Background Preeclampsia complicates approximately 3–5% of pregnancies and remains a major cause of maternal and neonatal morbidity and mortality. It shares pathogenic similarities with adult ...cardiovascular disease as well as many risk factors. Pravastatin, a hydrophilic, 3-hydroxy-3-methyl-glutaryl-coenzyme A reductase inhibitor, has been shown in preclinical studies to reverse various pathophysiological pathways associated with preeclampsia, providing biological plausibility for its use for preeclampsia prevention. However, human trials are lacking. Objective As an initial step in evaluating the utility of pravastatin in preventing preeclampsia and after consultation with the US Food and Drug Administration, we undertook a pilot randomized controlled trial with the objective to determine pravastatin safety and pharmacokinetic parameters when used in pregnant women at high risk of preeclampsia. Study Design We conducted a pilot, multicenter, double-blind, placebo-controlled, randomized trial of women with singleton, nonanomalous pregnancies at high risk for preeclampsia. Women between 120/7 and 166/7 weeks’ gestation were assigned to daily pravastatin 10 mg or placebo orally until delivery. Primary outcomes were maternal-fetal safety and pharmacokinetic parameters of pravastatin during pregnancy. Secondary outcomes included rates of preeclampsia and preterm delivery, gestational age at delivery, birthweight, and maternal and cord blood lipid profile ( clinicaltrials.gov identifier NCT01717586 ). Results Ten women assigned to pravastatin and 10 to placebo completed the trial. There were no differences between the 2 groups in rates of study drug side effects, congenital anomalies, or other adverse or serious adverse events. There was no maternal, fetal, or neonatal death. Pravastatin renal clearance was significantly higher in pregnancy compared with postpartum. Four subjects in the placebo group developed preeclampsia compared with none in the pravastatin group. Although pravastatin reduced maternal cholesterol concentrations, umbilical cord cholesterol concentrations and infant birthweight were not different between the groups. The majority of umbilical cord and maternal pravastatin plasma concentrations at the time of delivery were below the lower limit of quantification of the assay. Pravastatin use was associated with a more favorable pregnancy angiogenic profile. Conclusion This study provides preliminary safety and pharmacokinetic data regarding the use of pravastatin for preventing preeclampsia in high-risk pregnant women. Although the data are preliminary, no identifiable safety risks were associated with pravastatin use in this cohort. This favorable risk-benefit analysis justifies using pravastatin in a larger clinical trial with dose escalation.
Background Extracorporeal membrane oxygenation (ECMO) has been used with increasing frequency to support pregnant and postpartum patients with severe cardiac or pulmonary failure, although patient ...management and clinical outcomes are underreported. This study represents patients who received ECMO during the peripartum period. Methods All pregnant or postpartum patients treated with ECMO in the medical intensive care unit between January 1, 2009, and June 30, 2015, were included in this study. Data were analyzed retrospectively. The primary objective was to characterize the circumstances and clinical characteristics of the patients who received ECMO, describe our management during pregnancy and at the time of delivery, evaluate maternal and fetal outcomes, and report bleeding and thrombotic complications. Results Eighteen peripartum patients were treated with ECMO during the study period; 4 were pregnant at the time of cannulation. Median age was 32.6 years, and median gestational age in pregnant patients was 32 weeks. Sixteen patients (88.9%) survived to hospital discharge. Fetal survival was 14 (77.8%) in the entire cohort and 100% in patients cannulated after fetal viability. Two patients successfully delivered on ECMO. Bleeding complications developed in 6 patients (33.3%) and were associated with disseminated intravascular coagulation. No fetal complications were attributed to ECMO. Conclusions ECMO can be used during pregnancy and postpartum with favorable maternal and fetal outcomes, and it outweighs the risk of bleeding or thrombotic complications when managed by an experienced, multidisciplinary team.
The rise in maternal morbidity and mortality has resulted in national and international attention at optimally organizing systems and teams for pregnancy care. Given that maternal morbidity and ...mortality can occur unpredictably in any obstetric setting, specialists in general obstetrics and gynecology along with other primary maternal care providers should be integrally involved in efforts to improve the safety of obstetric care delivery. Quality improvement initiatives remain vital to meeting this goal. The evidence-based utilization of triggers, bundles, protocols, and checklists can aid in timely diagnosis and treatment to prevent or limit the severity of morbidity as well as facilitate interdisciplinary, patient-centered care. The purpose of this document is to summarize the pertinent elements from this forum to assist primary maternal care providers in their utilization and implementation of these safety tools.
