Develop a Multi-disciplinary Approach for a Personalized Prenatal Diagnostics and Care for Twin Pregnancies

Last updated: October 4, 2021
Sponsor: Assaf-Harofeh Medical Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT04595214
0043-20-ASF
JTC 2019-061 2019-00
  • Ages > 18
  • Female
  • Accepts Healthy Volunteers

Study Summary

Different screening modalities evaluation to develop algorithms to predict pregnancy complications in twin pregnancies, and evaluation of serologic response to BNT162b2 Pfeizer/BioNTech vaccination.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Monoamniotic twins
  • Triplet pregnancies that had undergone embryo reduction to twins or with one vanishingtwin
  • Women who are unconscious or severely ill, those with learning difficulties, orserious mental illness;
  • Any other reason the clinical investigators think will prevent the potentialparticipant from complying with the trial protocol.

Study Design

Total Participants: 1200
Study Start date:
December 21, 2020
Estimated Completion Date:
December 31, 2023

Study Description

This is a multi-center study to identify biomarkers or marker combinations for early prediction of pregnancy complications in twin pregnancies in the first, second or third trimester.

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.

Connect with a study center

  • CHU Brugmann,

    Brussels, 1020
    Belgium

    Site Not Available

  • University of Montreal Medical Centre, Canada

    Montréal, H4A 3J1,
    Canada

    Site Not Available

  • University Hospital Bonn, Bonn, Germany

    Bonn, 53127
    Germany

    Active - Recruiting

  • Oliver Kagan

    Tubingen, 72706
    Germany

    Active - Recruiting

  • Department of ObGyn, Assaf Harofe-Shamir Medical Center

    Zrifin, 70300
    Israel

    Active - Recruiting

  • Hospital Clinic, Barcelona,

    Barcelona, Catalonia 08036
    Spain

    Site Not Available

  • The Fetal Medicine Foundation

    London, W1G 6BG
    United Kingdom

    Site Not Available

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