Discrimination and Adverse Perinatal Health Outcomes: A Latent Class Analysis.

INTRODUCTION: An intersectionality framework recognizes individuals as simultaneously inhabiting multiple intersecting social identities embedded within systems of disadvantage and privilege. Previous research links perceived discrimination with worsened health outcomes yet is limited by a focus on racial discrimination in isolation. We applied an intersectional approach to the study of discrimination to examine the association with adverse perinatal health outcomes. METHODS: We analyzed data from a cohort of 2,286 pregnant participants (Black, n = 933; Hispanic, n = 471; White, n = 853; and Other, n = 29) from the Centering and Racial Disparities trial. Perceived discrimination was assessed via the Everyday Discrimination Scale (EDS) and perinatal health outcomes collected via electronic medical record review. Latent class analysis was used to identify subgroups of discrimination based on EDS item response and the rate of adverse perinatal health outcomes compared between subgroups using a Bolck, Croon and Hagenaars 3-step approach. RESULTS: Four discrimination subgroups were identified: no discrimination, general discrimination, discrimination attributed to one or several social identities, and discrimination attributed to most or all social identities. Experiencing general discrimination was associated with postpartum depression symptoms when compared with experiencing no discrimination among Black (9% vs 5%, P = .04) and White participants (18% vs 9%, P = .01). White participants experiencing general discrimination gave birth to low birthweight infants at a higher rate than those experiencing no discrimination (11% vs 6%, P = .04). No significant subgroup differences were observed among Hispanic participants. CONCLUSION: Perceived discrimination may play an influential role in shaping perinatal health. More research applying an intersectional lens to the study of discrimination and perinatal health outcomes is needed.

Inflammatory markers in serum and placenta in a randomized controlled trial of group prenatal care.

BACKGROUND: Racial and socioeconomic disparities in preterm birth and small for gestational age births are growing in the United States, increasing the burden of morbidity and mortality particularly among Black women and birthing persons and their infants. Group prenatal care is one of the only interventions to show potential to reduce the disparity, but the mechanism is unclear. OBJECTIVE: The goal of this project was to identify if group prenatal care, when compared with individual prenatal care, was associated with a reduction in systemic inflammation during pregnancy and a lower prevalence of inflammatory lesions in the placenta at delivery. STUDY DESIGN: The Psychosocial Intervention and Inflammation in Centering Study was a prospective cohort study that exclusively enrolled participants from a large randomized controlled trial of group prenatal care (the Cradle study, R01HD082311, ClinicalTrials.gov: NCT02640638) that was performed at a single site in Greenville, South Carolina, from 2016 to 2020. In the Cradle study, patients were randomized to either group prenatal care or individual prenatal care, and survey data were collected during the second and third trimesters. The Psychosocial Intervention and Inflammation in Centering Study cohort additionally provided serum samples at these 2 survey time points and permitted collection of placental biopsies for inflammatory and histologic analysis, respectively. We examined associations between group prenatal care treatment and a composite of z scored serum inflammatory biomarkers (C-reactive protein, interleukin-6, interleukin-1 receptor antagonist, interleukin-10, and tumor necrosis factor α) in both the second and third trimesters and the association with the prevalence of acute and chronic maternal placental inflammatory lesions. Analyses were conducted using the intent to treat principle, and the results were also examined by attendance of visits in the assigned treatment group (modified intent to treat and median or more number of visits) and were stratified by race and ethnicity. RESULTS: A total of 1256 of 1375 (92%) Cradle participants who were approached enrolled in the Psychosocial Intervention and Inflammation in Centering Study, which included 54% of all the Cradle participants. The Psychosocial Intervention and Inflammation in Centering Study cohort did not differ from the Cradle cohort by demographic or clinical characteristics. Among the 1256 Psychosocial Intervention and Inflammation in Centering Study participants, 1133 (89.6%) had placental data available for analysis. Among those, 549 were assigned to group prenatal care and 584 of 1133 were assigned to individual prenatal care. In the intent to treat and modified intent to treat cohorts, participation in group prenatal care was associated with a higher serum inflammatory score, but it was not associated with an increased prevalence of placental inflammatory lesions. In the stratified analyses, group prenatal care was associated with a higher second trimester inflammatory biomarker composite (modified intent to treat: B=1.17; P=.02; and median or more visits: B=1.24; P=.05) among Hispanic or Latine participants. CONCLUSION: Unexpectedly, group prenatal care was associated with higher maternal serum inflammation during pregnancy, especially among Hispanic or Latine participants.

Randomized Controlled Trial on the Effect of Group Versus Individual Prenatal Care on Psychosocial Outcomes.

OBJECTIVE: To assess the effect of group prenatal care (GPNC) compared with individual prenatal care (IPNC) on psychosocial outcomes in late pregnancy, including potential differences in outcomes by subgroups. DESIGN: Randomized controlled trial. SETTING: An academic medical center in the southeastern United States. PARTICIPANTS: A total of 2,348 women with low-risk pregnancies who entered prenatal care before 20 6/7 weeks gestation were randomized to GPNC (n = 1,175) or IPNC (n = 1,173) and stratified by self-reported race and ethnicity. METHODS: We surveyed participants during enrollment (M = 12.21 weeks gestation) and in late pregnancy (M = 32.51 weeks gestation). We used standard measures related to stress, anxiety, coping strategies, empowerment, depression symptoms, and stress management practices in an intent-to-treat regression analysis. To account for nonadherence to GPNC treatment, we used an instrumental variable approach. RESULTS: The response rates were high, with 78.69% of participants in the GPNC group and 83.89% of participants in the IPNC group completing the surveys. We found similar patterns for both groups, including decrease in distress and increase in anxiety between surveys and comparable levels of pregnancy empowerment and stress management at the second survey. We identified greater use of coping strategies for participants in the GPNC group, particularly those who identified as Black or had low levels of partner support. CONCLUSION: Group prenatal care did not affect stress and anxiety in late pregnancy; however, the increased use of coping strategies may suggest a benefit of GPNC for some participants.

Group vs Individual Prenatal Care and Gestational Diabetes Outcomes: A Secondary Analysis of a Randomized Clinical Trial.

Importance: The impact of group-based prenatal care (GPNC) model in the US on the risk of gestational diabetes (GD) and related adverse obstetric outcomes is unknown. Objective: To determine the effects of the GPNC model on risk of GD, its progression, and related adverse obstetric outcomes. Design, Setting, and Participants: This is a single-site, parallel-group, randomized clinical trial conducted between February 2016 and March 2020 at a large health care system in Greenville, South Carolina. Participants were individuals aged 14 to 45 years with pregnancies earlier than 21 weeks' gestational age; follow-up continued to 8 weeks post partum. This study used an intention-to-treat analysis, and data were analyzed from March 2021 to July 2022. Interventions: Eligible participants were randomized to receive either CenteringPregnancy, a widely used GPNC model, with 10 group-based sessions or traditional individual prenatal care (IPNC). Main Outcomes and Measures: The primary outcome was the incidence of GD diagnosed between 24 and 30 weeks of gestation. The secondary outcomes included progression to A2 GD (ie, GD treated with medications) and GD-related adverse obstetric outcomes (ie, preeclampsia, cesarean delivery, and large for gestational age). Log binomial models were performed to estimate risk differences (RDs), 95% CIs, and P values between GPNC and IPNC groups, adjusting for all baseline covariates. Results: Of all 2348 participants (mean [SD] age, 25.1 [5.4] years; 952 Black participants [40.5%]; 502 Hispanic participants [21.4%]; 863 White participants [36.8%]), 1176 participants were randomized to the GPNC group and 1174 were randomized to the IPNC group. Among all participants, 2144 (91.3%) completed a GD screening (1072 participants [91.3%] in GPNC vs 1071 [91.2%] in IPNC). Overall, 157 participants (6.7%) developed GD, and there was no difference in GD incidence between the GPNC (83 participants [7.1%]) and IPNC (74 participants [6.3%]) groups, with an adjusted RD of 0.7% (95% CI, -1.2% to 2.7%). Among participants with GD, GPNC did not reduce the risk of progression to A2 GD (adjusted RD, -6.1%; 95% CI, -21.3% to 9.1%), preeclampsia (adjusted RD, -7.9%; 95% CI, -17.8% to 1.9%), cesarean delivery (adjusted RD, -8.2%; 95% CI, -12.2% to 13.9%), and large for gestational age (adjusted RD, -1.2%; 95% CI, -6.1% to 3.8%) compared with IPNC. Conclusions and Relevance: In this secondary analysis of a randomized clinical trial among medically low-risk pregnant individuals, the risk of GD was similar between participants who received GPNC intervention and traditional IPNC, indicating that GPNC may be a feasible treatment option for some patients. Trial Registration: ClinicalTrials.gov Identifier: NCT02640638.

