Rates Of Adverse Pregnancy Outcomes Research Articles

Thyroid and Pregnancy in Tehran, Iran: Objectives and Study Protocol.

BackgroundThyroid dysfunction is the second most common endocrine disease in females of reproductive age. There are controversial data on the adverse effect of subclinical thyroid dysfunctions on adverse feto-maternal outcomes.ObjectivesThe current study aimed to identify the prevalence of thyroid dysfunction during pregnancy and to assess the effectiveness of treatment with levothyroxine on pregnancy outcomes of females with thyroid autoimmunity with or without subclinical thyroid dysfunction in Tehran, Iran.Patients and MethodsThe study encompassed two phases: 1) a population based cross sectional study using a cluster sampling method that screened first trimester pregnant females for thyroid disorders, 2) a double-blind randomized clinical trial to determine the effectiveness of levothyroxine on adverse pregnancy outcomes in females with thyroid autoimmunity with or without subclinical thyroid dysfunction. Pregnant females were assessed at their first prenatal visit for serum TSH, T4, T-uptake, TPOAb and urinary iodine following which they were classified as: 1) normal, 2) subclinical TPOAb negative and 3) subclinical/euthyroid TPOAb positive. Females in groups two and three were randomly divided into two groups: group A was treated with levothyroxine (LT4), and group B did not receive any treatment. There was a follow-up program for participants and rates of adverse pregnancy outcomes in the treated and untreated groups were measured.ResultsResults of the study provided reliable information regarding the prevalence of thyroid dysfunction among females in Tehran using universal thyroid screening, along with identification of the iodine status of their community. The study aimed to determine whether LT4 treatment exerts beneficial effects in females without overt thyroid dysfunction.

Antiretroviral Resistance and Pregnancy Characteristics of Women with Perinatal and Nonperinatal HIV Infection.

Objective. To compare HIV drug resistance in pregnant women with perinatal HIV (PHIV) and those with nonperinatal HIV (NPHIV) infection. Methods. We conducted a multisite cohort study of PHIV and NPHIV women from 2000 to 2014. Sample size was calculated to identify a fourfold increase in antiretroviral (ARV) drug resistance in PHIV women. Continuous variables were compared using Student's t-test and Wilcoxon rank-sum tests. Categorical variables were compared using χ 2 and Fisher's exact tests. Univariate analysis was used to determine factors associated with antiretroviral drug resistance. Results. Forty-one PHIV and 41 NPHIV participants were included. Women with PHIV were more likely to have drug resistance than those with NPHIV ((55% versus 17%, p = 0.03), OR 6.0 (95% CI 1.0–34.8), p = 0.05), including multiclass resistance (15% versus 0, p = 0.03), and they were more likely to receive nonstandard ARVs during pregnancy (27% versus 5%, p = 0.01). PHIV and NPHIV women had similar rates of preterm birth (11% versus 28%, p = 0.08) and cesarean delivery (47% versus 46%, p = 0.9). Two infants born to a single NPHIV woman acquired HIV infection. Conclusions. PHIV women have a high frequency of HIV drug resistance mutations, leading to nonstandard ARVs use during pregnancy. Despite nonstandard ARV use during pregnancy, PHIV women did not experience increased rates of adverse pregnancy outcomes.

Abnormal Biochemical Analytes Used for Aneuploidy Screening and Adverse Pregnancy Outcomes in Twin Gestations.

The objective of this study was to determine if first- and second-trimester biochemical markers for aneuploidy have an association with adverse pregnancy outcomes in twin gestations. A retrospective cohort study of patients who presented with dichorionic diamniotic twin gestations was performed. Patients with first-trimester low pregnancy-associated plasma protein A (PAPP-A) or low free β human chorionic gonadotropin (β-hCG), or second-trimester elevated α-fetoprotein (AFP), elevated inhibin A, elevated hCG, or low unconjugated estradiol were identified. The rates of adverse pregnancy outcomes were compared between patients with or without abnormal analytes with p < 0.05 used as significance. In this study, 340 pregnancies were included. Patients with a low PAPP-A had an increased risk for delivery < 37 weeks. Patients with an elevated second-trimester hCG had an increased risk for spontaneous delivery < 28 weeks and neonatal intensive care unit (NICU) admission. Patients with an elevated inhibin A had an increased risk of spontaneous delivery at < 37 and NICU admission. Patients with an elevated AFP had an increased risk of a NICU admission. Certain abnormal aneuploidy markers are associated with an increased risk of adverse pregnancy outcomes in twin gestations.

