Very Preterm Birth is Reduced in Women Receiving an Integrated Behavioral Intervention: A Randomized Controlled Trial

Background This study examines whether an integrated behavioral intervention with proven efficacy in reducing psycho-behavioral risks (smoking, environmental tobacco smoke exposure (ETSE), depression, and intimate partner violence (IPV)) in African-Americans is associated with improved pregnancy outcomes Methods A randomized controlled trial targeting risks during pregnancy was conducted in the District of Columbia. African-American women were recruited if reporting at least one of the risks mentioned above. Randomization to intervention or usual care was site and risk specific. Sociodemographic, health risk and pregnancy outcome data were collected. Data on 819 women, and their singleton live born infants were analyzed using an intent-to-treat approach. Bivariate analyses preceded a reduced logistical model approach to elucidate the effect of the intervention on the reduction of prematurity and low birth weight. Results The incidence of low birthweight LBW was 12% and very low birthweight VLBW was 1.6%. Multivariate logistic regression results showed that depression was associated with LBW (OR=1.71, 95%CI=1.12-2.62). IPV was associated with PTB and VPTB (OR 1.64, 95%CI=1.07-2.51, OR=2.94, 95%CI=1.40-6.16, respectively). The occurrence of VPTB was significantly reduced in the intervention compared to the usual care group (OR=0.42, 95%CI=0.19-0.93). Conclusions Our study confirms the significant associations between multiple psycho-behavioral risks and poor pregnancy outcomes, including LBW and PTB. Our behavioral intervention with demonstrated efficacy in addressing multiple risk factors simultaneously reduced VPTB within an urban minority population

Sequential screening for psychosocial and behavioural risk during pregnancy in a population of urban African Americans

Objective: Screening for psychosocial and behavioral risks, such as depression, intimate partner violence and smoking, during pregnancy is considered state-of-the-art in prenatal care (PNC). This prospective longitudinal analysis examines the added benefit of repeated screening over a one-time screen in identifying such risks during pregnancy. Design: Data were collected as part of a randomized controlled trial to address intimate partner violence (IPV), depression, smoking and environmental tobacco smoke exposure (ETSE) in African-Americans women. Setting: PNC sites in the District of Columbia serving mainly minority women Population: 1044 African-American pregnant women in the District of Columbia Methods: Mothers were classified by their initial response (acknowledgement of risks) and updated during pregnancy. Risks were considered new if they were not previously reported. Standard hypothesis tests and logistic regression were used to predict acknowledgment of any new risk(s) during pregnancy. Main Outcome Measures: New risks; psychosocial variables to understand what factors might help identify acknowledgement of additional risk(s). Results: Repeated screening identified more mothers acknowledging risk over time. Reported smoking increased by 11%, ETSE by 19%, IPV by 9%, and depression by 20%. The psychosocial variables collected at the baseline that were entered into the logistic regression model included relationship status, education, Medicaid, illicit drug use, and alcohol use during pregnancy. Among these, only education less than high school was associated in acknowledgement of new risk in the bivariate analyses and significantly predicted identification of new risks (OR=1.39, 95%CI, 1.01-1.90). Conclusions: It is difficult early on to predict who will acknowledge new risks over the course of pregnancy, thus all women should be screened repeatedly to allow identification and intervention during PNC

An Intervention to Reduce Environmental Tobacco Smoke Exposure Improves Pregnancy Outcomes

Objective—We tested the efficacy of a cognitive-behavioral intervention in reducing environmental tobacco smoke exposure (ETSE) and improving pregnancy outcomes among African-American women. Methods—We recruited 1,044 women to a randomized controlled trial during 2001-2004 in Washington, DC. Data on 691 women with self-reported ETSE were analyzed. A subset of 520 ETSE women and salivary cotinine levels (SCLs)/ml was also analyzed. Individually tailored counseling sessions adapted from evidence-based interventions for ETSE and other risks, were delivered to the intervention group. The usual care group received routine prenatal care as determined by their provider. Logistic regression models were used to predict ETSE before delivery and adverse pregnancy outcomes. Results—Women in the intervention were less likely to self-report ETSE before delivery when controlling for other covariates (OR=0.50, 95%CI=0.35-0.71). Medicaid recipients were more likely to have ETSE (OR=1.97, 95%CI=1.31-2.96). With advancing maternal age, the likelihood of ETSE was less (OR=0.96, 95%CI=0.93-0.99). For women in the intervention the rates of very low birth weight (VLBW) and very preterm birth (VPTB) were significantly improved (OR=0.11, 95%CI=0.01-0.86; OR=0.22, 95%CI=0.07-0.68, respectively). For women with SCL/ml, maternal age was not significant. Intimate partner violence at baseline significantly increased the chances of VLBW and VPTB (OR=3.75, 95%CI=1.02-13.81; OR=2.71, 95%CI=1.11-6.62, respectively). These results were true for mothers who reported ETSE overall and for those with SCL/ml. Conclusions—This is the first randomized clinical trial demonstrating efficacy of a cognitivebehavioral intervention targeting ETSE in pregnancy. We significantly reduced ETSE as well as VPTB and VLBW, leading causes of neonatal mortality and morbidity in minority populations. This intervention may reduce health disparities seen in reproductive outcomes

