Prevalence of Congenital Uterine Malformations

• Conditions: Congenital Uterine Anomalies

• Registration Number: NCT01487616
• Lead Sponsor: University of Nottingham

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 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.

Study Timeline

• Study First Submitted: 2011-12-05
• Study First Submitted QC: 2011-12-05
• Study First Posted: 2011-12-07
• Study Start: 2012-09
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-17
• Last Update Posted: 2016-02-18
• Primary Completion: 2016-03
• Study Completion: 2016-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 246

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Presence of uterine malformations	At least 8 weeks after the end of last pregnancy	Presence of uterine malformations in study group compared to control group

Secondary Outcome Measures

Name	Time	Method
Ultrasound markers on pelvic 3D ultrasound	At least 8 weeks after the end of last pregnancy	Ultrasound markers on pelvic 3D ultrasound in study versus control group

Trial Locations

Locations (1)

Academic Imaging Suite, The University of Nottingham; 🇬🇧 Nottingham, Nottinghamshire, United Kingdom