Polycystic Ovary SyndromeNCT01355536
Metabolic and Endocrine Status in Women With Prior Preterm Birth
An observational study of Polycystic Ovary Syndrome and Preterm Birth, run by Namsos Hospital at 1 site in Norway.
Trial 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… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Polycystic Ovary Syndrome, Preterm Birth, Diabetes Mellitus
- How many people
- 262 participants
- Where
- 1 siteNorway
- Study dates
- Oct 2006to Apr 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- One or more preterm birth in the given period of time
- Having Namsos Hospital as their local Hospital during pregnancy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Norway1 site
Namsos Hospital, Nord- Trøndelag Hospital Trust
Namsos, Nord- Trøndelag, 7800
About this study
Official title: 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.
- 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
- Medical subject headings
- Polycystic Ovary Syndrome, Premature Birth, Diabetes Mellitus, Obstetric Labor, Premature, Hyperandrogenism, Hirsutism, Ovarian Cysts, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Preterm birth group | Women with prior preterm birth | |
| Term birth group | Women with prior term birth |
What is being measured
The primary outcome is the main question the study is designed to answer.
The prevalence of PCOS
The prevalence of PCOS will be assessed in both study groups and the difference between the groups will be reported.
Measured: one week after enrollment.
The prevalence of Diabetes Mellitus
The prevalence of Diabetes Mellitus will be assessed in both study groups and the difference between the groups will be reported.
Measured: one week after enrollment
Secondary outcomes (7)
Ovarian antral follicle count
Difference between study groups.
Measured: three years.
Difference in quality of life between study groups.
Quality of life will be assessed by using Short form 36 Health Survey Questionnaire (SF- 36)
Measured: four years
Serum levels of androgens
Difference between study groups
Measured: one year
Difference in anxiety between study groups.
Anxiety will be assessed by using Spielberger State Anxiety Inventory Y1 and Y2 (STAI Y1 and Y2).
Measured: four years
Serum levels of AMH
Difference between study groups
Measured: One year
Serum levels of glucose
Difference between study groups
Measured: One year
Serum levels of insulin
Difference between study groups
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2011 (estimated)
- Study startOct 2006
- Primary completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 262 participants (actual)
Sponsor and investigators
- Lead sponsor
- Namsos Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian University of Science and Technology, The Royal Norwegian Ministry of Health
- Investigators
- Tina Eilertsen, MD, Principal investigator, Namsos Hospital, Nord- Trøndelag Hospital Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01355536
- Sponsor's protocol ID
- 46011600-57
- Status last verified
- May 2011
- First submitted
- 9 May 2011
- Last updated
- 18 May 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22693172Eilertsen 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.
PubMed 22168920
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic and Endocrine Status in Women With Prior Preterm Birth. A Cross Sectional, Case- Control Study
- ClinicalTrials.gov ID
- NCT01355536
- Acronym / sponsor ID
- 46011600-57
- Conditions
- Polycystic Ovary Syndrome, Preterm Birth, Diabetes Mellitus
- Keywords
- Preterm birth, Preterm labour, Polycystic Ovary Syndrome, PCOS, Diabetes Mellitus, Hyperandrogenism, Hirsutism, Ovarian cysts
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 262 participants (actual)
- Lead sponsor
- Namsos HospitalUniversity, hospital or other
- Collaborators
- Norwegian University of Science and Technology, The Royal Norwegian Ministry of Health
- Study start
- Oct 2006
- Primary completion
- Apr 2008 (actual)
- First posted
- 18 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preterm birth group | – | –Women with prior preterm birth |
| Term birth group | – | –Women with prior term birth |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- One or more preterm birth in the given period of time
- Having Namsos Hospital as their local Hospital during pregnancy
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
7 secondary outcomes
Ovarian antral follicle count
Time frame: three years.
Difference in quality of life between study groups.
Time frame: four years
Serum levels of androgens
Time frame: one year
Difference in anxiety between study groups.
Time frame: four years
Serum levels of AMH
Time frame: One year
Serum levels of glucose
Time frame: One year
Serum levels of insulin
Time frame: One year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2011.
- Derived from this study: PubMed 22693172Eilertsen 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.
- Derived from this study: PubMed 22168920Eilertsen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tina Eilertsen, MD principal investigator
Namsos Hospital, Nord- Trøndelag Hospital Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Polycystic Ovary Syndrome and Preterm Birth, run by Namsos Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The prevalence of PCOS (time frame: one week after enrollment.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01355536, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2011.