NCT04595214

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 1,200 (estimated)
• Sponsor: Assaf-Harofeh Medical Center · Other Government
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-12-21
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2020-10-20
• Last updated: 2021-10-11

Locations

7 sites across 6 countries: Belgium, Canada, Germany, Israel, Spain, United Kingdom