Associations between maternal serum free beta human chorionic gonadotropin (β-hCG) levels and adverse pregnancy outcomes

The objective was to determine the strength of relationship between maternal free beta human chorionic gonadotropin (β-hCG) concentrations and rates of adverse pregnancy outcomes. Consecutive records of the database of our Down screening project were assessed for free β-hCG levels and pregnancy outcomes. Pregnancies with foetal chromosomal or structural anomalies and those with underlying disease were excluded. Free β-hCG levels of < 0.5, > 0.5 and < 2.0, and ≥ 2.0 MoM were categorised as low, normal and high, respectively. Of 17,082 screened women, 13,620 were available for analysis. In the first trimester (n = 8150), low β-hCG levels significantly increased risk for intrauterine growth restriction (IUGR), preterm birth, low birth weight (LBW) and low Apgar score with relative risk of 1.66, 1.43, 1.83 and 2.89; whereas high β-hCG group had a significant decreased risk of preterm birth and GDM with relative risk of 0.73 and 0.62. In the second trimester (n = 5470), both low and high β-hCG groups had significant increased risks of the most common adverse outcomes, i.e. spontaneous abortion, IUGR and preterm birth. In conclusion, abnormally low (< 0.5MoM) or high (> 2.0 MoM) free β-hCG levels are generally associated with an increased risk of adverse pregnancy outcomes. Nevertheless, high free β-hCG levels in the first trimester may possibly decrease risk of preterm delivery and GDM.

Pregnancy Outcomes Among U.S. Women With Intellectual and Developmental Disabilities.

The existing research on pregnancy outcomes for women with intellectual and developmental disabilities (IDD) is sparse. This study analyzed the 2010 Healthcare Cost and Utilization Project Nationwide Inpatient Sample and compared deliveries among women with IDD (n = 340) to the general obstetric population. Women with IDD had longer hospital stays and were more likely to have Caesarean deliveries in contrast to other women. Rates of adverse pregnancy outcomes were elevated for women with IDD across a range of measures, including early labor, preterm birth, and preeclampsia, and their infants were more likely to have low birth weight, even after adjusting for age, race, ethnicity, and insurance type. Targeted interventions are needed to address these deleterious outcomes.

Effectiveness of prepregnancy care for women with pregestational diabetes mellitus: protocol for a systematic review of the literature and identification of a core outcomes set using a Delphi survey

BackgroundWomen with pregnancy complicated by pregestational diabetes experience increased rates of adverse pregnancy outcomes. Prepregnancy care is the targeted support and additional care offered to those women who are planning pregnancy and is associated with improved outcomes. However, there is significant heterogeneity in the outcomes measured and reported in studies evaluating the effects of prepregnancy care, which makes meaningful comparison difficult. The aim of this article is to present a protocol for a study to develop a Core Outcome Set (COS) for trials and other studies evaluating the effectiveness of prepregnancy care for women with pregestational diabetes mellitus.Methods/DesignThis study will include a systematic review of the literature to identify outcomes that have previously been reported in studies evaluating prepregnancy care for women with pregestational diabetes. We will then prioritise these outcomes from the perspective of key stakeholders, including women with pregestational diabetes as well as clinicians, using a Delphi survey. A final consensus meeting will be held with stakeholders to review and finalise the outcomes.DiscussionThe expectation is that the COS will always be collected and reported in all clinical trials, audits of practice and other forms of research that involve prepregnancy care programs for women with pregestational diabetes. This will facilitate comparing and contrasting of studies and allow for combining of appropriate studies with the ultimate goal of improved patient care.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-015-0894-8) contains supplementary material, which is available to authorized users.

