Prenatal DisorderPRETWINSCRENNCT04595214
Develop a Multi-disciplinary Approach for a Personalized Prenatal Diagnostics and Care for Twin Pregnancies
An observational study of Prenatal Disorder and Premature Birth, run by Assaf-Harofeh Medical Center at 7 sites in 6 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Prenatal Disorder, Premature Birth, Twin Pregnancy With Antenatal Problem
- What is being tested?
- TTTS cases are treated by intra-uterine laser for separation.
- How many people
- 1,200 participants
- Where
- 7 sitesin 6 countries
- Study dates
- 21 Dec 2020to 31 Dec 2023
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
7 sites in 6 countries.
7 sites in 6 countries
Germany2 sites, 2 recruiting
- Recruiting
University Hospital Bonn, Bonn, Germany
Bonn, 53127
Annegrete Geipel, MD, +49 (0) 228-287-15942, annegret.geipel@ukbonn.de
Brigitte Strizek, +49 (0) 228-287-15942
- Recruiting
Oliver Kagan
Tübingen, 72706
Oliver Kagan, 70712984807, karl.kagan@med.uni-tuebingen.de
Markus Hoopmann, 07071 298 5619, markus.hooperman@med.uni-tubingen.da
Belgium1 site, 1 recruiting
- Not yet recruiting
CHU Brugmann,
Brussels, 1020
Jacques Jani, MD, jackjani@hotmail.com
Canada1 site, 1 recruiting
- Not yet recruiting
University of Montreal Medical Centre, Canada
Montreal, H4A 3J1,
Richard N Brown, MD, 1+ 514-9341934 ext. 34074, Richard.brown.ca@gmail.com
Piere Miron, MD, PhD, 1+ 450-934-9156
Israel1 site, 1 recruiting
- Recruiting
Department of ObGyn, Assaf Harofe-Shamir Medical Center
Zrifin, 70300
Hamutal MeiriP, PhD, +972-54-7774762, hamutal62@hotmail.com
Ran Svirsky, MD, +972-53-7346603, rsvirs@gmail.com
Spain1 site, 1 recruiting
- Not yet recruiting
Hospital Clinic, Barcelona,
Barcelona, Catalonia, 08036
Anna Gonce, MD, PhD, +34 664197885, agnoce@clinic.cat
Antony Borrell, MD, +34 664197885, ABORELL@clinic.cat
United Kingdom1 site, 1 recruiting
- Not yet recruiting
The Fetal Medicine Foundation
London, W1G 6BG
Kypros H Nicolaides, MD, +44 (0)207 034 3070, kypros@fetalmedicine.com
Argyro Syngeleki, PhD, +44-75109639, argyro.syngelaki@nhs.net
About this study
Different screening modalities evaluation to develop algorithms to predict pregnancy complications in twin pregnancies, and evaluation of serologic response to BNT162b2 Pfeizer/BioNTech vaccination.
Read the 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
- 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
- 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
- Newborn admission to neonatal intensive care units (NICU), length of stay and therapies during the admission.
- 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
- 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
- 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
- Being tested
- TTTS cases are treated by intra-uterine laser for separation.
- Keywords
- Twin pregnancy, Risk stratification algorithm,, Feto-Maternal complications (preeclampsia, IUGR, PTD, GDM),, TTTS, cfDNA, NIPT
- Medical subject headings
- Premature Birth, Pre-Eclampsia, Fetal Growth Retardation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TTTS cases are treated by intra-uterine laser for separation.Other
Also called Placenta previa and acreta are treated according to protocol., NIPS is used to screen for trisomy 21,13 and 18
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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,
Measured: through study completion, an average of 1 year
Adverse neonatal outcome
Admission to neonatal intensive care unit, Sepsis, asphyxia, intraventricular hemorrhage, intrauterine growth retardation
Measured: 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
Measured: through study completion, an average of 2 year including stored samples collected before vaccination was avaluable.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2020
- Study start21 Dec 2020
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prenatal DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,200 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Assaf Harofeh MC, Assaf-Harofeh Medical Center
- Investigators
- Ron Maymon, MD,PhD, Principal investigator, Assaf-Harofeh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04595214
- Sponsor's protocol ID
- 0043-20-ASF
- Other IDs
- JTC 2019-061 2019-00
- Acronym
- PRETWINSCREN
- Status last verified
- Oct 2021
- First submitted
- 3 Aug 2020
- Last updated
- 11 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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
Publications
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.
PubMed 38734805
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Develop a Multi-disciplinary Approach for a Personalized Prenatal Diagnostics and Care for Twin Pregnancies
- ClinicalTrials.gov ID
- NCT04595214
- Acronym / sponsor ID
- PRETWINSCREN / 0043-20-ASF
- 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
- Keywords
- Twin pregnancy, Risk stratification algorithm,, Feto-Maternal complications (preeclampsia, IUGR, PTD, GDM),, TTTS, cfDNA, NIPT
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Study start
- 21 Dec 2020 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 20 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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
- 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
- Newborn admission to neonatal intensive care units (NICU), length of stay and therapies during the admission.
- 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
- 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
- Evaluation of serologic response to BNT162b2 Pfeizer/BioNTech vaccination.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TTTS cases are treated by intra-uterine laser for separation.Also: Placenta previa and acreta are treated according to protocol., NIPS is used to screen for trisomy 21,13 and 18MC 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 | Other | – |
Primary outcome
Adverse pregnancy outcome
Time frame: through study completion, an average of 1 year
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,
Adverse neonatal outcome
Time frame: through study completion, an average of 2 year
Admission to neonatal intensive care unit, Sepsis, asphyxia, intraventricular hemorrhage, intrauterine growth retardation
Evaluation of serologic response to BNT162b2 Pfeizer/BioNTech vaccination.
Time frame: through study completion, an average of 2 year including stored samples collected before vaccination was avaluable.
Testing blood sample drawn for the study for antybody levels in conjunction to BNT162b2 Pfeizer/BioNTech vaccination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2021.
- Derived from this study: PubMed 38734805Svirsky 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.
- Individual participant dataSharing planned: Undecided. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ron Maymon, MD,PhD principal investigator
Assaf-Harofeh Medical Center
7 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prenatal Disorder and Premature Birth, run by Assaf-Harofeh Medical Center at 7 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Germany, Belgium, Canada, Israel, Spain and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ron Maymon, MD, PhD (+972-8-9779695, Ronm@shamir.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse pregnancy outcome (time frame: through study completion, an average of 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04595214, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2021.