Evidence map›Paper›PMID 18827129›Full record

Trial reportObstetrics and gynecology2008

Nicotine gum for pregnant smokers: a randomized controlled trial.

Cheryl Oncken, Ellen Dornelas, John Greene, Heather Sankey, Allen Glasmann, Richard Feinn, Henry R Kranzler

Registry-linked trialOpen access · greenAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Obstetrics and gynecology, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00115687 (Nicotine Replacement Treatment for Pregnant Smokers), which is not on this map. Cited by 47 papers, 12 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
47citing papers in PubMed, 12 pooled it
5.9field-weighted citation impact, top 3% of its field
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.

NCT00115687 phase2terminatednot on this map

Nicotine Replacement Treatment for Pregnant Smokers

TypeinterventionalSponsorNational Institute on Drug Abuse (NIDA)Ran2002 to 2007Enrolled250ConditionsTobacco Use DisorderArmsplacebo, 2 mg nicotine polacrilex
3 · Its place in the literature

Who cites it

47 citing papers in PubMed, 12 syntheses or guidelines pooled it, 113 citations in OpenAlex.

  1. Pooled it
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  6. Nicotine replacement therapy versus control for smoking cessation.The Cochrane database of systematic reviews · 2018
    Pooled it
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  13. Trial
  14. Placebo-controlled trial of bupropion for smoking cessation in pregnant women.American journal of obstetrics & gynecology MFM · 2021
    Trial
  15. Randomized Trial of Nicotine Inhaler for Pregnant Smokers.American journal of obstetrics & gynecology MFM · 2019
    Trial
  16. Trial
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  18. Comparison of cotinine levels in pregnant women while smoking and when using nicotine replacement therapy.Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco · 2014
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  20. Trial
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

7 authors at 6 institutions in 2 countries.

Cheryl OnckenDepartments of Medicine and Obstetrics and Gynecology, University of Connecticut School of Medicine, Farmington, Connecticut 06030-3940, USA. oncken@nso2.uchc.edu
Ellen Dornelas
John Greene
Heather Sankey
Allen Glasmann
Richard Feinn
Henry R Kranzler
University of Connecticut · USBaystate Medical Center · USGeneral Department of Preventive Medicine · VNHartford Financial Services (United States)UConn Health · USYale University · US

Funding

ZONISAMIDE VERSUS PLACEBOM01RR006192 · NCRR · UNIVERSITY OF CONNECTICUT SCH OF MED/DNT · PI DRAZINIC, CAROLYN M · 1994 to 2008
$22.1M
Tobacco Dependence &Risk Factors for Treatment FailureP50AA015632 · NIAAA · YALE UNIVERSITY · PI PICCIOTTO, MARINA R · 2004 to 2008
$9.2M
TOBACCO DEPENDENCE AND RISK FACTORS FOR TREATMENT FAILURP50DA013334 · NIDA · YALE UNIVERSITY · PI O'MALLEY, STEPHANIE S · 1999 to 2003
$8.0M
Nicotine Replacement Treatment for Pregnant SmokersR01DA015167 · NIDA · UNIVERSITY OF CONNECTICUT SCH OF MED/DNT · PI ONCKEN, CHERYL ANN · 2002 to 2006
$1.7M
Novel Approaches to Alcoholism Pharmacotherapy and RiskK24AA013736 · NIAAA · UNIVERSITY OF PENNSYLVANIA · PI KRANZLER, HENRY RICHARD · 2002 to 2012
$1.5M
NCRR NIH HHS M01 RR006192NIAAA NIH HHS K24 AA013736NIAAA NIH HHS K24 AA13736NIAAA NIH HHS P50 AA015632NIDA NIH HHS P50 DA013334NIDA NIH HHS R01 DA015167NIDA NIH HHS R01 DA15167
6 · The paper itself

Abstract

objectiveTo estimate the safety and efficacy of treatment with 2-mg nicotine gum for smoking cessation during pregnancy.

methodsPregnant women who smoked daily received individualized behavioral counseling and random assignment to a 6-week treatment with 2-mg nicotine gum or placebo followed by a 6-week taper period. Women who did not quit smoking were instructed to reduce the number of cigarettes smoked by substituting with gum. Measures of tobacco exposure were obtained throughout the study.

resultsParticipants in the nicotine (n = 100) and placebo (n = 94) groups were comparable in age, race/ethnicity, and smoking history. Biochemically validated smoking-cessation rates were not significantly higher with nicotine gum compared with placebo (after 6 weeks of treatment: 13% compared with 9.6%, P=.45; at 32-34 weeks of gestation: 18% compared with 14.9%, P=.56). Using a completer analysis, nicotine gum significantly reduced the number of cigarettes smoked per day (nicotine gum: -5.7 [standard deviation (SD)=6.0]; placebo: -3.5 [SD=5.7], P=.035), and cotinine concentration (nicotine gum: -249 ng/mL [SD=397]; placebo: -112 ng/mL [SD=333]; P=.04). Birth weights were significantly greater with nicotine gum compared with placebo (3,287 g [SD=566] and 2,950 g [SD=653], respectively, P<.001). Gestational age was also greater with nicotine-replacement therapy than with placebo (38.9 weeks [SD=1.7] and 38.0 weeks [SD=3.3], respectively; P=.014).

conclusionAlthough nicotine gum did not increase quit rates, use of nicotine gum increased birth weight and gestational age, two key parameters in predicting neonatal wellbeing.

Indexed as

Chewing GumBirth WeightCotinineCounselingDouble-Blind MethodFemaleHumansNicotineNicotinic AgonistsPregnancyPregnancy OutcomeProspective StudiesSmoking CessationChewing GumCotinineNicotineNicotinic Agonists

Identifiers

PMID18827129
PMCPMC2630492
OpenAlexW2135464095

What OpenQuestion holds

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LicenceTDM
Read underepoch 390

Registered trials

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.