A Cohort of Maternal Vascular Malperfusion-related FGR (C... | NCT06104748

Studies
A Cohort of Maternal Vascular Malperfusion-related FGR (CoMVMFGR)

NCT06104748

Sponsor

Shanghai First Maternity and Infant Hospital

Status

Unknown status

Last Update Posted

Jun 7, 2024Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

MVM-FGR

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 10, 2023Actual

Primary Completion Date

Dec 30, 2025Estimated

Completion Date

Dec 30, 2025Estimated

First Submitted Date

Oct 16, 2023

First Submission Date that Met QC Criteria

Oct 23, 2023

First Posted Date

Oct 27, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 6, 2024

Last Update Posted Date

Jun 7, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

2 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

500Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	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	death during the pregnancy (average gestational age of 40 weeks), or death in 28 days after birth

Secondary Outcomes

Measure	Description	Time Frame
Distribution of genetic etiologies of FGR	Distribution of genetic etiologies of FGR under the standard assessment process.	the day at birth
Severe maternal complications	Severe maternal complications in MVM-FGR cohort

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

pregnant women

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

severe FGR singletons

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jianping Chen, Master	Contact	+86 13916159565		urchin_chen@163.com

Overall Officials

Name	Affiliation	Role
Luming Sun, Doctor	Department of Fetal Medicine, Shanghai First Maternity and Infant Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shanghai First Maternity and Infant Hospital	Recruiting	Shanghai	Shanghai Municipality	201204	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Description

Maternal serum and plasma samples will be used for omics analysis, amniotic fluid will underwent genetic testing (including karyotyping, chromosomal microarray analysis and exome sequencing), and/or infection testing. Placenta will perform pathological testing after delivery.