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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Microplastic Levels in Placenta and Cord Blood
• Intervention / Treatment: Other: Analyzing of microplastic level

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 Type: Observational
• Enrollment (Anticipated): 40

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

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

Description

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:

-

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1: FGR group; Estimated fetal weight <10th percentile	Other: 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.
Group 2: Control group; Healthy pregnants who will give birth 37th and after gestational week	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 month

Collaborators and Investigators

• Sponsor: Kutahya Health Sciences University

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): March 29, 2022
• Primary Completion (Anticipated): February 26, 2023
• Study Completion (Anticipated): March 26, 2023

Study Registration Dates

• First Submitted: October 6, 2021
• First Submitted That Met QC Criteria: October 6, 2021
• First Posted (Actual): October 7, 2021

Study Record Updates

• Last Update Posted (Actual): April 1, 2022
• Last Update Submitted That Met QC Criteria: March 31, 2022
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Fetal Diseases; Pregnancy Complications; Growth Disorders; Fetal Growth Retardation
• Other Study ID Numbers: Kutahya HSU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No