Environmental Tobacco Smoke Avoidance Among Pregnant African-American Nonsmokers

Background—Environmental tobacco smoke (ETS) exposure during pregnancy contributes to adverse infant health outcomes. Limited previous research has focused on identifying correlates of ETS avoidance. This study sought to identify proximal and more distal correlates of ETS avoidance early in pregnancy among African-American women. Methods—From a sample of low-income, black women (n=1044) recruited in six urban, prenatal care clinics (July 2001–October 2003), cotinine-confirmed nonsmokers with partners, household/ family members, or friends who smoked (n=450) were identified and divided into two groups: any past-7-day ETS exposure and cotinine-confirmed ETS avoidance. Bivariate and multivariate logistic regression analyses identified factors associated with ETS avoidance. Data were initially analyzed in 2004. Final models were reviewed and revised in 2007 and 2008. Results—Twenty-seven percent of pregnant nonsmokers were confirmed as ETS avoiders. In multivariate logistic regression analysis, the odds of ETS avoidance were increased among women who reported household smoking bans (OR=2.96; 95% CI=1.83, 4.77; p Conclusions—Social contextual factors were the strongest determinants of ETS avoidance during pregnancy. Results highlight the importance of prenatal screening to identify pregnant nonsmokers at risk, encouraging household smoking bans, gaining support from significant others, and fully understanding the interpersonal context of a woman’s pregnancy before providing behavioral counseling and advice to prevent ETS exposure

Smoking Cessation and Relapse Among Pregnant African-American Smokers in Washington, DC

Smoking is the single most preventable cause of perinatal morbidity. This study examines smoking behaviors during pregnancy in a high risk population of African Americans. The study also examines risk factors associated with smoking behaviors and cessation in response to a cognitive behavioral therapy (CBT) intervention. This study is a secondary analysis of data from a randomized controlled trial addressing multiple risks during pregnancy. Five hundred African-American Washington, DC residents who reported smoking in the 6 months preceding pregnancy were randomized to a CBT intervention. Psycho-social and behavioral data were collected. Self-reported smoking and salivary cotinine levels were measured prenatally and postpartum to assess changes in smoking behavior. Comparisons were made between active smokers and those abstaining at baseline and follow-up in pregnancy and postpartum. Sixty percent of participants reported quitting spontaneously during pregnancy. In regression models, smoking at baseline was associated with older age,\a high school education and illicit drug use. At follow-up closest to delivery, smoking was associated with lower education, smoking and cotinine level at baseline and depression. At postpartum, there was a relapse of 34%. Smokers postpartum were significantly more likely to smoke at baseline and use illicit drugs in pregnancy. Mothers in the CBT intervention were less likely to relapse. African-American women had a high spontaneous quit rate and no response to a CBT intervention during pregnancy. Postpartum mothers’ resolve to maintain a quit status seems to wane despite their prolonged period of cessation. CBT reduced postpartum relapse rates

An integrated intervention to reduce intimate partner violence in pregnancy: a randomized trial

OBJECTIVE: We estimated the efficacy of a psycho-behavioral intervention in reducing intimate partner violence (IPV) recurrence during pregnancy and postpartum, and in improving birth outcomes in African-American women METHODS: We conducted a randomized controlled trial in which 1,044 women were recruited. Individually-tailored counseling sessions were adapted from evidence-based interventions for IPV and other risks. Logistic regression was used to model IPV victimization recurrence, to predict minor, severe, physical and sexual IPV. RESULTS: Women randomized to the intervention were less likely to have recurrent episodes of IPV victimization (OR=0.48, 95%CI=0.29-0.80). Women with minor IPV were significantly less likely to experience further episodes during pregnancy (OR=0.48, 95%CI=0.26-0.86, OR=0.53, 95%CI=0.28-0.99) and postpartum (OR=0.56, 95%CI=0.34-0.93). Numbers needed to treat were 17, 12, and 22, respectively as compared to the usual care Women with severe IPV showed significantly reduced episodes at postpartum (OR=0.39, 95%CI=0.18-0.82) and number needed to treat is 27. Women who experienced physical IPV showed significant reduction at the first follow-up (OR=0.49, 95%CI=0.27-0.91) and postpartum (OR=0.47, 95%CI=0.27-0.82) and number needed to treat is 18 and 20, respectively. Intervention women had significantly fewer very preterm infants (p=0.03) and an increased mean gestational age (p=0.016). CONCLUSION: A relatively brief intervention during pregnancy had discernable effects on IPV and pregnancy outcomes. Screening for IPV as well as other psychosocial and behavioral risks and incorporating similar interventions in prenatal care is strongly recommended

