Fetal Growth RestrictionNCT07701837
Placental Progesterone Membrane Receptors in Fetal Growth Restriction
An observational study of Fetal Growth Restriction and Placenta, run by Samsun University at 2 sites in Turkey (Türkiye).
Trial summary
This prospective observational case-control study aims to compare placental expression levels of progesterone membrane receptors, including PGRMC1, PGRMC2, and PAQR family receptors, among pregnancies affected by impaired fetal growth and appropriately grown control pregnancies. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fetal Growth Restriction, Placenta, Progesterone Membrane Receptor
- How many people
- 110 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Aug 2025to 20 Jul 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Pregnant women aged 18-45 years delivering at Samsun Training and Research Hospital will be enrolled. The study population will consist of singleton pregnancies with suspected fetal growth impairment and healthy pregnancies with appropriate fetal growth. Before biomarker analyses, pregnancies with suspected fetal growth impairment will be classified according to the Delphi consensus definition and ISUOG Practice Guidelines into fetal growth restriction (FGR) or small for gestational age (SGA). The final study cohort consists of three groups: FGR, SGA, and healthy controls. Placental tissue samples will be collected immediately after delivery for molecular analysis.
Who may be able to join
- FGR Group
- Pregnant women aged ≥18 years.
- Singleton pregnancy.
- Gestational age ≥24 weeks.
- Diagnosis of fetal growth restriction according to the Delphi consensus criteria (or your institutional protocol if that is what was used in the study).
- Planned delivery at the participating hospital.
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- Written informed consent. SGA Group
- Pregnant women aged ≥18 years.
- Singleton pregnancy.
- Estimated fetal weight or birth weight <10th percentile without evidence of fetal growth restriction.
- Planned delivery at the participating hospital.
- Written informed consent Control Group
- Pregnant women aged ≥18 years.
- Singleton pregnancy.
- Appropriate-for-gestational-age fetus (birth weight between the 10th and 90th percentile).
- No maternal or fetal complications affecting fetal growth.
- Planned delivery at the participating hospital.
- Written informed consent.
Who cannot join
- Multiple pregnancy.
- Major fetal structural or chromosomal anomalies.
- Congenital fetal infection.
- Known genetic syndromes.
- Intrauterine fetal demise.
- Maternal malignancy.
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- Chronic inflammatory or autoimmune disease.
- Refusal or inability to provide informed consent.
- Inadequate maternal blood or placental sample for analysis.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Canan Soyer Çalışkan
Samsun
Samsun University Faculty of Medicine Samsun Training and Research Hospital
Samsun
About this study
Official title: Expression of Progesterone Membrane Receptors in Placentas From Pregnancies Complicated by Intrauterine Growth Restriction: A Prospective Observational Case-Control Study
This prospective observational case-control study aims to compare placental expression levels of progesterone membrane receptors, including PGRMC1, PGRMC2, and PAQR family receptors, among pregnancies affected by impaired fetal growth and appropriately grown control pregnancies. Pregnancies with suspected impaired fetal growth were phenotypically classified before biomarker analyses according to the contemporary Delphi consensus and ISUOG diagnostic criteria into fetal growth restriction (FGR) and small for gestational age (SGA). Placental tissue samples obtained at delivery were analyzed using quantitative real-time polymerase chain reaction (qRT-PCR). The final study cohort comprised 110 singleton pregnancies, including 48 FGR, 29 SGA, and 33 appropriately grown controls. The study also evaluated the association between progesterone membrane receptor expression and adverse perinatal outcomes.
Read the detailed description
Intrauterine growth restriction (IUGR) remains one of the leading causes of perinatal morbidity and mortality. Although placental insufficiency is considered the major underlying mechanism, the molecular pathways responsible for impaired fetal growth are not fully understood.
Progesterone is essential for maintaining pregnancy and exerts its biological effects through both classical nuclear receptors and membrane progesterone receptors. Among these, progesterone receptor membrane component-1 (PGRMC1), progesterone receptor membrane component-2 (PGRMC2), and members of the progestin and adipoQ receptor (PAQR) family have recently attracted attention because of their roles in placental development, angiogenesis, immune regulation, and maintenance of placental integrity.
The present study will prospectively recruit women diagnosed with IUGR and healthy pregnant women delivering at the same institution. Placental samples collected immediately after delivery will undergo molecular analysis using quantitative real-time PCR to determine receptor expression levels. Clinical and obstetric characteristics together with neonatal outcomes will be recorded prospectively.
The findings may contribute to a better understanding of the molecular mechanisms underlying placental dysfunction in IUGR and may identify potential biomarkers associated with adverse pregnancy outcomes.
