Fetal Growth RetardationNCT06096805
Prediction of Placental Fetal Growth Restriction in High Risk Population (PoPFGR)
An observational study of Fetal Growth Retardation, run by Shanghai First Maternity and Infant Hospital at 1 site in China.
Trial summary
This study intends to prospectively enroll high-risk pregnant women to establish a multicenter cohort. By combining maternal basic characteristics, medical history, early pregnancy ultrasound, and biological markers, we aim to construct a joint predictive model for MVM-FGR. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Fetal Growth Retardation
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 10 Aug 2023to 30 Dec 2025
- 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
- Adult
Study population: First trimester pregnancy women who are at higher risk of fetal growth restriction.
Who may be able to join
- Pregnant women with gestational age of <14 weeks
- Maternal age between 18 and 45 years old
- With at least one of FGR high risk factors:
- Maternal age >40 years
- Nulliparous, Maternal age >38 years
- Previous pregnancy with FGR, PE or placental abruption
Show all 13Show fewer
- Maternal medical history of chronic hypertension, diabetes mellitus, chronic nephritis or autoimmune diseases (such as SLE or APS)
- Recurrent spontaneous abortion (RSA) > 3 times with unknown causes
- Or with at least two of the following FGR high risk factors:
- Maternal age 35~40 years
- BMI ≥ 28 kg/m2 or BMI < 18.5 kg/m2
- Conception with assisted reproductive technology
- Interval from previous delivery: > 5 years or < 6 months
Who cannot join
- Presence of fetal genetic abnormalities or severe structural abnormalities in prenatal ultrasound or genetic testing.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai First Maternity and Infant Hospital
Shanghai, Shanghai Municipality, 201204
Luming Sun, Ph, 021-20261151, luming_sun@163.com
About this study
This study intends to prospectively enroll high-risk pregnant women to establish a multicenter cohort. By combining maternal basic characteristics, medical history, early pregnancy ultrasound, and biological markers, we aim to construct a joint predictive model for MVM-FGR.
Read the detailed description
Clinical guidelines do not recommend clinical screening for MVM-FGR in low-risk populations. Predictive models for FGR are often based on preeclampsia prediction models or Down syndrome serum screening models, which have limited utility. This study aims to establish a multi-center prospective cohort of pregnant women at high risk for FGR. We will collect baseline characteristics of pregnant women, ultrasound measurements of fetal growth, structural scans, maternal-fetal Doppler blood flow, as well as maternal serum and plasma in first and mid-trimester. Serum and plasma biomarker testing will be conducted. We will regularly observe fetal growth data, maternal-fetal complications during pregnancy, and collect delivery information, conditions of the newborn and placental pathology results after birth. By integrating maternal medical history, serum and plasma biomarkers, Doppler ultrasound, and other factors, we will establish a combined predictive model for early and mid-term MVM-FGR.
- Conditions
- Fetal Growth Retardation
- Medical subject headings
- Fetal Growth Retardation
What is being measured
The primary outcome is the main question the study is designed to answer.
Present of maternal-vascular-malperfusion (MVM)-FGR
Development of MVM Fetal growth restriction
Measured: during the pregnancy, up to an average gestational age of 40 weeks
Secondary outcomes (2)
Other adverse pregnancy outcome
including miscarriage, preeclampsia; intrauterine fetal death
Measured: pregnancy-born after 28 days
GA at delivery, birth weight, neonatal outcomes.
GA at delivery, birth weight, neonatal outcomes.
Measured: the day at birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2023
- Study start10 Aug 2023
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal Growth RetardationStudies 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
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai First Maternity and Infant Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luming Sun, Shanghai First Maternity and Infant Hospital
- Investigators
- Luming Sun, Docter, Principal investigator, Shanghai First Maternity and Infant Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06096805
- Sponsor's protocol ID
- ShanghaiFMIH-FMU7
- Status last verified
- Jun 2024
- First submitted
- 16 Oct 2023
- Last updated
- 7 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Placental Fetal Growth Restriction in High Risk Population (PoPFGR)
- ClinicalTrials.gov ID
- NCT06096805
- Acronym / sponsor ID
- ShanghaiFMIH-FMU7
- Conditions
- Fetal Growth Retardation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Shanghai First Maternity and Infant HospitalUniversity, hospital or other
- Study start
- 10 Aug 2023 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 24 Oct 2023 (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.
This study intends to prospectively enroll high-risk pregnant women to establish a multicenter cohort. By combining maternal basic characteristics, medical history, early pregnancy ultrasound, and biological markers, we aim to construct a joint predictive model for MVM-FGR.
Detailed description
Clinical guidelines do not recommend clinical screening for MVM-FGR in low-risk populations. Predictive models for FGR are often based on preeclampsia prediction models or Down syndrome serum screening models, which have limited utility. This study aims to establish a multi-center prospective cohort of pregnant women at high risk for FGR. We will collect baseline characteristics of pregnant women, ultrasound measurements of fetal growth, structural scans, maternal-fetal Doppler blood flow, as well as maternal serum and plasma in first and mid-trimester. Serum and plasma biomarker testing will be conducted. We will regularly observe fetal growth data, maternal-fetal complications during pregnancy, and collect delivery information, conditions of the newborn and placental pathology results after birth. By integrating maternal medical history, serum and plasma biomarkers, Doppler ultrasound, and other factors, we will establish a combined predictive model for early and mid-term MVM-FGR.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- First trimester pregnancy women who are at higher risk of fetal growth restriction.
Key inclusion criteria (13 listed)
- Pregnant women with gestational age of <14 weeks
- Maternal age between 18 and 45 years old
- With at least one of FGR high risk factors:
- Or with at least two of the following FGR high risk factors:
Key exclusion criteria (1 listed)
- Presence of fetal genetic abnormalities or severe structural abnormalities in prenatal ultrasound or genetic testing.
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
Present of maternal-vascular-malperfusion (MVM)-FGR
Time frame: during the pregnancy, up to an average gestational age of 40 weeks
Development of MVM Fetal growth restriction
2 secondary outcomes
Other adverse pregnancy outcome
Time frame: pregnancy-born after 28 days
GA at delivery, birth weight, neonatal outcomes.
Time frame: the day at birth
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2024.
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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.
Luming Sun, Docter principal investigator
Shanghai First Maternity and Infant Hospital
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 Fetal Growth Retardation, run by Shanghai First Maternity and Infant Hospital at 1 site in China.
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 13 inclusion and 1 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 Jun 2024. 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 China. 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 Jianping Chen, Master (13916159565 ext. +86, urchin_chen@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Present of maternal-vascular-malperfusion (MVM)-FGR (time frame: during the pregnancy, up to an average gestational age of 40 weeks). 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 7 Jun 2024.