Idiopathic Fetal Growth RestrictionNCT07025031
Fetal Growth Restriction a Case Control Study
An observational study of Idiopathic Fetal Growth Restriction, run by National University of Malaysia at 2 sites in Malaysia.
Trial summary
The study aims to investigate the responsible factors that leads to idiopathic fetal growth restriction. Read more about this study
- Who is it for?
- Ages 19 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Idiopathic Fetal Growth Restriction
- How many people
- 58 participants
- Where
- 2 sitesMalaysia
- Study dates
- 1 Jul 2025to 1 Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Women diagnosed to have fetal growth restriction within 24 until 32 weeks gestation the absence of hypertension, diabetes or autoimmune disease.
Who may be able to join
- singleton
- dated pregnancy
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Malaysia2 sites, 2 recruiting
- Not yet recruiting
Hospital Canselor Tuanku Muhriz
Kuala Lumpur, Kuala Lumpur, 56000
Rahana Abd Rahman, MOG (UKM), +60122719985 ext. 5964, drrahana@hctm.ukm.edu.my
- Recruiting
Hospital Canselor Tuanku Muhriz
Kuala Lumpur, 56000
Rahana Rahman, drrahana@ukm.edu.my
About this study
Official title: Maternal Serum Progesterone And Placental Heme Oxgenase-1 Expression In Early Onset Idiopathic Fetal Growth Restriction: A Case Control Study
The study aims to investigate the responsible factors that leads to idiopathic fetal growth restriction.
Read the 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.
- Conditions
- Idiopathic Fetal Growth Restriction
- Keywords
- progesterone, Heme Oxygenase-1, Idiopathic fetal growth restriction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Women with pregnancies affected by idiopathic fetal growth restriction | Women with normal pregnancies and normally growing foetus |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: At delivery within 24 until 38 weeks gestation.
Secondary outcomes (1)
Placenta histopathology examination
Placenta will be examined histopathologically
Measured: At delivery within 24 until 38 weeks gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2025
- Study start1 Jul 2025
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Fetal Growth RestrictionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University of Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07025031
- Sponsor's protocol ID
- JEP-2025-183
- Status last verified
- Jun 2026
- First submitted
- 9 Jun 2025
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will only be shared if necessary
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal Serum Progesterone And Placental Heme Oxgenase-1 Expression In Early Onset Idiopathic Fetal Growth Restriction: A Case Control Study
- ClinicalTrials.gov ID
- NCT07025031
- Acronym / sponsor ID
- JEP-2025-183
- Conditions
- Idiopathic Fetal Growth Restriction
- Keywords
- progesterone, Heme Oxygenase-1, Idiopathic fetal growth restriction
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- National University of MalaysiaUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 17 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women with pregnancies affected by idiopathic fetal growth restriction | – | –Women with normal pregnancies and normally growing foetus |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women diagnosed to have fetal growth restriction within 24 until 32 weeks gestation the absence of hypertension, diabetes or autoimmune disease.
Key inclusion criteria (2 listed)
- singleton
- dated pregnancy
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Maternal serum level of progesterone
Time frame: At the point of recruitment from 24 until 32 weeks gestation.
Maternal blood will be withdrawn and serum isolated. Measurement of progesterone level will be performed from the serum sample using ELISA.
Placental immunoexpression of Heme Oxygenase 1
Time frame: At delivery within 24 until 38 weeks gestation.
Immunoexpression of Heme Oxygenase 1 in syncytiotrophoblasts, cytotrophoblasts, fetal endothelial cells, maternal vessels and decidual cells.
1 secondary outcome
Placenta histopathology examination
Time frame: At delivery within 24 until 38 weeks gestation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Individual participant dataSharing planned: No. IPD will only be shared if necessary
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Idiopathic Fetal Growth Restriction, run by National University of Malaysia at 2 sites in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rahana Abd Rahman, MOG (UKM) (+60122719985 ext. 5964, drrahana@hctm.ukm.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal serum level of progesterone (time frame: At the point of recruitment from 24 until 32 weeks gestation.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.