Clinical trial NCT06678152: Nicotine's Effect on Cancer Stem Cell Markers in Human Umbilical Cord Tissue
Official title: Investigation of Nicotine in Umbilical Cord Tissue: Immunohistochemical and Biochemical Analysis of Cancer Stem Cell Markers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Umbilical Cord Issue
Nicotine Addiction
Pregnancy Related
Cancer
Keywords: umblical cord
nicotine addiction
Cd44
Cd34
Cd90
ALDH
Lead sponsor: Celal Bayar University
Sponsor class: OTHER
First posted: 2024-11-07
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: pregnant women smokers pregnant women nonsmokers

Brief summary: The umbilical cord is generally an organ that clinicians and pathologists do not pay sufficient attention to. The absence of significant pathology in the umbilical cords, along with the lack of association between certain placental pathologies and perinatal mortality and morbidity, have led both clinicians and pathologists to inadequately evaluate the placenta and umbilical cord. In our study, İnvestigators aimed to perform immunohistochemical and biochemical analysis by comparing two groups, one consisting of women who smoked throughout their pregnancy and the other of those who never smoked, including different markers in accordance with the literature.

Method: The pregnant women included in the study were categorized according to their smoking status as follows:

Group I: Non-smokers (smoking -) Group II: Smokers (smoking +) during pre-pregnancy and throughout the pregnancy In this study, 40 pregnant women who smoked during their pregnancy (between 37 and 42 weeks of gestation) and 37 age- and parity-matched healthy non-smoking pregnant women with full-term births between 37 and 42 weeks of gestation were selected as the control group. Umbilical cord samples (2 ml of blood and a 5 cm tissue sample) were collected from both groups without delay and fixed in 10% formalin. The tissue samples were processed for histological analysis with routine hematoxylin and eosin (H\&E) staining following fixation in 10% formalin solution and routine paraffin embedding.

İnvestigators aimed to examine the presence of oncological factors such as CD44, CD34, CD90, and ALDH molecules in the umbilical cord tissue of smokers during pregnancy through immunohistochemistry, and to explore the biochemical relationship of these molecules with their counterparts, CD34, CD44, CD90, and ALDH, found in the umbilical cord blood.


Eligibility criteria: Inclusion Criteria:

* Healthy pregnancy under 37 weeks
* Age range 18-50
* Being literate in Turkish
* Not having any additional disease
* Agreeing to participate in the study

Exclusion Criteria:

* High-risk pregnancies (gestational hypertension, preeclampsia, HELLP syndrome, chronic hypertension, gestational and pregestational diabetes, cholestasis, intrauterine growth retardation, etc.)
* Multiple pregnancy
* Pregnant women under the age of 18
* Smoking
* Medication use (excluding routinely used food supplements during pregnancy)
* Additional disease (thyroid, renal failure, liver failure, hepatitis, heart disease, connective tissue disease, etc.)
* Immunosuppressive use
* Presence of active or chronic infection
* Presence of active or chronic inflammatory disease
* Patients who gave birth at an external center or later chose to withdraw from the study
* Patients who did not have any exclusion criteria at the time of smokers or when blood was drawn for the control group, but who later developed any exclusion criteria.
* Premature birth of patients included in the control group

Primary outcomes:
measure: Hospitalized pregnant women's with smokers and nonsmokers 80%umblical cord tissues 3x3 cm collected while birth during the study .umblical tissues staining will be Measured by Cd34, Cd44, Cd90 and ALDH immunohistochemistry technique.
timeFrame: Baseline
measure: Hospitalized pregnant women's with smokers and nonsmokers 80% umblical blood 5-7 ml collected while birth during the study. Bloods will be measured by Cd34, Cd44, Cd90 and ALDH biochemistry elisa technique.
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Manisa
country: Turkey
facility: Hayrunnisa yeşil Sarsmaz
state: Mani̇sa
Study officials:
References: