Cohort for studying fetal growth restriction related to maternal vascular issues
A Cohort of Maternal Vascular Malperfusion-related FGR (CoMVMFGR)
This study is trying to understand how problems with blood flow in pregnant women can affect their baby's growth and health by following a group of pregnancies with these issues for two years after birth.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Shanghai First Maternity and Infant Hospital Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06104748 on ClinicalTrials.gov |
What this trial studies
This observational study aims to establish a cohort of singleton pregnancies diagnosed with maternal vascular malperfusion-related fetal growth restriction (MVM-FGR) through a multicenter approach. Utilizing a stringent diagnostic standard process, the study will compile a comprehensive dataset and conduct long-term follow-up to identify predictive indicators for both short-term and long-term adverse outcomes associated with MVM-FGR. Techniques such as Doppler ultrasound, MRI, and electronic fetal heart monitoring will be employed to assess fetal conditions, with follow-up extending until the child reaches two years postpartum.
Who should consider this trial
Good fit: Ideal candidates include pregnant individuals with singleton pregnancies diagnosed with fetal growth restriction according to established criteria.
Not a fit: Patients with definitive genetic disorders related to fetal growth restriction or confirmed intrauterine infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved early intervention strategies for fetal growth restriction, potentially reducing morbidity and mortality rates.
How similar studies have performed: While the approach of establishing a cohort for MVM-FGR is not widely tested, similar studies focusing on fetal growth restriction have shown promise in identifying risk factors and improving outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1.Singleton pregnancy 2. diagnosed as FGR according the delphi consensus: 1. 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). 2. 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. Exclusion Criteria: * 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
Where this trial is running
Shanghai, Shanghai Municipality
- Shanghai First Maternity and Infant Hospital — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Principal investigator: Luming Sun, Doctor — Department of Fetal Medicine, Shanghai First Maternity and Infant Hospital
- Study coordinator: Jianping Chen, Master
- Email: urchin_chen@163.com
- Phone: +86 13916159565
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.