This study was retrospectively registered in ClinicalTrials.gov (NCT07701837). At the time of protocol development, the term intrauterine growth restriction (IUGR) was used to describe pregnancies with suspected impaired fetal growth. Before biomarker analyses, all growth-impaired pregnancies were phenotypically reclassified according to the contemporary Delphi consensus definition and ISUOG Practice Guidelines into fetal growth restriction (FGR) or small for gestational age (SGA). Consecutive participant recruitment continued throughout the approved study period, resulting in a final cohort of 110 singleton pregnancies (48 FGR, 29 SGA, and 33 appropriately grown controls). Comparisons between the FGR and SGA phenotypes were performed as secondary, hypothesis-generating analyses. No changes were made to participant recruitment procedures, biospecimen collection, laboratory methods, or primary biomarker measurements following this phenotypic classification.
- Conditions
- Fetal Growth Restriction, Placenta, Progesterone Membrane Receptor, PGRMC1, PGRMC2, Placental Dysfunction
- Medical subject headings
- Fetal Growth Retardation
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 |
|---|---|---|
| Fetal Growth Restriction Group | Singleton pregnancies meeting the Delphi consensus and ISUOG diagnostic criteria for fetal growth restriction (FGR). Placental tissue samples were collected at delivery for molecular analyses of progesterone membrane receptor expression. | |
| Appropriately Grown Control Group | Singleton pregnancies with appropriate fetal growth and without maternal or fetal complications. Placental tissue samples were collected at delivery for molecular analysis. | |
| Small for Gestational Age (SGA) | Singleton pregnancies with birth weight below the 10th percentile that did not meet the Delphi consensus and ISUOG diagnostic criteria for fetal growth restriction (FGR). Placental tissue were collected at delivery for molecular analyses for progesterone membrane receptor expression. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal serum and placental concentrations of membrane progesterone receptors (mPRα/PAQR7, PGRMC1, and PGRMC2)
Maternal serum and placental concentrations of mPRα (PAQR7), PGRMC1, and PGRMC2 will be quantified at delivery using enzyme-linked immunosorbent assay (ELISA)
Measured: At delivery
Secondary outcomes (3)
Diagnostic performance of membrane progesterone receptor concentrations for fetal growth restriction
The diagnostic accuracy of individual and combined serum and placental concentrations of mPRα (PAQR7), PGRMC1, and PGRMC2 for distinguishing FGR from SGA and uncomplicated pregnancies will be evaluated using receiver operating characteristic (ROC) curve analysis, including the area under the curve (AUC), sensitivity, specificity, positive predictive value, and negative predictive value.
Measured: At delivery
Comparison of membrane progesterone receptor concentrations between early- and late-onset fetal growth restriction
Maternal serum and placental concentrations of mPRα (PAQR7), PGRMC1, and PGRMC2 will be compared between pregnancies with early-onset and late-onset FGR.
Measured: At delivery
Association between membrane progesterone receptor concentrations and fetal growth restriction
The association between maternal serum and placental concentrations of mPRα (PAQR7), PGRMC1, and PGRMC2 and the presence of fetal growth restriction will be assessed using multivariable logistic regression analysis.
Measured: At delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2026
- Study start1 Aug 2025
- Primary completion20 Jul 2026
- Study completion20 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsun University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Canan Soyer Çalışkan, MD, Associate Professor, Principal investigator, Samsun University, Samsun Education and Research Hospital, Samsun, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07701837
- Sponsor's protocol ID
- OMUK2025/309
- Status last verified
- Aug 2026
- First submitted
- 8 Jul 2026
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expression of Progesterone Membrane Receptors in Placentas From Pregnancies Complicated by Intrauterine Growth Restriction: A Prospective Observational Case-Control Study
- ClinicalTrials.gov ID
- NCT07701837
- Acronym / sponsor ID
- OMUK2025/309
- Conditions
- Fetal Growth Restriction, Placenta, Progesterone Membrane Receptor, PGRMC1, PGRMC2, Placental Dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Samsun UniversityUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 20 Jul 2026 (actual)
- Study completion
- 20 Jul 2026 (actual)
- First posted
- 14 Jul 2026 (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.
This prospective observational case-control study aims to compare placental expression levels of progesterone membrane receptors, including PGRMC1, PGRMC2, and PAQR family receptors, among pregnancies affected by impaired fetal growth and appropriately grown control pregnancies. Pregnancies with suspected impaired fetal growth were phenotypically classified before biomarker analyses according to the contemporary Delphi consensus and ISUOG diagnostic criteria into fetal growth restriction (FGR) and small for gestational age (SGA). Placental tissue samples obtained at delivery were analyzed using quantitative real-time polymerase chain reaction (qRT-PCR). The final study cohort comprised 110 singleton pregnancies, including 48 FGR, 29 SGA, and 33 appropriately grown controls. The study also evaluated the association between progesterone membrane receptor expression and adverse perinatal outcomes.
Detailed description
Intrauterine growth restriction (IUGR) remains one of the leading causes of perinatal morbidity and mortality. Although placental insufficiency is considered the major underlying mechanism, the molecular pathways responsible for impaired fetal growth are not fully understood.
