Maternal characteristics and obstetrical complications impact neonatal outcomes in Indonesia: a prospective study.

BACKGROUND: We investigated associations between maternal characteristics, access to care, and obstetrical complications including near miss status on admission or during hospitalization on perinatal outcomes among Indonesian singletons. METHODS: We prospectively collected data on inborn singletons at two hospitals in East Java. Data included socio-demographics, reproductive, obstetric and neonatal variables. Reduced multivariable models were constructed. Outcomes of interest included low and very low birthweight (LBW/VLBW), asphyxia and death. RESULTS: Referral from a care facility was associated with a reduced risk of LBW and VLBW [AOR = 0.28, 95% CI = 0.11-0.69, AOR = 0.18, 95% CI = 0.04-0.75, respectively], stillbirth [AOR = 0.41, 95% CI = 0.18-0.95], and neonatal death [AOR = 0.2, 95% CI = 0.05-0.81]. Mothers age <20 years increased the risk of VLBW [AOR = 6.39, 95% CI = 1.82-22.35] and neonatal death [AOR = 4.10, 95% CI = 1.29-13.02]. Malpresentation on admission increased the risk of asphyxia [AOR = 4.65, 95% CI = 2.23-9.70], stillbirth [AOR = 3.96, 95% CI = 1.41-11.15], and perinatal death [AOR = 3.89 95% CI = 1.42-10.64], as did poor prenatal care (PNC) [AOR = 11.67, 95%CI = 2.71-16.62]. Near-miss on admission increased the risk of neonatal [AOR = 11.67, 95% CI = 2.08-65.65] and perinatal death [AOR = 13.08 95% CI = 3.77-45.37]. CONCLUSIONS: Mothers in labor should be encouraged to seek care early and taught to identify early danger signs. Adequate PNC significantly reduced perinatal deaths. Improved hospital management of malpresentation may significantly reduce perinatal morbidity and mortality. The importance of hospital-based prospective studies helps evaluate specific areas of need in training of obstetrical care providers.

Maternal characteristics and clinical diagnoses influence obstetrical outcomes in Indonesia.

This Indonesian study evaluates associations between near-miss status/death with maternal demographic, health care characteristics, and obstetrical complications, comparing results using retrospective and prospective data. The main outcome measures were obstetric conditions and socio-economic factors to predict near-miss/death. We abstracted all obstetric admissions (1,358 retrospective and 1,240 prospective) from two district hospitals in East Java, Indonesia between 4/1/2009 and 5/15/2010. Prospective data added socio-economic status, access to care and referral patterns. Reduced logistic models were constructed, and multivariate analyses used to assess association of risk variables to outcome. Using multivariate analysis, variables associated with risk of near-miss/death include postpartum hemorrhage (retrospective AOR 5.41, 95 % CI 2.64-11.08; prospective AOR 10.45, 95 % CI 5.59-19.52) and severe preeclampsia/eclampsia (retrospective AOR 1.94, 95 % CI 1.05-3.57; prospective AOR 3.26, 95 % CI 1.79-5.94). Associations with near-miss/death were seen for antepartum hemorrhage in retrospective data (AOR 9.34, 95 % CI 4.34-20.13), and prospectively for poverty (AOR 2.17, 95 % CI 1.33-3.54) and delivering outside the hospital (AOR 2.04, 95 % CI 1.08-3.82). Postpartum hemorrhage and severe preeclampsia/eclampsia are leading causes of near-miss/death in Indonesia. Poverty and delivery outside the hospital are significant risk factors. Prompt recognition of complications, timely referrals, standardized care protocols, prompt hospital triage, and structured provider education may reduce obstetric mortality and morbidity. Retrospective data were reliable, but prospective data provided valuable information about barriers to care and referral patterns.

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

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.

Relationships between self-reported smoking, household environmental tobacco smoke exposure and depressive symptoms in a pregnant minority population.

