Research article
Preventing Alcohol-Exposed Pregnancies: A Randomized Controlled Trial

https://doi.org/10.1016/j.amepre.2006.08.028Get rights and content

Background

Prenatal alcohol exposure is a leading preventable cause of birth defects and developmental disabilities in the United States.

Design

A randomized controlled trial (2002–2005; data analyzed 2005–2006) of a brief motivational intervention to reduce the risk of an alcohol-exposed pregnancy (AEP) in preconceptional women by focusing on both risk drinking and ineffective contraception use.

Setting/Participants

A total of 830 nonpregnant women, aged 18–44 years, and currently at risk for an AEP were recruited in six diverse settings in Florida, Texas, and Virginia. Combined settings had higher proportions of women at risk for AEP (12.5% overall) than in the general population (2%).

Interventions

Participants were randomized to receive information plus a brief motivational intervention (n=416) or to receive information only (n=414). The brief motivational intervention consisted of four counseling sessions and one contraception consultation and services visit.

Main Outcome Measures

Women consuming more than five drinks on any day or more than eight drinks per week on average, were considered risk drinkers; women who had intercourse without effective contraception were considered at risk of pregnancy. Reversing either or both risk conditions resulted in reduced risk of an AEP.

Results

Across the follow-up period, the odds ratios (ORs) of being at reduced risk for AEP were twofold greater in the intervention group: 3 months, 2.31 (95% confidence interval [CI]=1.69–3.20); 6 months, 2.15 (CI=1.52–3.06); 9 months, 2.11 (CI=1.47–3.03). Between-groups differences by time phase were 18.0%, 17.0%, and 14. 8%, respectively.

Conclusions

A brief motivational intervention can reduce the risk of an AEP.

Introduction

Alcohol is a known teratogen and a leading preventable cause of birth defects and developmental disabilities in the United States.1, 2 Each year 500,000 pregnant women report alcohol use in the past month, and 80,000 report binge drinking.3 Fetal exposure to alcohol results in a spectrum of adverse effects known as Fetal Alcohol Spectrum Disorders,4 with the brain and central nervous system being particularly susceptible to alcohol throughout gestation.5 Fetal Alcohol Syndrome, a severe lifelong condition, has an estimated overall prevalence of up to 2 of every 1000 live births in the United States6 and an estimated lifetime cost of $2 million per case.7

Most women reduce alcohol consumption after learning that they are pregnant,8 but many do not recognize that they are pregnant during the early critical weeks of gestation and continue hazardous drinking.9 Studies from the Centers for Disease Control and Prevention (CDC) show that approximately one in two women of childbearing age (18–44 years) report alcohol use in the past month, and one in eight report binge drinking.10 Furthermore, in the United States, almost half of pregnancies are unplanned,11 of which about half occur in women who are using contraception ineffectively or intermittently.12 Enhancing effective contraception use in women of childbearing age who are risky drinkers (consuming eight or more drinks per week, or five or more drinks on one occasion, or binge drinking) could avert many alcohol-exposed pregnancies (AEP).

Randomized controlled trials (RCTs) of women of childbearing age who are risky drinkers have shown brief interventions to be a promising strategy for reducing AEP.13, 14 The Project CHOICES Feasibility Study, a single-arm trial, evaluated a motivational intervention for women determined to be at risk for an alcohol-exposed pregnancy (AEP).15 The intervention was based on theory and research in brief interventions,16 motivational interviewing,17 and the Transtheoretical Model.18 At 6 months postenrollment, 68.5% of the women had reduced their risk for AEP by reducing drinking, using effective contraception methods, or both. This paper presents the major findings from an RCT that followed the feasibility study.

Section snippets

Participants

Project CHOICES was a multisite collaborative study involving the CDC, Nova Southeastern University in Ft. Lauderdale FL, the University of Texas Health Science Center in Houston TX, and Virginia Commonwealth University in Richmond VA. The study was conducted in six community-based settings. Recruitment was from July 1, 2002 to January 30, 2004, and the follow-up period ended August 15, 2005. An earlier epidemiologic study estimated the risk of AEP in these combined settings to be 12.5%,

Results

Figure 1 summarizes the study flow and shows that 4626 women were screened at the six sites. Three fourths (3591) of those screened were ineligible, including 3019 who did not meet the ineffective contraception criteria and 1396 who did not meet drinking criteria (not mutually exclusive). In addition, 205 eligible women (19.8%) refused to participate after being informed about the study. Their distribution across sites was proportionally similar. There were 830 eligible, consenting women who

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