PreeclampsiaNCT02879942
First Trimester Placental Assessment in the Screening of Preeclampsia and Intrauterine Growth Restriction
An observational study of Preeclampsia and Intrauterine Growth Restriction, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial summary
Preeclampsia (PE) and intrauterine growth restriction (IUGR) are clinical manifestations of placental insufficiency. These complications affect 5-15% of pregnancies, and are responsible for up to 20% of preterm births. Read more about this study
- Who is it for?
- Ages 11 to 60 years, women only
- Conditions the study is for
- Preeclampsia, Intrauterine Growth Restriction
- What is being tested?
- Ultrasound study of the placenta and Measurement of angiogenic and anti-angiogenic factors (sFlt-1 and PlGF) in the first trimestre blood test
- How many people
- 1,390 participants
- Where
- 1 siteSpain
- Study dates
- Aug 2016to Jul 2020
- 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 11 to 60 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: Patients with singleton pregnancies and ultrasonographic evaluation between 11+0 and 13+6 weeks of gestation
Who may be able to join
- pregnancies with fetuses with CRL between 45 and 80mm
- absence of chromosomal abnormalities
- absence of congenital anomalies
- absence of congenital infections
Who cannot join
- patient not accepting to participate in the study
- multiple pregnancies
- pregnancies without ultrasonographic confirmation of gestational age
Trial locations and contacts
1 site in 1 country.
About this study
Official title: First-trimester Study of the Morphometric Characteristics of the Placenta to Assess the Risk of Preeclampsia and Intrauterine Growth Restriction in Singleton Pregnancies
Preeclampsia (PE) and intrauterine growth restriction (IUGR) are clinical manifestations of placental insufficiency. These complications affect 5-15% of pregnancies, and are responsible for up to 20% of preterm births. Women who develop PE during pregnancy also have an increased risk for cardiovascular events, both at short and long term. This justifies the need to improve diagnostic tools to identify patients at risk for these complications. PE and IUGR are multifactorial entities. Screening algorithms should thus include several parameters to achieve high detection rates. Research has mainly focused in the analysis of biophysical and biochemical parameters, and the study of the placenta itself has not been included in current diagnostic strategies. Investigators hypothesize that detection rates of preeclampsia and intrauterine growth restriction could be improved by the study of placental characteristics in the first trimester of pregnancy.
- Conditions
- Preeclampsia, Intrauterine Growth Restriction
- Being tested
- Ultrasound study of the placenta, Measurement of angiogenic and anti-angiogenic factors (sFlt-1 and PlGF) in the first trimestre blood test
- Keywords
- Placental volume, First-trimester screening, Ultrasound, Preeclampsia, Intrauterine growth restriction, Biochemical markers, Uterine artery doppler
- Medical subject headings
- Pre-Eclampsia, Fetal Growth Retardation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound study of the placentaOther
The placenta will be scanned to measure the placental volume, chorionic plate, basal plate and thickness.
Measurement of angiogenic and anti-angiogenic factors (sFlt-1 and PlGF) in the first trimestre blood testOther
| Study group | Role | What they receive |
|---|---|---|
| Case cohort | Patients with pregnancies complicated by placental insufficiency (preeclampsia and/or intrauterine growth restriction) will be included in this cohort. Receives: Other: Ultrasound study of the placenta; Other: Measurement of angiogenic and anti-angiogenic factors (sFlt-1 and PlGF) in the first trimestre blood test | |
| Control cohort | Patients with pregnancies not complicated by placental insufficiency (preeclampsia and/or intrauterine growth restriction) will be included in this cohort. Receives: Other: Ultrasound study of the placenta; Other: Measurement of angiogenic and anti-angiogenic factors (sFlt-1 and PlGF) in the first trimestre blood test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of preeclampsia
Pre-eclampsia is diagnosed after 20 week of gestation with systolic blood pressure equal to or greater than 140 mmHg, diastolic blood pressure equal to or greater than 90 mmHg and proteinuria greater than or equal 0.3 g/d by 24 hour urine collection
Measured: Up to birth
Development of intrauterine growth restriction
Intrauterine growth restriction is defined as birthweight below 10th centile according to local standards
Measured: At birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionFeb 2020
- Study completionJul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreeclampsiaStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe sponsor's other registered studies.