UNLABELLED: This study sought to examine relationships between depressive symptoms and prenatal smoking and/or household environmental tobacco smoke exposure (HH-ETSE) among urban minority women. We analyzed private, audio computer-assisted self interview data from a clinic-based sample of 929 minority pregnant women in Washington, DC. Depressive symptoms were assessed via the Beck Depression Inventory Fast Screen. HH-ETSE, current smoking, and former smoking were assessed via self-report. Depression levels and demographic characteristics were compared: (1) among nonsmokers, for those reporting HH-ETSE versus no HH-ETSE; and (2) among smokers, for those reporting current smoking (in last 7 days) versus former smokers. Measures associated with HH-ETSE/current smoking in bivariate analysis at P < 0.20 were included in adjusted logistic regression models. HH-ETSE, as a possible indicator of a social smoking network, was assessed as a mediator for the relationship between depression and current smoking. RESULTS: Non-smokers reporting moderate-to-severe depressive symptoms showed significantly higher adjusted odds of prenatal HH-ETSE (AOR 2.5, 95% CI [1.2, 5.2]). Smokers reporting moderate-to-severe or mild depressive symptoms showed significantly higher adjusted odds of current smoking (AOR 1.9, 95% CI [1.1, 3.5] and AOR 1.8, 95% CI [1.1, 3.1], respectively). Among smokers, HH-ETSE was a significant mediator for the association between moderate-to-severe symptoms and current smoking. In conclusion, health care providers should be aware that depressed urban minority women are at risk of continued smoking/HH-ETSE during pregnancy. Interventions designed to encourage behavior change should include screening for depression, and build skills so that women are better able to address the social environment.

Understanding the association of biomedical, psychosocial and behavioral risks with adverse pregnancy outcomes among African-Americans in Washington, DC.

This study investigates the relationship between adverse pregnancy outcomes in high-risk African American women in Washington, DC and sociodemographic risk factors, behavioral risk factors, and the most common and interrelated medical conditions occurring during pregnancy: diabetes, hypertension, preeclampsia, and Body Mass Index (BMI). 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. 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; employment was the first splitter for miscarriage. Preconceptional factors strongly influence pregnancy outcomes. For many of these women, the high risks they brought into pregnancy were more likely to impact their pregnancy outcomes than events during pregnancy.

Effectiveness of a combined home visiting and group intervention for low income African American mothers: the pride in parenting program.

Intervention strategies are needed to improve maternal and infant outcomes in minority populations living in poverty. Home visiting by nurses has improved outcomes for mothers and young children, but use of professional staff makes these programs expensive. Pride in Parenting was a randomized controlled trial of paraprofessional home visitation to provide health and developmental intervention for high-risk African American mothers in Washington, DC. This study proposed to test whether paraprofessional visitors drawn from the community could effectively influence health and mothers' parenting behaviors and attitudes. African American mothers with inadequate prenatal care were recruited at delivery and randomized to intervention or usual care groups. The intervention curriculum was delivered through both home visitation and parent-infant groups for 1 year. The intervention curriculum was designed to improve knowledge, influence attitudes, and promote life skills that would assist low-income mothers in offering better health oversight and development for their infants. Both intervention and usual care groups received monthly social work contact over the one-year study period to provide referrals for identified needs. The intervention participants improved their home environments, a characteristic important for promoting good child development. Mothers' perceptions of available social support improved and child-rearing attitudes associated with child maltreatment were reduced. Paraprofessional home visitors can be successful in improving the child-rearing environments and parenting attitudes for infants at risk, perhaps offering a less costly option to professional home visitors.

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,

Very preterm birth is reduced in women receiving an integrated behavioral intervention: a randomized controlled trial.

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. 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. 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 preterm birth (PTB) and very preterm birth (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). 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.

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 black women. METHODS: We recruited 1044 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 women with ETSE and salivary cotinine levels (SCLs) of <20 ng/mL were 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 (odds ratio [OR]: 0.50 [95% confidence interval (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] and OR: 0.22 [95% CI: 0.07-0.68], respectively). For women with an SCL of <20 ng/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] and 2.71 [95% CI: 1.11-6.62], respectively). These results were true for mothers who reported ETSE overall and for those with an SCL of <20 ng/mL. CONCLUSIONS: This is the first randomized clinical trial demonstrating efficacy of a cognitive-behavioral 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 in reproductive outcomes.

