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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06456645
Other study ID # MCBU_Smoking
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 1, 2017
Est. completion date November 5, 2019

Study information

Verified date June 2024
Source Celal Bayar University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Maternal smoking during pregnancy although it is known to be associated with fetal growth restriction, it's effect on postpartum breastfeeding is not yet clear. The aim of the present study was to examine the impacts of smoking in pregnancy on breastfeeding as well as its impacts on placental immunoreactivity.


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.


Recruitment information / eligibility

Status Completed
Enrollment 70
Est. completion date November 5, 2019
Est. primary completion date June 17, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility 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 Design


Locations

Country Name City State
Turkey Manisa Celal Bayar Universitesi Manisa

Sponsors (1)

Lead Sponsor Collaborator
Celal Bayar University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Baseline
Secondary Sociodemographic, birth history, and breastfeeding questions were measured by survey technique. Baseline
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