Well Child Visit Attendance for Group Prenatal Care Participants.

OBJECTIVES: Participation in group prenatal care (GPNC) has been associated with increased attendance at prenatal, family planning and postpartum visits. We explored whether GPNC participation is associated with pediatric care engagement by measuring well-child visit (WCV) attendance among infants whose births were covered by Medicaid. METHODS: We used Medicaid claims and vital statistics from the South Carolina Department of Health and Human Services and GPNC site participation records (2013-2018). We compared WCV attendance of CenteringPregnancy GPNC patients to a propensity-score matched cohort of individual prenatal care patients (IPNC) across 21 prenatal care practices using linear probability models. The primary outcome measure was attending 6 or more WCVs in the first 15 months, a Healthcare Effectiveness Data and Information Set (HEDIS) performance measure. RESULTS: No differences in WCV were observed when comparing any exposure to GPNC (one or more sessions) to IPNC. We identified 3191 patients who participated in GPNC and matched these with 5184 in IPNC. Participation in 5 or more GPNC sessions compared to 5 or more prenatal visits was associated with higher rates of WCV compliance over the first 15 months (4.7 percentage point difference [95% CI 3.1-6.3%, P < .001]), with stronger associations between GPNC and WCV attendance for low birthweight infants, for Black infants, and for infants of mothers with no previous live births. CONCLUSIONS: This study suggests GPNC may modestly influence WCV attendance. The potential mechanisms and dose response require further investigation. Gaps in WCV attendance compared to benchmarks persist regardless of PNC model.

Clinical and economic evaluation of a proteomic biomarker preterm birth risk predictor: cost-effectiveness modeling of prenatal interventions applied to predicted higher-risk pregnancies within a large and diverse cohort.

OBJECTIVES: Preterm birth occurs in more than 10% of U.S. births and is the leading cause of U.S. neonatal deaths, with estimated annual costs exceeding $25 billion USD. Using real-world data, we modeled the potential clinical and economic utility of a prematurity-reduction program comprising screening in a racially and ethnically diverse population with a validated proteomic biomarker risk predictor, followed by case management with or without pharmacological treatment. METHODS: The ACCORDANT microsimulation model used individual patient data from a prespecified, randomly selected sub-cohort (N = 847) of a multicenter, observational study of U.S. subjects receiving standard obstetric care with masked risk predictor assessment (TREETOP; NCT02787213). All subjects were included in three arms across 500 simulated trials: standard of care (SoC, control); risk predictor/case management comprising increased outreach, education and specialist care (RP-CM, active); and multimodal management (risk predictor/case management with pharmacological treatment) (RP-MM, active). In the active arms, only subjects stratified as higher risk by the predictor were modeled as receiving the intervention, whereas lower-risk subjects received standard care. Higher-risk subjects' gestational ages at birth were shifted based on published efficacies, and dependent outcomes, calibrated using national datasets, were changed accordingly. Subjects otherwise retained their original TREETOP outcomes. Arms were compared using survival analysis for neonatal and maternal hospital length of stay, bootstrap intervals for neonatal cost, and Fisher's exact test for neonatal morbidity/mortality (significance, p < .05). RESULTS: The model predicted improvements for all outcomes. RP-CM decreased neonatal and maternal hospital stay by 19% (p = .029) and 8.5% (p = .001), respectively; neonatal costs' point estimate by 16% (p = .098); and moderate-to-severe neonatal morbidity/mortality by 29% (p = .025). RP-MM strengthened observed reductions and significance. Point estimates of benefit did not differ by race/ethnicity. CONCLUSIONS: Modeled evaluation of a biomarker-based test-and-treat strategy in a diverse population predicts clinically and economically meaningful improvements in neonatal and maternal outcomes.

