Babybreathe Trial (A randomised controlled trial of a complex intervention to prevent return to smoking postpartum)

We are acting as the Scottish recruitment hub for a large randomised controlled trial. Compared the effectiveness of an intervention for preventing postpartum return to smoking with usual care

Health Condition(s) or Problem(s) Studied

Healthy postpartum women who have achieved abstinence from tobacco smoking prior to or during pregnancy. The intervention is to prevent postpartum relapse to tobacco smoking.

Intervention(s)

BabyBreathe intervention: This is a complex behavioural intervention involving health visitor support and advice at every routine antenatal and postnatal contact, motivational products (BabyBreathe leaflets and BabyBreathe box), nicotine replacement therapy, electronic carbon monoxide testing, text message support and self-help via the BabyBreathe app and website, offering tailored advice and support for 12 months postpartum.

Control: Usual antenatal and postnatal care as per the NHS maternity care pathway (no routine relapse prevention support).

Key Inclusion and Exclusion Criteria

Study population:

Pregnant women who have quit smoking in the 12 months before or during pregnancy, where smoking abstinence is defined as having stopped smoking for at least 4 weeks prior to recruitment.

Inclusion criteria:

Pregnant women who have stopped smoking completely in the 12 months prior to pregnancy, or at any time during pregnancy.

At 26 weeks gestation or any time up until birth, woman confirms having not smoked a single puff of a cigarette for at least 4 weeks.

Able to read and understand English.

Willing and able to give informed consent for participation in the study.

Expired carbon monoxide (CO) reading less than 4 parts per million (ppm).

Exclusion criteria:

Under the age of 16

Study Type

Randomised controlled trial.

Target Sample Size

880

Primary Outcome(s)

The primary effectiveness outcome is self-reported continuous postpartum smoking abstinence, biochemically validated by CO monitoring at 12 months postpartum, with cut off of less than 8ppm (a reading of 7ppm or less), according to the Russell standard. Adapting the Russell standard, we will grant a period of ‘grace’, allowing up to 5 smoking lapses between the birth of the baby and the 12-month follow-up, before the outcome is counted as relapse.

Key Secondary Outcomes

At 6 months postpartum:

Postpartum self-reported abstinence

Self-reported time to relapse

Self-reported partner smoking status

Relapse predictors

Self-efficacy related to long-term smoking abstinence

Edinburgh postnatal depression scale

Behavioural support use

Nicotine product use

Perceived stress

AUDIT-C

EQ-5D-5L

At 12 months postpartum:

Self-reported time to relapse

Self-reported partner smoking status

Relapse predictors

Self-efficacy related to long-term smoking abstinence

Edinburgh postnatal depression scale

Behavioural support use

Nicotine product use

Perceived stress

AUDIT-C

EQ-5D-5L

Participant resource use

Infant health outcomes