MVM-FGRNCT06104748
A Cohort of Maternal Vascular Malperfusion-related FGR (CoMVMFGR)
An observational study of MVM-FGR, run by Shanghai First Maternity and Infant Hospital at 1 site in China.
Trial summary
Based on a precise diagnostic standard process, through a multicenter study, we will establish a cohort focusing on placenta-mediated fetal growth restriction (FGR). Long-term follow-up will be conducted to seek predictive indicators for short-term and long-term adverse outcomes of maternal vascular… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- MVM-FGR
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 10 Aug 2023to 30 Dec 2025
- How long will I take part?
- 2 Years
- 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
- No healthy volunteers
- Adult
Study population: severe FGR singletons
Who may be able to join
- 1.Singleton pregnancy 2. diagnosed as FGR according the delphi consensus:
- Early-onset FGR(<32 weeks) Estimated fetal weight (EFW) or abdominal circumference (AC) < 3rd; or EFW or AC < 10th, combined with abnormal doppler, including uterine artery pulsatility index(UtA PI) >95th percentile, umbilical artery pulsatility index(UA PI) >95th percentile； or umbilical artery absent end-diastolic flow (UA-AEDF) or umbilical artery reversed end-diastolic flow(UA-REDF).
- Late-onset FGR(≥32 weeks) Estimated fetal weight (EFW) or abdominal circumference (AC) < 3rd; or >2 of the following 3 criteria:
- EFW or AC <10th percentile
- EFW or AC crossing percentiles>2 quartiles on growth percentiles
- CPR <5th percentile or UA-Pl>95th percentile 3.provision of signed written informed consent.
Who cannot join
- Fetus with definitive genetic disorders related to FGR, fetus with confirmed intrauterine infection (CMV, syphilis and etc.), fetus with structural anomalies
- Incomplete information or absence of informed consent
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, MD; PhD, 021-20261151, luming_sun@163.com
About this study
Based on a precise diagnostic standard process, through a multicenter study, we will establish a cohort focusing on placenta-mediated fetal growth restriction (FGR). Long-term follow-up will be conducted to seek predictive indicators for short-term and long-term adverse outcomes of maternal vascular malperfusion-related FGR (MVM-FGR).
Read the detailed description
Fetal Growth Restriction (FGR) denotes the inability of fetal growth to attain its inherent genetic potential due to diverse pathological influences. It stands as a significant determinant of morbidity and mortality during the perinatal phase, intricately linked with adverse long-term consequences. The etiology of FGR is complex, involving maternal, placental/umbilical, and fetal factors. Among these, maternal vascular malperfusion-related FGR (MVM-FGR) emerges as the prevalent subtype, which is considered to have potential for early intervention and prevention.
To address this, we will establish a cohort dedicated to MVM-FGR, guided by a stringent diagnostic standard process tailored for FGR. Our objective is to compile a comprehensive dataset of singleton pregnancies diagnosed with MVM-FGR cases through multicenter collaboration. The definition of FGR aligns with the FIGO consensus criteria. We conduct thorough prenatal screenings for fetal factors, including genetic abnormalities, infections, and structural anomalies, subsequently enrolling MVM-FGR cases into our cohort.
Techniques including Doppler ultrasound, magnetic resonance imaging (MRI), and electronic fetal heart monitoring will be employed to assess fetal conditions. Follow-up continues until the child reaches the age of two years postpartum. Pathological examination of the placenta is performed after delivery, with additional placental genetic testing if necessary.
- Conditions
- MVM-FGR
- Keywords
- FGR, maternal vascular malperfusion, Doppler, placenta, etiologies
What is being measured
The primary outcome is the main question the study is designed to answer.
short-term and long-term outcomes associated with MVM-FGR
Exploration of short-term and long-term outcomes associated with MVM-FGR, encompassing intrauterine fetal demise, neonatal mortality, and severe neonatal morbidity.
Measured: during the pregnancy, up to an average gestational age of 40 weeks
predictive model for adverse outcomes
Development of a predictive model for adverse outcomes of MVM-FGR through the integration of maternal and fetal indicators
Measured: death during the pregnancy (average gestational age of 40 weeks), or death in 28 days after birth
Secondary outcomes (2)
Distribution of genetic etiologies of FGR
Distribution of genetic etiologies of FGR under the standard assessment process.
