Obstetric Outcomes in Women With PCOS

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Marianne Andersen, Odense University Hospital
ClinicalTrials.gov Identifier:
NCT01983202
First received: October 24, 2013
Last updated: November 6, 2013
Last verified: November 2013
  Purpose

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.


Condition
Polycystic Ovary Syndrome, PCOS

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Size at Birth in Newborn Children and Obstetric Outcomes in Women With PCOS

Resource links provided by NLM:


Further study details as provided by Odense University Hospital:

Primary Outcome Measures:
  • Anthropometric measures [ Time Frame: Date of birth (1 day) ] [ Designated as safety issue: No ]
    Abdominal circumference, birth weight, birth length, and head circumference.


Secondary Outcome Measures:
  • Adverse obstetric outcomes [ Time Frame: From beginning of pregnancy until the date of delivery (approximately 9 months) ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • Neonatal complications [ Time Frame: Date of birth (1 day) ] [ Designated as safety issue: No ]
    Registration of Apgar score 5 minutes after birth and admission to neonatal intensive care unit.


Enrollment: 1248
Study Start Date: January 2003
Study Completion Date: September 2013
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Criteria

Inclusion Criteria:

  • Diagnosed with PCOS and giving birth during 2003-2011

Exclusion Criteria:

  • Multiple pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01983202

Locations
Denmark
Department of Endocrinology, Odense University Hospital
Odense, Denmark, 5000
Sponsors and Collaborators
Odense University Hospital
Investigators
Principal Investigator: Marianne Andersen, DMSci Odense University Hospital
  More Information

No publications provided

Responsible Party: Marianne Andersen, Consultant, Odense University Hospital
ClinicalTrials.gov Identifier: NCT01983202     History of Changes
Other Study ID Numbers: 25624548
Study First Received: October 24, 2013
Last Updated: November 6, 2013
Health Authority: Denmark: Danish Dataprotection Agency

Keywords provided by Odense University Hospital:
PCOS
Pregnancy
Obstetric

Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases

ClinicalTrials.gov processed this record on October 19, 2014