Clinical trial NCT01995409: Mothers Learning About Second-hand Smoke - MLASS Study
Official title: Mothers Learning About Second-hand Smoke - MLASS Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: The Effects of Second-hand Smoke in New Borns
Lead sponsor: The Leeds Teaching Hospitals NHS Trust
Sponsor class: OTHER
First posted: 2013-11-26
Sex: ALL
Minimum age (years): 17
Maximum age (years): 40
Standard ages: CHILD
ADULT
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: Salivary cotinine levels in women who do not smoke during pregnancy, and urine cotinine levels in newborns.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: The Leeds Teaching Hospital NHS Trust
Study officials:
References: