Michele Kiely

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

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

BackgroundResearchers 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.MethodsPregnant 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.ResultsOf 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.ConclusionWe 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.

Genetic variants and the risk of gestational diabetes mellitus: a systematic review

BACKGROUND Several studies have examined associations between genetic variants and the risk of gestational diabetes mellitus (GDM). However, inferences from these studies were often hindered by limited statistical power and conflicting results. We aimed to systematically review and quantitatively summarize the association of commonly studied single nucleotide polymorphisms (SNPs) with GDM risk and to identify important gaps that remain for consideration in future studies. METHODS Genetic association studies of GDM published through 1 October 2012 were searched using the HuGE Navigator and PubMed databases. A SNP was included if the SNP-GDM associations were assessed in three or more independent studies. Two reviewers independently evaluated the eligibility for inclusion and extracted the data. The allele-specific odds ratios (ORs) and 95% confidence intervals (CIs) were pooled using random effects models accounting for heterogeneity. RESULTS Overall, 29 eligible articles capturing associations of 12 SNPs from 10 genes were included for the systematic review. The minor alleles of rs7903146 (TCF7L2), rs12255372 (TCF7L2), rs1799884 (-30G/A, GCK), rs5219 (E23K, KCNJ11), rs7754840 (CDKAL1), rs4402960 (IGF2BP2), rs10830963 (MTNR1B), rs1387153 (MTNR1B) and rs1801278 (Gly972Arg, IRS1) were significantly associated with a higher risk of GDM. Among them, genetic variants in TCF7L2 showed the strongest association with GDM risk, with ORs (95% CIs) of 1.44 (1.29-1.60, P < 0.001) per T allele of rs7903146 and 1.46 (1.15-1.84, P = 0.002) per T allele of rs12255372. CONCLUSIONS In this systematic review, we found significant associations of GDM risk with nine SNPs in seven genes, most of which have been related to the regulation of insulin secretion.

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.

Adipokine levels during the first or early second trimester of pregnancy and subsequent risk of gestational diabetes mellitus: A systematic review.

OBJECTIVE We aimed to systematically review available literature linking adipokines to gestational diabetes mellitus (GDM) for a comprehensive understanding of the roles of adipokines in the development of GDM. METHODS We searched PubMed/MEDLINE and EMBASE databases for published studies on adipokines and GDM through October 21, 2014. We included articles if they had a prospective study design (i.e., blood samples for adipokines measurement were collected before GDM diagnosis). Random-effects models were used to pool the weighted mean differences comparing levels of adipokines between GDM cases and non-GDM controls. RESULTS Of 1523 potentially relevant articles, we included 25 prospective studies relating adipokines to incident GDM. Our meta-analysis of nine prospective studies on adiponectin and eight prospective studies on leptin indicated that adiponectin levels in the first or early second trimester of pregnancy were 2.25 μg/ml lower (95% CI: 1.75-2.75), whereas leptin levels were 7.25 ng/ml higher (95% CI 3.27-11.22), among women who later developed GDM than women who did not. Prospective data were sparse and findings were inconsistent for visfatin, retinol binding protein (RBP-4), resistin, tumor necrosis factor-α (TNF-α), interleukin-6 (IL-6), and vaspin. We did not identify prospective studies for several novel adipokines, including chemerin, apelin, omentin, or adipocyte fatty acid-binding protein. Moreover, no published prospective studies with longitudinal assessment of adipokines and incident GDM were identified. CONCLUSION Adiponectin levels in the first or second trimester of pregnancy are lower among pregnant women who later develop GDM than non-GDM women, whereas leptin levels are higher. Well-designed prospective studies with longitudinal assessment of adipokines during pregnancy are needed to understand the trajectories and dynamic associations of adipokines with GDM risk.

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 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. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00381823 LEVEL OF EVIDENCE: I

Gestational diabetes, pre-pregnancy obesity and pregnancy weight gain in relation to excess fetal growth: variations by race/ethnicity

Aims/hypothesisThe escalating rate of childhood obesity is a public health concern worldwide, with children in certain ethnic groups being disproportionately affected. Our objective was to examine the joint effects of pre-pregnancy adiposity, pregnancy weight gain and gestational diabetes (GDM) in relation to excess fetal growth and to identify susceptible races or ethnic populations.MethodsThe risk for delivery of a large-for-gestational-age (LGA) infant, specific to race and fetal sex, was evaluated in 105,985 pregnancies in the Consortium on Safe Labor from 2002–2008. Generalised estimating equations were used to estimate the risk for delivery of LGA infants. Joint effects were employed to evaluate the interplay of three risk factors. Models were stratified by racial group considering one, two or three factors (i.e. pre-pregnancy adiposity, pregnancy weight gain and GDM, with 0 factors as the reference group).ResultsGreater pre-pregnancy adiposity, pregnancy weight gain and GDM were independently associated with increased risk of giving birth to an LGA infant across all races (except GDM among non-Hispanic whites), in both underweight and normal-weight women. Among non-Hispanic white, non-Hispanic black and Hispanic women, the three-factor joint effect was associated with substantially increased odds of LGA (OR [95% CI] 11.27 [8.40, 15.11], 7.09 [4.81, 10.45] and 10.19 [6.84, 15.19], respectively). However, for Asian women the joint effect of all three factors (OR [95% CI] 5.14 [2.11, 12.50]) was approximately the same as any of the two factors.Conclusions/interpretationGDM, pre-pregnancy obesity and excessive pregnancy weight gain were jointly associated with elevated risk of giving birth to an LGA infant and the effects varied by race. This suggests that those involved in public health efforts aimed at preventing LGA deliveries should consider variations in racial groups when devising effective strategies.

Health Beliefs and Parenting Attitudes Influence Breastfeeding Patterns Among Low-income African-American women

OBJECTIVE: To describe breastfeeding initiation among 210 urban African-American mothers with inadequate prenatal care.METHODS:This study is a case–control study of postpartum mothers recruited from four large urban hospitals.RESULTS: Mothers who chose to breastfeed were more educated, employed before birth, married, and using contraception postnatally. Regression model analysis controlling for demographic differences revealed that breastfeeding was significantly associated with a higher perception of severity of illness and higher confidence in the ability of health care to prevent illness. Breastfeeding mothers were less likely to reverse parent–child roles and had a lower perception of hassle from their infants behavior. When comparing mothers who breastfed longer than 8 weeks to those who did not breastfeed, breastfeeding mothers had high scores related to empathy toward infants on the Adult–Adolescent Parenting Inventory as well as a low perception of hassle on the Parenting Daily Hassle. The perception of existing formal or informal social support did not influence breastfeeding behavior.Personal attributes of low-income urban mothers such as health beliefs and parental attitudes may play a role in the initiation and duration of breastfeeding. Low-income African-American mothers may be influenced in their choice to breastfeed by supportive messages from physicians and nurses delivering care to mothers and their newborns. Emphasis should be placed on the role breastfeeding can play in preventing childhood illnesses.

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.