NCT06678152

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 14, 2017

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
5.4 years until next milestone

First Submitted

Initial submission to the registry

November 5, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 7, 2024

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 5, 2024

Completed
Last Updated

January 27, 2025

Status Verified

January 1, 2025

Enrollment Period

2.5 years

First QC Date

November 5, 2024

Last Update Submit

January 24, 2025

Conditions

Keywords

umblical cordnicotine addictionCd44Cd34Cd90ALDH

Outcome Measures

Primary Outcomes (2)

  • 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.

    Baseline

  • 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.

    Baseline

Study Arms (2)

Group 1:

smokers

Group 2:

nonsmokers

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

pregnant women smokers pregnant women nonsmokers

You may qualify if:

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

You may not qualify if:

  • 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
  • Premature birth of patients included in the control group

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hayrunnisa yeşil Sarsmaz

Manisa, Mani̇sa, 45030, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITH DNA

umblical cord tissues and blood

MeSH Terms

Conditions

Tobacco Use DisorderNeoplasms

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
2 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 5, 2024

First Posted

November 7, 2024

Study Start

January 14, 2017

Primary Completion

July 1, 2019

Study Completion

December 5, 2024

Last Updated

January 27, 2025

Record last verified: 2025-01

Locations