
Hirsutism
Ovarian cysts
Anti Muller Hormone
Hypertension
Lead sponsor: Namsos Hospital
Sponsor class: OTHER
Collaborators: name: Norwegian University of Science and Technology
name: The Royal Norwegian Ministry of Health
First posted: 2011-05-18
Enrollment: 262
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

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.


Eligibility 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

Primary outcomes:
measure: The prevalence of PCOS
timeFrame: one week after enrollment.
measure: The prevalence of Diabetes Mellitus
timeFrame: one week after enrollment
Secondary outcomes:
measure: Ovarian antral follicle count
timeFrame: three years.
measure: Difference in quality of life between study groups.
timeFrame: four years
measure: Serum levels of androgens
timeFrame: one year
measure: Difference in anxiety between study groups.
timeFrame: four years
measure: Serum levels of AMH
timeFrame: One year
measure: Serum levels of glucose
timeFrame: One year
measure: Serum levels of insulin
timeFrame: One year
Other outcomes:
Locations:
city: Namsos
country: Norway
facility: Namsos Hospital, Nord- Trøndelag Hospital Trust
state: Nord- Trøndelag
Study officials:
affiliation: Namsos Hospital, Nord- Trøndelag Hospital Trust
name: Tina Eilertsen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Eilertsen TB, Vanky E, Carlsen SM. Anti-Mullerian hormone in the diagnosis of polycystic ovary syndrome: can morphologic description be replaced? Hum Reprod. 2012 Aug;27(8):2494-502. doi: 10.1093/humrep/des213. Epub 2012 Jun 12.
citation: Eilertsen TB, Vanky E, Carlsen SM. Increased prevalence of diabetes and polycystic ovary syndrome in women with a history of preterm birth: a case-control study. BJOG. 2012 Feb;119(3):266-75. doi: 10.1111/j.1471-0528.2011.03206.x. Epub 2011 Dec 13.