Effects of Smoking on Placenta and Lactation

Breastfeeding Clinical Trial

Official title:

The Impacts of Maternal Smoking During Pregnancy on Breastfeeding and the Correlation of IGF, Leptin, HPL Expression in Placenta Tissue

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06456645
• Other study ID #: MCBU_Smoking
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Breastfeeding
• Fetal Conditions
• Placenta Diseases
• Smoking, Tobacco

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