NCT03171909

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2017

Longer than P75 for all trials

Geographic Reach
1 country

13 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2017

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

May 15, 2017

Completed
16 days until next milestone

First Posted

Study publicly available on registry

May 31, 2017

Completed
7.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

May 31, 2017

Status Verified

May 1, 2017

Enrollment Period

7.7 years

First QC Date

May 15, 2017

Last Update Submit

May 28, 2017

Conditions

Twin Dichorionic Diamniotic PlacentaTwin Monochorionic Monoamniotic PlacentaTwin-To-Twin Transfusion SyndromeTwin Pregnancy With Antenatal Problem

Outcome Measures

Primary Outcomes (1)

  • occurrence of specific complications

    TTTS, sIUGR, TAPS, TRAP, IUFD, malformations, miscarriage

    from 12 weeks of gestation to delivery

Secondary Outcomes (8)

  • gestational age at delivery

    at delivery

  • birth weight

    at first day of life

  • body length at birth

    at first day of life

  • umbilical artery pH-value

    immediately after birth

  • cord blood hemoglobin levels

    immediately after birth

  • +3 more secondary outcomes

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Dichorionic twin pregnancies or higher-grade multiples without a monochorionic pair

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Medical University of Graz

Graz, Styria, 8043, Austria

RECRUITING

Brothers of Saint John of God Eisenstadt

Eisenstadt, Austria

RECRUITING

Medical University Innsbruck

Innsbruck, Austria

RECRUITING

Klinikum Klagenfurt am Wörthersee

Klagenfurt, Austria

RECRUITING

Hospital Hochsteiermark

Leoben, Austria

RECRUITING

Johannes Kepler University of Linz

Linz, Austria

RECRUITING

Mödling Hospital

Mödling, Austria

RECRUITING

Paracelsus Medical University

Salzburg, Austria

RECRUITING

Landesklinikum Sankt Polten

Sankt Pölten, Austria

RECRUITING

Medical University Vienna

Vienna, Austria

RECRUITING

SMZ-Ost Donauspital

Vienna, Austria

RECRUITING

Klinikum Wels-Grieskirchen

Wels, Austria

RECRUITING

Klinikum Wiener Neustadt

Wiener Neustadt, Austria

RECRUITING

MeSH Terms

Conditions

Fetofetal Transfusion

Condition Hierarchy (Ancestors)

Anemia, NeonatalAnemiaHematologic DiseasesHemic and Lymphatic DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Philipp Klaritsch, MD

    Department of Obstetrics and Gynecology, Medical University of Graz, Austria

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Philipp Klaritsch, MD

CONTACT

+4331638581641philipp.klaritsch@medunigraz.at

Isabella Pfniss, MD

CONTACT

+4331638580829isabella.pfniss@medunigraz.at

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
8 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2017

First Posted

May 31, 2017

Study Start

May 1, 2017

Primary Completion

January 1, 2025

Study Completion

January 1, 2025

Last Updated

May 31, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

AU(13)