The role of maternal age in twin pregnancy outcomes McLennan, Amelia S., MD; Gyamfi-Bannerman, Cynthia, MD, MSc; Ananth, Cande V., PhD, MPH ...
American journal of obstetrics and gynecology,
07/2017, Letnik:
217, Številka:
1
Journal Article
Recenzirano
Odprti dostop
Background There are limited data on how maternal age is related to twin pregnancy outcomes. Objective The purpose of this study was to assess the relationship between maternal age and risk for ...preterm birth, fetal death, and neonatal death in the setting of twin pregnancy. Study Design This population-based study of US birth, fetal death, and period-linked birth-infant death files from 2007–2013 evaluated neonatal outcomes for twin pregnancies. Maternal age was categorized as 15–17, 18–24, 25–29, 30–34, 35–39, and ≥40 years of age. Twin live births and fetal death delivered at 20–42 weeks were included. Primary outcomes included preterm birth (<34 weeks and <37 weeks), fetal death, and neonatal death at <28 days of life. Analyses of preterm birth at <34 and <37 weeks were adjusted for demographic and medical factors, with maternal age modeled with the use of restricted spline transformations. Results A total of 955,882 twin live births from 2007–2013 were included in the analysis. Preterm birth rates at <34 and <37 weeks gestation were highest for women 15–17 years of age, decreased across subsequent maternal age categories, nadired for women 35–39 years old, and then increased slightly for women ≥40 years old. Risk for fetal death generally decreased across maternal age categories. Risk for fetal death was 39.9 per 1000 live births for women 15–17 years old, 24.2 for women 18–24 years old, 17.8 for women 25–29 years old, 16.4 for women 30–34 years old, 17.2 for women 35–39 years old, and 15.8 for women ≥40 years old. Risk for neonatal death at <28 days was highest for neonates born to women 15–17 years old (10.0 per 1,000 live births), decreased to 7.3 for women 18–24 years old and 5.5 for women 25–29 years old and ranged from 4.3–4.6 for all subsequent maternal age categories. In adjusted models, risk for preterm birth at <34–<37 weeks gestation was not elevated for women in their mid-to-late 30s; however, risk was elevated for women <20 years old and increased progressively with age for women in their 40s. Conclusion Although twin pregnancy is associated with increased risk for most adverse perinatal outcomes, this analysis did not find advanced maternal age to be an additional risk factor for fetal death and infant death. Preterm birth risk was relatively low for women in their late 30s. Risks for adverse outcomes were higher among younger women; further research is indicated to improve outcomes for this demographic group. It may be reasonable to counsel women in their 30s that their age is not a major additional risk factor for adverse obstetric outcomes in the setting of twin pregnancy.
Objective Fetal growth is associated with long-term health yet no appropriate standards exist for the early identification of undergrown or overgrown fetuses. We sought to develop contemporary fetal ...growth standards for 4 self-identified US racial/ethnic groups. Study Design We recruited for prospective follow-up 2334 healthy women with low-risk, singleton pregnancies from 12 community and perinatal centers from July 2009 through January 2013. The cohort comprised: 614 (26%) non-Hispanic whites, 611 (26%) non-Hispanic blacks, 649 (28%) Hispanics, and 460 (20%) Asians. Women were screened at 8w0d to 13w6d for maternal health status associated with presumably normal fetal growth (aged 18-40 years; body mass index 19.0-29.9 kg/m2 ; healthy lifestyles and living conditions; low-risk medical and obstetrical history); 92% of recruited women completed the protocol. Women were randomized among 4 ultrasonography schedules for longitudinal fetal measurement using the Voluson E8 (GE Healthcare, Milwaukee, WI). In-person interviews and anthropometric assessments were conducted at each visit; medical records were abstracted. The fetuses of 1737 (74%) women continued to be low risk (uncomplicated pregnancy, absent anomalies) at birth, and their measurements were included in the standards. Racial/ethnic-specific fetal growth curves were estimated using linear mixed models with cubic splines. Estimated fetal weight (EFW) and biometric parameter percentiles (5th, 50th, 95th) were determined for each gestational week and comparisons made by race/ethnicity, with and without adjustment for maternal and sociodemographic factors. Results EFW differed significantly by race/ethnicity >20 weeks. Specifically at 39 weeks, the 5th, 50th, and 95th percentiles were 2790, 3505, and 4402 g for white; 2633, 3336, and 4226 g for Hispanic; 2621, 3270, and 4078 g for Asian; and 2622, 3260, and 4053 g for black women (adjusted global P < .001). For individual parameters, racial/ethnic differences by order of detection were: humerus and femur lengths (10 weeks), abdominal circumference (16 weeks), head circumference (21 weeks), and biparietal diameter (27 weeks). The study-derived standard based solely on the white group erroneously classifies as much as 15% of non-white fetuses as growth restricted (EFW <5th percentile). Conclusion Significant differences in fetal growth were found among the 4 groups. Racial/ethnic-specific standards improve the precision in evaluating fetal growth.