Progesterone is essential for maintaining pregnancy and exerts its biological effects through both classical nuclear receptors and membrane progesterone receptors. Among these, progesterone receptor membrane component-1 (PGRMC1), progesterone receptor membrane component-2 (PGRMC2), and members of the progestin and adipoQ receptor (PAQR) family have recently attracted attention because of their roles in placental development, angiogenesis, immune regulation, and maintenance of placental integrity.
The present study will prospectively recruit women diagnosed with IUGR and healthy pregnant women delivering at the same institution. Placental samples collected immediately after delivery will undergo molecular analysis using quantitative real-time PCR to determine receptor expression levels. Clinical and obstetric characteristics together with neonatal outcomes will be recorded prospectively.
The findings may contribute to a better understanding of the molecular mechanisms underlying placental dysfunction in IUGR and may identify potential biomarkers associated with adverse pregnancy outcomes.
This study was retrospectively registered in ClinicalTrials.gov (NCT07701837). At the time of protocol development, the term intrauterine growth restriction (IUGR) was used to describe pregnancies with suspected impaired fetal growth. Before biomarker analyses, all growth-impaired pregnancies were phenotypically reclassified according to the contemporary Delphi consensus definition and ISUOG Practice Guidelines into fetal growth restriction (FGR) or small for gestational age (SGA). Consecutive participant recruitment continued throughout the approved study period, resulting in a final cohort of 110 singleton pregnancies (48 FGR, 29 SGA, and 33 appropriately grown controls). Comparisons between the FGR and SGA phenotypes were performed as secondary, hypothesis-generating analyses. No changes were made to participant recruitment procedures, biospecimen collection, laboratory methods, or primary biomarker measurements following this phenotypic classification.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fetal Growth Restriction Group | – | –Singleton pregnancies meeting the Delphi consensus and ISUOG diagnostic criteria for fetal growth restriction (FGR). Placental tissue samples were collected at delivery for molecular analyses of progesterone membrane receptor expression. |
| Appropriately Grown Control Group | – | –Singleton pregnancies with appropriate fetal growth and without maternal or fetal complications. Placental tissue samples were collected at delivery for molecular analysis. |
| Small for Gestational Age (SGA) | – | –Singleton pregnancies with birth weight below the 10th percentile that did not meet the Delphi consensus and ISUOG diagnostic criteria for fetal growth restriction (FGR). Placental tissue were collected at delivery for molecular analyses for progesterone membrane receptor expression. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant women aged 18-45 years delivering at Samsun Training and Research Hospital will be enrolled. The study population will consist of singleton pregnancies with suspected fetal growth impairment and healthy pregnancies with appropriate fetal growth. Before biomarker analyses, pregnancies with suspected fetal growth impairment will be classified according to the Delphi consensus definition and ISUOG Practice Guidelines into fetal growth restriction (FGR) or small for gestational age (SGA). The final study cohort consists of three groups: FGR, SGA, and healthy controls. Placental tissue samples will be collected immediately after delivery for molecular analysis.
Key inclusion criteria (18 listed)
- FGR Group
- Pregnant women aged ≥18 years.
- Singleton pregnancy.
- Gestational age ≥24 weeks.
- Diagnosis of fetal growth restriction according to the Delphi consensus criteria (or your institutional protocol if that is what was used in the study).
Key exclusion criteria (9 listed)
- Multiple pregnancy.
- Major fetal structural or chromosomal anomalies.
- Congenital fetal infection.
- Known genetic syndromes.
- Intrauterine fetal demise.
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 and placental concentrations of membrane progesterone receptors (mPRα/PAQR7, PGRMC1, and PGRMC2)
Time frame: At delivery
Maternal serum and placental concentrations of mPRα (PAQR7), PGRMC1, and PGRMC2 will be quantified at delivery using enzyme-linked immunosorbent assay (ELISA)
3 secondary outcomes
Diagnostic performance of membrane progesterone receptor concentrations for fetal growth restriction
Time frame: At delivery
Comparison of membrane progesterone receptor concentrations between early- and late-onset fetal growth restriction
Time frame: At delivery
Association between membrane progesterone receptor concentrations and fetal growth restriction
Time frame: At delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
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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. This study is not recruiting at the moment.
Canan Soyer Çalışkan, MD, Associate Professor principal investigator
Samsun University, Samsun Education and Research Hospital, Samsun, Turkey
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 Fetal Growth Restriction and Placenta, run by Samsun University at 2 sites in Turkey (Türkiye).
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 18 inclusion and 9 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: finished, as of the sponsor's last update on 7 Aug 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal serum and placental concentrations of membrane progesterone receptors (mPRα/PAQR7, PGRMC1, and PGRMC2) (time frame: At delivery). 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 7 Aug 2026.