Care of the Pregnant Patient With Inflammatory Bowel Disease

Inflammatory bowel disease affects women in their peak reproductive years. Patients and physicians often have questions regarding the effect of inflammatory bowel disease on a woman's ability to conceive and to carry a pregnancy safely to term as well as the effect of inflammatory bowel disease and the medications used to treat it on pregnancy outcomes. Women with inflammatory bowel disease have the same rates of fertility as women without inflammatory bowel disease unless they have had prior surgery in the pelvis or active disease. However, women with inflammatory bowel disease do have higher rates of adverse pregnancy outcomes. A multidisciplinary approach involving gastroenterologists, obstetricians, and maternal-fetal medicine physicians should focus on preconception planning and disease optimization before pregnancy. Women with inflammatory bowel disease should be followed as high-risk obstetric patients. Most medications used to treat inflammatory bowel disease can be continued safely during pregnancy and lactation. The greatest risk to the pregnancy is active disease, which can be precipitated by discontinuation of effective maintenance medications. Preconception counseling should include education regarding the low risk of most inflammatory bowel disease medications during pregnancy and lactation and the high risk of a significant disease flare during pregnancy. This review outlines important considerations for obstetricians caring for women with inflammatory bowel disease before and during pregnancy and in the postpartum period.

O128. Placental vascularization indices and uterine artery peak systolic velocity in pregnancy hypertension

Introduction Hypertension during pregnancy affects about 6–9% of pregnant women, it is a leading cause of maternal and fetal morbidity and mortality, and remarkable portion of pregnancy hypertension cases are accompanied by gestational diabetes (GDM). There is a great effort worldwide on reaching greater effectiveness in prediction and prevention in these pathological pregnancies. Objectives The aim of the study was to analyze placental vascularization, uterine artery peak systolic velocity (PSV), placental volume and pre-gestational BMI for the better prediction rate of adverse pregnancy outcomes in pregnant women with essential hypertension (EH), EH associated with gestational diabetes (EH + GDM), pregnancy induced hypertension (PIH), and PIH associated with gestational diabetes (PIH + GDM) compared to a normal blood pressure (NBP) group. Methods We measured placental 3-dimensional power Doppler indices, such as vascularization index (VI), flow index (FI) and vascularization flow index (VFI), and uterine artery PSV in pregnancies complicated with EH ( N = 51), EH + GDM ( N = 13) PIH ( N = 57) and PIH + GDM ( N = 23), and compared these to pregnancies with NBP ( N = 146) with the help of 3-dimensional analysing VOCAL program. We analyzed the correlation between the above mentioned indices, volume of the placenta, pre-gestational BMI, and gestational age. Results VI and VFI were significantly higher in pregnancies with EH (VI:13.27% ±9.77; VFI:5.94 ± 4.99 (mean ± SD)) and significantly lower in pregnancies with PIH (VI:7.75% ±6.50; VFI:3.00 ± 2.3(mean ± SD)) than in pregnancies with NBP (VI:10.18% ±6.16; VFI:5 ± 3.49 (mean ± SD)) ( p p p > 0.01). FI (31.35 ± 12.48) and VFI (1.87 ± 1.20) were significantly ( p p > 0.01). VI(4.13 ± 2.77) and VFI (1.70 ± 1.31) were significantly ( p p > 0.01) PSV was significantly higher in PIH + GDM (66.01 cm/s ±26.03) compared to PIH (56.27 cm/s ±26.56) ( p p The placental volume was smaller ( z -score:-1.5) in EH and PIH than in NBP and higher in EH + GDM and PIH + GDM than in NBP ( z -score:+0.8). Pre-gestational BMI was significantly higher ( p Conclusion The 3-DPD indices combined with PSV in pregnancies complicated with EH + GDM and PIH + GDM showed that GDM aggravates EH and PIH cases significantly. Although our study proved that pre-gestational BMI and placental volume do have effect on placental vascularization, it seems that adverse pregnancy outcomes can be predicted more effectively with the help of 3-DPD indices and PSV measurements during the entire pregnancy compared to conventional uterine artery findings.

