Austrian Registry on the Outcome of Monochorionic Pregnancies

Study Overview
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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.

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

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

Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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What is the study measuring?
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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 |