Prediction of Placental Fetal Growth Restriction in High Risk Population (PoPFGR)

NCT06096805 | Recruiting

• 1 other identifier: ShanghaiFMIH-FMU7
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fetal Growth Retardation

Outcome Measures

Primary Outcomes (1)

• Present of maternal-vascular-malperfusion (MVM)-FGR

  Development of MVM Fetal growth restriction

  during the pregnancy, up to an average gestational age of 40 weeks

Secondary Outcomes (2)

• Other adverse pregnancy outcome

  pregnancy-born after 28 days

• GA at delivery, birth weight, neonatal outcomes.

  the day at birth

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: First trimester pregnancy women who are at higher risk of fetal growth restriction.
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

First trimester pregnancy women who are at higher risk of fetal growth restriction.

You may qualify if:

• 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
• 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

You may not qualify if:

• Presence of fetal genetic abnormalities or severe structural abnormalities in prenatal ultrasound or genetic testing.

Sponsors & Collaborators

• Shanghai First Maternity and Infant Hospital: lead

Study Sites (1)

Shanghai First Maternity and Infant Hospital

Shanghai, Shanghai Municipality, 201204, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

maternal blood, urine

MeSH Terms

Conditions

Fetal Growth Retardation

Condition Hierarchy (Ancestors)

Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Luming Sun, Docter

  Shanghai First Maternity and Infant Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jianping Chen, Master

CONTACT

13916159565; urchin_chen@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 16, 2023
• First Posted: October 24, 2023
• Study Start: August 10, 2023
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: June 7, 2024

Record last verified: 2024-06

Locations

CN (1)