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

Premature Birth Clinical Trial

— PRETWINSCREN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04595214
• Other study ID #: 0043-20-ASF
• Secondary ID: JTC 2019-061 201
• Status: Recruiting
• 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
• 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.

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.