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Comparison of Pesticide and Pharmaceutical Contaminants 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
NCT05088148
Collaborator
(none)
40
Enrollment
11.9
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: . Pesticide and Pharmaceutical analysis

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 [Patient Registry]
Anticipated Enrollment :
40 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
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
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: . 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.

Outcome Measures

Primary Outcome Measures

  1. Pesticide and Pharmaceutical analysis [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.

Secondary Outcome Measures

  1. Multi logistic regression analysis. [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.

  2. ROC analysis [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.

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:

  • 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

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:
NCT05088148
Other Study ID Numbers:
  • Kutahya Health Sciences Uni
First Posted:
Oct 21, 2021
Last Update Posted:
Apr 1, 2022
Last Verified:
Oct 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Fetal Growth Retardation

Study Results

No Results Posted as of Apr 1, 2022