Nationwide registry-based ecological analysis of Q fever incidence and pregnancy outcome during an outbreak in the Netherlands

ObjectiveWhether areas affected by Q fever during a large outbreak (2008–2010) had higher rates of adverse pregnancy outcomes than areas not affected by Q fever.DesignNationwide registry-based ecological study.SettingPregnant women in...

Pre-pregnancy counselling for women with chronic kidney disease: a retrospective analysis of nine years’ experience

BackgroundWomen with chronic kidney disease have an increased risk of maternal and fetal complications in pregnancy. Pre-pregnancy counselling is recommended but the format of the counselling process and the experience of the patient have never been assessed. This study examines the experience of women with chronic kidney disease attending pre-pregnancy counselling and evaluates their pregnancy outcomes.MethodsThis is a cross-sectional assessment of 179 women with chronic kidney disease attending a pre-pregnancy counselling clinic (2003–2011) with retrospective evaluation of aetiology, comorbidity, treatment and adverse pregnancy outcome compared with 277 hospital controls. It includes an analysis of descriptive data and free text content from 72 questionnaire responders.Results65/72 (90%) of women found the clinic informative. 66 women (92%) felt that the consultation had helped them decide about pursuing pregnancy. 12 women (17%) found the multidisciplinary process intimidating. Free text comments supported the positive nature of the counselling experience, but also highlighted issues of access and emotional impact. Adverse pregnancy outcome rates were significantly higher in women with chronic kidney disease: 7/35 (20%) had pre-eclampsia (p < 0.001), 8/35 (23%) infants were small for gestational age (p < 0.001), 11/35 (31%) had preterm deliveries (<37 weeks) (p < 0.001) and 5/35 (14%) had a pregnancy loss compared with 4%, 10%, 8% and 3% of controls respectively.ConclusionsWomen with a diverse range of renal disease severity and complexity attend pre-pregnancy counselling. Factors affecting pregnancy include hypertension, proteinuria and teratogenic medication. It is important to be able to inform women of the risks to them and their babies before pregnancy in order to facilitate informed-decision making. Most women with chronic kidney disease attending a pre-pregnancy counselling clinic report a positive experience.Electronic supplementary materialThe online version of this article (doi:10.1186/s12882-015-0024-6) contains supplementary material, which is available to authorized users.

1 Achievement of Developmental Milestones Among Offspring of Women With Inflammatory Bowel Disease: The PIANO Registry

Introduction: IBD in the mother is associated with higher rates of adverse pregnancy outcomes. However, long-term effects of maternal IBD on childhood growth and development are not known. The aim of this study was to determine the impact of IBD medication exposure in utero on newborn developmental milestones. Methods: We created a prospective cohort of pregnant women at 30 US IBD centers to follow patients through pregnancy and first four years of a child's life. We ascertained IBD medications and disease activity during gestation, complications of pregnancy and delivery, and achievement of developmental milestones. Patients were classified by exposure to drugs taken between conception and delivery: 6MP/Azathioprine (Group A), infliximab, adalimumab, certolizumab (Group B), combination therapy (Group AB). We compared these groups to women who did not take any Group A or B drugs. Developmental milestones achieved by the infant, based on Denver Childhood Developmental Score, were measured by the mother at months 4, 9 and 12 and by the validated Ages and Stages Questionnaire at 1,2,3 and 4 years of age. Follow up is ongoing. Results: 1289 women are enrolled in the study as of Nov 12 2013: 1097 have completed pregnancy, 1039 with live births. There were 215 live births in Group A, 364 in Group B, 137 in Group AB and 323 to unexposed mothers. When compared to the unexposed infants, infants in Group A, B and AB always had equivalent or better achievement of milestones. These results were unchanged when controlled for maternal income and education level. Table 1 lists the milestones in which the exposed infants had better outcomes that the unexposed. Conclusions: Infants with in utero exposure to immunomodulator and biologic therapy did not exhibit developmental delay compared to infants not exposed to these agents, controlling for preterm birth. Overall, developmental scores were similar between exposed and unexposed infants, and scores of exposed infants were slightly higher in some categories. Significant Differences in Developmental Milestones by Drug Exposure

