Obstetric Outcomes in Women With PCOS

November 6, 2013 updated by: Marianne Andersen, Odense University Hospital

Size at Birth in Newborn Children and Obstetric Outcomes in Women With PCOS

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.

Study Overview

Status

Completed

Conditions

Detailed Description

A prospective cohort study investigating 208 women with PCOS giving birth after singleton pregnancies at Odense Univesity Hospital during 2003-2011 and a date-of-childbirth matched control group of 1040 women. Anthropometric data from children is recorded as well as data on maternal parity, age, pre-gestational BMI, and adverse obstetric outcomes.

Study Type

Observational

Enrollment (Actual)

1248

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Odense, Denmark, 5000
        • Department of Endocrinology, Odense University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability 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.

Description

Inclusion Criteria:

  • Diagnosed with PCOS and giving birth during 2003-2011

Exclusion Criteria:

  • Multiple pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anthropometric measures
Time Frame: Date of birth (1 day)
Abdominal circumference, birth weight, birth length, and head circumference.
Date of birth (1 day)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse obstetric outcomes
Time Frame: From beginning of pregnancy until the date of delivery (approximately 9 months)
Presence of gestational diabetes mellitus, pregnancy induced hypertension, or pre-eclampsia during pregnancy. Registration of gestational age at childbirth, medical induction of birth, caesarean section,instrumental delivery, anal sphincter rupture, and shoulder dystocia.
From beginning of pregnancy until the date of delivery (approximately 9 months)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neonatal complications
Time Frame: Date of birth (1 day)
Registration of Apgar score 5 minutes after birth and admission to neonatal intensive care unit.
Date of birth (1 day)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Odense University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2003

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

October 24, 2013

First Submitted That Met QC Criteria

November 6, 2013

First Posted (Estimate)

November 13, 2013

Study Record Updates

Last Update Posted (Estimate)

November 13, 2013

Last Update Submitted That Met QC Criteria

November 6, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25624548

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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