Microplastic Levels in Placenta and Cord BloodNCT05070715
Comparison of Microplastic Levels in Placenta and Cord Blood Samples of Pregnant Women With Fetal Growth Retardation and Healthy Pregnant Women
An observational study of Microplastic Levels in Placenta and Cord Blood, run by Kutahya Health Sciences University.
Trial summary
In this study, microplastic levels in the placenta and cord blood of pregnant women with fetal growth retardation and healthy pregnant women will be compared in placenta and cord blood samples after delivery. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Microplastic Levels in Placenta and Cord Blood
- What is being tested?
- Analyzing of microplastic level
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 29 Mar 2022to 26 Mar 2023
- 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 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: * Multiple pregnancies * Cardiovascular disease * Chronic hypertension * Autoimmune disease * Intrahepatic cholestasis of pregnancy * Preeclampsia-eclampsia * Sepsis * Placenta accreta spectrum * Abnormalities of placenta * The chromosomal or congenital structural anomaly of the fetus * Smoking * BMI >30 kg/m2
Who may be able to join
- Between the ages of 18-40 years
- Gestational age between 320/7 - 396/7 weeks
- Singleton pregnancy
- For the FGR group: estimated fetal weight <10th percentile
- For the control group: being healthy pregnant
- Intact amniotic membrane
Who cannot join
- -
About this study
In this study, microplastic levels in the placenta and cord blood of pregnant women with fetal growth retardation and healthy pregnant women will be compared in placenta and cord blood samples after delivery.
Read the detailed description
The study will be conducted with a total of 40 pregnant women, 20 of whom are in the control groups and those with FGR diagnoses. Cases in both groups will be matched in terms of demographic information. Demographic information (including socioeconomic status, educational level, region of residence), ultrasound and Doppler examination results, newborn weight at birth, APGAR score, gender, mode of delivery, whether there is a need for neonatal intensive care or not will be recorded.
- Being tested
- Analyzing of microplastic level
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Analyzing of microplastic levelOther
Blood samples will be taken from the vein of the umbilical cord. Placental tissues will be taken from the maternal side of the placenta. Placental tissues and serum samples will be stored in the temperature set to -80 °C until analysis. Extraction methods involving chemical reactions will be used to separate and purify microplastics in placenta and cord blood samples. After the extraction process, analysis of microplastic levels in tissues and serum will be done by µ-Raman spectroscopy.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: FGR group | Estimated fetal weight <10th percentile Receives: Other: Analyzing of microplastic level | |
| Group 2: Control group | Healthy pregnants who will give birth 37th and after gestational week Receives: Other: Analyzing of microplastic level |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analyzing of microplastic levels in the placenta and cord blood of pregnant women
Microplastic levels in pregnant women's placenta and cord blood will be measured in placenta and cord blood samples after delivery.
Measured: 1 year
Secondary outcomes (1)
Investigation of the effect of microplastic level in placenta and cord blood on FGR
If there is a significant difference in other data, including the microplastic level, in the FGR group, the effect of each factor on the development of FGR will be analyzed by multi logistic regression analysis. In addition, if the microplastic level is found to be significantly higher in the FGR group, the cut-off value will be obtained by ROC analysis.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2021
- Study start29 Mar 2022 (estimated)
- Primary completion26 Feb 2023 (estimated)
- Study completion26 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Microplastic Levels in Placenta and Cord BloodStudies of the same condition, open and under way.
- More trials run by Kutahya Health Sciences UniversityThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05070715
- Sponsor's protocol ID
- Kutahya HSU
- Status last verified
- Oct 2021
- First submitted
- 6 Oct 2021
- Last updated
- 1 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ragusa A, Svelato A, Santacroce C, Catalano P, Notarstefano V, Carnevali O, Papa F, Rongioletti MCA, Baiocco F, Draghi S, D'Amore E, Rinaldo D, Matta M, Giorgini E. Plasticenta: First evidence of microplastics in human placenta. Environ Int. 2021 Jan;146:106274. doi: 10.1016/j.envint.2020.106274. Epub 2020 Dec 2.
