Status:

UNKNOWN

Prevalence of Congenital Uterine Malformations

Lead Sponsor:

University of Nottingham

Conditions:

Congenital Uterine Anomalies

Eligibility:

FEMALE

18+ years

Brief Summary

Aims: We plan to investigate how common uterine malformations are in high-risk women (with history of miscarriage or preterm delivery), by analysing different characteristics in these groups. This stu...

Detailed Description

Background: Congenital abnormally shaped wombs (uterine malformations) have long been thought to be more common in women with poor pregnancy outcomes, e.g. miscarriage (Rackow and Arici 2007) and pret...

Eligibility Criteria

Inclusion

  • Women with a previous miscarriage
  • Age: 18 years old or more
  • Definition of miscarriage: the spontaneous pregnancy loss up until 24 weeks of gestation, where the pregnancy was confirmed histologically or with previous presence of a gestational sac with or without fetal pole and fetal heart activity on ultrasound scanning.
  • At least 8 weeks after the end of last pregnancy
  • Women with preterm birth
  • Age: 18 years old or more
  • Definition of preterm birth: birth at less than 37 weeks of gestation.
  • At least 8 weeks after the end of last pregnancy
  • Control group (women with term birth)
  • Age: 18 years old or more
  • Definition of term birth: birth at 37 or more weeks of gestation
  • At least 8 weeks after the end of last pregnancy

Exclusion

  • Pregnant at the date of the 3D TVUS
  • Recent uterine or endometrial surgery
  • Women unable to tolerate 3D TVUS
  • Unable to give informed consent

Key Trial Info

Start Date :

September 1 2012

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

March 1 2016

Estimated Enrollment :

246 Patients enrolled

Trial Details

Trial ID

NCT01487616

Start Date

September 1 2012

End Date

March 1 2016

Last Update

February 18 2016

Active Locations (1)

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1

Academic Imaging Suite, The University of Nottingham

Nottingham, Nottinghamshire, United Kingdom, NG7 2UH