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CompletedNCT06456645Updated Jun 13, 2024

Effects of Smoking on Placenta and Lactation

An observational study in Smoking, Tobacco, Placenta Diseases and Breastfeeding, sponsored by Manisa Celal Bayar University. Completed at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-06-13.

Sponsored by Manisa Celal Bayar University · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
70
Ages
18 Years to 45 Years
Sex
Female
01

Study 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.

Read the detailed 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.

02

Conditions studied

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

Keywords

  • Smoking cigarette
  • placenta
  • IGF-1
  • Leptin
  • HPL
  • breastfeeding
03

In context

Tobacco Smoking

81 studies on the registry are indexed under Tobacco Smoking; 27 are open to participants now.

This study's enrollment of 70 is below the median of 151 across 11 observational studies indexed under Tobacco Smoking.

Browse Tobacco Smoking studies →

Lead sponsor

Manisa Celal Bayar University is the lead sponsor of 33 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Pregnant women who have started smoking at least 100 cigarettes in her lifetime and who now smokes every day

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • multiple pregnancy
  • insulin dependent diabetes
  • pregnant women who have had a cesarean section
  • preeclampsia
  • thyroid disease
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
70 participants (actual)
Target follow-up
6 Months
Patient registry
Yes
Biospecimen retention
Samples with dna

Groups and cohorts

  • Group 1:

    Smokers (study group)

  • Group 2:

    Non-Smokers (control group)

06

What researchers measure

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

07

Study locations

1 site
  • Manisa Celal Bayar Universitesi
    Manisa, Turkey (Türkiye)
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from May 2017 to primary completion in Jun 2019, 25 months.

How these figures are worked out, and which studies are left out of them.

Registered
May 29, 2024
First posted
Jun 13, 2024
StartActual
May 1, 2017
Primary completionActual
Jun 17, 2019
CompletionActual
Nov 5, 2019
Last update
Jun 13, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 13, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06456645
Lead sponsor
Manisa Celal Bayar University
Responsible party
Sponsor
First posted
Jun 13, 2024
Start date
May 1, 2017
Primary completion
Jun 17, 2019
Completion
Nov 5, 2019
Last update
Jun 13, 2024

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

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