Develop a Multi-disciplinary Approach for a Personalized Prenatal Diagnostics and Care for Twin Pregnancies
NCT ID: NCT04595214
Last Updated: 2021-10-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
1200 participants
OBSERVATIONAL
2020-12-21
2023-12-31
Brief Summary
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Detailed Description
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In the future, the identified patients' risk will enable patients' referrals for proper prevention when such will become available
Specifically the investigators aim for
* Predicting the risk to develop preeclampsia, IUGR, preterm delivery, gestational Diabetes Melitus
* Assessment of major and minor markers for chromosomal and structural anomalies
* Identification of placenta accrete spectrum disorders and vasa previa
* Diagnosis of specific MC twin complications such as TTTS
The investigators will stratify and assess all the above according to chorionicity and delivery with complications at \<32 weeks, \<34 weeks, \<37 weeks, and at any gestation.
Screening methods will be conducted in the first, second or third trimester or at any gestation
Also the investigators aim to Identify the risk to lose one or both twins at \<32 weeks, \<34 weeks, \<37 weeks and at any gestation, the ability to predict fetal birth weight at \<32 weeks, \<34 weeks, \<37 weeks and at any gestation
The investigators also aim for monitoring any of the following maternal complications including placental abruption (clinically or on placental examination), postpartum hemorrhage (defined as blood loss ≥1 L within the first 24 hours after birth) at \<32 weeks, \<34 weeks, \<37 weeks and at any gestation.
The investigators will monitor
1. Neonatal morbidity due to intraventricular hemorrhage (IVH) grade II or above - Defined as bleeding into the ventricles, Grade II (moderate) - IVH occupies \<50% of the lateral ventricle volume, Grade III (severe) - IVH occupies ≥50% of the lateral ventricle volume or Grade IV (severe) - Hemorrhagic infarction in periventricular white matter ipsilateral to a large IVH
2. Neonatal sepsis confirmed bacteremia in cultures, anemia defined as low Hemoglobin and / or hematocrit requiring blood transfusion, respiratory distress syndrome defined as need for treatment by surfactant and ventilation, necrotizing enterocolitis requiring surgical intervention, and composite of any of the above
3. Newborn admission to neonatal intensive care units (NICU), length of stay and therapies during the admission.
4. Ventilation defined as a need for a positive pressure (continuous positive airway pressure (CPAP), nasal continuous positive airway pressure (NCPAP)) or intubation and a composite of any of the above
5. Any maternal complications within the first 6-10 weeks post delivery. The investigators will recruit patients in the different sites aiming for 1200 twin pregnancy and will collect the patients' entire pregnancy data for developing an algorithm to calculate the risk to develop the complications
6. Evaluation of serologic response to BNT162b2 Pfeizer/BioNTech vaccination.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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TTTS cases are treated by intra-uterine laser for separation.
MC twin anaestemosis separatio by laser. Vasa previa and placenta accreta are treated with steroids or other protocols, Positive trisomies by NIPS undergoes CVS or amniocentesis
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
FEMALE
Yes
Sponsors
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Assaf-Harofeh Medical Center
OTHER_GOV
Responsible Party
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Assaf Harofeh MC
Prof. Ron Maymon, MD, PhD Chairman ObGyn
Principal Investigators
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Ron Maymon, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Assaf-Harofeh Medical Center
Locations
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CHU Brugmann,
Brussels, , Belgium
University of Montreal Medical Centre, Canada
Montreal, , Canada
University Hospital Bonn, Bonn, Germany
Bonn, , Germany
Oliver Kagan
Tübingen, , Germany
Department of ObGyn, Assaf Harofe-Shamir Medical Center
Zrifin, , Israel
Hospital Clinic, Barcelona,
Barcelona, Catalonia, Spain
The Fetal Medicine Foundation
London, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Piere Miron, MD, PhD
Role: backup
Brigitte Strizek
Role: backup
References
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Svirsky R, Rabbi ML, Hamad RA, Sharabi-Nov A, Kugler N, Galoyan N, Sharon NZ, Meiri H, Maymon R, Levtzion-Korach O. Vaccination in twin pregnancies: comparison between immunization before conception and during pregnancy. Sci Rep. 2024 May 11;14(1):10813. doi: 10.1038/s41598-024-61504-6.
Other Identifiers
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JTC 2019-061 2019-00
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
0043-20-ASF
Identifier Type: -
Identifier Source: org_study_id
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