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.

Long-term risk of type 2 diabetes mellitus in relation to BMI and weight change among women with a history of gestational diabetes mellitus: a prospective cohort study.

AIMS/HYPOTHESIS: Women with a history of gestational diabetes mellitus (GDM) are advised to control their weight after pregnancy. We aimed to examine how adiposity and weight change influence the long-term risk of developing type 2 diabetes after GDM. METHODS: We included 1,695 women who had incident GDM between 1991 and 2001, as part of the Diabetes & Women's Health study, and followed them until the return of the 2009 questionnaire. Body weight and incident type 2 diabetic cases were reported biennially. We defined baseline as the questionnaire period when women reported an incident GDM pregnancy. We estimated HRs and 95% CIs using Cox proportional hazards models. RESULTS: We documented 259 incident cases of type 2 diabetes during up to 18 years of follow-up. The adjusted HRs of type 2 diabetes associated with each 1 kg/m(2) increase in BMI were 1.16 (95% CI 1.12, 1.19) for baseline BMI and 1.16 (95% CI 1.13, 1.20) for most recent BMI. Moreover, each 5 kg increment of weight gain after GDM development was associated with a 27% higher risk of type 2 diabetes (adjusted HR 1.27; 95% CI 1.04, 1.54). Jointly, women who had a BMI ≥30.0 kg/m(2) at baseline and gained ≥5 kg after GDM had an adjusted HR of 43.19 (95% CI 13.60, 137.11), compared with women who had a BMI <25.0 kg/m(2) at baseline and gained <5 kg after GDM. CONCLUSIONS/INTERPRETATION: Baseline BMI, most recent BMI and weight gain after GDM were significantly and positively associated with risk of progression from GDM to type 2 diabetes.

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.

Rationale, design, and method of the Diabetes & Women's Health study--a study of long-term health implications of glucose intolerance in pregnancy and their determinants.

Women who develop gestational diabetes mellitus or impaired glucose tolerance during pregnancy are at substantially increased risk for type 2 diabetes and comorbidities after pregnancy. Little is known about the role of genetic factors and their interactions with environmental factors in determining the transition from gestational diabetes mellitus to overt type 2 diabetes mellitus. These critical data gaps served as the impetus for this Diabetes & Women's Health study with the overall goal of investigating genetic factors and their interactions with risk factors amenable to clinical or public health interventions in relation to the transition of gestational diabetes mellitus to type 2 diabetes mellitus. To achieve the goal efficiently, we are applying a hybrid design enrolling and collecting data longitudinally from approximately 4000 women with a medical history of gestational diabetes mellitus in two existing prospective cohorts, the Nurses' Health Study II and the Danish National Birth Cohort. Women who had a medical history of gestational diabetes mellitus in one or more of their pregnancies are eligible for the present study. After enrollment, we follow study participants for an additional 2 years to collect updated information on major clinical and environmental factors that may predict type 2 diabetes mellitus risk as well as with biospecimens to measure genetic and biochemical markers implicated in glucose metabolism. Newly collected data will be appended to the relevant existing data for the creation of a new database inclusive of genetic, epigenetic and environmental data. Findings from the study are critical for the development of targeted and more effective strategies to prevent type 2 diabetes mellitus and its complications in this high-risk population.

The association between a medical history of depression and gestational diabetes in a large multi-ethnic cohort in the United States.

BACKGROUND: Both major depression and gestational diabetes mellitus (GDM) are prevalent among women of reproductive age. Our objective was to determine whether a medical history of depression is related to subsequent development of GDM. METHODS: The Consortium on Safe Labor was a US retrospective cohort study of 228,562 births between 2002 and 2008. Exclusion criteria for the present analysis included multiple gestation pregnancies (n = 5059), pre-existing diabetes (n = 12,771), deliveries <24 weeks (n = 395), site GDM prevalence (<1%) (n = 20, 721) and missing data on pre-pregnancy body mass index (BMI) (n = 61,321). Using generalised estimating equations, we estimated the association between a history of depression and a pregnancy complicated by GDM. RESULTS: The final analytic population included 121, 260 women contributing 128 295 pregnancies, of which 5606 were affected by GDM. A history of depression was significantly associated with an increased risk of developing GDM (multivariate odds ratio [aOR] = 1.42 [95% confidence interval (CI) 1.26, 1.60]). Adjusting for pre-pregnancy BMI and weight gain during pregnancy attenuated the association, although it remained statistically significant (aOR = 1.17 [95% CI 1.03, 1.33]). CONCLUSIONS: A history of depression was significantly associated with an increased GDM risk among a large multi-ethnic US cohort of women. If the association is confirmed, depression presents a potentially modifiable risk factor of GDM and provides additional clues to the underlying pathophysiology of GDM.

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.

Patterns of alcohol consumption among pregnant African-American women in Washington, DC, USA.