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

OBJECTIVE: To estimate the efficacy of a psycho-behavioral intervention in reducing intimate partner violence recurrence during pregnancy and postpartum and in improving birth outcomes in African-American women. METHODS: We conducted a randomized controlled trial for which 1,044 women were recruited. Women were randomly assigned to receive either intervention (n=521) or usual care (n=523). Individually tailored counseling sessions were adapted from evidence-based interventions for intimate partner violence and other risks. Logistic regression was used to model intimate partner violence victimization recurrence and to predict minor, severe, physical, and sexual intimate partner violence. RESULTS: Women randomly assigned to the intervention group were less likely to have recurrent episodes of intimate partner violence victimization (odds ratio [OR] 0.48, 95% confidence interval [CI] 0.29-0.80). Women with minor intimate partner violence 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 with the usual care group. Women with severe intimate partner violence showed significantly reduced episodes postpartum (OR 0.39, 95% CI 0.18-0.82); the number needed to treat was 27. Women who experienced physical intimate partner violence 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); the numbers needed to treat were 18 and 20, respectively. Women in the intervention group had significantly fewer very preterm neonates (1.5% intervention group, 6.6% usual care group; P=.03) and an increased mean gestational age (38.2+/-3.3 intervention group, 36.9+/-5.9 usual care group; P=.016). CONCLUSION: A relatively brief intervention during pregnancy had discernible effects on intimate partner violence and pregnancy outcomes. Screening for intimate partner violence as well as other psychosocial and behavioral risks and incorporating similar interventions in prenatal care is strongly recommended. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00381823. LEVEL OF EVIDENCE: I.

Prediction of birth weight by cotinine levels during pregnancy in a population of black smokers.

OBJECTIVE: The goal was to investigate the association between maternal salivary cotinine levels (SCLs) and pregnancy outcomes among black smokers. METHODS: In a randomized, controlled trial conducted in 2001-2004 in Washington, DC, 714 women (126 active smokers [18%]) were tested for SCLs at the time of recruitment and later in pregnancy. Sociodemographic health risks and pregnancy outcomes were recorded. RESULTS: Birth weights were significantly lower for infants born to mothers with baseline SCLs of > or =20 ng/mL in comparison with <20 ng/mL (P = .024), > or =50 ng/mL in comparison with <50 ng/mL (P = .002), and > or =100 ng/mL in comparison with <100 ng/mL (P = .002), in bivariate analyses. In linear regression analyses adjusting for sociodemographic and medical factors, SCLs of > or =20 ng/mL were associated with a reduction in birth weight of 88 g when SCLs were measured at baseline (P = .042) and 205 g when SCLs were measured immediately before delivery (P < .001). Corresponding results were 129 g (P = .006) and 202 g (P < .001) for > or =50 ng/mL and 139 g (P = .007) and 205 g (P < .001) for > or =100 ng/mL. Gestational age was not affected significantly at any SCL, regardless of when SCLs were measured. CONCLUSIONS: Elevated SCLs early in pregnancy or before delivery were associated with reductions in birth weight. At any cutoff level, birth weight reduction was more significant for the same SCL measured in late pregnancy. Maintaining lower levels of smoking for women who are unable to quit may be beneficial.

Reducing psychosocial and behavioral pregnancy risk factors: results of a randomized clinical trial among high-risk pregnant african american women.

OBJECTIVES: We evaluated the efficacy of a primary care intervention targeting pregnant African American women and focusing on psychosocial and behavioral risk factors for poor reproductive outcomes (cigarette smoking, secondhand smoke exposure, depression, and intimate partner violence). METHODS: Pregnant African American women (N = 1044) were randomized to an intervention or usual care group. Clinic-based, individually tailored counseling sessions were adapted from evidence-based interventions. Follow-up data were obtained for 850 women. Multiple imputation methodology was used to estimate missing data. Outcome measures were number of risks at baseline, first follow-up, and second follow-up and within-person changes in risk from baseline to the second follow-up. RESULTS: Number of risks did not differ between the intervention and usual care groups at baseline, the second trimester, or the third trimester. Women in the intervention group more frequently resolved some or all of their risks than did women in the usual care group (odds ratio = 1.61; 95% confidence interval = 1.08, 2.39; P = .021). CONCLUSIONS: In comparison with usual care, a clinic-based behavioral intervention significantly reduced psychosocial and behavioral pregnancy risk factors among high-risk African American women receiving prenatal care.

