Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05088148
Recruitment Status : Not yet recruiting
First Posted : October 21, 2021
Last Update Posted : October 21, 2021
Sponsor:
Information provided by (Responsible Party):
Kutahya Health Sciences University

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
Fetal Growth Retardation 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.

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 40 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
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
Estimated Study Start Date : October 15, 2021
Estimated Primary Completion Date : October 15, 2022
Estimated Study Completion Date : November 15, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Medicines Pesticides

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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.


Biospecimen Retention:   Samples Without DNA
placenta and cord blood samples of pregnant women


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Pregnant
Accepts Healthy Volunteers:   Yes
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.
Criteria

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
Layout table for additonal information
Responsible Party: Kutahya Health Sciences University
ClinicalTrials.gov Identifier: NCT05088148    
Other Study ID Numbers: Kutahya Health Sciences Uni
First Posted: October 21, 2021    Key Record Dates
Last Update Posted: October 21, 2021
Last Verified: October 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Fetal Growth Retardation
Fetal Diseases
Pregnancy Complications
Growth Disorders
Pathologic Processes