Austrian Registry on the Outcome of Monochorionic Pregnancies

Twin Pregnancy With Antenatal Problem Clinical Trial

— MonoReg  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03171909
• Other study ID #: 1497/2016
• Status: Recruiting
• Phase: N/A
• First received: May 15, 2017
• Last updated: May 28, 2017
• Start date: May 1, 2017
• Est. completion date: January 2025

Study information

• Verified date: May 2017
• Source: Medical University of Graz
• Contact: Philipp Klaritsch, MD
• Phone: +4331638581641
• Email: philipp.klaritsch[@]medunigraz.at
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Austria	Brothers of Saint John of God Eisenstadt	Eisenstadt
Austria	Medical University of Graz	Graz	Styria
Austria	Medical University Innsbruck	Innsbruck
Austria	Klinikum Klagenfurt am Wörthersee	Klagenfurt
Austria	Hospital Hochsteiermark	Leoben
Austria	Johannes Kepler University of Linz	Linz
Austria	Mödling Hospital	Mödling
Austria	Paracelsus Medical University	Salzburg
Austria	Landesklinikum Sankt Polten	St. Pölten
Austria	Medical University Vienna	Vienna
Austria	SMZ-Ost Donauspital	Vienna
Austria	Klinikum Wels-Grieskirchen	Wels
Austria	Klinikum Wiener Neustadt	Wiener Neustadt

Sponsors (14)

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

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	occurrence of specific complications	TTTS, sIUGR, TAPS, TRAP, IUFD, malformations, miscarriage	from 12 weeks of gestation to delivery
Secondary	gestational age at delivery	gestational age (weeks+days) at delivery	at delivery
Secondary	birth weight	birth weight in grams	at first day of life
Secondary	body length at birth	body length in cm	at first day of life
Secondary	umbilical artery pH-value	pH-Value derived from umbilical cord blood after birth	immediately after birth
Secondary	cord blood hemoglobin levels	hemoglobin levels derived from umbilical cord blood after birth	immediately after birth
Secondary	APGAR score	APGAR score 1, 5 and 10 min following delivery	within 10 min after birth
Secondary	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
Secondary	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