The Mare Reproductive Loss Syndrome and the Eastern Tent Caterpillar: A Toxicokinetic/Statistical Analysis With Clinical, Epidemiologic, and Mechanistic Implications

During 2001, central Kentucky experienced acute transient epidemics of early and late fetal losses, pericarditis, and unilateral endophthalmitis, collectively referred to as mare reproductive loss syndrome (MRLS). A toxicokinetic/statistical analysis of experimental and field MRLS data was conducted using accelerated failure time (AFT) analysis of abortions following administration of Eastern tent caterpillars (ETCs; 100 or 50 g/day or 100 g of irradiated caterpillars/day) to late-term pregnant mares. In addition, 2001 late-term fetal loss field data were used in the analysis. Experimental data were fitted by AFT analysis at a high (P \u3c .0001) significance. Times to first abortion (“lag time”) and abortion rates were dose dependent. Lag times decreased and abortion rates increased exponentially with dose. Calculated dose × response data curves allow interpretation of abortion data in terms of “intubated ETC equivalents.” Analysis suggested that field exposure to ETCs in 2001 in central Kentucky commenced on approximately April 27, was initially equivalent to approximately 5 g of intubated ETCs/day, and increased to approximately 30 g/day at the outbreak peak. This analysis accounts for many aspects of the epidemiology, clinical presentations, and manifestations of MRLS. It allows quantitative interpretation of experimental and field MRLS data and has implications for the basic mechanisms underlying MRLS. The results support suggestions that MRLS is caused by exposure to or ingestion of ETCs. The results also show that high levels of ETC exposure produce intense, focused outbreaks of MRLS, closely linked in time and place to dispersing ETCs, as occurred in central Kentucky in 2001. With less intense exposure, lag time is longer and abortions tend to spread out over time and may occur out of phase with ETC exposure, obscuring both diagnosis of this syndrome and the role of the caterpillars

Understanding the Association of Biomedical, Psychosocial and Behavioral Risks with Adverse Pregnancy Outcomes

Objectives: This study investigates the relationship between diabetes, hypertension, preeclampsia, and Body Mass Index (BMI) -- the most common and interrelated medical conditions occurring during pregnancy; sociodemographic and behavioral risk factors; and adverse pregnancy outcomes in high-risk urban African American women in Washington, DC. Methods: Data are from a randomized controlled trial conducted in 6 prenatal clinics. Women in their 1st or 2nd trimester were screened for behavioral risks (smoking, environmental tobacco smoke exposure, depression, and intimate partner violence) and demographic eligibility. 1,044 were eligible, interviewed and followed through their pregnancies. Classification and Regression Trees (CART) methodology was used to: 1) explore the relationship between medical and behavioral risks (reported at enrollment), sociodemographic factors and pregnancy outcomes, 2) identify the relative importance of various predictors of adverse pregnancy outcomes, and 3) characterize women at the highest risk of poor pregnancy outcomes. Results: Overall, the strongest predictors of poor outcomes were prepregnancy BMI, preconceptional diabetes, employment status, intimate partner violence, and depression. In CART analysis, preeclampsia was the first splitter for low birthweight; preconceptional diabetes was the first splitter for preterm birth (PTB) and neonatal intensive care admission; BMI was the first splitter for very PTB, large for gestational age, Cesarean section and perinatal death; and employment was the first splitter for miscarriage. Conclusions: Preconceptional factors play a very important role in pregnancy outcomes. For many of these women, the risks that they bring into the pregnancy were more likely to impact their pregnancy outcome than events during pregnancy

Controlling anal incontinence in women by performing anal exercises with biofeedback or loperamide (CAPABLe) trial: Design and methods

The goals of this trial are to determine the efficacy and safety of two treatments for women experiencing fecal incontinence. First, we aim to compare the use of loperamide to placebo and second, to compare the use of anal sphincter exercises with biofeedback to usual care. The primary outcome is the change from baseline in the St. Mark's (Vaizey) Score 24 weeks after treatment initiation. As a Pelvic Floor Disorders Network (PFDN) trial, subjects are enrolling from eight PFDN clinical centers across the United States. A centralized data coordinating center supervises data collection and analysis. These two first-line treatments for fecal incontinence are being investigated simultaneously using a two-by-two randomized factorial design: a medication intervention (loperamide versus placebo) and a pelvic floor strength and sensory training intervention (anal sphincter exercises with manometry-assisted biofeedback versus usual care using an educational pamphlet). Interventionists providing the anal sphincter exercise training with biofeedback have received standardized training and assessment. Symptom severity, diary, standardized anorectal manometry and health-related quality of life outcomes are assessed using validated instruments administered by researchers masked to randomized interventions. Cost effectiveness analyses will be performed using prospectively collected data on care costs and resource utilization. This article describes the rationale and design of this randomized trial, focusing on specific research concepts of interest to researchers in the field of female pelvic floor disorders and all other providers who care for patients with fecal incontinence