Preterm birth, defined as delivery before 37 weeks' gestation, is the leading cause of illness and death in newborns. In the United States, more than 10% of infants are born prematurely, and this rate is substantially higher in lower-income, inner-city and Black populations. Prematurity associates with greatly increased risk of short- and long-term medical complications and can generate significant costs throughout the lives of affected children. Annual U.S. health care costs to manage short- and long-term prematurity complications are estimated to exceed $25 billion.Clinical interventions, including case management (increased patient outreach, education and specialist care), pharmacological treatment and their combination can provide benefit to pregnancies at higher risk for preterm birth. Early and sensitive risk detection, however, remains a challenge.We have developed and validated a proteomic biomarker risk predictor for early identification of pregnancies at increased risk of preterm birth. The ACCORDANT study modeled treatments with real-world patient data from a racially and ethnically diverse U.S. population to compare the benefits of risk predictor testing plus clinical intervention for higher-risk pregnancies versus no testing and standard care. Measured outcomes included neonatal and maternal length of hospital stay, associated costs and neonatal morbidity and mortality. The model projected improved outcomes and reduced costs across all subjects, including ethnic and racial minority populations, when predicted higher-risk pregnancies were treated using case management with or without pharmacological treatment. The biomarker risk predictor shows high potential to be a clinically important component of risk stratification for pregnant women, leading to tangible gains in reducing the impact of preterm birth.

Group vs traditional prenatal care for improving racial equity in preterm birth and low birthweight: the Centering and Racial Disparities randomized clinical trial study.

BACKGROUND: The United States has persistently high rates of preterm birth and low birthweight and is characterized by significant racial disparities in these rates. Innovative group prenatal care models, such as CenteringPregnancy, have been proposed as a potential approach to improve the rates of preterm birth and low birthweight and to reduce disparities in these pregnancy outcomes. OBJECTIVE: This study aimed to test whether participation in group prenatal care would reduce the rates of preterm birth and low birthweight compared with individual prenatal care and whether group prenatal care would reduce the racial disparity in these rates between Black and White patients. STUDY DESIGN: This was a randomized controlled trial among medically low-risk pregnant patients at a single study site. Eligible patients were stratified by self-identified race and ethnicity and randomly allocated 1:1 between group and individual prenatal care. The primary outcomes were preterm birth at <37 weeks of gestation and low birthweight of <2500 g. The primary analysis was performed according to the intent-to-treat principle. The secondary analyses were performed according to the as-treated principle using modified intent-to-treat and per-compliance approaches. The analysis of effect modification by race and ethnicity was planned. RESULTS: A total of 2350 participants were enrolled, with 1176 assigned to group prenatal care and 1174 assigned to individual prenatal care. The study population included 952 Black (40.5%), 502 Hispanic (21.4%), 863 White (36.8%), and 31 "other races or ethnicity" (1.3%) participants. Group prenatal care did not reduce the rate of preterm birth (10.4% vs 8.7%; odds ratio, 1.22; 95% confidence interval, 0.92-1.63; P=.17) or low birthweight (9.6% vs 8.9%; odds ratio, 1.08; 95% confidence interval, 0.80-1.45; P=.62) compared with individual prenatal care. In subgroup analysis, greater attendance in prenatal care was associated with lower rates of preterm birth and low birthweight. This effect was most noticeable for the rates of low birthweight for Black participants in group care: intent to treat (51/409 [12.5%]), modified intent to treat (36/313 [11.5%]), and per compliance (20/240 [8.3%]). Although the rates of low birthweight were significantly higher for Black participants than White participants seen in individual care (adjusted odds ratio, 2.00; 95% confidence interval, 1.14-3.50), the difference was not significant for Black participants in group care compared with their White counterparts (adjusted odds ratio, 1.58; 95% confidence interval, 0.74-3.34). CONCLUSION: There was no difference in the overall rates of preterm birth or low birthweight between group and individual prenatal care. With increased participation in group prenatal care, lower rates of preterm birth and low birthweight for Black participants were observed. The role of group care models in reducing racial disparities in these birth outcomes requires further study.

Group Prenatal Care and Emergency Room Utilization.

Pregnancy-related complaints are a significant driver of emergency room (ER) utilization among women. Because of additional time for patient education and provider relationships, group prenatal care may reduce ER visits among pregnant women by helping them identify appropriate care settings, improving understanding of common pregnancy discomforts, and reducing risky health behaviors. We conducted a retrospective cohort study, utilizing Medicaid claims and birth certificate data from a statewide expansion of group care, to compare ER utilization between pregnant women participating in group prenatal care and individual prenatal care. Using propensity score matching methods, we found that group care was associated with a significant reduction in the likelihood of having any ER utilization (-5.9% among women receiving any group care and -6.0% among women attending at least five group care sessions). These findings suggest that group care may reduce ER utilization among pregnant women and encourage appropriate health care utilization during pregnancy.

