Large for Gestational Age BabyPreMoLGANCT04838431
A First Trimester Prediction Model for Large for Gestational Age Infants: a Preliminary Study
An observational study of Large for Gestational Age Baby and Macrosomia, Fetal, run by University of Modena and Reggio Emilia at 1 site in Italy.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Large for Gestational Age Baby, Macrosomia, Fetal
- What is being tested?
- Blood sample and ultrasound at first trimester
- How many people
- 503 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2018to 31 Dec 2019
- 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 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Singleton pregnancies attending the first trimester Down syndrome screening at the University Hospital of Modena, in the North of Italy (tertiary Hospital).
Who may be able to join
- Singleton pregnancies attending the first trimester Down syndrome screening at the University Hospital of Modena, in the North of Italy (tertiary Hospital).
Who cannot join
- Twin pregnancies
- Pregnancies with major fetal abnormalities
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Large for Gestational Age Baby, Macrosomia, Fetal
- Being tested
- Blood sample and ultrasound at first trimester
- Keywords
- Prediction model, LGA, Singleton, Birtweight
- Medical subject headings
- Fetal Macrosomia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sample and ultrasound at first trimesterOther
The blood sample and the ultrasound are part of the routine care for the aneuploidy screening at first trimester. We deepened the biochemicals and biophysical markers for predicting the risk for large for gestational age infants
What is being measured
The primary outcome is the main question the study is designed to answer.
LGA
Risk for delivering a LGA infant, by combining the birtweight, the infant gender and the gestational age at birth
Measured: From 37-42 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2021
- Study start1 Jun 2018
- Primary completion30 Jun 2019
- Study completion31 Dec 2019
Why it stopped: Reached the sample size
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 Large for Gestational Age BabyStudies 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
- 503 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Modena and Reggio Emilia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Fabio Facchinetti, University of Modena and Reggio Emilia
- Investigators
- Fabio R Facchinetti, MD, Principal investigator, University of Modena and Reggio Emilia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04838431
- Sponsor's protocol ID
- AOU: 0001395/20
- Acronym
- PreMoLGA
- Status last verified
- May 2022
- First submitted
- 6 Apr 2021
- Last updated
- 24 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We plan to validate the predictive model
Publications
Monari F, Menichini D, Spano' Bascio L, Grandi G, Banchelli F, Neri I, D'Amico R, Facchinetti F. A first trimester prediction model for large for gestational age infants: a preliminary study. BMC Pregnancy Childbirth. 2021 Sep 24;21(1):654. doi: 10.1186/s12884-021-04127-3.
PubMed 34560843
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Prediction Model for Large for Gestational Age Infants at First Trimester: a Preliminary Study
- ClinicalTrials.gov ID
- NCT04838431
- Acronym / sponsor ID
- PreMoLGA / AOU: 0001395/20
- Conditions
- Large for Gestational Age Baby, Macrosomia, Fetal
- Keywords
- Prediction model, LGA, Singleton, Birtweight
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Reached the sample size
- Enrolment
- 503 participants (actual)
- Lead sponsor
- University of Modena and Reggio EmiliaUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 9 Apr 2021 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Singleton pregnancies attending the first trimester Down syndrome screening at the University Hospital of Modena, in the North of Italy (tertiary Hospital).
Key inclusion criteria (1 listed)
- Singleton pregnancies attending the first trimester Down syndrome screening at the University Hospital of Modena, in the North of Italy (tertiary Hospital).
Key exclusion criteria (2 listed)
- Twin pregnancies
- Pregnancies with major fetal abnormalities
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 |
|---|---|---|
| Blood sample and ultrasound at first trimesterThe blood sample and the ultrasound are part of the routine care for the aneuploidy screening at first trimester. We deepened the biochemicals and biophysical markers for predicting the risk for large for gestational age infants | Other | – |
Primary outcome
LGA
Time frame: From 37-42 weeks
Risk for delivering a LGA infant, by combining the birtweight, the infant gender and the gestational age at birth
Results and safety
The study was stopped early (reason given: Reached the sample size). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2022.
- Derived from this study: PubMed 34560843Monari F, Menichini D, Spano' Bascio L, Grandi G, Banchelli F, Neri I, D'Amico R, Facchinetti F. A first trimester prediction model for large for gestational age infants: a preliminary study. BMC Pregnancy Childbirth. 2021 Sep 24;21(1):654. doi: 10.1186/s12884-021-04127-3.
- Individual participant dataSharing planned: Undecided. We plan to validate the predictive model
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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.
Fabio R Facchinetti, MD principal investigator
University of Modena and Reggio Emilia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Large for Gestational Age Baby and Macrosomia, Fetal, run by University of Modena and Reggio Emilia at 1 site in Italy.
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 1 inclusion and 2 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: stopped early, as of the sponsor's last update on 24 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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?
The study was stopped early (reason given: Reached the sample size). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LGA (time frame: From 37-42 weeks). 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 NCT04838431, 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 24 May 2022.