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Twin Dichorionic Diamniotic PlacentaMonoRegNCT03171909

Austrian Registry on the Outcome of Monochorionic Pregnancies

An observational study of Twin Dichorionic Diamniotic Placenta and Twin Monochorionic Monoamniotic Placenta, run by Medical University of Graz at 13 sites in Austria.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

About one third of twin pregnancies are resulting from a single fertilized oocyte. Two third of these monozygotic twins share a common placenta and are therefore called monochorionic. Read more about this study

Who is it for?
Ages 18 to 50 years, women onlyHealthy volunteers can take part
How many people
1,000 participants
Where
13 sitesAustria
Study dates
1 May 2017to Jan 2025
How long will I take part?
8 Years
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 to 50 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Study population: All monochorionic pregnancies diagnosed from 11+0 weeks of gestation on

Who may be able to join

  • All monochorionic pregnancies diagnosed from 11+0 weeks of gestation

Who cannot join

  • Dichorionic twin pregnancies or higher-grade multiples without a monochorionic pair

Trial locations and contacts

13 sites in 1 country.

Philipp Klaritsch, MD contact

+4331638581641

philipp.klaritsch@medunigraz.at

Isabella Pfniss, MD contact

+4331638580829

isabella.pfniss@medunigraz.at

13 sites in 1 country

Austria13 sites, 13 recruiting

  • Brothers of Saint John of God Eisenstadt

    Eisenstadt

    Herbert Mock, MD

    Recruiting

  • Medical University of Graz

    Graz, Styria, 8043

    Philipp Klaritsch, MD, +4331638581641, philipp.klaritsch@medunigraz.at

    Isabella Pfniss, MD, +43316380829, isabella.pfniss@medunigraz.at

    Recruiting

  • Medical University Innsbruck

    Innsbruck

    Angela Ramoni, MD

    Recruiting

  • Klinikum Klagenfurt am Wörthersee

    Klagenfurt

    Manfred Mörtl, MD

    Recruiting

  • Hospital Hochsteiermark

    Leoben

    Werner Schaffer

    Recruiting

  • Johannes Kepler University of Linz

    Linz

    Wolfgang Arzt, MD

    Recruiting

  • Mödling Hospital

    Mödling

    Michael Burger, MD

    Recruiting

  • Paracelsus Medical University

    Salzburg

    Dagmar Wertaschnigg, MD

    Recruiting

  • Landesklinikum Sankt Polten

    Sankt Pölten

    Matthias Klein, MD

    Recruiting

  • Medical University Vienna

    Vienna

    Christof Worda, MD

    Recruiting

  • SMZ-Ost Donauspital

    Vienna

    Erich Hafner, MD

    Recruiting

  • Klinikum Wels-Grieskirchen

    Wels

    Alfred Bacherer, MD

    Recruiting

  • Klinikum Wiener Neustadt

    Wiener Neustadt

    Philipp Tschak, MD

    Recruiting

Other trials in Austria

About this study

Official title: Austrian Registry on the Outcome of Monochorionic Multiple Pregnancies: A Multicenter Registry Study

About one third of twin pregnancies are resulting from a single fertilized oocyte. Two third of these monozygotic twins share a common placenta and are therefore called monochorionic. Due to placental sharing and the ever-present inter-fetal vascular connections, specific complications may arise and lead to an increased risk of intrauterine death and long-term neurodevelopmental impairment. Specific complications include twin-to-twin transfusion syndrome (TTTS), twin-anemia-polycythemia sequence (TAPS), selective intrauterine growth restriction (sIUGR) and discordant major anomalies, occurring in about 10%, 5%, 20% and 6% of monochorionic diamniotic twins. Prenatal interventions may improve perinatal and long-term outcome of affected fetuses. However, general knowledge about early diagnosis of monochorionic twins and their specific complications is still limited in a significant number of practitioners in Austria and systematic analysis of pregnancy outcomes are not conducted.

In this prospective multicenter registry study, the investigators aim to include all monochorionic pregnancies in Austria. Main outcome parameter is the occurrence of complications. Secondary outcomes are gestational age at occurrence of complications, gestational age delivery and neonatal outcome. The investigators also strive for long-term outcome, especially of infants following complicated pregnancies or preterm birth.

Medical subject headings
Fetofetal Transfusion

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. occurrence of specific complications

    TTTS, sIUGR, TAPS, TRAP, IUFD, malformations, miscarriage

    Measured: from 12 weeks of gestation to delivery

Secondary outcomes (8)

  1. gestational age at delivery

    gestational age (weeks+days) at delivery

    Measured: at delivery

  2. birth weight

    birth weight in grams

    Measured: at first day of life

  3. body length at birth

    body length in cm

    Measured: at first day of life

  4. umbilical artery pH-value

    pH-Value derived from umbilical cord blood after birth

    Measured: immediately after birth

  5. cord blood hemoglobin levels

    hemoglobin levels derived from umbilical cord blood after birth

    Measured: immediately after birth

  6. APGAR score

    APGAR score 1, 5 and 10 min following delivery

    Measured: within 10 min after birth

  7. neonatal complications

    occurrence of neonatal complications including neonatal death, cerebral hemorrhage, periventricular leucomalacia, bronchopulmonary dysplasia, sepsis, retinopathy of the newborn, necrotizing enterocolitis, seizures

    Measured: within 1 month after birth

  8. long-term outcome

    Neurodevelopmental outcome should be performed at the corrected age of 2 years. If available, neurodevelopment will be assessed by using the Bayley Scales of Infant Development. In other cases the Bayleys or the Ages \& Stages Questionnaires may be used.

    Measured: 2 years of age

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 May 2017
  2. Study start1 May 2017
  3. Primary completionJan 2025 (estimated)
  4. Study completionJan 2025 (estimated)

Resources

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
Cohort
Time perspective
Prospective
Enrolment
1,000 participants (estimated)
Target duration
8 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT03171909
Sponsor's protocol ID
1497/2016
Acronym
MonoReg
Status last verified
May 2017
First submitted
15 May 2017
Last updated
31 May 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Twin Dichorionic Diamniotic Placenta and Twin Monochorionic Monoamniotic Placenta, run by Medical University of Graz at 13 sites in Austria.

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 1 inclusion and 1 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 31 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Austria. 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 Philipp Klaritsch, MD (+4331638581641, philipp.klaritsch@medunigraz.at), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

occurrence of specific complications (time frame: from 12 weeks of gestation to delivery). 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 NCT03171909.

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 31 May 2017.

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