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

NCT04595214 | Unknown DMC

• 2 other identifiers: 0043-20-ASFJTC 2019-061 2019-00
• Study Type: observational
• Target: 1,200
• Locations: 6 countries
• Sites: 7

Brief 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.

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

Keywords

Twin pregnancy; Risk stratification algorithm,; Feto-Maternal complications (preeclampsia, IUGR, PTD, GDM),; TTTS; cfDNA, NIPT

Outcome Measures

Primary Outcomes (3)

• 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

• Adverse neonatal outcome

  Admission to neonatal intensive care unit, Sepsis, asphyxia, intraventricular hemorrhage, intrauterine growth retardation

  through study completion, an average of 2 year

• 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.

Interventions

TTTS cases are treated by intra-uterine laser for separation. OTHER

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

Also known as: Placenta previa and acreta are treated according to protocol., NIPS is used to screen for trisomy 21,13 and 18

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: pregnant women with live twin pregnancy at gestational week 11+0 days and 13+6 days
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This is prospective multi-centre study that includes a site in Israel, two sites in Germany, a site in Catalonia, Spain, a site in Quebec, Canada and a site in the UK. In the participating centres, all eligible women with DC or MC twin pregnancy attending for their routine first hospital visit in pregnancy at 11-13 weeks' gestation will be invited to participate in the trial. pregnancy characteristics will be followed and biomarkers determined. We follow ISUOG and FMF guidelines on how to undertake the appropriate measurements

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assaf-Harofeh Medical Center: lead

Study Sites (7)

CHU Brugmann,

Brussels, 1020, Belgium

NOT YET RECRUITING

University of Montreal Medical Centre, Canada

Montreal, H4A 3J1,, Canada

NOT YET RECRUITING

University Hospital Bonn, Bonn, Germany

Bonn, 53127, Germany

RECRUITING

Oliver Kagan

Tübingen, 72706, Germany

RECRUITING

Department of ObGyn, Assaf Harofe-Shamir Medical Center

Zrifin, 70300, Israel

RECRUITING

Hospital Clinic, Barcelona,

Barcelona, Catalonia, 08036, Spain

NOT YET RECRUITING

The Fetal Medicine Foundation

London, W1G 6BG, United Kingdom

NOT YET RECRUITING

Related Publications (1)

• 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.

  PMID: 38734805 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Serum and plasma samples are collected at 11-13, 20-22 and 32-34 weeks. Some tested at blood drawing and some are stored at -70oC for testing at study conclusion

MeSH Terms

Conditions

Premature Birth; Pre-Eclampsia; Fetal Growth Retardation

Interventions

Divorce

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension, Pregnancy-Induced; Fetal Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Marital Status; Family Characteristics; Demography; Population Characteristics; Socioeconomic Factors

Study Officials

• Ron Maymon, MD,PhD

  Assaf-Harofeh Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ron Maymon, MD, PhD

CONTACT

+972-8-9779695; Ronm@shamir.gov.il

Hamutal Meiri

CONTACT

+972-54-7774762; hamutal62@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Ron Maymon, MD, PhD Chairman ObGyn

Study Record Dates

• First Submitted: August 3, 2020
• First Posted: October 20, 2020
• Study Start: December 21, 2020
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: October 11, 2021

Record last verified: 2021-10

Locations

DE (2); GB (1); IL (1); CA (1); BE (1); ES (1)