Austrian Registry on the Outcome of Monochorionic Pregnancies
- Conditions
- Twin Dichorionic Diamniotic PlacentaTwin Monochorionic Monoamniotic PlacentaTwin-To-Twin Transfusion SyndromeTwin Pregnancy With Antenatal Problem
- Registration Number
- NCT03171909
- Lead Sponsor
- Medical University of Graz
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 1000
- All monochorionic pregnancies diagnosed from 11+0 weeks of gestation
- Dichorionic twin pregnancies or higher-grade multiples without a monochorionic pair
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method occurrence of specific complications from 12 weeks of gestation to delivery TTTS, sIUGR, TAPS, TRAP, IUFD, malformations, miscarriage
- Secondary Outcome Measures
Name Time Method gestational age at delivery at delivery gestational age (weeks+days) at delivery
body length at birth at first day of life body length in cm
cord blood hemoglobin levels immediately after birth hemoglobin levels derived from umbilical cord blood after birth
neonatal complications within 1 month after birth occurrence of neonatal complications including neonatal death, cerebral hemorrhage, periventricular leucomalacia, bronchopulmonary dysplasia, sepsis, retinopathy of the newborn, necrotizing enterocolitis, seizures
birth weight at first day of life birth weight in grams
umbilical artery pH-value immediately after birth pH-Value derived from umbilical cord blood after birth
APGAR score within 10 min after birth APGAR score 1, 5 and 10 min following delivery
long-term outcome 2 years of age 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.
Trial Locations
- Locations (13)
Medical University Innsbruck
🇦🇹Innsbruck, Austria
Klinikum Klagenfurt am Wörthersee
🇦🇹Klagenfurt, Austria
Landesklinikum Sankt Polten
🇦🇹St. Pölten, Austria
Klinikum Wiener Neustadt
🇦🇹Wiener Neustadt, Austria
Klinikum Wels-Grieskirchen
🇦🇹Wels, Austria
Hospital Hochsteiermark
🇦🇹Leoben, Austria
Paracelsus Medical University
🇦🇹Salzburg, Austria
SMZ-Ost Donauspital
🇦🇹Vienna, Austria
Medical University Vienna
🇦🇹Vienna, Austria
Johannes Kepler University of Linz
🇦🇹Linz, Austria
Medical University of Graz
🇦🇹Graz, Styria, Austria
Brothers of Saint John of God Eisenstadt
🇦🇹Eisenstadt, Austria
Mödling Hospital
🇦🇹Mödling, Austria