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Austrian Registry on the Outcome of Monochorionic Pregnancies

NCT ID: NCT03171909

Last Updated: 2017-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-05-01

Study Completion Date

2025-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Twin Dichorionic Diamniotic Placenta Twin Monochorionic Monoamniotic Placenta Twin-To-Twin Transfusion Syndrome Twin Pregnancy With Antenatal Problem

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Dichorionic twin pregnancies or higher-grade multiples without a monochorionic pair
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role collaborator

Medical University Innsbruck

OTHER

Sponsor Role collaborator

Johannes Kepler University of Linz

OTHER

Sponsor Role collaborator

Paracelsus Medical University

OTHER

Sponsor Role collaborator

Klinikum Klagenfurt am Wörthersee

OTHER

Sponsor Role collaborator

Brothers of Saint John of God Eisenstadt

UNKNOWN

Sponsor Role collaborator

SMZ-Ost Donauspital

OTHER

Sponsor Role collaborator

Hospital Hochsteiermark

UNKNOWN

Sponsor Role collaborator

Landesklinikum Sankt Polten

OTHER

Sponsor Role collaborator

Klinikum Wels-Grieskirchen

OTHER

Sponsor Role collaborator

Landeskrankenhaus Feldkirch

OTHER

Sponsor Role collaborator

Landesklinkum Wiener Neustadt

OTHER

Sponsor Role collaborator

Mödling Hospital

OTHER

Sponsor Role collaborator

Medical University of Graz

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Philipp Klaritsch, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Obstetrics and Gynecology, Medical University of Graz, Austria

Locations

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Medical University of Graz

Graz, Styria, Austria

Site Status RECRUITING

Brothers of Saint John of God Eisenstadt

Eisenstadt, , Austria

Site Status RECRUITING

Medical University Innsbruck

Innsbruck, , Austria

Site Status RECRUITING

Klinikum Klagenfurt am Wörthersee

Klagenfurt, , Austria

Site Status RECRUITING

Hospital Hochsteiermark

Leoben, , Austria

Site Status RECRUITING

Johannes Kepler University of Linz

Linz, , Austria

Site Status RECRUITING

Mödling Hospital

Mödling, , Austria

Site Status RECRUITING

Paracelsus Medical University

Salzburg, , Austria

Site Status RECRUITING

Landesklinikum Sankt Polten

Sankt Pölten, , Austria

Site Status RECRUITING

Medical University Vienna

Vienna, , Austria

Site Status RECRUITING

SMZ-Ost Donauspital

Vienna, , Austria

Site Status RECRUITING

Klinikum Wels-Grieskirchen

Wels, , Austria

Site Status RECRUITING

Klinikum Wiener Neustadt

Wiener Neustadt, , Austria

Site Status RECRUITING

Countries

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Austria

Central Contacts

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Philipp Klaritsch, MD

Role: CONTACT

Phone: +4331638581641

Email: [email protected]

Isabella Pfniss, MD

Role: CONTACT

Phone: +4331638580829

Email: [email protected]

Facility Contacts

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Philipp Klaritsch, MD

Role: primary

Isabella Pfniss, MD

Role: backup

Herbert Mock, MD

Role: primary

Angela Ramoni, MD

Role: primary

Manfred Mörtl, MD

Role: primary

Werner Schaffer

Role: primary

Wolfgang Arzt, MD

Role: primary

Michael Burger, MD

Role: primary

Dagmar Wertaschnigg, MD

Role: primary

Matthias Klein, MD

Role: primary

Christof Worda, MD

Role: primary

Erich Hafner, MD

Role: primary

Alfred Bacherer, MD

Role: primary

Philipp Tschak, MD

Role: primary

Other Identifiers

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1497/2016

Identifier Type: -

Identifier Source: org_study_id