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

NCT05088148 | Unknown

• 1 other identifier: Kutahya Health Sciences Uni
• Study Type: observational
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Fetal Growth Retardation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Multi logistic regression analysis.

  1 month

• ROC analysis

  1 month

Study Arms (2)

Group 1: FGR group

Estimated fetal weight \<10th percentile

Other: . Pesticide and Pharmaceutical analysis

Group 2: Control group

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

Other: . Pesticide and Pharmaceutical analysis

Interventions

. Pesticide and Pharmaceutical analysis OTHER

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

Group 1: FGR group; Group 2: Control group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Pregnant
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kutahya Health Sciences University: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

placenta and cord blood samples of pregnant women

MeSH Terms

Conditions

Fetal Growth Retardation

Interventions

Pesticides

Condition Hierarchy (Ancestors)

Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Agrochemicals; Specialty Uses of Chemicals; Chemical Actions and Uses; Toxic Actions

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2021
• First Posted: October 21, 2021
• Study Start: March 29, 2022
• Primary Completion: February 26, 2023
• Study Completion: March 26, 2023
• Last Updated: April 1, 2022

Record last verified: 2021-10