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Clinical Trials/ISRCTN11214785
ISRCTN11214785
Completed
未知

Smoking cessation Through Optimisation of clinical care in Pregnancy - the STOP trial

Royal College of Surgeons in Ireland0 sites434 target enrollmentFebruary 8, 2018
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ConditionsSmoking in pregnancyPregnancy and Childbirth

Overview

Phase
未知
Intervention
Not specified
Conditions
Smoking in pregnancy
Sponsor
Royal College of Surgeons in Ireland
Enrollment
434
Status
Completed
Last Updated
3 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

2019 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/31481110 protocol 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36216314/ (added 27/10/2022)

Registry
who.int
Start Date
February 8, 2018
End Date
December 31, 2020
Last Updated
3 years ago
Study Type
Interventional
Sex
Female

Investigators

Eligibility Criteria

Inclusion Criteria

  • •1\. \= 18yrs old
  • •2\. Singleton pregnancy
  • •3\. Smoking \= 1 cigarette daily
  • •4\. English language spoken

Exclusion Criteria

  • •1\. Significant maternal medical disorder, eg. cardiac, haematological or endocrine disease (including GDM on metformin or insulin) requiring specialised maternal antenatal care.
  • •2\. Significant maternal psychiatric disorder, eg. delusional or psychotic disorders, severe depression requiring hospitalisation, use of \=2 psychotropic drugs for treatment.
  • •3\. Serious co\-morbid addiction issues eg opiate abuse, methadone maintenance program
  • •4\. Positive serology requiring specialised antenatal care
  • •5\. Significant fetal anomaly defined as aneuploidy, life limiting or lethal fetal anomaly
  • •6\. Intellectual disability or lack of capacity
  • •7\. Poor English / No English

Outcomes

Primary Outcomes

Not specified

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NL-OMON213902100.0071 (Zon MW)ZonMwLaan van Nieuw Oost Indië 3342593 CE DEN HAAGTel: 070-3495192Fax: 070-34953915,000