Background Systematic evaluation and estimation of growth trajectories in twins require ultrasound measurements across gestation that are performed in controlled clinical settings. Currently, there ...are few such data for contemporary populations. There is also controversy about whether twin fetal growth should be evaluated with the use of the same benchmarks as singleton growth. Objectives Our objective was to define the trajectory of fetal growth in dichorionic twins empirically using longitudinal 2-dimensional ultrasonography and to compare the fetal growth trajectories for dichorionic twins with those based on a growth standard that was developed by our group for singletons. Study Design A prospective cohort of 171 women with twin gestations was recruited from 8 US sites from 2012–2013. After an initial sonogram at 11 weeks 0 days–13 weeks 6 days of gestation during which dichorionicity was confirmed, women were assigned randomly to 1 of 2 serial ultrasonography schedules. Growth curves and percentiles were estimated with the use of linear mixed models with cubic splines. Percentiles were compared statistically at each gestational week between the twins and 1731 singletons, after adjustment for maternal age, race/ethnicity, height, weight, parity, employment, marital status, insurance, income, education, and infant sex. Linear mixed models were used to test for overall differences between the twin and singleton trajectories with the use of likelihood ratio tests of interaction terms between spline mean structure terms and twin-singleton indicator variables. Singleton standards were weighted to correspond to the distribution of maternal race in twins. For those ultrasound measurements in which there were significant global tests for differences between twins and singletons, we tested for week-specific differences using Wald tests that were computed at each gestational age. In a separate analysis, we evaluated the degree of reclassification in small for gestational age, which was defined as <10th percentile that would be introduced if fetal growth estimation for twins was based on an unweighted singleton standard. Results Women underwent a median of 5 ultrasound scans. The 50th percentile abdominal circumference and estimated fetal weight trajectories of twin fetuses diverged significantly beginning at 32 weeks of gestation; biparietal diameter in twins was smaller from 34–36 weeks of gestation. There were no differences in head circumference or femur length. The mean head circumference/abdominal circumference ratio was progressively larger for twins compared with singletons beginning at 33 weeks of gestation, which indicated a comparatively asymmetric growth pattern. At 35 weeks of gestation, the average gestational age at delivery for twins, the estimated fetal weights for the 10th, 50th, and 90th percentiles were 1960, 2376, and 2879 g for dichorionic twins, respectively, and 2180, 2567, and 3022 g for the singletons, respectively. At 32 weeks of gestation, the initial week when the mean estimated fetal weight for twins was smaller than that of singletons, 34% of twins would be classified as small for gestational age with the use of a singleton, non-Hispanic white standard. By 35 weeks of gestation, 38% of twins would be classified as small for gestational age. Conclusion The comparatively asymmetric growth pattern in twin gestations, initially evident at 32 weeks of gestation, is consistent with the concept that the intrauterine environment becomes constrained in its ability to sustain growth in twin fetuses. Near term, nearly 40% of twins would be classified as small for gestational age based on a singleton growth standard.
Background In the setting of persistently high risk for maternal death and severe obstetric morbidity, little is known about the relationship between hospital delivery volume and maternal outcomes. ...Objective The objectives of this analysis were (1) to determine maternal risk for severe morbidity during delivery hospitalizations by hospital delivery volume in the United States and (2) to characterize, by hospital volume, the risk for death in the setting of severe obstetric morbidity, a concept known as failure to rescue. Study Design This cohort study evaluated 50,433,539 delivery hospitalizations across the United States from 1998–2010. The main outcome measures were (1) severe morbidity that was defined as a composite of any 1 of 15 diagnoses that are representative of acute organ injury and critical illness and (2) failure to rescue that was defined as death in the setting of severe morbidity. Results The prevalence of severe morbidity rose from 471.2–751.5 cases per 100,000 deliveries from 1998–2010, which was an increase of 59.5%. Failure to rescue was highest in 1998 (1.5%), decreased to 0.6% in 2007, and rose to 0.9% in 2010. In models that were adjusted for comorbid risk and hospital factors, both low and high annualized delivery volume were associated with increased risk for failure to rescue and severe morbidity. However, the relative importance of hospital volume for both outcomes compared with other factors was relatively small. Conclusion Although low-and high-delivery volume are associated with increased risk for both failure to rescue and severe maternal morbidity, other factors, in particular characteristics of individual centers, may be more important in the determination of outcomes.