Performance of a proteomic preterm delivery predictor in a large independent prospective cohort.

BACKGROUND: Preterm birth remains a common and devastating complication of pregnancy. There remains a need for effective and accurate screening methods for preterm birth. Using a proteomic approach, we previously discovered and validated (Proteomic Assessment of Preterm Risk study, NCT01371019) a preterm birth predictor comprising a ratio of insulin-like growth factor-binding protein 4 to sex hormone-binding globulin. OBJECTIVE: To determine the performance of the ratio of insulin-like growth factor-binding protein 4 to sex hormone-binding globulin to predict both spontaneous and medically indicated very preterm births, in an independent cohort distinct from the one in which it was developed. STUDY DESIGN: This was a prospective observational study (Multicenter Assessment of a Spontaneous Preterm Birth Risk Predictor, NCT02787213) at 18 sites in the United States. Women had blood drawn at 170/7 to 216/7 weeks' gestation. For confirmation, we planned to analyze a randomly selected subgroup of women having blood drawn between 191/7 and 206/7 weeks' gestation, with the results of the remaining study participants blinded for future validation studies. Serum from participants was analyzed by mass spectrometry. Neonatal morbidity and mortality were analyzed using a composite score by a method from the PREGNANT trial (NCT00615550, Hassan et al). Scores of 0-3 reflect increasing numbers of morbidities or length of neonatal intensive care unit stay, and 4 represents perinatal mortality. RESULTS: A total of 5011 women were enrolled, with 847 included in this planned substudy analysis. There were 9 preterm birth cases at <320/7 weeks' gestation and 838 noncases at ≥320/7 weeks' gestation; 21 of 847 infants had neonatal composite morbidity and mortality index scores of ≥3, and 4 of 21 had a score of 4. The ratio of insulin-like growth factor-binding protein 4 to sex hormone-binding globulin ratio was substantially higher in both preterm births at <320/7 weeks' gestation and there were more severe neonatal outcomes. The ratio of insulin-like growth factor-binding protein 4 to sex hormone-binding globulin ratio was significantly predictive of birth at <320/7 weeks' gestation (area under the receiver operating characteristic curve, 0.71; 95% confidence interval, 0.55-0.87; P=.016). Stratification by body mass index, optimized in the previous validation study (22

Core strategies, social processes, and contextual influences of early phases of implementation and statewide scale-up of group prenatal care in South Carolina.

This mixed-methods process evaluation examined a state-wide, interagency collaborative in South Carolina that expanded CenteringPregnancy group prenatal care from two to five additional healthcare practices from 2012 to 2015. The evaluation focused on delineating core processes, strategies, and external contextual elements of group prenatal care implementation and scale-up. Success of this scale-up was enhanced by the effective use and creation of windows of opportunity, which allowed stakeholders to pursue actions consistent with their own values, at both state and organizational levels. Most importantly, strong political advocacy and state-level financial commitment for group prenatal care made it possible for clinics throughout South Carolina to begin providing CenteringPregnancy to their patients. Improved understanding of the processes involved in scaling-up pilot interventions may enhance the effectiveness and efficiency of future expansion efforts.

The Impact of CenteringPregnancy Group Prenatal Care on Birth Outcomes in Medicaid Eligible Women.

