Clinical trial NCT03171909: Austrian Registry on the Outcome of Monochorionic Pregnancies
Official title: Austrian Registry on the Outcome of Monochorionic Multiple Pregnancies: A Multicenter Registry Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Twin Dichorionic Diamniotic Placenta
Twin Monochorionic Monoamniotic Placenta
Twin-To-Twin Transfusion Syndrome
Twin Pregnancy With Antenatal Problem
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
Collaborators: name: Medical University of Vienna
name: Medical University Innsbruck
name: Johannes Kepler University of Linz
name: Paracelsus Medical University
name: Klinikum Klagenfurt am Wörthersee
name: Brothers of Saint John of God Eisenstadt
name: SMZ-Ost Donauspital
name: Hospital Hochsteiermark
name: Landesklinikum Sankt Polten
name: Klinikum Wels-Grieskirchen
name: Landeskrankenhaus Feldkirch
name: Landesklinkum Wiener Neustadt
name: Mödling Hospital
First posted: 2017-05-31
Enrollment: 1000
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All monochorionic pregnancies diagnosed from 11+0 weeks of gestation on

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.


Eligibility criteria: 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

Primary outcomes:
measure: occurrence of specific complications
timeFrame: from 12 weeks of gestation to delivery
Secondary outcomes:
measure: gestational age at delivery
timeFrame: at delivery
measure: birth weight
timeFrame: at first day of life
measure: body length at birth
timeFrame: at first day of life
measure: umbilical artery pH-value
timeFrame: immediately after birth
measure: cord blood hemoglobin levels
timeFrame: immediately after birth
measure: APGAR score
timeFrame: within 10 min after birth
measure: neonatal complications
timeFrame: within 1 month after birth
measure: long-term outcome
timeFrame: 2 years of age
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University of Graz
state: Styria
city: Eisenstadt
country: Austria
facility: Brothers of Saint John of God Eisenstadt
city: Innsbruck
country: Austria
facility: Medical University Innsbruck
city: Klagenfurt
country: Austria
facility: Klinikum Klagenfurt am Wörthersee
city: Leoben
country: Austria
facility: Hospital Hochsteiermark
city: Linz
country: Austria
facility: Johannes Kepler University of Linz
city: Mödling
country: Austria
facility: Mödling Hospital
city: Salzburg
country: Austria
facility: Paracelsus Medical University
city: St. Pölten
country: Austria
facility: Landesklinikum Sankt Polten
city: Vienna
country: Austria
facility: Medical University Vienna
city: Vienna
country: Austria
facility: SMZ-Ost Donauspital
city: Wels
country: Austria
facility: Klinikum Wels-Grieskirchen
city: Wiener Neustadt
country: Austria
facility: Klinikum Wiener Neustadt
Study officials:
affiliation: Department of Obstetrics and Gynecology, Medical University of Graz, Austria
name: Philipp Klaritsch, MD
role: PRINCIPAL_INVESTIGATOR
References: