Stopping smoking to optimise pregnancy

Stopping Smoking To Optimise Pregnancy (SSTOP): a randomised controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN49741320

Enrollment

220

Registered

2016-05-26

Start date

2016-05-01

Completion date

Unknown

Last updated

2018-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Smoking cessation in pregnant women Mental and Behavioural Disorders

Interventions

Interventions as of 18/09/2018: The control group will receive standard antenatal care in which they will receive routine advice on diet, exercise and smoking cessation. Women allocated to the inter

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: Participant inclusion criteria as of 18/09/2018: 1. Age >18 years 2. 18 years 2. <24 weeks gestation 3. Fluent in English 4. Ongoing singleton pregnancy 5. Self-reported smoker 6. Able to give written informed consent

Exclusion criteria

Exclusion criteria: Participant exclusion criteria as of 18/09/2018: 1. Age 17 weeks gestation 3. Non-English speaking 4. Multiple pregnancy 5. Non-smoker 6. Unable to give written informed consent Previous participant exclusion criteria: 1. Age 24 weeks gestation 3. Non-English speaking 4. Multiple pregnancy 5. Non-smoker 6. Unable to give written informed consent

Design outcomes

Primary

Measure	Time frame
Primary outcome measure as of 18/09/2018: Smoking cessation measured using urine samples and carbon monoxide breath tests. These will be collected at <17 weeks gestation and two months post recruitment. Previous primary outcome measure: Smoking cessation measured using urine samples and carbon monoxide breath tests. These will be collected at <24 weeks gestation, two months post recruitment, at delivery and 6 weeks postnatal.	—

Measure

Time frame

Primary outcome measure as of 18/09/2018: Smoking cessation measured using urine samples and carbon monoxide breath tests. These will be collected at <17 weeks gestation and two months post recruitment. Previous primary outcome measure: Smoking cessation measured using urine samples and carbon monoxide breath tests. These will be collected at <24 weeks gestation, two months post recruitment, at delivery and 6 weeks postnatal.

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Secondary

Measure	Time frame
Secondary outcome measure as of 19/09/2018: 1. Perceived stress score will be collected by questionnaire at <17 weeks gestation and two months post recruitment 2. Nicotine dependency will be collected by questionnaire at <17 weeks gestation and two months post recruitment 3. Preterm birth collected post-delivery from hospital's computerised system 4. Birthweight collected post-delivery from hospital's computerised system 5. Perinatal mortality collected post-delivery from hospital's computerised system 6. NICU admissions collected post-delivery from hospital's computerised system Previous secondary outcome measure: 1. Perceived stress score will be collected by questionnaire at <24 weeks gestation, two months post recruitment, at delivery and 6 weeks postnatal 2. Nicotine dependency will be collected by questionnaire at <24 weeks gestation, two months post recruitment, at delivery and 6 weeks postnatal 3. Preterm birth collected post-delivery from hospital's computerised system 4. Birthweight collected post-delivery from hospital's computerised system 5. Perinatal mortality collected post-delivery from hospital's computerised system 6. NICU admissions collected post-delivery from hospital's computerised system	—

Measure

Time frame

Secondary outcome measure as of 19/09/2018: 1. Perceived stress score will be collected by questionnaire at <17 weeks gestation and two months post recruitment 2. Nicotine dependency will be collected by questionnaire at <17 weeks gestation and two months post recruitment 3. Preterm birth collected post-delivery from hospital's computerised system 4. Birthweight collected post-delivery from hospital's computerised system 5. Perinatal mortality collected post-delivery from hospital's computerised system 6. NICU admissions collected post-delivery from hospital's computerised system Previous secondary outcome measure: 1. Perceived stress score will be collected by questionnaire at <24 weeks gestation, two months post recruitment, at delivery and 6 weeks postnatal 2. Nicotine dependency will be collected by questionnaire at <24 weeks gestation, two months post recruitment, at delivery and 6 weeks postnatal 3. Preterm birth collected post-delivery from hospital's computerised system 4. Birthweight collected post-delivery from hospital's computerised system 5. Perinatal mortality collected post-delivery from hospital's computerised system 6. NICU admissions collected post-delivery from hospital's computerised system

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Countries

Ireland

Contacts

Public ContactCiara Reynolds

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026