Prevalence of Congenital Uterine Malformations (PUMA)

This study is currently recruiting participants.
Verified November 2012 by University of Nottingham
Sponsor:
Information provided by (Responsible Party):
University of Nottingham
ClinicalTrials.gov Identifier:
NCT01487616
First received: December 5, 2011
Last updated: November 21, 2012
Last verified: November 2012

December 5, 2011
November 21, 2012
September 2012
February 2014   (final data collection date for primary outcome measure)
Presence of uterine malformations [ Time Frame: At least 8 weeks after the end of last pregnancy ] [ Designated as safety issue: No ]
Presence of uterine malformations in study group compared to control group
Same as current
Complete list of historical versions of study NCT01487616 on ClinicalTrials.gov Archive Site
Ultrasound markers on pelvic 3D ultrasound [ Time Frame: At least 8 weeks after the end of last pregnancy ] [ Designated as safety issue: No ]
Ultrasound markers on pelvic 3D ultrasound in study versus control group
Same as current
Not Provided
Not Provided
 
Prevalence of Congenital Uterine Malformations
Prevalence of Congenital Uterine Malformations in Women With a History of Preterm Delivery or Miscarriage

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 study will also investigate other ultrasound characteristics detected on these women. This study will point towards the possible mechanism of how uterine malformations may affect pregnancy outcomes.

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 preterm delivery (Tomazevic, Ban-Frangez et al. 2007). However, the true prevalence is difficult to assess as there are no universally agreed classification systems and some of the best investigations are invasive. In addition, previous prevalence studies have not examined the details of subfertility or pregnancy loss, such as duration of subfertility, the gestation of pregnancy loss, or miscarriage pattern.

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 study will also investigate other ultrasound characteristics detected on these women. This study will point towards the possible mechanism of how uterine malformations may affect pregnancy outcomes.

Methods: We plan to recruit women who have had miscarriage or preterm delivery into our study. A sample of women who had normal term deliveries will be recruited as comparison. All women will undergo one 3-dimensional ultrasound scan each.

Outcomes: The proportions of women with congenital uterine malformations will be determined. Any ultrasound-detected markers found especially in women with poor pregnancy outcomes may point towards how uterine malformations affect pregnancies.

Observational
Observational Model: Case Control
Time Perspective: Prospective
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Probability Sample

Secondary care: Patients from Nottingham University Hospitals NHS Trust

Congenital Uterine Anomalies
Not Provided
  • Women with previous preterm birth
    Women with history of preterm birth (birth of a baby of less than 37 weeks gestational age, where labour was spontaneous) regardless of past pregnancy history.
  • Women with previous miscarriage
    Women with history of miscarriage (spontaneous pregnancy loss before 24 weeks of gestation), regardless of past pregnancy history.
  • Women with previous term births
    Women with previous term births (37 or more weeks of gestation)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
246
February 2014
February 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. 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
  2. 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
  3. 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 Criteria:

  • Pregnant at the date of the 3D TVUS
  • Recent uterine or endometrial surgery
  • Women unable to tolerate 3D TVUS
  • Unable to give informed consent
Female
18 Years and older
Yes
Contact: Nicholas Raine-Fenning, MBChB PhD +44(0)1158230700 Nick.Raine-Fenning@nottingham.ac.uk
Contact: Yee Yin Chan, BMBS mgxyyc@nottingham.ac.uk
United Kingdom
 
NCT01487616
11072
No
University of Nottingham
University of Nottingham
Not Provided
Principal Investigator: Nicholas Raine-Fenning, MBChB PhD The University of Nottingham
University of Nottingham
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP