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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04595214
Other study ID # 0043-20-ASF
Secondary ID JTC 2019-061 201
Status Recruiting
Phase
First received
Last updated
Start date December 21, 2020
Est. completion date December 31, 2023

Study information

Verified date October 2021
Source Assaf-Harofeh Medical Center
Contact Ron Maymon, MD, PhD
Phone +972-8-9779695
Email Ronm@shamir.gov.il
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


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.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms

  • Premature Birth
  • Prenatal Disorder
  • Twin Dichorionic Diamniotic Placenta
  • Twin Monochorionic Monoamniotic Placenta
  • Twin Pregnancy With Antenatal Problem
  • Twin Pregnancy, Antepartum Condition or Complication
  • Twin; Pregnancy, Affecting Fetus or Newborn

Intervention

Other:
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

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Assaf-Harofeh Medical Center

Countries where clinical trial is conducted

Belgium,  Canada,  Germany,  Israel,  Spain,  United Kingdom, 

Outcome

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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