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Prevalence of Congenital Uterine Malformations

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01487616
Acronym
PUMA
Enrollment
246
Registered
2011-12-07
Start date
2012-09-30
Completion date
2016-03-31
Last updated
2016-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital Uterine Anomalies

Keywords

Mullerian anomalies, Congenital uterine malformations or anomalies, Arcuate, Septate, Subseptate, Bicornuate, Unicornuate, Didelphys, T-shaped

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.

Interventions

None listed

Sponsors

University of Nottingham
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Presence of uterine malformationsAt least 8 weeks after the end of last pregnancyPresence of uterine malformations in study group compared to control group

Secondary

MeasureTime frameDescription
Ultrasound markers on pelvic 3D ultrasoundAt least 8 weeks after the end of last pregnancyUltrasound markers on pelvic 3D ultrasound in study versus control group

Countries

United Kingdom

Contacts

Primary ContactNicholas Raine-Fenning, MBChB PhD
Nick.Raine-Fenning@nottingham.ac.uk+44(0)1158230700
Backup ContactYee Yin Chan, BMBS
mgxyyc@nottingham.ac.uk

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026