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OpenTrials
Completed

NCT Number: NCT06456645

Effects of Smoking on Placenta and Lactation

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.

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Key information

Conditions

Smoking, Tobacco Behavior Breast Feeding Breastfeeding Cigarette Smoking Feeding Behavior Female Urogenital Diseases and Pregnancy Complications Fetal Conditions Placenta Diseases Pregnancy Complications Smoking Tobacco Smoking Tobacco Use Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Manisa Celal Bayar Universitesi

Manisa, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. Sociodemographic, birth history, and breastfeeding questions were measured by survey technique.

    Time frame: Baseline

Sponsors and collaborators

Lead sponsor

Manisa Celal Bayar University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jun 13, 2024
Registry last updated
Jun 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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