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

March 31, 2022 updated by: Kutahya Health Sciences University
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

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.

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:

  • 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1: FGR group
Estimated fetal weight <10th percentile
Other: . Pesticide and Pharmaceutical analysis
Pesticide and Pharmaceutical analysis will be done with LC-MS/MS device.
Group 2: Control group
Healthy pregnants who will give birth 37th and after gestational week
Other: . Pesticide and Pharmaceutical analysis
Pesticide and Pharmaceutical analysis will be done with LC-MS/MS device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pesticide and Pharmaceutical analysis
Time Frame: 1 year
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Multi logistic regression analysis.
Time Frame: 1 month
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
ROC analysis
Time Frame: 1 month
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kutahya Health Sciences University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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 11, 2021

First Submitted That Met QC Criteria

October 11, 2021

First Posted (Actual)

October 21, 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

Other Study ID Numbers

  • Kutahya Health Sciences Uni

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Fetal Growth Retardation

Clinical Trials on . Pesticide and Pharmaceutical analysis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Tanzania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe