Evidence map›Paper›PMID 22761006›Full record

Trial reportMaternal and child health journal2013

A randomized clinical trial of trans-dermal nicotine replacement in pregnant African-American smokers.

Ayman A E El-Mohandes, Richard Windsor, Sylvia Tan, David C Perry, Marie G Gantz, Michele Kiely

Abstract readComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in Maternal and child health journal, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 10 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 10 pooled it
1.0field-weighted citation impact, top 25% 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.

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

15 citing papers in PubMed, 10 syntheses or guidelines pooled it, 27 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Nicotine replacement therapy versus control for smoking cessation.The Cochrane database of systematic reviews · 2018
    Pooled it
  7. A scoping review and meta-analysis of psychosocial and pharmacological treatments for cannabis and tobacco use among African Americans.Psychology of addictive behaviors : journal of the Society of Psychologists in Addictive Behaviors · 2017
    Pooled it
  8. Pooled it
  9. Pooled it
  10. Pooled it
  11. Trial
  12. Review
  13. Article
  14. Substance use during pregnancy.F1000Research · 2016
    Review
  15. Substance Use in the Perinatal Period.Current psychiatry reports · 2015
    Review
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

6 authors at 4 institutions in 1 country.

Ayman A E El-MohandesCollege of Public Health, University of Nebraska Medical Center, Omaha, NE, USA.
Richard Windsor
Sylvia Tan
David C Perry
Marie G Gantz
Michele Kiely
George Washington University · USRTI International · USNational Institutes of Health · USUniversity of Nebraska Medical Center · US

Funding

Data Coordination Center for the NIH-DC InitiativeU01HD031206 · NICHD · RESEARCH TRIANGLE INSTITUTE · PI GANTZ, MARIE G · 2004 to 2009
$7.0M
NIH DC INITIATIVE TO REDUCE INFANT MORTALITYU18HD031206 · NICHD · RESEARCH TRIANGLE INSTITUTE · PI EL-KHORAZATY, NABIL · 1993 to 2003
$6.0M
Reduction of Tobacco Exposure in Pregnancy and InfancyU10HD036104 · NICHD · GEORGE WASHINGTON UNIVERSITY · PI PERRY, DAVID CARTER · 2004 to 2009
$4.7M
NIH D.C. INITIATIVE TO REDUCE INFANT MORTALITYU18HD036104 · NICHD · GEORGE WASHINGTON UNIVERSITY · PI EL-MOHANDES, AYMAN A · 1998 to 2003
$2.7M
Intramural NIH HHSNICHD NIH HHS U01 HD031206NICHD NIH HHS U10 HD036104NICHD NIH HHS U18 HD031206NICHD NIH HHS U18 HD031206-07NICHD NIH HHS U18 HD036104
6 · The paper itself

Abstract

We compared acceptability, adherence and efficacy of trans-dermal nicotine patches and cognitive behavioral therapy (Group 1) to cognitive behavioral therapy alone (Group 2) in minority pregnant smokers. This is a randomized controlled trial. 52 women were recruited during pregnancy with a mean gestational age 18.5 ± 5.0 weeks and followed through delivery. Randomization was by site and initial cotinine levels. Interventionists and interviewers were blinded to group assignment. Two different nicotine replacement therapy dosing regiments were administered according to the baseline salivary cotinine level. A process evaluation model summarized patient adherence. The main outcome measure was self-report of cessation since last visit, confirmed by exhaled carbon monoxide. Analyses of categorical and continuous measures were conducted as well as linear trend tests of salivary cotinine levels. Women lost to follow-up were considered treatment failures. Participants were on average 27.5 ± 5.4 years old, 81 % were single, 69 % unemployed and 96 % were Medicaid eligible. A process evaluation indicated patients in both groups were adherent to scheduled program procedures through Visit 4, but not for Visits 5 and 6. Confirmed quit rates were: at visit 3, 23 (Group 1) and 0 % (Group 2) (p = 0.02); at visits 4 and 5, no difference; at visit 6, 19 (Group 1) and 0 % (Group 2) (p = 0.05). Group 1 delivered infants with a mean gestational age of 39.4 weeks versus 38.4 weeks in Group 2 (p = 0.02). 73 % (52/71) of the eligible smokers agreed to participate and 65 % (17/26) of Group 1 completed the protocol (i.e. attended 6 visits). A comparison of Group 1 and 2 quit rates confirmed a non-significant difference.

Indexed as

Cognitive Behavioral TherapyTobacco Use Cessation DevicesAdministration, CutaneousAdultBlack or African AmericanCarbon MonoxideFemaleGestational AgeHumansNicotineNicotinic AgonistsPatient Acceptance of Health CarePregnancyPregnancy ComplicationsPregnancy OutcomeSalivaCarbon MonoxideNicotineNicotinic Agonists

Identifiers

PMID22761006
PMCPMC3679235
OpenAlexW1971054330

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

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.