Prevalence of Congenital Uterine Malformations (PUMA)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2012 by University of Nottingham
Sponsor:
Information provided by (Responsible Party):
University of Nottingham
ClinicalTrials.gov Identifier:
NCT01487616
First received: December 5, 2011
Last updated: November 21, 2012
Last verified: November 2012
  Purpose

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.


Condition
Congenital Uterine Anomalies

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Prevalence of Congenital Uterine Malformations in Women With a History of Preterm Delivery or Miscarriage

Resource links provided by NLM:


Further study details as provided by University of Nottingham:

Primary Outcome Measures:
  • Presence of uterine malformations [ Time Frame: At least 8 weeks after the end of last pregnancy ] [ Designated as safety issue: No ]
    Presence of uterine malformations in study group compared to control group


Secondary Outcome Measures:
  • Ultrasound markers on pelvic 3D ultrasound [ Time Frame: At least 8 weeks after the end of last pregnancy ] [ Designated as safety issue: No ]
    Ultrasound markers on pelvic 3D ultrasound in study versus control group


Estimated Enrollment: 246
Study Start Date: September 2012
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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)

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Secondary care: Patients from Nottingham University Hospitals NHS Trust

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01487616

Contacts
Contact: Nicholas Raine-Fenning, MBChB PhD +44(0)1158230700 Nick.Raine-Fenning@nottingham.ac.uk
Contact: Yee Yin Chan, BMBS mgxyyc@nottingham.ac.uk

Locations
United Kingdom
Academic Imaging Suite, The University of Nottingham Recruiting
Nottingham, Nottinghamshire, United Kingdom, NG7 2UH
Principal Investigator: Nicholas Raine-Fenning, MBChB PhD         
Sponsors and Collaborators
University of Nottingham
Investigators
Principal Investigator: Nicholas Raine-Fenning, MBChB PhD The University of Nottingham
  More Information

Publications:
Responsible Party: University of Nottingham
ClinicalTrials.gov Identifier: NCT01487616     History of Changes
Other Study ID Numbers: 11072
Study First Received: December 5, 2011
Last Updated: November 21, 2012
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University of Nottingham:
Mullerian anomalies
Congenital uterine malformations or anomalies
Arcuate
Septate
Subseptate
Bicornuate
Unicornuate
Didelphys
T-shaped

Additional relevant MeSH terms:
Congenital Abnormalities
Urogenital Abnormalities

ClinicalTrials.gov processed this record on October 29, 2014