PubMed 33395930Braun T, Ehrlich L, Henrich W, Koeppel S, Lomako I, Schwabl P, Liebmann B. Detection of Microplastic in Human Placenta and Meconium in a Clinical Setting. Pharmaceutics. 2021 Jun 22;13(7):921. doi: 10.3390/pharmaceutics13070921.
PubMed 34206212
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Microplastic Levels in Placenta and Cord Blood Samples of Pregnant Women With Fetal Growth Retardation and Healthy Pregnant Women
- ClinicalTrials.gov ID
- NCT05070715
- Acronym / sponsor ID
- Kutahya HSU
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Study start
- 29 Mar 2022 (estimated)
- Primary completion
- 26 Feb 2023 (estimated)
- Study completion
- 26 Mar 2023 (estimated)
- First posted
- 7 Oct 2021 (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.
In this study, microplastic levels in the placenta and cord blood of pregnant women with fetal growth retardation and healthy pregnant women will be compared in placenta and cord blood samples after delivery.
Detailed description
The study will be conducted with a total of 40 pregnant women, 20 of whom are in the control groups and those with FGR diagnoses. Cases in both groups will be matched in terms of demographic information. Demographic information (including socioeconomic status, educational level, region of residence), ultrasound and Doppler examination results, newborn weight at birth, APGAR score, gender, mode of delivery, whether there is a need for neonatal intensive care or not will be recorded.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: FGR group | – | Other: Analyzing of microplastic levelEstimated fetal weight <10th percentile |
| Group 2: Control group | – | Other: Analyzing of microplastic levelHealthy pregnants who will give birth 37th and after gestational week |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- * Multiple pregnancies * Cardiovascular disease * Chronic hypertension * Autoimmune disease * Intrahepatic cholestasis of pregnancy * Preeclampsia-eclampsia * Sepsis * Placenta accreta spectrum * Abnormalities of placenta * The chromosomal or congenital structural anomaly of the fetus * Smoking * BMI >30 kg/m2
Key inclusion criteria (6 listed)
- Between the ages of 18-40 years
- Gestational age between 320/7 - 396/7 weeks
- Singleton pregnancy
- For the FGR group: estimated fetal weight <10th percentile
- For the control group: being healthy pregnant
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Analyzing of microplastic levelBlood samples will be taken from the vein of the umbilical cord. Placental tissues will be taken from the maternal side of the placenta. Placental tissues and serum samples will be stored in the temperature set to -80 °C until analysis. Extraction methods involving chemical reactions will be used to separate and purify microplastics in placenta and cord blood samples. After the extraction process, analysis of microplastic levels in tissues and serum will be done by µ-Raman spectroscopy. | Other | Group 1: FGR group, Group 2: Control group |
Primary outcome
Analyzing of microplastic levels in the placenta and cord blood of pregnant women
Time frame: 1 year
Microplastic levels in pregnant women's placenta and cord blood will be measured in placenta and cord blood samples after delivery.
1 secondary outcome
Investigation of the effect of microplastic level in placenta and cord blood on FGR
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2022.
- Results publication: PubMed 33395930Ragusa A, Svelato A, Santacroce C, Catalano P, Notarstefano V, Carnevali O, Papa F, Rongioletti MCA, Baiocco F, Draghi S, D'Amore E, Rinaldo D, Matta M, Giorgini E. Plasticenta: First evidence of microplastics in human placenta. Environ Int. 2021 Jan;146:106274. doi: 10.1016/j.envint.2020.106274. Epub 2020 Dec 2.
- Results publication: PubMed 34206212Braun T, Ehrlich L, Henrich W, Koeppel S, Lomako I, Schwabl P, Liebmann B. Detection of Microplastic in Human Placenta and Meconium in a Clinical Setting. Pharmaceutics. 2021 Jun 22;13(7):921. doi: 10.3390/pharmaceutics13070921.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Microplastic Levels in Placenta and Cord Blood, run by Kutahya Health Sciences University.
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 6 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 1 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Analyzing of microplastic levels in the placenta and cord blood of pregnant women (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05070715, which also lists 2 linked publications.
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 1 Apr 2022.