Clinical trial NCT01487616: Prevalence of Congenital Uterine Malformations
Official title: Prevalence of Congenital Uterine Malformations in Women With a History of Preterm Delivery or Miscarriage
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Congenital Uterine Anomalies
Keywords: Mullerian anomalies
Congenital uterine malformations or anomalies
Arcuate
Septate
Subseptate
Bicornuate
Unicornuate
Didelphys
T-shaped
Lead sponsor: University of Nottingham
Sponsor class: OTHER
First posted: 2011-12-07
Enrollment: 246
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Secondary care: Patients from Nottingham University Hospitals NHS Trust

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.

Eligibility criteria: 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

Primary outcomes:
measure: Presence of uterine malformations
timeFrame: At least 8 weeks after the end of last pregnancy
Secondary outcomes:
measure: Ultrasound markers on pelvic 3D ultrasound
timeFrame: At least 8 weeks after the end of last pregnancy
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Academic Imaging Suite, The University of Nottingham
state: Nottinghamshire
Study officials:
affiliation: The University of Nottingham
name: Nicholas Raine-Fenning, MBChB PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chan YY, Jayaprakasan K, Zamora J, Thornton JG, Raine-Fenning N, Coomarasamy A. The prevalence of congenital uterine anomalies in unselected and high-risk populations: a systematic review. Hum Reprod Update. 2011 Nov-Dec;17(6):761-71. doi: 10.1093/humupd/dmr028. Epub 2011 Jun 24.
citation: Chan YY, Jayaprakasan K, Tan A, Thornton JG, Coomarasamy A, Raine-Fenning NJ. Reproductive outcomes in women with congenital uterine anomalies: a systematic review. Ultrasound Obstet Gynecol. 2011 Oct;38(4):371-82. doi: 10.1002/uog.10056.