Gestational DiabetesPREDICTIONNCT04877119
sFlt-1:PlGF Ratio in Gestational Diabetes: PREDICTION (PREeclampsia in DIabetiC gestaTION) Study
An observational study of Gestational Diabetes and Gestational Hypertension, run by Azienda Ospedaliero, Universitaria Pisana at 1 site in Italy.
Trial summary
The ratio of soluble fms-like tyrosine kinase 1 (sFlt-1) to placental growth factor (PlGF) is elevated in pregnant women before the clinical onset of preeclampsia and can be used to predict the preeclampsia. However, its predictive value in pregnancy complicated by gestational diabetes is unclear. 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
- Gestational Diabetes, Gestational Hypertension, Pre-Eclampsia
- How many people
- 500 participants
- Where
- 1 siteItaly
- Study dates
- 14 Oct 2019to 31 Dec 2022
- How long will I take part?
- 25 Weeks
- 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: Pregnant women with gestational diabetes
Who may be able to join
- Age > 18 years
- Diagnosis of GDM in the current pregnancy
Who cannot join
- Twin pregnancies
- Pre-pregnancy diabetes (type 1 or type 2 diabetes)
- Gestosis already diagnosed during the current pregnancy
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Azienda Ospedaliero-Universitaria Pisana - U.O. Malattie Metaboliche e Diabetologia
Pisa, PI, 56124
Cristina Bianchi, MD, PhD, +39050995136, c.bianchi@ao-pisa.toscana.it
About this study
Official title: Predictive Value for Preeclampsia of the sFlt-1:PlGF (Soluble Foms-like Tyrosine Kinase 1/Placental Growth Factor) Ratio in Pregnancy Complicated by Gestational Diabetes: The PREDICTION (PREeclampsia in DIabetiC gestaTION) Study
The ratio of soluble fms-like tyrosine kinase 1 (sFlt-1) to placental growth factor (PlGF) is elevated in pregnant women before the clinical onset of preeclampsia and can be used to predict the preeclampsia. However, its predictive value in pregnancy complicated by gestational diabetes is unclear. This study purposes are to validate a ratio of serum sFlt-1 to PlGF that would be predictive of the absence or presence of preeclampsia in the short term in women with singleton pregnancies complicated by diabetes in whom preeclampsia was suspected, and to evaluate the relationship among sFlt-1 to PlGF and placental histopathological alterations.
Read the detailed description
Single center, observational, prospective study designed to validate a cutoff point of the sFlt-1:PlGF ratio for the prediction of the short-term absence or presence of preeclampsia in pregnancy complicated by gestational diabetes (GDM).
GDM women will be recruited at diabetes screening time (16-18 or 24-27 gestational weeks), performed according with the Italian National Guidelines by 75g - 2 hour Oral Glucose Tolerance Test. GDM will be defined according with International Association of Diabetes and Pregnancy Study Groups/World Health Organization 2013 criteria. A standardized medical history will be obtained in all the women at the time of their first visit, collecting data about maternal age, parity, last menstruation, pre-gestational weight, history of GDM, hypertension and macrosomia in previous pregnancies, family history of diabetes mellitus, education and employment. Moreover, during their visit, the women's weights were taken and their blood pressure measured. Blood samples for assessments of sFlt-1:PlGF ratio will be collected at visit 1 (baseline visit) and every 30±7 days after the previous visit until 36 gestational week (for a maximum of 4 determinations). At baseline and at each follow-up visits update of medical history, clinical assessments, laboratory testing and pregnancy evolution will be evaluated. During pregnancy all women will be receive standard diabetes and obstetric care, according with national guidelines. Diagnostic criteria for preeclampsia will be a new onset of both hypertension (systolic blood pressure ≥140 mmHg, diastolic blood pressure ≥90 mmHg, or both) and proteinuria (2+ protein or greater on dipstick urinalysis, ≥300 mg of protein per 24-hour urine collection, ≥30 mg /dl of protein in a spot urine sample, or a ratio of protein to creatinine of ≥30 mg/mmol) after 20 weeks of gestation. Only cases that met these prespecified criteria will be included in the analyses. At delivery, data items on maternal body weight at the end of pregnancy, time and mode of delivery, newborn bodyweight, preeclampsia as well as other maternal and fetal outcomes will be collected. Placental histopathological alterations will be detected in women who delivery by planned Cesarian section.
- Medical subject headings
- Diabetes, Gestational, Hypertension, Pregnancy-Induced, Pre-Eclampsia
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictive SFLT-1 / PLGF ratio cat-off point for preeclampsia
Evaluation of a specific SFLT-1 / PLGF ratio cat-off point for women with diabetes during pregnancy (pre-pregnancy or gestational) in the prediction of preeclampsia
Measured: 25 weeks
Secondary outcomes (1)
Correlation between SFLT-1 / PLGF ratio and placental histopathology
Correlation between SFLT-1 / PLGF ratio and rate of placental histopathological alterations in pregnancy complicated by diabetes (pre-pregnancy or gestational)
Measured: 25 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2021
- Study start14 Oct 2019
- Primary completion31 Mar 2022 (estimated)
- Study completion31 Dec 2022 (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 Gestational DiabetesStudies 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
- 500 participants (estimated)
- Target duration
- 25 Weeks
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero, Universitaria Pisana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cristina Bianchi, Azienda Ospedaliero, Universitaria Pisana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04877119
- Sponsor's protocol ID
- 14905
- Acronym
- PREDICTION
- Status last verified
- May 2021
- First submitted
- 29 Apr 2021
- Last updated
- 7 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Citro F, Bianchi C, Nicoli F, Aragona M, De Gennaro G, Del Prato S, Penno G, Bertolotto A, Battini L. Predictive Value for Preeclampsia of sFlt-1:PlGF Ratio in Pregnancy Complicated by Gestational Diabetes. Diabetes Metab Res Rev. 2026 Sep;42(6):e70217. doi: 10.1002/dmrr.70217.
