NCT07701837

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, between pregnancies complicated by intrauterine growth restriction (IUGR) and uncomplicated healthy pregnancies. Placental tissue samples obtained at delivery will be analyzed using quantitative real-time polymerase chain reaction (qRT-PCR). The study also aims to investigate the association between receptor expression levels and perinatal outcomes in order to better understand the role of progesterone membrane receptors in the pathophysiology of IUGR.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
5mo left

Started Nov 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress64%
Nov 2025Jan 2027

Study Start

First participant enrolled

November 1, 2025

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 8, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 14, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

July 14, 2026

Status Verified

July 1, 2026

Enrollment Period

1.2 years

First QC Date

July 8, 2026

Last Update Submit

July 8, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Placental PGRMC1,PGRMC2 and PAQR mRNA expression levels

    Relative placental mRNA expression levels of PGRMC1, PGRMC2 and PAQR family receptors measured by quantitative real-time polymerase chain reaction (qRT-PCR) in placental tissue collected immediately after delivery.

    At delivery

Other Outcomes (1)

  • association between placental progesterone membrane receptor expression and neonatal outcomes

    at delivery

Study Arms (2)

Fetal Growth Restriction Group

Pregnant women diagnosed with fetal growth restriction who will undergo placental tissue collection at delivery for molecularanalysis.

Healthy Control Group

Healthy pregnant women with appropriate fetal growth who will undergo placental tissue collection at delivery for molecular analysis.

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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 women with singleton pregnancies complicated by fetal growth restriction (FGR) and healthy pregnant women with appropriate fetal growth serving as the control group. Placental tissue samples will be collected immediately after delivery for molecular analysis.

You may qualify if:

  • Singleton pregnancy Maternal age 18-45 years Diagnosis of IUGR according to institutional criteria

You may not qualify if:

  • Multiple pregnancy Major fetal structural anomaly Chromosomal abnormality Congenital infection Maternal chronic systemic disease Autoimmune disease Chronic hypertension Pregestational diabetes mellitus Placental abruption Intrauterine fetal demise

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsun University Faculty of Medicine Samsun Training and Research Hospital

Samsun, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Fetal Growth Retardation

Condition Hierarchy (Ancestors)

Fetal DiseasesPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGrowth DisordersPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Canan Soyer Çalışkan, MD, Associate Professor

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Canan SOYER ÇALIŞKAN, MD, Associate Professor

CONTACT

Canan SOYER ÇALIŞKAN, MD, Associate Professor

CONTACT

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

November 1, 2025

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Last Updated

July 14, 2026

Record last verified: 2026-07

Locations