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| ID | Type | Description | Link |
|---|---|---|---|
| JTC 2019-061 2019-00 | Other Grant/Funding Number | ERAPERMED |
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Different screening modalities evaluation to develop algorithms to predict pregnancy complications in twin pregnancies, and evaluation of serologic response to BNT162b2 Pfeizer/BioNTech vaccination.
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
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
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
pregnant women with live twin pregnancy at gestational week 11+0 days and 13+6 days
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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
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ron Maymon, MD, PhD | Contact | +972-8-9779695 | Ronm@shamir.gov.il | |
| Hamutal Meiri | Contact | +972-54-7774762 | hamutal62@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Ron Maymon, MD,PhD | Assaf-Harofeh Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Brugmann, | Not yet recruiting | Brussels | 1020 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38734805 | Derived | 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. |
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A single database will be unified from all sites. Patents are entered after coding and personal anonymization. Level of sharing will be decided upon the policy of peer review journal. If acessible - dat be stored at the fetal medicine foundation website
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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
| University of Montreal Medical Centre, Canada | Not yet recruiting | Montreal | H4A 3J1, | Canada |
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| University Hospital Bonn, Bonn, Germany | Recruiting | Bonn | 53127 | Germany |
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| Oliver Kagan | Recruiting | Tübingen | 72706 | Germany |
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| Department of ObGyn, Assaf Harofe-Shamir Medical Center | Recruiting | Zrifin | 70300 | Israel |
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| Hospital Clinic, Barcelona, | Not yet recruiting | Barcelona | Catalonia | 08036 | Spain |
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| The Fetal Medicine Foundation | Not yet recruiting | London | W1G 6BG | United Kingdom |
|
| ID | Term |
|---|---|
| D047928 | Premature Birth |
| D011225 | Pre-Eclampsia |
| D005317 | Fetal Growth Retardation |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D046110 | Hypertension, Pregnancy-Induced |
| D005315 | Fetal Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006130 | Growth Disorders |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D004243 | Divorce |
| ID | Term |
|---|---|
| D017533 | Marital Status |
| D005191 | Family Characteristics |
| D003710 | Demography |
| D011154 | Population Characteristics |
| D012959 | Socioeconomic Factors |
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