PubMed 42625275
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Value for Preeclampsia of the sFlt-1:PlGF (Soluble Foms-like Tyrosine Kinase 1/Placental Growth Factor) Ratio in Pregnancy Complicated by Gestational Diabetes: The PREDICTION (PREeclampsia in DIabetiC gestaTION) Study
- ClinicalTrials.gov ID
- NCT04877119
- Acronym / sponsor ID
- PREDICTION / 14905
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Azienda Ospedaliero, Universitaria PisanaUniversity, hospital or other
- Study start
- 14 Oct 2019 (actual)
- Primary completion
- 31 Mar 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 7 May 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.
The ratio of soluble fms-like tyrosine kinase 1 (sFlt-1) to placental growth factor (PlGF) is elevated in pregnant women before the clinical onset of preeclampsia and can be used to predict the preeclampsia. However, its predictive value in pregnancy complicated by gestational diabetes is unclear. This study purposes are to validate a ratio of serum sFlt-1 to PlGF that would be predictive of the absence or presence of preeclampsia in the short term in women with singleton pregnancies complicated by diabetes in whom preeclampsia was suspected, and to evaluate the relationship among sFlt-1 to PlGF and placental histopathological alterations.
Detailed description
Single center, observational, prospective study designed to validate a cutoff point of the sFlt-1:PlGF ratio for the prediction of the short-term absence or presence of preeclampsia in pregnancy complicated by gestational diabetes (GDM).
GDM women will be recruited at diabetes screening time (16-18 or 24-27 gestational weeks), performed according with the Italian National Guidelines by 75g - 2 hour Oral Glucose Tolerance Test. GDM will be defined according with International Association of Diabetes and Pregnancy Study Groups/World Health Organization 2013 criteria. A standardized medical history will be obtained in all the women at the time of their first visit, collecting data about maternal age, parity, last menstruation, pre-gestational weight, history of GDM, hypertension and macrosomia in previous pregnancies, family history of diabetes mellitus, education and employment. Moreover, during their visit, the women's weights were taken and their blood pressure measured. Blood samples for assessments of sFlt-1:PlGF ratio will be collected at visit 1 (baseline visit) and every 30±7 days after the previous visit until 36 gestational week (for a maximum of 4 determinations). At baseline and at each follow-up visits update of medical history, clinical assessments, laboratory testing and pregnancy evolution will be evaluated. During pregnancy all women will be receive standard diabetes and obstetric care, according with national guidelines. Diagnostic criteria for preeclampsia will be a new onset of both hypertension (systolic blood pressure ≥140 mmHg, diastolic blood pressure ≥90 mmHg, or both) and proteinuria (2+ protein or greater on dipstick urinalysis, ≥300 mg of protein per 24-hour urine collection, ≥30 mg /dl of protein in a spot urine sample, or a ratio of protein to creatinine of ≥30 mg/mmol) after 20 weeks of gestation. Only cases that met these prespecified criteria will be included in the analyses. At delivery, data items on maternal body weight at the end of pregnancy, time and mode of delivery, newborn bodyweight, preeclampsia as well as other maternal and fetal outcomes will be collected. Placental histopathological alterations will be detected in women who delivery by planned Cesarian section.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 25 Weeks
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women with gestational diabetes
Key inclusion criteria (2 listed)
- Age > 18 years
- Diagnosis of GDM in the current pregnancy
Key exclusion criteria (3 listed)
- Twin pregnancies
- Pre-pregnancy diabetes (type 1 or type 2 diabetes)
- Gestosis already diagnosed during the current pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Predictive SFLT-1 / PLGF ratio cat-off point for preeclampsia
Time frame: 25 weeks
Evaluation of a specific SFLT-1 / PLGF ratio cat-off point for women with diabetes during pregnancy (pre-pregnancy or gestational) in the prediction of preeclampsia
1 secondary outcome
Correlation between SFLT-1 / PLGF ratio and placental histopathology
Time frame: 25 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2021.
- Derived from this study: PubMed 42625275Citro F, Bianchi C, Nicoli F, Aragona M, De Gennaro G, Del Prato S, Penno G, Bertolotto A, Battini L. Predictive Value for Preeclampsia of sFlt-1:PlGF Ratio in Pregnancy Complicated by Gestational Diabetes. Diabetes Metab Res Rev. 2026 Sep;42(6):e70217. doi: 10.1002/dmrr.70217.
- Individual participant dataSharing planned: No
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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.
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 Gestational Diabetes and Gestational Hypertension, run by Azienda Ospedaliero, Universitaria Pisana 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 2 inclusion and 3 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 7 May 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cristina Bianchi, MD, PhD (+39050995136, c.bianchi@ao-pisa.toscana.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predictive SFLT-1 / PLGF ratio cat-off point for preeclampsia (time frame: 25 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 NCT04877119, 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 7 May 2021.