Premature Birth Clinical Trial
— PRETWINSCRENOfficial title:
Develop a Multi-disciplinary Approach for a Personalized Prenatal Diagnostics and Care for Twin Pregnancies
Different screening modalities evaluation to develop algorithms to predict pregnancy complications in twin pregnancies, and evaluation of serologic response to BNT162b2 Pfeizer/BioNTech vaccination.
Status | Recruiting |
Enrollment | 1200 |
Est. completion date | December 31, 2023 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age > 18 years; - Di-chorionic (DC)or Mono-chorionic (MC) twin pregnancies; - Both live fetuses at 11+0-13+6 weeks of gestation; - Informed and written consent Exclusion Criteria: - Monoamniotic twins - Triplet pregnancies that had undergone embryo reduction to twins or with one vanishing twin - Women who are unconscious or severely ill, those with learning difficulties, or serious mental illness; - Any other reason the clinical investigators think will prevent the potential participant from complying with the trial protocol. |
Country | Name | City | State |
---|---|---|---|
Belgium | CHU Brugmann, | Brussels | |
Canada | University of Montreal Medical Centre, Canada | Montréal | |
Germany | University Hospital Bonn, Bonn, Germany | Bonn | |
Germany | Oliver Kagan | Tubingen | |
Israel | Department of ObGyn, Assaf Harofe-Shamir Medical Center | Zrifin | |
Spain | Hospital Clinic, Barcelona, | Barcelona | Catalonia |
United Kingdom | The Fetal Medicine Foundation | London |
Lead Sponsor | Collaborator |
---|---|
Assaf-Harofeh Medical Center |
Belgium, Canada, Germany, Israel, Spain, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Adverse pregnancy outcome | preterm delivery before 37 weeks of gestation , or hypertension of >90/140, from gestational week 24 and above throughout pregnancy , baby birth weight below the 5 lower centile for the gestation week, or shoulder dyctorcia at delivery, or newborn admission to NICU for any complication or placental position complications such as placenta accreta, or vasa previa, or intra uterine fetal death, | through study completion, an average of 1 year | |
Primary | Adverse neonatal outcome | Admission to neonatal intensive care unit, Sepsis, asphyxia, intraventricular hemorrhage, intrauterine growth retardation | through study completion, an average of 2 year | |
Primary | Evaluation of serologic response to BNT162b2 Pfeizer/BioNTech vaccination. | Testing blood sample drawn for the study for antybody levels in conjunction to BNT162b2 Pfeizer/BioNTech vaccination | through study completion, an average of 2 year including stored samples collected before vaccination was avaluable. |
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