Placental Progesterone Membrane Receptors in Fetal Growth Restriction

NCT07701837 | Completed

• 1 other identifier: OMUK2025/309
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Fetal Growth Restriction; Placenta; Progesterone Membrane Receptor; PGRMC1; PGRMC2; Placental Dysfunction; Pregnancy

Outcome Measures

Primary Outcomes (1)

• 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)

  At delivery

Secondary Outcomes (3)

• Diagnostic performance of membrane progesterone receptor concentrations for fetal growth restriction

  At delivery

• Comparison of membrane progesterone receptor concentrations between early- and late-onset fetal growth restriction

  At delivery

• Association between membrane progesterone receptor concentrations and fetal growth restriction

  At delivery

Other Outcomes (1)

• Comparison of membrane progesterone receptor concentrations among study groups

  at delivery

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.
• 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).

You may not qualify if:

• Multiple pregnancy.
• Major fetal structural or chromosomal anomalies.
• Congenital fetal infection.
• Known genetic syndromes.
• Intrauterine fetal demise.
• Maternal malignancy.
• Chronic inflammatory or autoimmune disease.
• Refusal or inability to provide informed consent.
• Inadequate maternal blood or placental sample for analysis.

Sponsors & Collaborators

• Samsun University: lead

Study Sites (2)

Canan Soyer Çalışkan

Samsun, Turkey (Türkiye)

Location

Samsun University Faculty of Medicine Samsun Training and Research Hospital

Samsun, Turkey (Türkiye)

Location

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

• Canan Soyer Çalışkan, MD, Associate Professor

  Samsun University, Samsun Education and Research Hospital, Samsun, Turkey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2026
• First Posted: July 14, 2026
• Study Start: August 1, 2025
• Primary Completion: July 20, 2026
• Study Completion: July 20, 2026
• Last Updated: August 7, 2026

Record last verified: 2026-08

Locations

TU (2)