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Completed

NCT Number: NCT01983202

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.

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Key information

Conditions

Polycystic Ovary Syndrome, PCOS Adnexal Diseases Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Neoplasms Ovarian Cysts Ovarian Diseases Polycystic Ovary Syndrome Urogenital Diseases

Sex eligibility

Female

Study type

Observational

Primary location

Department of Endocrinology, Odense University Hospital

Odense, 5000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosed with PCOS and giving birth during 2003-2011

Exclusion criteria

  • Multiple pregnancy

Treatment and study plan

Primary outcomes

  1. Anthropometric measures

    Time frame: Date of birth (1 day)

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

Secondary outcomes

  1. 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.

Other outcomes

  1. Neonatal complications

    Time frame: Date of birth (1 day)

    Registration of Apgar score 5 minutes after birth and admission to neonatal intensive care unit.

Sponsors and collaborators

Lead sponsor

Odense University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2011
Study completion
2013
First posted
Nov 13, 2013
Registry last updated
Nov 13, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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