Placental Insufficiency Hypertensive Disorders of Pregnancy Diabetes Mellitus in Pregnancy Thrombophilia in Pregnancy Adverse Perinatal OutcomesNCT07337759
Fetus Programming and Long Active Outcomes, Interaction Between Mother, Placenta and Fetus in Perinatal and Methabolic Disbalansces-focusing Diabetic Pregnancies
An observational study of Placental Insufficiency Hypertensive Disorders of Pregnancy Diabetes Mellitus in Pregnancy Thrombophilia in Pregnancy Adverse Perinatal Outcomes, run by University of Belgrade at 1 site in Serbia.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Placental Insufficiency Hypertensive Disorders of Pregnancy Diabetes Mellitus in Pregnancy Thrombophilia in Pregnancy Adverse Perinatal Outcomes
- How many people
- 440 participants
- Where
- 1 siteSerbia
- Study dates
- 15 Dec 2025to 4 Jan 2026
- How long will I take part?
- 9 Months
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Pregnant women with singleton pregnancies who delivered at the Clinic of Gynecology and Obstetrics, University Clinical Centre of Serbia. The study population includes both healthy pregnant women and women with maternal comorbidities such as hypertensive disorders, diabetes mellitus, and thrombophilia. Placentas were examined after delivery and classified according to placental weight for gestational age.
Who may be able to join
None listed.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Serbia1 site
Clinic of Gynecology and Obstetrics, University Clinical Center of Serbia
Belgrade
About this study
Official title: 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.
Read more
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).
- Being tested
- No intervention (observational study)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention (observational study)Other
observational study
| Study group | Role | What they receive |
|---|---|---|
| Appropriate-for-Gestational-Age Placenta (AGA-P) | regnant women whose placentas had a weight between the 10th and 90th percentile for gestational age. Receives: Other: No intervention (observational study) | |
| Small-for-Gestational-Age Placenta (SGA-P) | Pregnant women whose placentas had a weight below the 10th percentile for gestational age. Receives: Other: No intervention (observational study) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From delivery to 5 minutes after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start15 Dec 2025
- Primary completion4 Jan 2026
- Study completion4 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Placental Insufficiency Hypertensive Disorders of Pregnancy Diabetes Mellitus in Pregnancy Thrombophilia in Pregnancy Adverse Perinatal OutcomesStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 440 participants (actual)
- Target duration
- 9 Months
Sponsor and investigators
- Lead sponsor
- University of Belgrade
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Miroslava Gojnic Dugalic, University of Belgrade
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07337759
- Sponsor's protocol ID
- 1880/6
- Status last verified
- Jan 2026
- First submitted
- 4 Jan 2026
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Placental Weight and Surface as an Indicator of Placental Insufficiency and Adverse Perinatal Outcomes
- ClinicalTrials.gov ID
- NCT07337759
- Acronym / sponsor ID
- 1880/6
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 440 participants (actual)
- Lead sponsor
- University of BelgradeUniversity, hospital or other
- Study start
- 15 Dec 2025 (actual)
- Primary completion
- 4 Jan 2026 (actual)
- Study completion
- 4 Jan 2026 (actual)
- First posted
- 13 Jan 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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 9 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Appropriate-for-Gestational-Age Placenta (AGA-P) | – | Other: No intervention (observational study)regnant women whose placentas had a weight between the 10th and 90th percentile for gestational age. |
| Small-for-Gestational-Age Placenta (SGA-P) | – | Other: No intervention (observational study)Pregnant women whose placentas had a weight below the 10th percentile for gestational age. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pregnant women with singleton pregnancies who delivered at the Clinic of Gynecology and Obstetrics, University Clinical Centre of Serbia. The study population includes both healthy pregnant women and women with maternal comorbidities such as hypertensive disorders, diabetes mellitus, and thrombophilia. Placentas were examined after delivery and classified according to placental weight for gestational age.
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention (observational study)observational study | Other | Appropriate-for-Gestational-Age Placenta (AGA-P), Small-for-Gestational-Age Placenta (SGA-P) |
Primary outcome
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
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 13 Jan 2026.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Placental Insufficiency Hypertensive Disorders of Pregnancy Diabetes Mellitus in Pregnancy Thrombophilia in Pregnancy Adverse Perinatal Outcomes, run by University of Belgrade at 1 site in Serbia.
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 0 inclusion and 5 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 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Serbia. 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?
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). 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 13 Jan 2026.