Evidence map›Paper›PMID 31481110›Full record

Trial reportTrials2019

Smoking cessation Through Optimisation of clinical care in Pregnancy: the STOP randomised controlled trial.

Brendan P McDonnell, Patrick Dicker, Sheila Keogan, Luke Clancy, Carmen Regan

Abstract readPragmatic Clinical Trial
In one paragraph

Trial report in Trials, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors.

Brendan P McDonnellCoombe Women & Infants University Hospital, Cork Street, Dublin 8, Ireland. bmcdonnell@rcsi.ie.ORCID http://orcid.org/0000-0001-8132-0097
Patrick DickerRoyal College of Surgeons in Ireland, 123 St Stephen's Green, Dublin 2, Ireland.
Sheila KeoganTobaccoFree Research Institute, Focas Research Institute, DIT Kevin Street, Camden Row, Dublin 2, Ireland.
Luke ClancyTobaccoFree Research Institute, Focas Research Institute, DIT Kevin Street, Camden Row, Dublin 2, Ireland.
Carmen ReganCoombe Women & Infants University Hospital, Cork Street, Dublin 8, Ireland.

Funding

Coombe Women and Infants University Hospital N/AFriends of the Coombe N/A
6 · The paper itself

Abstract

backgroundCigarette smoking negatively impacts on maternal and fetal health. Smoking cessation is one of the few interventions capable of improving pregnancy outcomes. Despite the risks, the most effective antenatal model of care for smokers is still unclear, and specific recommendations for screening for fetal growth restriction are absent.

methodsThis is a pragmatic randomised controlled trial of a dedicated smoking cessation clinic versus routine antenatal care as an intervention to reduce cigarette smoking behaviour. Smoking mothers randomised to the Smoking cessation Through Optimisation of clinical care in Pregnancy (STOP) clinic will have all antenatal care provided by a team comprising an obstetrician, a midwife, and a smoking cessation practitioner. This intervention includes ultrasound screening for fetal growth restriction. The control arm comprises two groups: one receiving standard care with ultrasound screening for fetal growth restriction, and one receiving standard care with ultrasound screening for growth restriction only if clinically indicated by their healthcare provider. Four hundred and fifty women will be recruited and randomised to either intervention or control arms stratifying for age, parity, and history of fetal growth restriction.

resultsThe primary outcome is self-reported, continuous abstinence from smoking between the quit date and end of pregnancy, validated by exhaled carbon monoxide or urinary cotinine. The quit date is targeted as being at or before 16 weeks' gestation and no further than 28 weeks' gestation. The secondary outcomes are a set of variables including maternal and fetal morbidity and mortality, neonatal complications and delivery outcomes, smoking and psychological outcomes, and qualitative measures.

conclusionsDespite much research into cigarette smoking in pregnancy, the optimal model of care for these women is still unknown. This study has the potential to improve the model of antenatal care provided to pregnant women who smoke and to improve outcomes for both mother and infant.

trial registrationISRCTN11214785 . Registered on 8 February 2018.

Indexed as

Prenatal CareSmoking CessationFemaleHumansInfant, NewbornPregnancyResearch DesignAntenatal careFetal growth restrictionSmokingSmoking cessation

Identifiers

PMID31481110
PMCPMC6724369

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.