Austrian Registry on the Outcome of Monochorionic Pregnancies (MonoReg)

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.

Study Overview

• Status: Recruiting
• Conditions: Twin Pregnancy With Antenatal Problem; Twin Dichorionic Diamniotic Placenta; Twin Monochorionic Monoamniotic Placenta; Twin-To-Twin Transfusion Syndrome

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: Philipp Klaritsch, MD; Phone Number: +4331638581641; Email: philipp.klaritsch@medunigraz.at
• Study Contact Backup: Name: Isabella Pfniss, MD; Phone Number: +4331638580829; Email: isabella.pfniss@medunigraz.at

Study Locations

• Austria
  • Eisenstadt, Austria
    • Recruiting
    • Brothers of Saint John of God Eisenstadt
    • Contact: Herbert Mock, MD
  • Innsbruck, Austria
    • Recruiting
    • Medical University Innsbruck
    • Contact: Angela Ramoni, MD
  • Klagenfurt, Austria
    • Recruiting
    • Klinikum Klagenfurt am Wörthersee
    • Contact: Manfred Mörtl, MD
  • Leoben, Austria
    • Recruiting
    • Hospital Hochsteiermark
    • Contact: Werner Schaffer
  • Linz, Austria
    • Recruiting
    • Johannes Kepler University of Linz
    • Contact: Wolfgang Arzt, MD
  • Mödling, Austria
    • Recruiting
    • Mödling Hospital
    • Contact: Michael Burger, MD
  • Salzburg, Austria
    • Recruiting
    • Paracelsus Medical University
    • Contact: Dagmar Wertaschnigg, MD
  • St. Pölten, Austria
    • Recruiting
    • Landesklinikum Sankt Pölten
    • Contact: Matthias Klein, MD
  • Vienna, Austria
    • Recruiting
    • Medical University Vienna
    • Contact: Christof Worda, MD
  • Vienna, Austria
    • Recruiting
    • SMZ-Ost Donauspital
    • Contact: Erich Hafner, MD
  • Wels, Austria
    • Recruiting
    • Klinikum Wels-Grieskirchen
    • Contact: Alfred Bacherer, MD
  • Wiener Neustadt, Austria
    • Recruiting
    • Klinikum Wiener Neustadt
    • Contact: Philipp Tschak, MD
  • Styria
    • Graz, Styria, Austria, 8043
      • Recruiting
      • Medical University of Graz
      • Contact: Philipp Klaritsch, MD; Phone Number: +4331638581641; Email: philipp.klaritsch@medunigraz.at
      • Contact: Isabella Pfniss, MD; Phone Number: +43316380829; Email: isabella.pfniss@medunigraz.at

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
occurrence of specific complications	TTTS, sIUGR, TAPS, TRAP, IUFD, malformations, miscarriage	from 12 weeks of gestation to delivery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
gestational age at delivery	gestational age (weeks+days) at delivery	at delivery
birth weight	birth weight in grams	at first day of life
body length at birth	body length in cm	at first day of life
umbilical artery pH-value	pH-Value derived from umbilical cord blood after birth	immediately after birth
cord blood hemoglobin levels	hemoglobin levels derived from umbilical cord blood after birth	immediately after birth
APGAR score	APGAR score 1, 5 and 10 min following delivery	within 10 min after birth
neonatal complications	occurrence of neonatal complications including neonatal death, cerebral hemorrhage, periventricular leucomalacia, bronchopulmonary dysplasia, sepsis, retinopathy of the newborn, necrotizing enterocolitis, seizures	within 1 month after birth
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.	2 years of age

Collaborators and Investigators

• Sponsor: Medical University of Graz
• Collaborators: Klinikum Wels-Grieskirchen; Medical University of Vienna; Landesklinkum Wiener Neustadt; Medical University Innsbruck; Johannes Kepler University of Linz; Paracelsus Medical University; Klinikum Klagenfurt am Wörthersee; Brothers of Saint John of God Eisenstadt; SMZ-Ost Donauspital; Hospital Hochsteiermark; Landesklinikum Sankt Polten; Landeskrankenhaus Feldkirch; Mödling Hospital
• Investigators: Principal Investigator: Philipp Klaritsch, MD, Department of Obstetrics and Gynecology, Medical University of Graz, Austria

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2017
• Primary Completion (Anticipated): January 1, 2025
• Study Completion (Anticipated): January 1, 2025

Study Registration Dates

• First Submitted: May 15, 2017
• First Submitted That Met QC Criteria: May 28, 2017
• First Posted (Actual): May 31, 2017

Study Record Updates

• Last Update Posted (Actual): May 31, 2017
• Last Update Submitted That Met QC Criteria: May 28, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Infant, Newborn, Diseases; Anemia; Anemia, Neonatal; Fetofetal Transfusion
• Other Study ID Numbers: 1497/2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No