- 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
- 1,390 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Spanish Clinical Research Network - SCReN
- Responsible party
- Sponsor
- Investigators
- Cristina Trilla, MD, Principal investigator, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02879942
- Sponsor's protocol ID
- IIBSP-PLA-2016-31
- Status last verified
- Mar 2022
- First submitted
- 20 Jul 2016
- Last updated
- 9 Mar 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First-trimester Study of the Morphometric Characteristics of the Placenta to Assess the Risk of Preeclampsia and Intrauterine Growth Restriction in Singleton Pregnancies
- ClinicalTrials.gov ID
- NCT02879942
- Acronym / sponsor ID
- IIBSP-PLA-2016-31
- Conditions
- Preeclampsia, Intrauterine Growth Restriction
- Keywords
- Placental volume, First-trimester screening, Ultrasound, Preeclampsia, Intrauterine growth restriction, Biochemical markers, Uterine artery doppler
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,390 participants (actual)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Collaborators
- Spanish Clinical Research Network - SCReN
- Study start
- Aug 2016
- Primary completion
- Feb 2020 (actual)
- Study completion
- Jul 2020 (actual)
- First posted
- 26 Aug 2016 (estimated)
- 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.
Preeclampsia (PE) and intrauterine growth restriction (IUGR) are clinical manifestations of placental insufficiency. These complications affect 5-15% of pregnancies, and are responsible for up to 20% of preterm births. Women who develop PE during pregnancy also have an increased risk for cardiovascular events, both at short and long term. This justifies the need to improve diagnostic tools to identify patients at risk for these complications. PE and IUGR are multifactorial entities. Screening algorithms should thus include several parameters to achieve high detection rates. Research has mainly focused in the analysis of biophysical and biochemical parameters, and the study of the placenta itself has not been included in current diagnostic strategies. Investigators hypothesize that detection rates of preeclampsia and intrauterine growth restriction could be improved by the study of placental characteristics in the first trimester of pregnancy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case cohort | – | Other: Ultrasound study of the placenta, Other: Measurement of angiogenic and anti-angiogenic factors (sFlt-1 and PlGF) in the first trimestre blood testPatients with pregnancies complicated by placental insufficiency (preeclampsia and/or intrauterine growth restriction) will be included in this cohort. |
| Control cohort | – | Other: Ultrasound study of the placenta, Other: Measurement of angiogenic and anti-angiogenic factors (sFlt-1 and PlGF) in the first trimestre blood testPatients with pregnancies not complicated by placental insufficiency (preeclampsia and/or intrauterine growth restriction) will be included in this cohort. |
Who may qualify
- Ages
- 11 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients with singleton pregnancies and ultrasonographic evaluation between 11+0 and 13+6 weeks of gestation
Key inclusion criteria (4 listed)
- pregnancies with fetuses with CRL between 45 and 80mm
- absence of chromosomal abnormalities
- absence of congenital anomalies
- absence of congenital infections
Key exclusion criteria (3 listed)
- patient not accepting to participate in the study
- multiple pregnancies
- pregnancies without ultrasonographic confirmation of gestational age
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 |
|---|---|---|
| Ultrasound study of the placentaThe placenta will be scanned to measure the placental volume, chorionic plate, basal plate and thickness. | Other | Case cohort, Control cohort |
| Measurement of angiogenic and anti-angiogenic factors (sFlt-1 and PlGF) in the first trimestre blood test | Other | Case cohort, Control cohort |
Primary outcome
Development of preeclampsia
Time frame: Up to birth
Pre-eclampsia is diagnosed after 20 week of gestation with systolic blood pressure equal to or greater than 140 mmHg, diastolic blood pressure equal to or greater than 90 mmHg and proteinuria greater than or equal 0.3 g/d by 24 hour urine collection
Development of intrauterine growth restriction
Time frame: At birth
Intrauterine growth restriction is defined as birthweight below 10th centile according to local standards
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2022.
Related trials for Preeclampsia
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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.
Cristina Trilla, MD principal investigator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
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 Preeclampsia and Intrauterine Growth Restriction, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
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 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: finished, as of the sponsor's last update on 9 Mar 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 Spain. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Development of preeclampsia (time frame: Up to birth). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Mar 2022.