NCT01487616

Prevalence of Congenital Uterine Malformations

Prevalence of Congenital Uterine Malformations in Women With a History of Preterm Delivery or Miscarriage

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 246 (estimated)
• Sponsor: University of Nottingham · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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 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.

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 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.

Conditions

• Congenital Uterine Anomalies

Timeline

• Start date: 2012-09-01
• Primary completion: 2016-03-01
• Completion: 2016-03-01
• First posted: 2011-12-07
• Last updated: 2016-02-18

Locations

1 site across 1 country: United Kingdom