Fetal Growth RetardationNCT05088148
Comparison of Pesticide and Pharmaceutical Contaminants Levels in Placenta and Cord Blood Samples of Pregnant Women With Fetal Growth Retardation and Healthy Pregnant Women
An observational study of Fetal Growth Retardation, run by Kutahya Health Sciences University.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fetal Growth Retardation
- What is being tested?
- . Pesticide and Pharmaceutical analysis
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 29 Mar 2022to 26 Mar 2023
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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
Who cannot join
- Multiple pregnancies
- Cardiovascular disease
- Chronic hypertension
- Autoimmune disease
- Intrahepatic cholestasis of pregnancy
- Preeclampsia-eclampsia
Show all 12Show fewer
- Sepsis
- Placenta accreta spectrum
- Abnormalities of placenta
- The chromosomal or congenital structural anomaly of the fetus
- Smoking
- BMI >30 kg/m2
About this study
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.
Read the 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.
- Conditions
- Fetal Growth Retardation
- Being tested
- . Pesticide and Pharmaceutical analysis
- Medical subject headings
- Fetal Growth Retardation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
. Pesticide and Pharmaceutical analysisOther
Pesticide and Pharmaceutical analysis will be done with LC-MS/MS device.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: FGR group | Estimated fetal weight <10th percentile Receives: Other: . Pesticide and Pharmaceutical analysis | |
| Group 2: Control group | Healthy pregnants who will give birth 37th and after gestational week Receives: Other: . Pesticide and Pharmaceutical analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (2)
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.
Measured: 1 month
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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2021
- Study start29 Mar 2022 (estimated)
- Primary completion26 Feb 2023 (estimated)
- Study completion26 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal Growth RetardationStudies of the same condition, open and under way.
- More trials run by Kutahya Health Sciences UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05088148
- Sponsor's protocol ID
- Kutahya Health Sciences Uni
- Status last verified
- Oct 2021
- First submitted
- 11 Oct 2021
- Last updated
- 1 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05088148
- Acronym / sponsor ID
- Kutahya Health Sciences Uni
- Conditions
- Fetal Growth Retardation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Study start
- 29 Mar 2022 (estimated)
- Primary completion
- 26 Feb 2023 (estimated)
- Study completion
- 26 Mar 2023 (estimated)
- First posted
- 21 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: FGR group | – | Other: . Pesticide and Pharmaceutical analysisEstimated fetal weight <10th percentile |
| Group 2: Control group | – | Other: . Pesticide and Pharmaceutical analysisHealthy pregnants who will give birth 37th and after gestational week |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- Multiple pregnancies
- Cardiovascular disease
- Chronic hypertension
- Autoimmune disease
- Intrahepatic cholestasis of pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| . Pesticide and Pharmaceutical analysisPesticide and Pharmaceutical analysis will be done with LC-MS/MS device. | Other | Group 1: FGR group, Group 2: Control group |
Primary outcome
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.
2 secondary outcomes
Multi logistic regression analysis.
Time frame: 1 month
ROC analysis
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Fetal Growth Retardation, run by Kutahya Health Sciences University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pesticide and Pharmaceutical analysis (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2022.