Congenital Uterine AnomaliesPUMANCT01487616
Prevalence of Congenital Uterine Malformations
An observational study of Congenital Uterine Anomalies, run by University of Nottingham at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Congenital Uterine Anomalies
- How many people
- 246 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2012to Mar 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Secondary care: Patients from Nottingham University Hospitals NHS Trust
Who may be able to join
- 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
- Women with preterm birth
- Age: 18 years old or more
Show all 12Show fewer
- Definition of preterm birth: birth at less than 37 weeks of gestation.
- At least 8 weeks after the end of last pregnancy
- 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
Who cannot join
- Pregnant at the date of the 3D TVUS
- Recent uterine or endometrial surgery
- Women unable to tolerate 3D TVUS
- Unable to give informed consent
Trial locations and contacts
1 site in 1 country.
Yee Yin Chan, BMBS contact
United Kingdom1 site, 1 recruiting
- Recruiting
Academic Imaging Suite, The University of Nottingham
Nottingham, Nottinghamshire, NG7 2UH
Nicholas Raine-Fenning, MBChB PhD
About this study
Official title: Prevalence of Congenital Uterine Malformations in Women With a History of Preterm Delivery or Miscarriage
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.
Read the 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
- Keywords
- Mullerian anomalies, Congenital uterine malformations or anomalies, Arcuate, Septate, Subseptate, Bicornuate, Unicornuate, Didelphys, T-shaped
- Medical subject headings
- Congenital Abnormalities, Uterine Didelphys
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of uterine malformations
Presence of uterine malformations in study group compared to control group
Measured: At least 8 weeks after the end of last pregnancy
Secondary outcomes (1)
Ultrasound markers on pelvic 3D ultrasound
Ultrasound markers on pelvic 3D ultrasound in study versus control group
Measured: At least 8 weeks after the end of last pregnancy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2011 (estimated)
- Study startSep 2012
- Primary completionMar 2016 (estimated)
- Study completionMar 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Congenital Uterine AnomaliesStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 246 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicholas Raine-Fenning, MBChB PhD, Principal investigator, The University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01487616
- Sponsor's protocol ID
- 11072
- Acronym
- PUMA
- Status last verified
- Feb 2016
- First submitted
- 5 Dec 2011
- Last updated
- 18 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 21705770Chan 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.
PubMed 21830244
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Congenital Uterine Malformations in Women With a History of Preterm Delivery or Miscarriage
- ClinicalTrials.gov ID
- NCT01487616
- Acronym / sponsor ID
- PUMA / 11072
- Conditions
- Congenital Uterine Anomalies
- Keywords
- Mullerian anomalies, Congenital uterine malformations or anomalies, Arcuate, Septate, Subseptate, Bicornuate, Unicornuate, Didelphys
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 246 participants (estimated)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Mar 2016 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 7 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Secondary care: Patients from Nottingham University Hospitals NHS Trust
Key inclusion criteria (12 listed)
- Women with a previous miscarriage
- Women with preterm birth
- Control group (women with term birth)
Key exclusion criteria (4 listed)
- Pregnant at the date of the 3D TVUS
- Recent uterine or endometrial surgery
- Women unable to tolerate 3D TVUS
- Unable to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Presence of uterine malformations
Time frame: At least 8 weeks after the end of last pregnancy
Presence of uterine malformations in study group compared to control group
1 secondary outcome
Ultrasound markers on pelvic 3D ultrasound
Time frame: At least 8 weeks after the end of last pregnancy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2016.
- Background: PubMed 21705770Chan 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.
- Background: PubMed 21830244Chan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yee Yin Chan, BMBS contact
Nicholas Raine-Fenning, MBChB PhD principal investigator
The University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Uterine Anomalies, run by University of Nottingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nicholas Raine-Fenning, MBChB PhD (+44(0)1158230700, Nick.Raine-Fenning@nottingham.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of uterine malformations (time frame: At least 8 weeks after the end of last pregnancy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01487616, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2016.