NCT06117943

Brief Summary

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?

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2023

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 11, 2023

Completed
27 days until next milestone

First Posted

Study publicly available on registry

November 7, 2023

Completed
24 days until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
Last Updated

November 7, 2023

Status Verified

October 1, 2023

Enrollment Period

2 months

First QC Date

October 11, 2023

Last Update Submit

November 3, 2023

Conditions

Keywords

pregnancyactive smokingpassive smokingfetusknowledge

Outcome Measures

Primary Outcomes (2)

  • smoking effects on pregnancy questionnaire

    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

    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

Study Arms (1)

Pregnant women

Pregnant women who smoke personally or are passively exposed to cigarette smoke

Other: data collection

Interventions

Pregnant women who smoke personally or are passively exposed to cigarette smoke

Pregnant women

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Pregnant women exposed to passive or active smoking.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ufr Medecine Urca

Reims, 51100, France

Location

Université de Reims Champagne Ardenne

Reims, 51100, France

Location

MeSH Terms

Interventions

Data Collection

Intervention Hierarchy (Ancestors)

Epidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 11, 2023

First Posted

November 7, 2023

Study Start

December 1, 2023

Primary Completion

February 1, 2024

Study Completion

May 1, 2024

Last Updated

November 7, 2023

Record last verified: 2023-10

Locations