Background: CenteringPregnancy group prenatal care (GPNC) has been shown to reduce rates of preterm birth (PTB). We evaluated the impact of GPNC on spontaneous PTB (sPTB) as a first step in exploring the possible mechanism by which GPNC may decrease rates of PTB. We also evaluated whether attending more than five GPNC sessions affected PTB risk and examined all differences by race/ethnicity. Materials and Methods: We conducted a retrospective cohort study among women delivering at a single institution between April 2009 and March 2014. Birth outcome data from vital statistics records were appended to patient records, and detailed chart abstraction was used to determine spontaneous versus indicated PTB. The association between GPNC and attending more than five GPNC sessions and birth outcomes (i.e., PTB, sPTB, low birth weight [LBW], and neonatal intensive care unit [NICU] admissions) was analyzed using generalized estimating equation log binomial regression models. We examined effect modification of the associations by race/ethnicity. Results: The analysis included 1,292 women in GPNC and 8,703 in traditional individual prenatal care (IPNC). After controlling for potential confounders, the risk of PTB (risk ratio [RR] 0.38; 95% confidence interval [CI] 0.31-0.47), sPTB (RR 0.49; 95% CI 0.38-0.63), LBW (RR 0.46; 95% CI 0.37-0.56), and NICU admissions (RR 0.46; 95% CI 0.37-0.57) was lower in GPNC compared to IPNC women. Results differed by maternal race/ethnicity, with the strongest associations among non-Hispanic white mothers and the weakest associations among Hispanic mothers, especially for sPTB. Similarly, the risk of PTB, LBW, and NICU admissions was lower among GPNC women who attended more than five sessions. Conclusion: Participation in GPNC demonstrated a decreased risk for sPTB, as well as other adverse birth outcomes. In addition, participation in more than five GPNC sessions demonstrated a decreased risk for adverse birth outcomes. Prospective longitudinal studies are needed to further explore mechanisms associated with these findings.

Effects of a Multi-site Expansion of Group Prenatal Care on Birth Outcomes.

Objectives Perinatal Quality Collaboratives across the United States are initiating projects to improve health and healthcare for women and infants. We compared an evidence-based group prenatal care model to usual individual prenatal care on birth outcomes in a multi-site expansion of group prenatal care supported by a state-wide multidisciplinary Perinatal Quality Collaborative. Methods We analyzed 15,330 pregnant women aged 14-48 across 13 healthcare practices in South Carolina (2013-2017) using a preferential-within cluster matching propensity score method and logistic regression. Outcomes were extracted from birth certificate data. We compared outcomes for (a) women at the intent-to-treat level and (b) for women participating in at least five group prenatal care visits to women with less than five group visits with at least five prenatal visits total. Results In the intent-to-treat analyses, women who received group prenatal care were significantly less likely to have preterm births (absolute risk difference - 3.2%, 95% CI - 5.3 to - 1.0%), low birth weight births (absolute risk difference - 3.7%, 95% CI - 5.5 to - 1.8%) and NICU admissions (absolute risk difference - 4.0%, 95% CI - 5.6 to - 2.3%). In the as-treated analyses, women had greater improvements compared to intent-to-treat analyses in preterm birth and low birth weight outcomes. Conclusions for Practice CenteringPregnancy group prenatal care is effective across a range of real-world clinical practices for decreasing the risk of preterm birth and low birth weight. This is a feasible approach for other Perinatal Quality Collaboratives to attempt in their ongoing efforts at improving maternal and infant health outcomes.

Maternal socioeconomic disadvantage is associated with transcriptional indications of greater immune activation and slower tissue maturation in placental biopsies and newborn cord blood.

Children from economically disadvantaged families experience worse cognitive, psychiatric, and medical outcomes compared to more affluent youth. Preclinical models suggest some of the adverse influence of disadvantage could be transmitted during gestation via maternal immune activation, but this hypothesis has not been tested in humans. It also remains unclear whether prenatal interventions can mitigate such effects. To fill these gaps, we conducted two studies. Study 1 characterized the socioeconomic conditions of 79 women during pregnancy. At delivery, placenta biopsies and umbilical blood were collected for transcriptional profiling. Maternal disadvantage was associated with a transcriptional profile indicative of higher immune activation and slower fetal maturation, particularly in pathways related to brain, heart, and immune development. Cord blood cells of disadvantaged newborns also showed indications of immaturity, as reflected in down-regulation of pathways that coordinate myeloid cell development. These associations were independent of fetal sex, and characteristics of mothers (age, race, adiposity, diabetes, pre-eclampsia) and babies (delivery method, gestational age). Study 2 performed the same transcriptional analyses in specimens from 20 women participating in CenteringPregnancy, a group-based psychosocial intervention, and 20 women in traditional prenatal care. In both placenta biopsies and cord blood, women in CenteringPregnancy showed up-regulation of transcripts found in Study 1 to be most down-regulated in conjunction with disadvantage. Collectively, these results suggest socioeconomic disparities in placental biology are evident at birth, and provide clues about the mechanistic origins of health disparities. They also suggest the possibility that psychosocial interventions could have mitigating influences.