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<0.0001), that the father wanted the baby (OR=2.70; CI=1.26, 5.76; p=0.01), and that no/few family members/friends smoked (OR=3.15; 95% CI=1.58, 6.29; p<0.001). The odds were decreased among women who had a current partner (OR=0.42; 95% CI=0.23, 0.76; p<0.01), reported any intimate partner violence during pregnancy (OR=0.43; 95% CI=0.19, 0.95; p<0.05), and reported little social support to prevent ETS exposure (OR=0.50; 95% CI=0.30, 0.85; p=0.01). Parity, emotional coping strategies, substance use during pregnancy, partner/household member smoking status, and self-confidence in avoiding ETS were significant in bivariate, but not multivariate analyses. 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.

An intervention to improve postpartum outcomes in African-American mothers: a randomized controlled trial.

OBJECTIVE: To evaluate the efficacy of an integrated multiple risk intervention, delivered mainly during pregnancy, in reducing such risks (cigarette smoking, environmental tobacco smoke exposure, depression, and intimate partner violence) postpartum. METHODS: Data from this randomized controlled trial were collected prenatally and on average 10 weeks postpartum in six prenatal care sites in the District of Columbia. African Americans were screened, recruited, and randomly assigned to the behavioral intervention or usual care. Clinic-based, individually tailored counseling was delivered to intervention women. The outcome measures were number of risks reported postpartum and reduction of these risks between baseline and postpartum. RESULTS: The intervention was effective in significantly reducing the number of risks reported in the postpartum period. In bivariate analyses, the intervention group was more successful in resolving all risks (47% compared with 35%, P=.007, number needed to treat=9, 95% confidence interval [CI] 5-31) and in resolving some risks (63% compared with 54%, P=.009, number needed to treat=11, 95% CI 7-43) as compared with the usual care group. In logistic regression analyses, women in the intervention group were more likely to resolve all risks (odds ratio 1.86, 95% CI 1.25-2.75, number needed to treat=7, 95% CI 4-19) and resolve at least one risk (odds ratio 1.60, 95% CI 1.15-2.22, number needed to treat=9, 95% CI 6-29). CONCLUSION: An integrated multiple risk factor intervention addressing psychosocial and behavioral risks delivered mainly during pregnancy can have beneficial effects in risk reduction postpartum.

Pregnancy intentions and happiness among pregnant black women at high risk for adverse infant health outcomes.

CONTEXT: Unintended pregnancy is associated with risk behaviors and increased morbidity or mortality for mothers and infants, but a woman's feelings about pregnancy may be more predictive of risk and health outcomes than her intentions. METHODS: A sample of 1,044 black women who were at increased risk were enrolled at prenatal care clinics in the District of Columbia in 2001-2003. Bivariate and multivariate analyses assessed associations between pregnancy intentions or level of happiness about being pregnant and multiple psychosocial and behavioral risk factors, and identified correlates of happiness to be pregnant. RESULTS: Pregnancy intentions and happiness were strongly associated, but happiness was the better predictor of risk. Unhappy women had higher odds than happy women of smoking, being depressed, experiencing intimate partner violence, drinking and using illicit drugs (odds ratios, 1.7-2.6). The odds of being happy were reduced among women who had other children or a child younger than two, who were single or did not have a current partner, who had had more than one sexual partner in the past year and who reported that the baby's father did not want the pregnancy (0.3-0.6). In contrast, the odds of being happy were elevated among women who had better coping strategies (1.03), who had not used birth control at conception (1.6) and who had 1-2 household members, rather than five or more (2.1). CONCLUSIONS: Additional psychosocial screening for happiness about being pregnant and for partner characteristics, particularly the father's desire to have this child, may help improve prenatal care services and prevent adverse health outcomes.

Recruitment and retention of low-income minority women in a behavioral intervention to reduce smoking, depression, and intimate partner violence during pregnancy.

