Prevalence of Congenital Uterine Malformations (PUMA)
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|ClinicalTrials.gov Identifier: NCT01487616|
Recruitment Status : Unknown
Verified February 2016 by University of Nottingham.
Recruitment status was: Recruiting
First Posted : December 7, 2011
Last Update Posted : February 18, 2016
|Condition or disease|
|Congenital Uterine Anomalies|
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.
|Study Type :||Observational|
|Estimated Enrollment :||246 participants|
|Observational Model:||Case Control|
|Official Title:||Prevalence of Congenital Uterine Malformations in Women With a History of Preterm Delivery or Miscarriage|
|Study Start Date :||September 2012|
|Estimated Primary Completion Date :||March 2016|
|Estimated Study Completion Date :||March 2016|
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)
- Presence of uterine malformations [ Time Frame: At least 8 weeks after the end of last pregnancy ]Presence of uterine malformations in study group compared to control group
- Ultrasound markers on pelvic 3D ultrasound [ Time Frame: At least 8 weeks after the end of last pregnancy ]Ultrasound markers on pelvic 3D ultrasound in study versus control group
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01487616
|Contact: Nicholas Raine-Fenning, MBChB PhD||+44(0)1158230700||Nick.Raine-Fenning@nottingham.ac.uk|
|Contact: Yee Yin Chan, BMBSemail@example.com|
|Academic Imaging Suite, The University of Nottingham||Recruiting|
|Nottingham, Nottinghamshire, United Kingdom, NG7 2UH|
|Principal Investigator: Nicholas Raine-Fenning, MBChB PhD|
|Principal Investigator:||Nicholas Raine-Fenning, MBChB PhD||The University of Nottingham|