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Mothers Learning About Second-hand Smoke - MLASS Study

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ClinicalTrials.gov Identifier: NCT01995409
Recruitment Status : Unknown
Verified September 2014 by The Leeds Teaching Hospitals NHS Trust.
Recruitment status was:  Recruiting
First Posted : November 26, 2013
Last Update Posted : September 25, 2014
Sponsor:
Information provided by (Responsible Party):
The Leeds Teaching Hospitals NHS Trust

Brief 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.

Condition or disease Intervention/treatment Phase
The Effects of Second-hand Smoke in New Borns Behavioral: No smoking material provided in households with newborn infants Not Applicable

Study Type : Interventional  (Clinical Trial)
Primary Purpose: Prevention
Official Title: Mothers Learning About Second-hand Smoke - MLASS Study
Study Start Date : September 2013
Estimated Primary Completion Date : September 2014



Primary Outcome Measures :
  1. Salivary cotinine levels in women who do not smoke during pregnancy, and urine cotinine levels in newborns. [ Time Frame: 1 year ]

    We will assess the level of smoking restrictions at home through a Household Survey (questionnaire) completed by the women. The survey is divided into two parts. Part One asks for demographic information and this information will only be collected once, at the start of the study. Part Two asks about smoking behaviour and is based on two questions; (a) Do people in the house smoke in front of pregnant mothers and children? (b) Where do people smoke? Participants will be asked to complete Part B at different points throughout their involvement in the study so that the impact of the delivery of different stages of the intervention can be assessed.

    Responses to question (a) will be assessed as a binary outcome. However, responses to question (b) will be grouped into one of three categories. Smoking takes place; (i) in any part of the house; (ii) in one room only; (iii) only outside the house. We will add an additional question to assess smoking restrictions on the visitors.




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Ages Eligible for Study:   17 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • Inclusion criteria for women

    • Pregnant
    • Smokers; or, non-smokers who live in a household with an adult who smokes or in a household with regular visitors to the home who smoke
    • Aged 17-40 years of age
    • Living in neighbourhoods in Leeds that are among the 40% most deprived in England Inclusion criteria for newborns
    • Born to a woman already recruited into the study

Exclusion Criteria:

  • Exclusion criteria for women

    • Not pregnant or have a miscarriage during pregnancy
    • Non-smokers who do not live in a household with an adult who smokes or in a household with regular visitors to the home who smoke
    • Having serious health complications during pregnancy or after childbirth
    • Known or suspected to be in an abusive relationship Exclusion criteria for newborns
    • Having serious health complications after birth or requiring hospitalisation
    • Living in neighbourhoods in Leeds that are not among the 40% most deprived in England . being permanently looked after in home separate from mother's

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01995409


Contacts
Contact: Julie Scarfe, RN, RM, BSc, MA. 0113 2066975 Julie.Scarfe@leedsth.nhs.uk

Locations
United Kingdom
The Leeds Teaching Hospital NHS Trust Recruiting
Leeds, United Kingdom, LS9 7TF
Contact: Julie Scarfe, RN, RM, BSc, MA.         
Sponsors and Collaborators
The Leeds Teaching Hospitals NHS Trust

Responsible Party: The Leeds Teaching Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT01995409     History of Changes
Other Study ID Numbers: OG13/10649
12/YH/0257 ( Other Identifier: Research Ethics Committee )
First Posted: November 26, 2013    Key Record Dates
Last Update Posted: September 25, 2014
Last Verified: September 2014