- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06456645
Effects of Smoking on Placenta and Lactation
The Impacts of Maternal Smoking During Pregnancy on Breastfeeding and the Correlation of IGF, Leptin, HPL Expression in Placenta Tissue
Study Overview
Status
Detailed Description
The study was conducted on 70 women who gave birth via spontaneous vaginal delivery. Groups were classified as Smokers (n=35) and Non-smokers (n=35). The breastfeeding conditions of both groups were evaluated prior to discharge and after postpartum 10th day.
Cross-sections were taken from the placenta tissues after which their IGF-1 (insulin like growth factor-1), Leptin, HPL (human placental lactogen) immunoreactivities were examined.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Manisa, Turkey
- Manisa Celal Bayar Universitesi
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Pregnant women who have started smoking at least 100 cigarettes in her lifetime and who now smokes every day,
- Pregnant women who have never smoked throughout their life, including pregnancy(16),
- Pregnant women who gave birth at term,
- Multiple pregnancy, preeclampsia, gestational diabetes, thyroid dysfunction, those who do not have a systemic disease and due to systemic disease during pregnancy those who do not use
- Pregnant women who had spontaneous vaginal delivery,
- In order not to encounter communication barriers and because cultural differences may vary, the pregnant woman is not a foreign national,
- Pregnant women who do not have any barriers to communication by phone,
- Those who do not have any health problems that prevent breastfeeding
Exclusion Criteria:
- multiple pregnancy
- insulin dependent diabetes
- pregnant women who have had a cesarean section
- preeclampsia
- thyroid disease
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Group 1:
Smokers (study group)
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Group 2:
Non-Smokers (control group)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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100% Patients's placenta with smoking in Pregnancy and 100% Patients's Placenta with from non-smoking in Pregnancy. Placenta Tissues Staining Measured by immunohistochemistry and biochemistry technique.
Time Frame: Baseline
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Baseline
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Sociodemographic, birth history, and breastfeeding questions were measured by survey technique.
Time Frame: Baseline
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Baseline
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MCBU_Smoking
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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