2 Pregnancy Outcomes Amongst Mothers With Inflammatory Bowel Disease Exposed to Systemic Corticosteroids: Results of the PIANO Registry

Introduction: IBD in the mother is associated with higher rates of adverse pregnancy outcomes. However, long-term effects of maternal IBD on childhood growth and development are not known. The aim of this study was to determine the impact of IBD medication exposure in utero on newborn developmental milestones. Methods: We created a prospective cohort of pregnant women at 30 US IBD centers to follow patients through pregnancy and first four years of a child's life. We ascertained IBD medications and disease activity during gestation, complications of pregnancy and delivery, and achievement of developmental milestones. Patients were classified by exposure to drugs taken between conception and delivery: 6MP/Azathioprine (Group A), infliximab, adalimumab, certolizumab (Group B), combination therapy (Group AB). We compared these groups to women who did not take any Group A or B drugs. Developmental milestones achieved by the infant, based on Denver Childhood Developmental Score, were measured by the mother at months 4, 9 and 12 and by the validated Ages and Stages Questionnaire at 1,2,3 and 4 years of age. Follow up is ongoing. Results: 1289 women are enrolled in the study as of Nov 12 2013: 1097 have completed pregnancy, 1039 with live births. There were 215 live births in Group A, 364 in Group B, 137 in Group AB and 323 to unexposed mothers. When compared to the unexposed infants, infants in Group A, B and AB always had equivalent or better achievement of milestones. These results were unchanged when controlled for maternal income and education level. Table 1 lists the milestones in which the exposed infants had better outcomes that the unexposed. Conclusions: Infants with in utero exposure to immunomodulator and biologic therapy did not exhibit developmental delay compared to infants not exposed to these agents, controlling for preterm birth. Overall, developmental scores were similar between exposed and unexposed infants, and scores of exposed infants were slightly higher in some categories. Significant Differences in Developmental Milestones by Drug Exposure

The fetal safety of cetirizine: An observational cohort study and meta-analysis

Cetirizine, a second-generation antihistamine, is an active metabolite of hydroxyzine used in the treatment of allergies, but the data on fetal safety are inconclusive. Pregnant women who were counselled by the ‘Motherisk Program’ regarding cetirizine exposure were enrolled in a cohort study and compared with pregnant women counselled for non-teratogenic exposures. The objective was to measure the rate of adverse pregnancy outcomes. Subsequently, we also conducted a meta-analysis of cohort studies that examined the pregnancy outcomes of women exposed to hydroxyzine or cetirizine during pregnancy. In the cohort study, there were no significant differences in the rates of major malformations between the cetirizine exposed and comparison group. In the meta-analysis, cetirizine was not associated with increased teratogenic risk. In contrast, a meta-analysis of cetirizine and hydroxyzine studies showed a marginal association with major malformations. Cetirizine is not associated with a clinically important increase in risk of adverse fetal outcomes.

Obstetric and Gynecologic Challenges in Women With Ehlers-Danlos Syndrome

To determine how often women with Ehlers-Danlos syndrome experience obstetric and gynecologic issues both compared with the general population and within the three most common subtypes of Ehlers-Danlos syndrome. An anonymous, prospective, online questionnaire in English was posted to the Ehlers-Danlos National Foundation web site (http://ednf.org). Of the 1,769 of those who completed the survey, 1,225 reported a typed diagnosis of Ehlers-Danlos syndrome. Further stratification to the three most common types and reproductive-aged women (n=775) allowed conclusions to be made about differences in rates of obstetric complications and gynecologic dysfunction compared with the general population and between types of Ehlers-Danlos syndrome. Rates of obstetric outcomes for women who reported at least one pregnancy included term pregnancy in 69.7%, preterm birth in 25.2%, spontaneous abortion in 57.2%, and ectopic pregnancy in 5.1%. Infertility was reported by 44.1% of survey respondents. Normal menstrual cycles were reported by only 32.8% with intermenstrual bleeding occurring in 18.6%. Heavy menstrual bleeding was reported by 32.9% survey participants. Gynecologic pain reported included dysmenorrhea by 92.5% and dyspareunia by 77.0%. There is a much greater prevalence of obstetric and gynecologic issues reported by women with Ehlers-Danlos syndrome than in the general population. Additionally, rates differed significantly among the three most common types of Ehlers-Danlos syndrome with vascular type having the highest rates of adverse pregnancy outcomes and menstrual abnormalities. Physician providers should be aware of these challenges and should counsel patients with Ehlers-Danlos syndrome about relevant options and risks.