Objective We examined predictors of massive blood loss for women with placenta accreta who had undergone hysterectomy. Study Design A retrospective review of women who underwent peripartum ...hysterectomy for pathologically confirmed placenta accreta was performed. Characteristics that are associated with massive blood loss (≥5000 mL) and large-volume transfusion (≥10 units packed red cells) were examined. Results A total of 77 patients were identified. The median blood loss was 3000 mL, with a median of 5 units of red cells transfused. There was no association among maternal age, gravidity, number of previous deliveries, number of previous cesarean deliveries, degree of placental invasion, or antenatal bleeding and massive blood loss or large-volume transfusion ( P > .05). Among women with a known diagnosis of placenta accreta, 41.7% had an estimated blood loss of ≥5000 mL, compared with 12.0% of those who did not receive the diagnosis antenatally with ultrasound scanning ( P = .01). Conclusion There are few reliable predictors of massive blood loss in women with placenta accreta.
Background Gastroschisis is a severe congenital anomaly the etiology of which is unknown. Research evidence supports attempted vaginal delivery for pregnancies complicated by gastroschisis in the ...absence of obstetric indications for cesarean delivery. Objective The objectives of the study evaluating pregnancies complicated by gastroschisis were to determine the proportion of women undergoing planned cesarean vs attempted vaginal delivery and to provide up-to-date epidemiology on the risk factors associated with this anomaly. Study Design This population-based study of US natality records from 2005 through 2013 evaluated pregnancies complicated by gastroschisis. Women were classified based on whether they attempted vaginal delivery or underwent a planned cesarean (n = 24,836,777). Obstetrical, medical, and demographic characteristics were evaluated. Multivariable log-linear regression models were developed to determine the factors associated with the mode of delivery. Factors associated with the occurrence of the anomaly were also evaluated in log-linear models. Results Of 5985 pregnancies with gastroschisis, 63.5% (n = 3800) attempted vaginal delivery and 36.5% (n = 2185) underwent a planned cesarean delivery. The rate of attempted vaginal delivery increased from 59.7% in 2005 to 68.8% in 2013. Earlier gestational age and Hispanic ethnicity were associated with lower rates of attempted vaginal delivery. Factors associated with the occurrence of gastroschisis included young age, smoking, high educational attainment, and being married. Protective factors included chronic hypertension, black race, and obesity. The incidence of gastroschisis was 3.1 per 10,000 pregnancies and did not increase during the study period. Conclusion Attempted vaginal delivery is becoming increasingly prevalent for women with a pregnancy complicated by gastroschisis. Recommendations from the research literature findings may be diffusing into clinical practice. A significant proportion of women with this anomaly still deliver by planned cesarean, suggesting further reduction of surgical delivery for this anomaly is possible.
Objective The purpose of this study was to determine whether surgical speed is associated with maternal outcomes in women who have a history of previous cesarean delivery (CD) and who require ...emergent delivery. Study Design This is a secondary analysis of a multicenter, prospective observational study of women with a history of previous CD. Women who attempted a vaginal birth after CD and required emergent CD were dichotomized into those with a skin incision-to-fetal delivery time of ≤2 min (I-D ≤2) or >2 min (I-D >2), based on the mode I-D. Rates of composite maternal complications and specific surgical complications were compared. Results Seven hundred ninety-three women had an emergency repeat CD: 108 women (13.6%) had I-D ≤2, and 685 women (86.4%) had I-D >2. The composite of maternal morbidity occurred in 36% of women with I-D≤2 and 23% with I-D>2 ( P < .01). Women with I-D ≤2 had higher odds of intraoperative transfusion, uterine artery ligation, and broad ligament hematoma. In a multivariable regression model, the only variable that remained associated with maternal outcome was I-D (relative risk, 1.66; 95% confidence interval, 1.23–2.23). There was no difference in the incidence of neonatal acidemia between groups. Conclusion Among women who underwent emergent repeat cesarean delivery, surgical speed was associated with an increased risk for maternal complications.
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