BACKGROUND: Researchers have frequently encountered difficulties in the recruitment and retention of minorities resulting in their under-representation in clinical trials. This report describes the successful strategies of recruitment and retention of African Americans and Latinos in a randomized clinical trial to reduce smoking, depression and intimate partner violence during pregnancy. Socio-demographic characteristics and risk profiles of retained vs. non-retained women and lost to follow-up vs. dropped-out women are presented. In addition, subgroups of pregnant women who are less (more) likely to be retained are identified. METHODS: Pregnant African American women and Latinas who were Washington, DC residents, aged 18 years or more, and of 28 weeks gestational age or less were recruited at six prenatal care clinics. Potentially eligible women were screened for socio-demographic eligibility and the presence of the selected behavioral and psychological risks using an Audio Computer-Assisted Self-Interview. Eligible women who consented to participate completed a baseline telephone evaluation after which they were enrolled in the study and randomly assigned to either the intervention or the usual care group. RESULTS: Of the 1,398 eligible women, 1,191 (85%) agreed to participate in the study. Of the 1,191 women agreeing to participate, 1,070 completed the baseline evaluation and were enrolled in the study and randomized, for a recruitment rate of 90%. Of those enrolled, 1,044 were African American women. A total of 849 women completed the study, for a retention rate of 79%. Five percent dropped out and 12% were lost-to-follow up. Women retained in the study and those not retained were not statistically different with regard to socio-demographic characteristics and the targeted risks. Retention strategies included financial and other incentives, regular updates of contact information which was tracked and monitored by a computerized data management system available to all project staff, and attention to cultural competence with implementation of study procedures by appropriately selected, trained, and supervised staff. Single, less educated, alcohol and drug users, non-working, and non-WIC women represent minority women with expected low retention rates. CONCLUSION: We conclude that with targeted recruitment and retention strategies, minority women will participate at high rates in behavioral clinical trials. We also found that women who drop out are different from women who are lost to follow-up, and require different strategies to optimize their completion of the study.

Low-income minority mothers' reports of infant health care utilisation compared with medical records.

This study aimed to investigate mothers' reporting of the nature, location, frequency and content of health care visits for their infants, as compared with data abstracted from the infants' medical records. It was part of a community-based parenting intervention designed to improve preventive health care utilisation among minority mothers in Washington, DC. Mothers >or=18 years old with newborn infants and with poor or no prenatal care were enrolled in the study. A total of 160 mother-infant dyads completed the 12-month study. Mothers were interviewed when the infants were 4, 8 and 12 months old, and were asked to recall infant visits to all health care providers. Medical records from identified providers were used for verification. The number and type of immunisations given, types of providers visited, and reason for the visits were compared. Only about a quarter of mothers agreed with their infants' medical records on the number of specific immunisations received. The mothers reported fewer polio (1.8 vs. 2.1, P = 0.006), diphtheria and tetanus toxoids and pertussis (DTP) (1.8 vs. 2.2, P = 0.002), and Haemophilus influenzae type b (HiB) (1.3 vs. 2.1, P < 0.0001) immunisations than were recorded. Similarly, about a quarter of the mothers were unaware of any polio, DTP or hepatitis B immunisations given, as documented in the medical records, and 38% did not know that their infant was immunised for HiB. Nearly half of the mothers recalled more infant doctors' visits than were recorded in the medical records (4.1 vs. 3.6 visits, P = 0.017). The mothers generally disagreed with the providers about the reason for a particular visit and reported fewer sick-baby visits (1.5 vs. 3.3, P < 0.0001) than the providers recorded. Mothers' reports and medical records matched in only 19% of the cases. In 47%, mothers under-reported and in 34% over-reported the total number of visits. The strongest agreement between mothers' reports and medical records was in the case of emergency room visits (63%). In conclusion, in this population, mothers' reporting did not match that of providers with respect to specific information: the number of immunisations, the location where services were provided, and the classification of sick- vs. well-baby visits. Future studies that evaluate health care utilisation data should take these discrepancies into consideration in their selection of information source, and in their interpretation of the data.

Male sex and intraventricular hemorrhage.