Centering and Racial Disparities (CRADLE study): rationale and design of a randomized controlled trial of centeringpregnancy and birth outcomes.

BACKGROUND: In the United States, preterm birth (PTB) before 37 weeks gestational age occurs at an unacceptably high rate, and large racial disparities persist. To date, medical and public health interventions have achieved limited success in reducing rates of PTB. Innovative changes in healthcare delivery are needed to improve pregnancy outcomes. One such model is CenteringPregnancy group prenatal care (GPNC), in which individual physical assessments are combined with facilitated group education and social support. Most existing studies in the literature on GPNC are observational. Although the results are promising, they are not powered to detect differences in PTB, do not address the racial disparity in PTB, and do not include measures of hypothesized mediators that are theoretically based and validated. The aims of this randomized controlled trial (RCT) are to compare birth outcomes as well as maternal behavioral and psychosocial outcomes by race among pregnant women who participate in GPNC to their counterparts in individual prenatal care (IPNC) and to investigate whether improving women's behavioral and psychosocial outcomes will explain the potential benefits of GPNC on birth outcomes and racial disparities. METHODS/DESIGN: This is a single site RCT study at Greenville Health System in South Carolina. Women are eligible if they are between 14-45 years old and enter prenatal care before 20 6/7 weeks of gestational age. Eligible, consenting women will be randomized 1:1 into GPNC group or IPNC group, stratified by race. Women allocated to GPNC will attend 2-h group prenatal care sessions according to the standard curriculum provided by the Centering Healthcare Institute, with other women due to deliver in the same month. Women allocated to IPNC will attend standard, traditional individual prenatal care according to standard clinical guidelines. Patients in both groups will be followed up until 12 weeks postpartum. DISCUSSION: Findings from this project will provide rigorous scientific evidence on the role of GPNC in reducing the rate of PTB, and specifically in reducing racial disparities in PTB. Establishing the improved effect of GPNC on pregnancy and birth outcomes can change the way healthcare is delivered, particularly with populations with higher rates of PTB. TRIAL REGISTRATION: NCT02640638 Date Registered: 12/20/2015.

Six- and twelve-month documented removal rates among women electing postpartum inpatient compared to delayed or interval contraceptive implant insertions after Medicaid payment reform.

OBJECTIVE: This study aims to document 6- and 12-month removal rates for women receiving the contraceptive implant inpatient postpartum versus those receiving the same contraceptive method during an outpatient visit, in a setting where postpartum inpatient long-acting reversible contraceptive (LARC) services (devices plus provider insertion costs) are reimbursed by Medicaid. STUDY DESIGN: We conducted a retrospective cohort study among Medicaid-enrolled women using medical record review for all women receiving the etonogestrel implant between July 1, 2007 and June 30, 2014. We compared the percentage of women with the implant removed at 6 and 12 months as well as reasons for early removal, for inpatient postpartum implant insertions vs. delayed postpartum or interval outpatient implant insertions. RESULTS: A total of 4% of women (34/776 insertions) had documented implant removal within 6 months post-insertion, with no difference between postpartum inpatient and outpatient (delayed postpartum or interval). A total of 12% (62/518 insertions) of women had documented implant removal within 12 months. A lower percentage of women with postpartum inpatient insertions had the implant removed at 12 months post-insertion, compared to outpatient insertions (7% vs. 14%, p=.04). After controlling for age, parity, race and body mass index, women with postpartum inpatient insertions were less likely to have the implant removed within 12 months (OR=0.44, 95% CI 0.20-0.97). The most commonly stated reason for removal was abnormal uterine bleeding, regardless of insertion timing. CONCLUSION: In a setting with a Medicaid policy that covers postpartum inpatient LARC insertion, a low percentage of women who received an implant immediately postpartum had it removed within 1 year of insertion. IMPLICATIONS: A Medicaid payment policy that removes institutional barriers to offering postpartum inpatient contraceptive implants to women free-of-charge may facilitate meeting women's desires and intentions to delay subsequent pregnancy, as evidenced by low removal rates up to 12 months post-insertion. Further research with women is needed to assess how these services meet their postpartum contraceptive needs and desires to postpone or prevent subsequent pregnancy.