NCT01983202

Brief Summary

The aim of the study is to investigate body composition in newborn children of women with PCOS and controls and to investigate adverse obstetric outcomes in pregnant women with PCOS.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,248

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2003

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 24, 2013

Completed
20 days until next milestone

First Posted

Study publicly available on registry

November 13, 2013

Completed
Last Updated

November 13, 2013

Status Verified

November 1, 2013

Enrollment Period

8 years

First QC Date

October 24, 2013

Last Update Submit

November 6, 2013

Conditions

Polycystic Ovary Syndrome, PCOS

Keywords

PCOSPregnancyObstetric

Outcome Measures

Primary Outcomes (1)

  • Anthropometric measures

    Abdominal circumference, birth weight, birth length, and head circumference.

    Date of birth (1 day)

Secondary Outcomes (1)

  • Adverse obstetric outcomes

    From beginning of pregnancy until the date of delivery (approximately 9 months)

Other Outcomes (1)

  • Neonatal complications

    Date of birth (1 day)

Study Arms (2)

Women with PCOS

208 women diagnosed with PCOS and giving birth after singleton pregnancies at Odense University Hospital during 2003-2011.

Controls

1040 women giving birth after singleton pregnancies at Odense University Hospital during 2003-2011, matched 1:5 to women with PCOS according to date-of-childbirth.

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

208 women diagnosed with PCOS at Department of Endocrinology and Metabolism and giving birth at Odense University Hospital during 2003-2011. Women with PCOS are matched 1:5 to a date-of-childbirth matched control group of 1040 pregnant women giving birth at Odense UNivesity Hospital.

You may qualify if:

  • Diagnosed with PCOS and giving birth during 2003-2011

You may not qualify if:

  • Multiple pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Endocrinology, Odense University Hospital

Odense, 5000, Denmark

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Study Officials

  • Marianne Andersen, DMSci

    Odense University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant

Study Record Dates

First Submitted

October 24, 2013

First Posted

November 13, 2013

Study Start

January 1, 2003

Primary Completion

January 1, 2011

Study Completion

September 1, 2013

Last Updated

November 13, 2013

Record last verified: 2013-11

Locations

DK(1)