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Austrian Registry on the Outcome of Monochorionic Pregnancies

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03171909
Acronym
MonoReg
Enrollment
1000
Registered
2017-05-31
Start date
2017-05-01
Completion date
2025-01-31
Last updated
2017-05-31

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

Conditions

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

Brief 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. 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.

Interventions

None listed

Sponsors

Medical University of Vienna
CollaboratorOTHER
Medical University Innsbruck
CollaboratorOTHER
Johannes Kepler University of Linz
CollaboratorOTHER
Paracelsus Medical University
CollaboratorOTHER
Klinikum Klagenfurt am Wörthersee
CollaboratorOTHER
Brothers of Saint John of God Eisenstadt
CollaboratorUNKNOWN
SMZ-Ost Donauspital
CollaboratorOTHER
Hospital Hochsteiermark
CollaboratorUNKNOWN
Landesklinikum Sankt Polten
CollaboratorOTHER
Klinikum Wels-Grieskirchen
CollaboratorOTHER
Landeskrankenhaus Feldkirch
CollaboratorOTHER
Landesklinkum Wiener Neustadt
CollaboratorOTHER
Mödling Hospital
CollaboratorOTHER
Medical University of Graz
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
occurrence of specific complicationsfrom 12 weeks of gestation to deliveryTTTS, sIUGR, TAPS, TRAP, IUFD, malformations, miscarriage

Secondary

MeasureTime frameDescription
birth weightat first day of lifebirth weight in grams
body length at birthat first day of lifebody length in cm
umbilical artery pH-valueimmediately after birthpH-Value derived from umbilical cord blood after birth
gestational age at deliveryat deliverygestational age (weeks+days) at delivery
APGAR scorewithin 10 min after birthAPGAR score 1, 5 and 10 min following delivery
neonatal complicationswithin 1 month after birthoccurrence of neonatal complications including neonatal death, cerebral hemorrhage, periventricular leucomalacia, bronchopulmonary dysplasia, sepsis, retinopathy of the newborn, necrotizing enterocolitis, seizures
long-term outcome2 years of ageNeurodevelopmental 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.
cord blood hemoglobin levelsimmediately after birthhemoglobin levels derived from umbilical cord blood after birth

Countries

Austria

Contacts

Primary ContactPhilipp Klaritsch, MD
philipp.klaritsch@medunigraz.at+4331638581641
Backup ContactIsabella Pfniss, MD
isabella.pfniss@medunigraz.at+4331638580829

Outcome results

None listed

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