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

Sponsor

Kutahya Health Sciences University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05070715

Collaborator

(none)

Enrollment

11.9

Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Microplastic Levels in Placenta and Cord Blood	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 Design

Study Type:

Observational

Anticipated Enrollment :

40 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Mar 29, 2022

Anticipated Primary Completion Date :

Feb 26, 2023

Anticipated Study Completion Date :

Mar 26, 2023

Arms and Interventions

Arm	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.

Arm

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

Outcome Measures

Primary Outcome Measures

Analyzing of microplastic levels in the placenta and cord blood of pregnant women [1 year]
Microplastic levels in pregnant women's placenta and cord blood will be measured in placenta and cord blood samples after delivery.

Secondary Outcome Measures

Investigation of the effect of microplastic level in placenta and cord blood on FGR [1 month]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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:

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Kutahya Health Sciences University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Kutahya Health Sciences University

ClinicalTrials.gov Identifier:

NCT05070715

Other Study ID Numbers:

Kutahya HSU

First Posted:

Oct 7, 2021

Last Update Posted:

Apr 1, 2022

Last Verified:

Oct 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Fetal Growth Retardation

Study Results

No Results Posted as of Apr 1, 2022