Predicting fetal growth issues in high-risk pregnant women
Prediction of Placental Fetal Growth Restriction in High Risk Population (PoPFGR)
This study is trying to find out if collecting information from high-risk pregnant women can help predict and manage growth problems in their babies before they are born.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2000 (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 | NCT06096805 on ClinicalTrials.gov |
What this trial studies
This observational study aims to enroll high-risk pregnant women to create a multicenter cohort for predicting fetal growth retardation (FGR). By collecting data on maternal characteristics, medical history, early pregnancy ultrasounds, and biological markers, researchers will develop a predictive model for MVM-FGR. The study will monitor fetal growth, maternal-fetal complications, and newborn conditions, integrating various factors to enhance prediction accuracy. This approach seeks to improve early detection and management of FGR in vulnerable populations.
Who should consider this trial
Good fit: Ideal candidates include pregnant women under 14 weeks gestation, aged 18 to 45, with specific high-risk factors for fetal growth retardation.
Not a fit: Patients with fetal genetic abnormalities or severe structural abnormalities detected in prenatal assessments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved early detection and management of fetal growth issues, potentially enhancing outcomes for high-risk pregnancies.
How similar studies have performed: While predictive models for FGR have been explored, this study's comprehensive approach in a high-risk cohort is relatively novel and untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
* 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:
1. Maternal age \>40 years
2. Nulliparous, Maternal age \>38 years
3. Previous pregnancy with FGR, PE or placental abruption
4. Maternal medical history of chronic hypertension, diabetes mellitus, chronic nephritis or autoimmune diseases (such as SLE or APS)
5. Recurrent spontaneous abortion (RSA) \> 3 times with unknown causes
* Or with at least two of the following FGR high risk factors:
1. Maternal age 35\~40 years
2. BMI ≥ 28 kg/m2 or BMI \< 18.5 kg/m2
3. Conception with assisted reproductive technology
4. Interval from previous delivery: \> 5 years or \< 6 months
Exclusion Criteria:
* Presence of fetal genetic abnormalities or severe structural abnormalities in prenatal ultrasound or genetic testing.
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, Docter — Shanghai First Maternity and Infant Hospital
- Study coordinator: Jianping Chen, Master
- Email: urchin_chen@163.com
- Phone: 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.