- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07337759
Fetus Programming and Long Active Outcomes, Interaction Between Mother, Placenta and Fetus in Perinatal and Methabolic Disbalansces-focusing Diabetic Pregnancies
Placental Weight and Surface as an Indicator of Placental Insufficiency and Adverse Perinatal Outcomes
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).
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Belgrade, Serbia
- Clinic of Gynecology and Obstetrics, University Clinical Center of Serbia
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria: Pregnant women who delivered at the Clinic of Gynecology and Obstetrics, University Clinical Centre of Serbia
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Appropriate-for-Gestational-Age Placenta (AGA-P)
regnant women whose placentas had a weight between the 10th and 90th percentile for gestational age.
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observational study
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Small-for-Gestational-Age Placenta (SGA-P)
Pregnant women whose placentas had a weight below the 10th percentile for gestational age.
|
observational study
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Adverse perinatal outcome defined as at least one of the following: delivery before 34 gestational weeks, birth weight below 2200 g, or Apgar score <7 at 5 minutes.
Time Frame: From delivery to 5 minutes after birth
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From delivery to 5 minutes after birth
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1880/6
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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