Pregnant Women's Knowledge of the Active and Passive Smok... | NCT06117943

Studies
Pregnant Women's Knowledge of the Active and Passive Smoking Effects on Pregnancy and the Fetus

NCT06117943

Sponsor

Université de Reims Champagne-Ardenne

Status

Unknown status

Last Update Posted

Nov 7, 2023Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

Pregnant Women's Tabacco Exposure

Interventions

data collection

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2023Estimated

Primary Completion Date

Feb 1, 2024Estimated

Completion Date

May 1, 2024Estimated

First Submitted Date

Oct 11, 2023

First Submission Date that Met QC Criteria

Nov 3, 2023

First Posted Date

Nov 7, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 3, 2023

Last Update Posted Date

Nov 7, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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?

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pregnant women		Pregnant women who smoke personally or are passively exposed to cigarette smoke	Other: data collection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
data collection	Other	Pregnant women who smoke personally or are passively exposed to cigarette smoke	Pregnant women

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Pregnant women exposed to passive or active smoking.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ufr Medecine Urca		Reims		51100	France
Université de Reims Champagne Ardenne

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D003625	Data Collection

Ancestor Terms

ID	Term
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms
D011787	Quality of Health Care

Browse Leaves

Not provided

Browse Branches

Not provided