Adverse Pregnancy Outcomes Following Motor Vehicle Crashes

Motor vehicle crashes are a leading cause of serious trauma during pregnancy, but little is known about their relationships with pregnancy outcomes. To estimate the association between motor vehicle crashes and adverse pregnancy outcomes. A retrospective cohort study of 878,546 pregnant women, aged 16-46 years, who delivered a singleton infant in North Carolina from 2001 to 2008. Pregnant drivers in crashes were identified by probabilistic linkage of vital records and crash reports. Poisson regression modeled the association among crashes, vehicle safety features, and adverse pregnancy outcomes. Analyses were conducted in 2012. In 2001-2008, 2.9% of pregnant North Carolina women were drivers in one or more crashes. After a single crash, compared to not being in a crash, pregnant drivers had slightly elevated rates of preterm birth (adjusted rate ratio [aRR]=1.23, 95% CI=1.19, 1.28); placental abruption (aRR=1.34, 95% CI=1.15, 1.56); and premature rupture of the membranes (PROM; aRR=1.32, 95% CI=1.21, 1.43). Following a second or subsequent crash, pregnant drivers had more highly elevated rates of preterm birth (aRR=1.54, 95% CI=1.24, 1.90); stillbirth (aRR=4.82, 95% CI=2.85, 8.14); placental abruption (aRR=2.97, 95% CI=1.60, 5.53); and PROM (aRR=1.95, 95% CI=1.27, 2.99). Stillbirth rates were elevated following crashes involving unbelted pregnant drivers (aRR=2.77, 95% CI=1.22, 6.28) compared to belted pregnant drivers. Crashes while driving during pregnancy were associated with elevated rates of adverse pregnancy outcomes, and multiple crashes were associated with even higher rates of adverse pregnancy outcomes. Crashes were especially harmful if drivers were unbelted.

Perinatal outcome in normal pregnant women with incidental thrombocytopenia at delivery

ObjectiveTo investigate the perinatal outcomes of women who suffered from thrombocytopenia at delivery but did not have other diseases during pregnancy. Materials and MethodsWe considered all singleton deliveries after 24 weeks of gestation at Chang Gung Memorial Hospital, Taipei, Taiwan between 2001 and 2010. Women were excluded from this study if they suffered from any of the following conditions: chronic hypertension, hepatitis, acute fatty liver, liver cirrhosis, nephropathy, overt diabetes mellitus, connective tissue disease, systemic lupus erythematosus, or immune thrombocytopenia. Pregnancies complicated by gestational hypertension, preeclampsia, or fetal anomalies during gestation were also excluded. A total of 18,384 deliveries were included for analysis. Women were divided into three groups according to platelet count at admission. ResultsA total of 787 pregnancies (4.3%) were complicated by thrombocytopenia. Thrombocytopenic women had a significantly higher rate of cesarean delivery compared to women who did not have this condition. No other differences were observed among these three groups regarding the rates of adverse pregnancy outcomes. ConclusionsThe results indicate that women who suffered from incidental thrombocytopenia at delivery but did not have other diseases during pregnancy were not at increased risk for adverse pregnancy outcomes.

S16.5 Management of Syphilis in Pregnancy

There are a number of clinical challenges that are specific to managing syphilis in pregnancy: Which women have the highest risk of adverse pregnancy outcome and is there anything extra...