The objective of this paper is to describe the patterns and associated behaviours related to alcohol consumption among a selected sample of pregnant women seeking prenatal care in inner city Washington DC. Women receiving prenatal care at one of nine sites completed an anonymous alcohol-screening questionnaire. Questions concerned the amount, type and pattern of alcohol consumption. Women were categorised as at no, low, moderate or high risk for alcohol consumption during pregnancy. For comparisons of risk levels of drinking, bivariate associations were examined using Fisher's exact test. Odds ratios (ORs) and 95% confidence intervals (CIs) were also computed. Although 31% of current/recent drinkers stated that they continued to drink during pregnancy, responses to quantity/frequency questions revealed that 42% continued to do so. Women who were at high compared with moderate risk acknowledged that others were worried about their consumption [OR=4.0, 95% CI 1.5, 10.6], that they drank upon rising [OR=6.7, 95% CI 1.8, 26.9], had a need to reduce drinking [OR=3.2, 95% CI 1.3, 8.1] and in the past 5 years had had fractures [OR=4.2, 95% CI 1.0, 17.8] or a road traffic injury [OR=3.4, 95% CI 1.0, 12.2]. Women in the high/moderate compared with low-risk group were more likely to have been injured in a fight or assault [OR=2.7, 95% CI 1.3, 5.6]. This study validated the usefulness of our questionnaire in identifying women who were at risk for alcohol consumption during pregnancy across a range of consumption levels. Using our screening tool, women were willing to disclose their drinking habits. This low-cost method identifies women appropriate for targeting of interventions.

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.

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,

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.

Efficacy of a randomized cell phone-based counseling intervention in postponing subsequent pregnancy among teen mothers.

Adolescent mothers in Washington, DC have a high rate of subsequent teen pregnancies, often within 24 months. Children of teen mothers are at risk for adverse psychosocial outcomes. When adolescents are strongly attached to parents, schools, and positive peers, they may be less likely to repeat a pregnancy. This study tested the efficacy of a counseling intervention delivered by cell phone and focused on postponing subsequent teen pregnancies by strengthening healthy relationships, reproductive practices, and positive youth assets. The objective of this study was to compare time to a repeat pregnancy between the intervention and usual care groups, and, secondarily, to determine whether treatment intensity influenced time to subsequent conception. Primiparous pregnant teens ages 15-19, were recruited in Washington, DC. Of 849 teens screened, 29.3% (n = 249) met inclusion criteria, consented to participate, and completed baseline measures. They were then randomized to the intervention (N = 124) or to usual care (N = 125). Intervention group teens received cell phones for 18 months of counseling sessions, and quarterly group sessions. Follow-up measures assessed subsequent pregnancy through 24 months post-delivery. A survival analysis compared time to subsequent conception in the two treatment groups. Additional models examined the effect of treatment intensity. By 24 months, 31% of the intervention and 36% of usual care group teens had a subsequent pregnancy. Group differences were not statistically significant in intent-to-treat analysis. Because there was variability in the degree of exposure of teens to the curriculum, a survival analysis accounting for treatment intensity was performed and a significant interaction with age was detected. Participants who were aged 15-17 years at delivery showed a significant reduction in subsequent pregnancy with increased levels of intervention exposure (P < 0.01), but not those ≥ 18 years. Adolescents ≥ 18 years faced considerable challenges to treatment success. Individual, social, and contextual factors are all important to consider in the prevention of repeat teen pregnancy. Cell phone-based approaches to counseling may not be the most ideal for addressing complex, socially-mediated behaviors such as this, except for selective subgroups. A lack of resources within the community for older teens may interfere with program success.

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.

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.

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.

A safety-net antibiotic prescription for otitis media: the effects of a PBRN study on patients and practitioners.

Pediatricians can decrease antibiotic use by treating acute otitis media (AOM) with a safety-net antibiotic prescription (SNAP). This study assessed whether the practitioners of the Practice-Based Research Network who participated in the study continued to use the SNAP and report a 60-day follow-up of the study patients. Charts were reviewed of study patients for 60 days following study enrollment. A survey on antibiotic use for AOM was mailed to the 17 study practitioners (SP) and 30 randomly selected community pediatricians (CP). Eight of the SP used the SNAP more than 20 times over the year following the study vs 1 of the CP. Sixty-two percent of patients never received antibiotics. The recurrence/relapse rate was greater in children younger than 2 years old compared to those older, 34% vs 10%. Practitioners who participate in a Practice-Based Research Network study are more likely to use a study intervention than others.

Reproductive Health Knowledge among African American Women Enrolled in a Clinic-Based Randomized Controlled Trial to Reduce Psychosocial and Behavioral Risk: Project DC-HOPE.

BACKGROUND: Washington, DC, has among the highest rates of sexually transmitted infections and unintended pregnancy in the United States. Increasing women's reproductive health knowledge may help to address these reproductive health issues. This analysis assessed whether high-risk pregnant African American women in Washington, DC, who participated in an intervention to reduce behavioral and psychosocial risks had greater reproductive health knowledge than women receiving usual care. METHODS: Project DC-HOPE was a randomized, controlled trial that included pregnant African American women in Washington, DC, recruited during prenatal care (PNC). Women in the intervention group were provided reproductive health education and received tailored counseling sessions to address their psychosocial and behavioral risk(s) (cigarette smoking, environmental tobacco smoke exposure, depression, and intimate partner violence). Women in the control group received usual PNC. Participants completed a 10-item reproductive knowledge assessment at baseline (n = 1,044) and postpartum (n = 830). Differences in total reproductive health knowledge scores at baseline and postpartum between groups were examined via χ(2) tests. Differences in postpartum mean total score by group were assessed via multiple linear regression. RESULTS: Women in both groups and at both time points scored approximately 50% on the knowledge assessments. At postpartum, women in the intervention group had higher total scores compared with women receiving usual care (mean 5.40 [SD 1.60] vs. 5.03 [SD 1.53] out of 10, respectively; p < .001). CONCLUSIONS: Although intervention participants increased reproductive health knowledge, overall scores remained low. Development of interventions designed to impart accurate, individually tailored information to women may promote reproductive health knowledge among high-risk pregnant African American women residing in Washington, DC.