Fetus Programming and Long Active Outcomes, Interaction Between Mother, Placenta and Fetus in Perinatal and Methabolic Disbalansces-focusing Diabetic Pregnancies

NCT ID: NCT07337759

Last Updated: 2026-01-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 440 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-12-15
• Study Completion Date: 2026-01-04

Brief Summary

The placenta is a temporary but essential organ that develops during pregnancy and supports the growth and survival of the fetus. It delivers oxygen and nutrients from the mother to the baby and removes waste products from the fetal circulation. Proper placental development and function are critical for a healthy pregnancy and good outcomes for both the mother and the newborn.

When the placenta does not grow or function properly, this condition is known as placental insufficiency. Placental insufficiency may lead to serious pregnancy complications, such as poor fetal growth, preterm birth, low birth weight, low Apgar scores, and increased risk of illness or death around the time of birth. In some cases, placental dysfunction may also contribute to maternal complications, including pregnancy-related hypertension.

Previous research has shown that simple physical characteristics of the placenta-such as its weight, size, thickness, and surface area-may reflect how well the placenta functions. Placentas that are smaller than expected for a given gestational age may indicate long-standing problems with blood flow between the mother and the fetus. However, these measurements are not yet routinely used as clinical markers of risk.

The purpose of this study was to examine whether placental weight, placental surface area, placental disk weight, and related histopathological changes are associated with adverse perinatal outcomes. The study included both healthy pregnant women and women with medical conditions known to affect pregnancy, such as hypertension, diabetes mellitus, and thrombophilia. Special attention was given to placentas classified as small for gestational age (SGA-P) compared with placentas appropriate for gestational age (AGA-P).

Conditions

Placental Insufficiency Hypertensive Disorders of Pregnancy Diabetes Mellitus in Pregnancy Thrombophilia in Pregnancy Adverse Perinatal Outcomes

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Appropriate-for-Gestational-Age Placenta (AGA-P)

regnant women whose placentas had a weight between the 10th and 90th percentile for gestational age.

No intervention (observational study)

Intervention Type: OTHER

observational study

Small-for-Gestational-Age Placenta (SGA-P)

Pregnant women whose placentas had a weight below the 10th percentile for gestational age.

No intervention (observational study)

Intervention Type: OTHER

observational study

Interventions

No intervention (observational study)

observational study

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Singleton pregnancy
• Available placental examination after delivery
• Available clinical and perinatal outcome data
• Gestational age at delivery ≥24 weeks

Exclusion Criteria

Multiple pregnancy (e.g., twins or higher-order gestations)

• Major congenital or chromosomal fetal anomalies
• Intrauterine fetal demise
• Conditions directly affecting placental weight (e.g., placental mosaicism)
• Incomplete clinical, placental, or histopathological data

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Belgrade

OTHER

Sponsor Role: lead

Responsible Party

Miroslava Gojnic Dugalic

Prof. dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Clinic of Gynecology and Obstetrics, University Clinical Center of Serbia

Belgrade, , Serbia

Countries

Serbia

Other Identifiers

1880/6

Identifier Type: -

Identifier Source: org_study_id