Concept Analysis: Prenatal Obesity, a Psychoneuroimmunology Perspective

To analyze the concept of prenatal obesity within a psychoneuroimmunology framework. By considering the psychosocial, neurological, endocrine, and immunological contributions, a psychoneuroimmunology framework maintains a holistic focus. Identifying the multidirectional mechanisms linking these systems will provide valuable insight into the mechanisms by which prenatal obesity increases the rate of adverse pregnancy outcomes. Utilization of the concept of prenatal obesity within a psychoneuroimmunology framework will facilitate multidisciplinary research to identify underlying mechanisms by which prenatal obesity leads to adverse pregnancy outcomes, as well as the development of interventions to treat obesity before, during, and after pregnancy.

Racial Disparities in Economic and Clinical Outcomes of Pregnancy Among Medicaid Recipients

To explore racial-ethnic disparities in adverse pregnancy outcomes among Medicaid recipients, and to estimate excess Medicaid costs associated with the disparities. Cross-sectional study of adverse pregnancy outcomes and Medicaid payments using data from Medicaid Analytic eXtract files on all Medicaid enrollees in fourteen southern states. Compared to other racial and ethnic groups, African American women tended to be younger, more likely to have a Cesarean section, to stay longer in the hospital and to incur higher Medicaid costs. African-American women were also more likely to experience preeclampsia, placental abruption, preterm birth, small birth size for gestational age, and fetal death/stillbirth. Eliminating racial disparities in adverse pregnancy outcomes (not counting infant costs), could generate Medicaid cost savings of $114 to $214 million per year in these 14 states. Despite having the same insurance coverage and meeting the same poverty guidelines for Medicaid eligibility, African American women have a higher rate of adverse pregnancy outcomes than White or Hispanic women. Racial disparities in adverse pregnancy outcomes not only represent potentially preventable human suffering, but also avoidable economic costs. There is a significant financial return-on-investment opportunity tied to eliminating racial disparities in birth outcomes. With the Affordable Care Act expansion of Medicaid coverage for the year 2014, Medicaid could be powerful public health tool for improving pregnancy outcomes.

Background Rates of Adverse Pregnancy Outcomes for Assessing the Safety of Maternal Vaccine Trials in Sub-Saharan Africa

BackgroundMaternal immunization has gained traction as a strategy to diminish maternal and young infant mortality attributable to infectious diseases. Background rates of adverse pregnancy outcomes are crucial to interpret results of clinical trials in Sub-Saharan Africa.MethodsWe developed a mathematical model that calculates a clinical trial's expected number of neonatal and maternal deaths at an interim safety assessment based on the person-time observed during different risk windows. This model was compared to crude multiplication of the maternal mortality ratio and neonatal mortality rate by the number of live births. Systematic reviews of severe acute maternal morbidity (SAMM), low birth weight (LBW), prematurity, and major congenital malformations (MCM) in Sub-Saharan African countries were also performed.FindingsAccounting for the person-time observed during different risk periods yields lower, more conservative estimates of expected maternal and neonatal deaths, particularly at an interim safety evaluation soon after a large number of deliveries. Median incidence of SAMM in 16 reports was 40.7 (IQR: 10.6–73.3) per 1,000 total births, and the most common causes were hemorrhage (34%), dystocia (22%), and severe hypertensive disorders of pregnancy (22%). Proportions of liveborn infants who were LBW (median 13.3%, IQR: 9.9–16.4) or premature (median 15.4%, IQR: 10.6–19.1) were similar across geographic region, study design, and institutional setting. The median incidence of MCM per 1,000 live births was 14.4 (IQR: 5.5–17.6), with the musculoskeletal system comprising 30%.InterpretationSome clinical trials assessing whether maternal immunization can improve pregnancy and young infant outcomes in the developing world have made ethics-based decisions not to use a pure placebo control. Consequently, reliable background rates of adverse pregnancy outcomes are necessary to distinguish between vaccine benefits and safety concerns. Local studies that quantify population-based background rates of adverse pregnancy outcomes will improve safety assessment of interventions during pregnancy.