Fetal Growth Restriction a Case Control Study | NCT07025031

Studies
Fetal Growth Restriction a Case Control Study

NCT07025031

Sponsor

National University of Malaysia

Status

Recruiting

Last Update Posted

Jun 16, 2026Actual

Enrollment

58Estimated

Phase

Not provided

Conditions

Idiopathic Fetal Growth Restriction

Interventions

Not provided

Countries

Malaysia

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 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2025Actual

Primary Completion Date

Apr 1, 2027Estimated

Completion Date

Apr 1, 2027Estimated

First Submitted Date

Jun 9, 2025

First Submission Date that Met QC Criteria

Jun 9, 2025

First Posted Date

Jun 17, 2025Actual

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 15, 2026

Last Update Posted Date

Jun 16, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

The study aims to investigate the responsible factors that leads to idiopathic fetal growth restriction.

Detailed Description

The study aims to investigate the relationship between maternal serum level of progesterone, immune-expression of HMOX-1 a placental angiogenesis marker with idiopathic fetal growth restriction.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

58Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Women with pregnancies affected by idiopathic fetal growth restriction		Women with normal pregnancies and normally growing foetus

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Maternal serum level of progesterone	Maternal blood will be withdrawn and serum isolated. Measurement of progesterone level will be performed from the serum sample using ELISA.	At the point of recruitment from 24 until 32 weeks gestation.
Placental immunoexpression of Heme Oxygenase 1	Immunoexpression of Heme Oxygenase 1 in syncytiotrophoblasts, cytotrophoblasts, fetal endothelial cells, maternal vessels and decidual cells.	At delivery within 24 until 38 weeks gestation.

Secondary Outcomes

Measure	Description	Time Frame
Placenta histopathology examination	Placenta will be examined histopathologically	At delivery within 24 until 38 weeks gestation

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

singleton
dated pregnancy

Exclusion Criteria:

fetus with structural or chromosomal anomaly
receive treatments such as aspirin, progestogen, low molecular weight heparin
has pre-existing medical disorders such as autoimmune disease, hypertension, diabetes
smoking
suspected intrauterine infection

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Women

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Women diagnosed to have fetal growth restriction within 24 until 32 weeks gestation the absence of hypertension, diabetes or autoimmune disease.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Rahana Abd Rahman, MOG (UKM)	Contact	+60122719985	5964	drrahana@hctm.ukm.edu.my

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Canselor Tuanku Muhriz	Not yet recruiting	Kuala Lumpur	Kuala Lumpur	56000	Malaysia

IPD Sharing Statement Module

Plan to Share IPD

Description

IPD will only be shared if necessary

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided