Preventing Alcohol and Tobacco Exposed Pregnancies: CHOICES Plus in Primary Care

Introduction

Alcohol and tobacco use are common among U.S. women, yet if used during pregnancy these substances present significant preventable risks to prenatal and perinatal health. Because use of alcohol and tobacco often continue into the first trimester and beyond, especially among women with unintended pregnancies, effective evidence-based approaches are needed to decrease these risk behaviors. This study was designed to test the efficacy of CHOICES Plus, a preconception intervention for reducing the risk of alcohol- and tobacco-exposed pregnancies (AEPs and TEPs).

Study design

RCT with two intervention groups: CHOICES Plus (n=131) versus Brief Advice (n=130). Data collected April 2011 to October 2013. Data analysis finalized February 2016.

Setting/participants

Settings were 12 primary care clinics in a large Texas public healthcare system. Participants were women who were non-sterile, non-pregnant, aged 18–44 years, drinking more than three drinks per day or more than seven drinks per week, sexually active, and not using effective contraception (N=261). Forty-five percent were smokers.

Intervention

Interventions were two CHOICES Plus sessions and a contraceptive visit or Brief Advice and referral to community resources.

Main outcome measures

Primary outcomes were reduced risk of AEP and TEP through 9-month follow-up.

Results

In intention-to-treat analyses across 9 months, the CHOICES Plus group was more likely than the Brief Advice group to reduce risk of AEP with an incidence rate ratio of 0.620 (95% CI=0.511, 0.757) and absolute risk reduction of –0.233 (95% CI=–0.239, –0.226). CHOICES Plus group members at risk for both exposures were more likely to reduce TEP risk (incidence rate ratio, 0.597; 95% CI=0.424, 0.840 and absolute risk reduction, –0.233; 95% CI=–0.019, –0.521).

Conclusions

CHOICES Plus significantly reduced AEP and TEP risk. Addressing these commonly co-occurring risk factors in a single preconception program proved both feasible and efficacious in a low-income primary care population. Intervening with women before they become pregnant could shift the focus in clinical practice from treatment of substance-exposed pregnancies to prevention of a costly public health concern.

Trial registration

This study is registered at clinicaltrials.gov NCT01032772.

Introduction

Alcohol and tobacco are among the most commonly used substances by women of childbearing age.1, 2 Alcohol-exposed pregnancies (AEPs) are associated with a range of adverse birth outcomes, including observable facial and organ system anomalies, prenatal and postnatal growth impairment, and behavioral and developmental deficits. Even small amounts of alcohol during pregnancy may result in negative outcomes.3, 4 Tobacco-exposed pregnancies (TEPs) are associated with stillbirth and miscarriage, placenta previa, placental abruption, and preterm birth.5, 6 The infant mortality rate from a TEP is 40% higher than in non-TEP infants, and 23%–34% of deaths due to sudden infant death syndrome are attributable to a TEP.7, 8 The combined effects of alcohol and tobacco use during pregnancy are synergistic rather than additive, further increasing the risk of preterm labor, low birth weight, and growth restriction. Modification of either behavior can produce a large reduction in risk for an adverse fetal outcome.⁹

Nearly half of all U.S. pregnancies are unintended¹⁰ and the number may be even higher for alcohol¹¹ and tobacco users.¹² Many women not aware of their pregnancy continue drinking or smoking cigarettes well into their first and even second trimesters—critical periods of fetal susceptibility.13, 14

Although preconception health care has been a subject of inquiry since the mid-1980s,¹⁵ the importance of addressing preconception health behaviors, such as alcohol and tobacco use, has been increasingly emphasized in recent years.16, 17, 18, 19, 20 Additionally, although AEPs and TEPs are considered healthcare priorities by several major groups, including the National Academy of Medicine (formerly the Institute of Medicine) and the U.S. DHHS,16, 20 most intervention trials among women of childbearing age have focused on cessation during pregnancy,21, 22, 23 rather than in the preconception period.24, 25

Project CHOICES is an efficacious four-session intervention developed through a Centers for Disease Control and Prevention–funded series of studies to prevent AEPs in various settings, including primary care.13, 26, 27 The CHOICES intervention uses motivational interviewing27, 28 and content aimed to increase participants’ motivation and commitment to change risky alcohol use^a and ineffective contraception^a together with a visit for contraception education and services. CHOICES Plus halves the number of sessions and adds tobacco as a target behavior, thus addressing the need for an efficacious bundle of preconception services in primary care settings where non-pregnant women of childbearing age are most likely to present for services when substance-exposed pregnancy is preventable. Women using alcohol and tobacco are more likely to seek general primary care than to present to alcohol treatment or smoking-cessation programs.29, 30 Thus, the current trial tested CHOICES Plus in a safety net healthcare system compared to Brief Advice and informational and referral brochures, using outcome measures and analytic methods similar to those used in the original CHOICES trial.