- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04838431
A First Trimester Prediction Model for Large for Gestational Age Infants: a Preliminary Study (PreMoLGA)
Development of a Prediction Model for Large for Gestational Age Infants at First Trimester: a Preliminary Study
Large for gestational age infants (LGA) have increased risks of adverse short-term perinatal outcomes. This study aims to develop a multivariable prediction model for the risk of giving birth to a LGA baby, by using biochemical, biophysical, anamnestic, and clinical maternal characteristics available at first trimester.
This prospective study includes all singleton pregnancies attending the first trimester aneuploidy screening at the Obstetric Unit of the University Hospital of Modena, in Northern Italy.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
For each subject, blood sample is collected in fasting conditions, then centrifuged, and the serum stored at minus 80° C, for subsequent biochemical analyses. PAPP-A, PlGF and Inibin A is measured with the automated DELFIA EXPRESS system (Thermo Fisher Scientific, Perkin Elmer ®). Insulin, high density lipoproteins (HDL) and triglycerides are measured through routine laboratory methods.
The mean arterial pressure (MAP) is measured with validated automated devices (Dinamap, BLTV6XX). After the women are seated and allowed to rest for 3-5 min, normal (22 to 32 cm) adult cuffs are fitted to their both arms. This is repeated two times with 1 min break in between. The MAP is calculated with the formula MAP DBP + 1/3(SBP - DBP) 21, where DBP represents diastolic blood pressure and SBP, systolic blood pressure. We calculate the final MAP as the average of all four measurements. Uterine artery Doppler studies including pulsatility index are measured through trans-abdominal ultrasound (Voluson E8 or Voluson E10) examinations. As indicated in Fetal Medicine Foundation (FMF), when carrying out Doppler studies, color flow mapping is used to identify each uterine artery along the side of the cervix and uterus at the level of the cervical internal os. Pulsed wave Doppler imaging is used with the sampling gate set at 2 mm to cover the whole vessel, and care is taken to ensure that the angle of insonation is less than 30°. When three to five similar consecutive waveforms are obtained, PI is measured. The uterine artery mPI is calculated by adding the right and left pulsatility index together, divided by two. All ultrasound and Doppler studies are carried out by a physician who had received the appropriate certificate of competence in the 11-13+6 week scans and Doppler study from the FMF.
Data on pregnancy outcome are collected from the hospital maternity records or directly from women if delivered elsewhere.
Medical records are reviewed by research associates to obtain anonymized data on mothers (i.e maternal demographics, BMI, age…) and their newborns (birthweight, gender, Apgar score, admission to the neonatal intensive care unit (NICU) and length of stay, neonatal morbidities, and mortality), and are organized in a password protected database.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Modena, Italy, 41124
- University Hospital of Modena
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Singleton pregnancies attending the first trimester Down syndrome screening at the University Hospital of Modena, in the North of Italy (tertiary Hospital).
Exclusion Criteria:
- Twin pregnancies
- Pregnancies with major fetal abnormalities
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
LGA
Time Frame: From 37-42 weeks
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Risk for delivering a LGA infant, by combining the birtweight, the infant gender and the gestational age at birth
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From 37-42 weeks
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Collaborators and Investigators
Investigators
- Principal Investigator: Fabio R Facchinetti, MD, University of Modena and Reggio Emilia
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AOU: 0001395/20
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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