Measured: the day at birth
Severe maternal complications
Severe maternal complications in MVM-FGR cohort
Measured: pregnancy-born after 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 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 MVM-FGRStudies 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
- 2 Years
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, Doctor, Principal investigator, Department of Fetal Medicine, Shanghai First Maternity and Infant Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06104748
- Sponsor's protocol ID
- ShanghaiFMIH-FMU6
- 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
- Individual data sharing
- Undecided
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
- A Cohort of Maternal Vascular Malperfusion-related FGR (CoMVMFGR)
- ClinicalTrials.gov ID
- NCT06104748
- Acronym / sponsor ID
- ShanghaiFMIH-FMU6
- Conditions
- MVM-FGR
- Keywords
- FGR, maternal vascular malperfusion, Doppler, placenta, etiologies
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 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
- 27 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.
Based on a precise diagnostic standard process, through a multicenter study, we will establish a cohort focusing on placenta-mediated fetal growth restriction (FGR). Long-term follow-up will be conducted to seek predictive indicators for short-term and long-term adverse outcomes of maternal vascular malperfusion-related FGR (MVM-FGR).
Detailed description
Fetal Growth Restriction (FGR) denotes the inability of fetal growth to attain its inherent genetic potential due to diverse pathological influences. It stands as a significant determinant of morbidity and mortality during the perinatal phase, intricately linked with adverse long-term consequences. The etiology of FGR is complex, involving maternal, placental/umbilical, and fetal factors. Among these, maternal vascular malperfusion-related FGR (MVM-FGR) emerges as the prevalent subtype, which is considered to have potential for early intervention and prevention.
To address this, we will establish a cohort dedicated to MVM-FGR, guided by a stringent diagnostic standard process tailored for FGR. Our objective is to compile a comprehensive dataset of singleton pregnancies diagnosed with MVM-FGR cases through multicenter collaboration. The definition of FGR aligns with the FIGO consensus criteria. We conduct thorough prenatal screenings for fetal factors, including genetic abnormalities, infections, and structural anomalies, subsequently enrolling MVM-FGR cases into our cohort.
Techniques including Doppler ultrasound, magnetic resonance imaging (MRI), and electronic fetal heart monitoring will be employed to assess fetal conditions. Follow-up continues until the child reaches the age of two years postpartum. Pathological examination of the placenta is performed after delivery, with additional placental genetic testing if necessary.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- severe FGR singletons
Key inclusion criteria (6 listed)
- Early-onset FGR(<32 weeks) Estimated fetal weight (EFW) or abdominal circumference (AC) < 3rd; or EFW or AC < 10th, combined with abnormal doppler, including uterine artery pulsatility index(UtA PI) >95th percentile, umbilical artery pulsatility index(UA PI) >95th percentile； or umbilical artery absent end-diastolic flow (UA-AEDF) or umbilical artery reversed end-diastolic flow(UA-REDF).
- Late-onset FGR(≥32 weeks) Estimated fetal weight (EFW) or abdominal circumference (AC) < 3rd; or >2 of the following 3 criteria:
Key exclusion criteria (2 listed)
- Fetus with definitive genetic disorders related to FGR, fetus with confirmed intrauterine infection (CMV, syphilis and etc.), fetus with structural anomalies
- Incomplete information or absence of informed consent
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
short-term and long-term outcomes associated with MVM-FGR
Time frame: during the pregnancy, up to an average gestational age of 40 weeks
Exploration of short-term and long-term outcomes associated with MVM-FGR, encompassing intrauterine fetal demise, neonatal mortality, and severe neonatal morbidity.
predictive model for adverse outcomes
Time frame: death during the pregnancy (average gestational age of 40 weeks), or death in 28 days after birth
Development of a predictive model for adverse outcomes of MVM-FGR through the integration of maternal and fetal indicators
2 secondary outcomes
Distribution of genetic etiologies of FGR
Time frame: the day at birth
Severe maternal complications
Time frame: pregnancy-born after 28 days
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.
- Individual participant dataSharing planned: Undecided
Related trials for MVM-FGR
Enrolling by invitationPhase 1
Melatonin and Perinatal Outcomes in MVM-Related Fetal Growth Restriction (MIMVMFGR)
Fetal Growth Restriction (FGR)
RecruitingObservational study
AI-Based Ultrasound Prediction of Pregnancy Outcomes in Placental-Related Fetal Growth Restriction (MVM-FGR): A Prospective Cohort Study
Fetal Growth Restriction (FGR)
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, Doctor principal investigator
Department of Fetal Medicine, 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 MVM-FGR, 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 6 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: 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 (+86 13916159565, urchin_chen@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
short-term and long-term outcomes associated with MVM-FGR (time frame: during the pregnancy, up to an average gestational age of 40 weeks). 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 7 Jun 2024.