NCT06456645

Brief 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.

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 May 2017

Typical duration 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

May 1, 2017

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 17, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 5, 2019

Completed
4.6 years until next milestone

First Submitted

Initial submission to the registry

May 29, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 13, 2024

Completed
Last Updated

June 13, 2024

Status Verified

June 1, 2024

Enrollment Period

2.1 years

First QC Date

May 29, 2024

Last Update Submit

June 7, 2024

Conditions

Keywords

Smoking cigaretteplacentaIGF-1LeptinHPLbreastfeeding

Outcome Measures

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.

    Baseline

Secondary Outcomes (1)

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

    Baseline

Study Arms (2)

Group 1:

Smokers (study group)

Group 2:

Non-Smokers (control group)

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant female
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Manisa Celal Bayar Universitesi

Manisa, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITH DNA

Placenta tissue

MeSH Terms

Conditions

Tobacco SmokingPlacenta DiseasesBreast FeedingCigarette Smoking

Condition Hierarchy (Ancestors)

SmokingBehaviorTobacco UsePregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesFeeding Behavior

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 29, 2024

First Posted

June 13, 2024

Study Start

May 1, 2017

Primary Completion

June 17, 2019

Study Completion

November 5, 2019

Last Updated

June 13, 2024

Record last verified: 2024-06

Locations