Table 9Evidence for Pregnant Women

Study IdentificationParticipantsInterventionsOutcomesStudy QualityQuality Rating/ Comments
Chang, 1999 162 N: 250 pregnant women.Following a comprehensive, 2-hour assessment interview focusing on alcohol (conducted by a research assistant), participants randomly assigned to IG or CG.In person follow-up interview, approximately 2 months post-partum.Allocation concealment: Satisfactory.GOOD.
Addiction Baseline Consumption (reported as mean number of DR/drinking day, currently, excluding abstainers):IG participants met with first author immediately after the assessment interview for a 45-minute brief intervention. This structured interview contained the following elements:
1.

review of participant's general health and pregnancy;

2.

review of life-style changes since pregnancy began, including alcohol consumption;

3.

identification of participant's drinking goals during pregnancy and reasons for these goals;

4.

identification of circumstances in which drinking was tempting;

5.

identification of alternatives to alcohol in tempting situations;

6.

summarizing session and emphasizing 4 key points of drinking goals, motivation, risk situations, alternatives to alcohol.

For interval between initial assessment and delivery:Attrition bias:
RCT conducted in US resident and family practices in an academic setting.Mean (SD)All participants informed of US Surgeon General's recommendation that prenatal abstinence is the most prudent drinking goal.Decrease in DR/drinking day,Intention-to-treat analysis was performed and there were very few losses to follow-up (1%).
Standard Drink (DR) = NRIG 1.5 (1.2)Given take-home manual, “How to prevent alcohol-related problems.”IG -0.3Patients and outcomes blinded: Satisfactory.
CG 2.1 (1.5)No further followup.CG -0.4Groups differ in some ways, but differences are handled in analysis.
Inc/Exc Criteria:Intervention delivery not reported.Difference not statistically significant (#s NR)Clearly delivered intervention:
Inclusion: Gestational age ≤ 28 weeks; Positive T-ACE (modified tolerance question - feeling high w/2 drinks, scored = 2); First 250 consecutive eligible women who agreed were randomized.CG: No special contact reported; presumably usual care.Episodes of drinkingYes.
Exclusion: Gestational age > 28 weeks; No alcohol consumption in 6 months before study participation; Miscarriage between survey & telephone interview; Non-English speaking; Intended abortion or false pregnancy; Current substance abuse treatment; Other (9% of those excluded)Harms not reported.IG 0.7
% Female: 100%CG 1.0
% Minority: 22%(p=0.12)
% Smokers: 8%For interval between delivery and followup assessment:
40% met DSM III-R criteria for lifetime alcohol abuse or dependence (none met criteria for current)Regression analysis showed no effect of study group on alcohol consumption
28% met DSM III-R criteria for lifetime drug abuse or dependence (none met criteria for current)Secondary, sub-group analyses:
Motivation Composite: NRAmong those abstinent at baseline (n=142), % who drank in antepartum period: p<.05
IG 72%
CG 86%
Among drinkers at baseline (n=105), overall decrease of 1.2 DR/drinking day, but no group differences.
Proportion benefiting: NR.
Reynolds, 1995 163 N: 78 pregnant women with prenatal appointments.IG: “Self-help” intervention included a 10-minute session conducted by an educator, and introduction to a self-help manual. The manual included 9 steps, to be completed over 9 days.Quit rate (reported by self report questionnaire):Allocation concealment: Satisfactory.GOOD
International Journal of the Addictions Baseline consumption (reported as mean DR/month):Based on social cognitive theory, intervention included goal setting, self-monitoring, perceived self-efficacy, negative outcome expectancies of drinking, positive outcome expectancies of quitting, and ability to identify & cope with drinking situations.IG 88%Attrition bias: Intention-to-treat analysis performed and very few losses to follow-up (8%).
RCT conducted in US public health primary care clinics.IG 44No tailoring explicitly reported.CG 69%Patients and outcomes blinded: Satisfactory.
