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NCT05088148 Clinical Trial

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

Fetal Growth Retardation Clinical Trial

Official title:
Comparison of Pesticide and Pharmaceutical Contaminants Levels in Placenta and Cord Blood Samples of Pregnant Women With Fetal Growth Retardation and Healthy Pregnant Women

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05088148
Other study ID # Kutahya Health Sciences Uni
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date March 29, 2022
Est. completion date March 26, 2023

Study information
Verified date October 2021
Source Kutahya Health Sciences University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Aim: In this study, pesticide and pharmaceutical contaminants 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.

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 40
Est. completion date March 26, 2023
Est. primary completion date February 26, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 40 Years
Eligibility 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: - 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• . Pesticide and Pharmaceutical analysis
Pesticide and Pharmaceutical analysis will be done with LC-MS/MS device.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Kutahya Health Sciences University

Outcome
Type Measure Description Time frame Safety issue
Primary Pesticide and Pharmaceutical analysis Pesticide and pharmaceutical contaminants levels in pregnant women's placenta and cord blood will be measured in placenta and cord blood samples after delivery. 1 year
Secondary Multi logistic regression analysis. If there is a significant difference in other data, including the pesticide and pharmaceutical contaminants levels, in the FGR group, the effect of each factor on the development of FGR will be analyzed by multi logistic regression analysis. 1 month
Secondary ROC analysis If the pesticide and pharmaceutical contaminants levels is found to be significantly higher in the FGR group, the cut-off value will be obtained by ROC analysis. 1 month
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