BACKGROUND: Neonatal mortality and morbidity are sex biased in low birth weight infants. The "Y chromosome effect" has been suggested to be responsible for these maturational differences. OBJECTIVE: To examine the association of sex and neonatal outcomes. DESIGN AND METHODS: A retrospective observational study. Data on all low birth weight infants who survived for >48 hrs were analyzed. Neonatal outcomes were compared between male and female infants. A regression model was used to detect the influence of sex on outcomes after controlling for confounders. Analysis was repeated after stratification of infants into three groups: group A (<1000 g), group B (1000-1499 g), and group C (1500-2499 g). RESULTS: A total of 833 infants were included in this study; 419 female infants and 414 male infants. Male infants had an increased rate of overall intraventricular hemorrhage (IVH) (12.2% vs. 7.2%, p = .02) and IVH grades 3-4 (4.8% vs. 2.3%, p = .04). In addition, male infants had higher bilirubin levels (10.19 +/- 3.1 mg/dL vs. 9.32 +/- 2.94 mg/dL, p = .001). In a regression model, male sex continued to have significant influence on IVH, IVH grades 3-4, death, and bilirubin. In group A, male infants had a significantly increased prevalence of death (regression coefficient, 1.82 +/- 0.65; p = .005) that could not be explained by the increased prevalence of IVH (p = .18) in regression analysis. In group B, male sex was significantly associated with a higher bilirubin level (regression coefficient, 0.94 + 0.3; p = .002). In bivariate analyses, IVH and IVH grades 3-4 were significantly higher in male compared with female infants (19.8% vs. 3.9%, p < .0001) and (8.5% vs. 0.97%, p = .02), respectively, but these differences lost significance in multiple-regression analysis. In group C, male sex positively influenced the prevalence of IVH (regression coefficient, 1.7 +/- 0.57; p = .003). Bilirubin measured higher in male infants (11.38 +/- 2.87 mg/dL vs. 10.19 +/- 3.22 mg/dL, p = .0004), but the difference lost significance in regression analysis (regression coefficient, 0.21 +/- 0.31; p = .5). CONCLUSIONS: Bilirubin, IVH, and death were significantly higher in male infants. In subgroup analysis, significance was retained in group A (<1000 g). Whether a single biological factor is responsible for these differences or perhaps a multi-causal process involving a complex interaction of physiologic, environmental, and pathologic responses needs to be further addressed in future research.

Is bloodstream infection preventable among premature infants? A tale of two cities.

BACKGROUND: Bloodstream infection (BSI) is a significant cause of morbidity and death encountered in the NICU. The rates of BSIs vary significantly in NICUs across the nation. However, no attempt has been made to correlate this variation with specific infection-control practices and policies. We experienced a significant increase in BSIs in the NICU at the George Washington University Hospital and were seeking additional precautionary measures to reduce BSI rates. Our objective was to review policies and practices associated with lower infection rates nationally and to test their reproducibility in our unit. DESIGN AND METHODS: Data on BSI rates in 16 NICUs were reviewed. The BSI rate at Connecticut Children's Medical Center (CCMC) was the lowest among those reviewed. A team from George Washington University Hospital conducted a site visit to CCMC to examine their practices. Differences in the aseptic precautions used for intravenous line management were noted at CCMC, where a closed medication system is used. This system was applied at George Washington University Hospital starting January 1, 2001. Infection rates among low birth weight infants (<2500 g) at George Washington University Hospital in the period from January 1998 to December 2000 (group 1) were compared with those in the period from January 2001 to December 2003 (group 2). Comparisons between the 2 cohorts were made with Fisher's exact test, the Kruskal-Wallis test, and Student's t test. Multivariate analysis was used to control for differences in birth weight, gestational age, central line days, and ventilator days. Analyses were repeated for the subgroup of very low birth weight infants (<1500 g). RESULTS: A total of 536 inborn low birth weight infants were included in this retrospective study (group 1, N = 169 infants; group 2, N = 367). The incidence of sepsis decreased significantly from group 1 to group 2 (25.4% and 2.2%, respectively). The reduction of sepsis observed in association with the new practice was statistically significant after controlling for birth weight, central line days, and ventilator days in a multiple regression model (regression coefficient: 0.95 +/- 0.29). The odds ratio of reduction in sepsis after implementation of the new practice was 2.6 (95% confidence interval: 1.5-4.5). The central line-related BSI rate decreased from 15.17 infections per 1000 line days to 2.1 infections per 1000 line days. The study included 233 very low birth weight infants, ie, 90 in group 1 and 143 in group 2. The rate of BSIs decreased significantly from group 1 to group 2 (46.7% and 5.6%, respectively). The decrease in sepsis rate remained significant in a multiple regression model (regression coefficient: 1.42 +/- 0.35). The odds ratio of decreased sepsis in relation to the new policy application among the very low birth weight infants was 4.15 (95% confidence interval: 2.1-8.3). CONCLUSION: Applying the closed medication system was associated with reduced BSI rates in our unit. This protocol was easily reproducible in our environment and showed immediate results. Serious attempts to share data can potentially optimize outcomes and standardize policies and practices among NICUs.