Pregnant Women's Knowledge of the Active and Passive Smoking Effects on Pregnancy and the Fetus (tabac-GO)

November 3, 2023 updated by: Université de Reims Champagne-Ardenne

There are two remaining areas where the standards for tobacco use during pregnancy have changed little: one area is the high level of consumption by pregnant women and the other is the limited care given to pregnant women.

Indeed, many pregnant women are still over-exposed to tobacco, either through personal use or passive exposure to cigarette smoke. This passive exposure often comes from the consumption of their loved ones, such as their future co-parent or family.

However, throughout our lives, health professionals, associations, and the government send a lot of information and messages about the negative effects of tobacco on health, pregnancy, and the fetus.

This information and the possibility of receiving help from a professional trained in tobacco use exist throughout the entire pregnancy.

However, many women and their partners still do not take the necessary precautions to reduce or stop smoking. Do couples who smoke during pregnancy really have an understanding of the smoking's effects on women and their fetuses? Could they realize it and would they reduce or stop their consumption, in case they knew these negative effects?

Study Overview

Status

Not yet recruiting

Intervention / Treatment

Detailed Description

The aims are:

  • To describe the knowledge of pregnant women who smoke or are exposed to tobacco smoke about the effects of active and passive smoking on the obstetrical and fetal systems.
  • To identify the information that has been received by pregnant women who smoke or are confronted with tobacco smoke about the effects of tobacco on pregnancy.
  • To identify information sources for pregnant women who smoke or are exposed to tobacco smoke about the negative effects of tobacco on pregnancy.

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Reims, France, 51100
        • Ufr Medecine Urca
      • Reims, France, 51100
        • Université de Reims Champagne Ardenne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Pregnant women exposed to passive or active smoking.

Description

Inclusion Criteria:

  • pregnant women after 32 weeks of amenorrhea
  • Primigravida women
  • women exposed to passive or active smoking
  • women aged over 18 years
  • Accepting to participate in the study

Exclusion Criteria:

  • Minors
  • protected by law (guardianship, custodianship, judicial protection)
  • refusing to participate in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Pregnant women
Pregnant women who smoke personally or are passively exposed to cigarette smoke
Pregnant women who smoke personally or are passively exposed to cigarette smoke

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
smoking effects on pregnancy questionnaire
Time Frame: day0
Pregnant women's knowledge of the active and passive smoking effects on pregnancy : does the woman know or not risk of miscarriage, ectopic pregnancy, premature birth, premature rupture of membranes, low-lying placenta and retro-placental hematoma associated with smoking
day0
smoking effects on the fetus questionnaire
Time Frame: day0
Pregnant women's knowledge of the active and passive smoking effects on the fetus : does the woman know or not risk of premature birth, growth delay, malformation, sudden infant death syndrome associated with smoking
day0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2023

Primary Completion (Estimated)

February 1, 2024

Study Completion (Estimated)

May 1, 2024

Study Registration Dates

First Submitted

October 11, 2023

First Submitted That Met QC Criteria

November 3, 2023

First Posted (Actual)

November 7, 2023

Study Record Updates

Last Update Posted (Actual)

November 7, 2023

Last Update Submitted That Met QC Criteria

November 3, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 2023_RIPH_013_tabac-GO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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