MedTrace Logo

Mothers Learning About Second-hand Smoke - MLASS Study

NCT01995409 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2014-09-25

No results posted yet for this study

Summary

Exposure to second-hand smoke during pregnancy and early infancy leads to low birth weight and childhood illnesses. 50% of all newborns in the UK are exposed to tobacco smoke due to maternal smoking or contact with second-hand smoke.

The purpose of this study is to test the feasibility of delivering and evaluating the effectiveness of a Smoke Free Homes (SFH) health education intervention with pregnant women and mothers with newborns to reduce unborn and newborn babies exposure to second-hand smoke. The intervention will be delivered through routine antenatal and postnatal healthcare settings provided by midwifery and health visiting services.

The intervention consists of educational materials to be given to the woman and a conversation held between the woman and midwife/health visitor about protecting the baby from second-hand smoke. The development of the intervention has been informed by the views of health professionals and service users, incorporates behaviour change theory and has drawn on other SFH materials developed for other settings. Different parts of the intervention will be delivered at different points along the antenatal and postnatal care pathway. 200 pregnant women and their newborns will be recruited.

We will measure salivary cotinine levels to assess the level of exposure to SHS in women and urinary cotinine levels in newborns. We plan to conduct a before-and-after study of the delivery of the intervention to test the feasibility of delivering, and methods to evaluate the effectiveness of the intervention.

Feasibility study outputs:

* A standardised, acceptable, feasible and appropriate health education intervention to protect unborn and newborn babies exposure to second-hand smoke at home, capable of being integrated into routine midwifery and health visiting practice
* A trial protocol to evaluate the effectiveness of the intervention on unborn and newborn babies' exposure to secondhand smoke.

Conditions

  • The Effects of Second-hand Smoke in New Borns

Interventions

BEHAVIORAL

No smoking material provided in households with newborn infants

Sponsors & Collaborators

  • The Leeds Teaching Hospitals NHS Trust

    lead OTHER

Study Design

Purpose
PREVENTION

Eligibility

Min Age
17 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2014-09-30

Countries

  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01995409 on ClinicalTrials.gov