Comparison of Microplastic Levels in Placenta and Cord Blood Samples of Pregnant Women With Fetal Growth Retardation and Healthy Pregnant Women

NCT ID: NCT05070715

Last Updated: 2022-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-03-29

Study Completion Date

2023-03-26

Brief Summary

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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

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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.

Conditions

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Microplastic Levels in Placenta and Cord Blood

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1: FGR group

Estimated fetal weight \<10th percentile

Analyzing of microplastic level

Intervention Type OTHER

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.

Group 2: Control group

Healthy pregnants who will give birth 37th and after gestational week

Analyzing of microplastic level

Intervention Type OTHER

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.

Interventions

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Analyzing of microplastic level

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Kutahya Health Sciences University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

References

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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.

Reference Type RESULT
PMID: 33395930 (View on PubMed)

Braun 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.

Reference Type RESULT
PMID: 34206212 (View on PubMed)

Other Identifiers

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Kutahya HSU

Identifier Type: -

Identifier Source: org_study_id

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