Standard Drink (DR) = NRCG 28No further followup.Chi-square difference test non-significant @ p=.058.Baseline groups comparable and maintained: Satisfactory.
Inc/Exc Criteria:CG: usual care, including routine information on alcohol's fetal effects, brief discussions with clinic staff, and video about prenatal care.DR/month (reported as an estimate of the amount of alcohol consumed in the past month):Clearly delivered intervention:
Inclusion: Pregnant women who had consumed alcohol in past month; ≤ 25 weeks gestation.Intervention delivery: all IG received educational session and self-help manual, 97% received reminder phone call. 5 CG members (13%) read part of the self-help manual.IG 0.36Yes.
Exclusion: > 25 weeks gestation; Non-drinkers.Harms not reported.CG 1.14
% Female: 100%t-test non-significant @ p=.06
% Minority: 69%Proportion benefiting: NR
56% with income less than $25K annually
Motivation Composite: NR
Handmaker, et al. 1999 161 N= 42 pregnant womenAfter consenting to study participation, women who reported consuming at least 1 drink in past month completed 1-hour alcohol assessments, including the Brief Drinker Profile (BDP) and a timeline reconstruction of drinking in past 2 months.Alcohol consumption outcomes from Brief Drinker Profile assessment, at 2 months followupAllocation concealment: Satisfactory.FAIR.
Journal of Studies on Alcohol Baseline Consumption:IG (n=20) given a 1-hour motivational interview at home or other convenient site, subsequent to the assessment, conducted by research personnel (first author).3 outcomes analyzed: total # of standard drinks in past 2 months, peak blood alcohol concentration (BAC), total days abstinent.Attrition bias: Intention-to-treat analysis appears to have been performed, but is unclear.
RCT conducted in US university medical center prenatal clinics.Overall group (reported as mean DR in the previous month): mean (SD) 9 (20.48)Interview began with ascertainment of participant's knowledge about effects of drinking during pregnancy.ANCOVA results for treatment group differences:Follow-up losses were 19%.
Standard Drink (DR) = standard ethanol content unit (SEC) = 0.5 oz (15 ml) ETOHPeak blood alcohol concentration (BAC), considered the best indicator of fetal exposure, estimated by self-reportIncluded feedback on potential harm to fetus caused by the participant's drinking.Total drinks: F=0.01, 1/31 df, p=0.94Replacement of missing values is NR.
Inc/Exc Criteria:Goal was to increase participant's perception of health risks drinking posed to the fetus while supporting self-efficacy to reduce or quit drinking.Days abstinent: F=1.25, 1/31 df, p=0.27Patients and outcomes blinded: Satisfactory.
Inclusion: Pregnant females consuming ≥ 1 drink in the previous month.Participants advised that quitting drinking at any time during pregnancy could lead to better outcomes. No explicit description of assistance toward reaching goal of abstention.Peak BAC: interaction between treatment group and peak BAC at baseline - among women with highest baseline BAC's, intervention reduced peak BAC at followup relative to controls.Group comparisons at baseline were not reported.
Exclusion: NRConducted using an empathic, client-centered but directive style.Estimate effect sizes (theta):Clearly delivered intervention:
% Female: 100%Although tailoring not mentioned specifically, interview began with determining each participant's level of knowledge about alcohol and pregnancy.Change in consumption:Yes.
% Minority: 62%Intervention delivery not reported.IG 0.46
Motivation Composite: Measured in the IG only using SOCRATES before and after intervention.No further followup.CG 0.40
CG (n=22) mailed a letter post-assessment informing them about risks of drinking during pregnancy and referring them to their health care providers.Change in BAC:
Harms not reported.IG 0.77
CG 0.46
Change in abstinent days:
IG 0.69
CG 0.20
Proportion benefiting:
NR

From: 2, Methods

Cover of Behavioral Counseling Interventions in Primary Care to Reduce Risky/Harmful Alcohol Use
Behavioral Counseling Interventions in Primary Care to Reduce Risky/Harmful Alcohol Use [Internet].
Systematic Evidence Reviews, No. 30.
Whitlock EP, Green CA, Polen MR, et al.

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