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Browsing by Author "Macones, George A."
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Item Advanced Maternal Age and the Risk of Major Congenital Anomalies(Thieme, 2017-02) Goetzinger, Katherine R.; Shanks, Anthony L.; Odibo, Anthony O.; Macones, George A.; Cahill, Alison G.; Department of Obstetrics and Gynecology, IU School of MedicineObjective This study aims to determine if advanced maternal age (AMA) is a risk factor for major congenital anomalies, in the absence of aneuploidy. Study Design Retrospective cohort study of all patients with a singleton gestation presenting for second trimester anatomic survey over a 19-year study period. Aneuploid fetuses were excluded. Study groups were defined by maternal age ≤ 34 and ≥ 35 years. The primary outcome was the presence of one or more major anomalies diagnosed at the second trimester ultrasound. Univariable and multivariable logistic regression analyses were used to estimate the risk of major anomalies in AMA patients. Results Of 76,156 euploid fetuses, 2.4% (n = 1,804) were diagnosed with a major anomaly. There was a significant decrease in the incidence of major fetal anomalies with increasing maternal age until the threshold of age 35 (p < 0.001). Being AMA was significantly associated with an overall decreased risk for major fetal anomalies (adjusted odds ratio: 0.59, 95% confidence interval: 0.52–0.66). The subgroup analysis demonstrated similar results for women ≥ 40 years of age. Conclusion AMA is associated with an overall decreased risk for major anomalies. These findings may suggest that the “all or nothing” phenomenon plays a more robust role in embryonic development with advancing oocyte age, with anatomically normal fetuses being more likely to survive.Item Clinical Diagnosis of Placenta Accreta and Clinicopathological Outcomes(Thieme, 2019) Rosenbloom, Joshua I.; Hirshberg, Jonathan S.; Stout, Molly J.; Cahill, Alison G.; Macones, George A.; Tuuli, Methodius G.; Obstetrics and Gynecology, School of MedicineObjective To investigate the association between the intraoperative diagnosis of placenta accreta at the time of cesarean hysterectomy and pathological diagnosis. Study Design This is a retrospective cohort study of all patients undergoing cesarean hysterectomy for suspected placenta accreta from 2000 to 2016 at Barnes-Jewish Hospital. The primary outcome was the presence of invasive placentation on the pathology report. We estimated predictive characteristics of clinical diagnosis of placenta accreta using pathological diagnosis as the correct diagnosis. Results There were 50 cesarean hysterectomies performed for suspected abnormal placentation from 2000 to 2016. Of these, 34 (68%) had a diagnosis of accreta preoperatively and 16 (32%) were diagnosed intraoperatively at the time of cesarean delivery. Two patients had no pathological evidence of invasion, corresponding to a false-positive rate of 4% (95% confidence interval [CI]: 0.5%, 13.8%) and a positive predictive value of 96% (95% CI: 86.3%, 99.5%). There were no differences in complications among patients diagnosed intraoperatively compared with those diagnosed preoperatively. Conclusion Most patients undergoing cesarean hysterectomy for placenta accreta do have this diagnosis confirmed on pathology. However, since the diagnosis of placenta accreta was made intraoperatively in nearly a third of cesarean hysterectomies, intraoperative vigilance is required as the need for cesarean hysterectomy may not be anticipated preoperatively.Item Effect of Prophylactic Negative Pressure Wound Therapy vs Standard Wound Dressing on Surgical-Site Infection in Obese Women After Cesarean Delivery(JAMA, 2020-09-22) Tuuli, Methodius G.; Liu, Jingxia; Tita, Alan T.N.; Longo, Sherri; Trudell, Amanda; Carter, Ebony B.; Shanks, Anthony L.; Woolfolk, Candice; Caughey, Aaron B.; Warren, David K.; Odibo, Anthony O.; Colditz, Graham; Macones, George A.; Harper, Lorie; Obstetrics and Gynecology, School of MedicineImportance: Obesity increases the risk of both cesarean delivery and surgical-site infection. Despite widespread use, it is unclear whether prophylactic negative pressure wound therapy reduces surgical-site infection after cesarean delivery in obese women. Objective: To evaluate whether prophylactic negative pressure wound therapy, initiated immediately after cesarean delivery, lowers the risk of surgical-site infections compared with standard wound dressing in obese women. Design, setting, and participants: Multicenter randomized trial conducted from February 8, 2017, through November 13, 2019, at 4 academic and 2 community hospitals across the United States. Obese women undergoing planned or unplanned cesarean delivery were eligible. The study was terminated after 1624 of 2850 participants were recruited when a planned interim analysis showed increased adverse events in the negative pressure group and futility for the primary outcome. Final follow-up was December 18, 2019. Interventions: Participants were randomly assigned to either undergo prophylactic negative pressure wound therapy, with application of the negative pressure device immediately after repair of the surgical incision (n = 816), or receive standard wound dressing (n = 808). Main outcomes and measures: The primary outcome was superficial or deep surgical-site infection according to the Centers for Disease Control and Prevention definitions. Secondary outcomes included other wound complications, composite of surgical-site infections and other wound complications, and adverse skin reactions. Results: Of the 1624 women randomized (mean age, 30.4 years, mean body mass index, 39.5), 1608 (99%) completed the study: 806 in the negative pressure group (median duration of negative pressure, 4 days) and 802 in the standard dressing group. Superficial or deep surgical-site infection was diagnosed in 29 participants (3.6%) in the negative pressure group and 27 (3.4%) in the standard dressing group (difference, 0.36%; 95% CI, -1.46% to 2.19%, P = .70). Of 30 prespecified secondary end points, 25 showed no significant differences, including other wound complications (2.6% vs 3.1%; difference, -0.53%; 95% CI, -1.93% to 0.88%; P = .46) and composite of surgical-site infections and other wound complications (6.5% vs 6.7%; difference, -0.27%; 95% CI, -2.71% to 2.25%; P = .83). Adverse skin reactions were significantly more frequent in the negative pressure group (7.0% vs 0.6%; difference, 6.95%; 95% CI, 1.86% to 12.03%; P < .001). Conclusions and relevance: Among obese women undergoing cesarean delivery, prophylactic negative pressure wound therapy, compared with standard wound dressing, did not significantly reduce the risk of surgical-site infection. These findings do not support routine use of prophylactic negative pressure wound therapy in obese women after cesarean delivery.Item Obesity, Second Stage Duration, and Labor Outcomes in Nulliparous Women(Thieme, 2021-03) Frolova, Antonina I.; Raghuraman, Nandini; Stout, Molly J.; Tuuli, Methodius G.; Macones, George A.; Cahill, Alison G.; Obstetrics and Gynecology, School of MedicineObjective: This study aimed to estimate second stage duration and its effects on labor outcomes in obese versus nonobese nulliparous women. Study design: This was a secondary analysis of a cohort of nulliparous women who presented for labor at term and reached complete cervical dilation. Adjusted relative risks (aRR) were used to estimate the association between obesity and second stage characteristics, composite neonatal morbidity, and composite maternal morbidity. Effect modification of prolonged second stage on the association between obesity and morbidity was assessed by including an interaction term in the regression model. Results: Compared with nonobese, obese women were more likely to have a prolonged second stage (aRR: 1.48, 95% CI: 1.18-1.85 for ≥3 hours; aRR: 1.65, 95% CI: 1.18-2.30 for ≥4 hours). Obesity was associated with a higher rate of second stage cesarean (aRR: 1.78, 95% CI: 1.34-2.34) and cesarean delivery for fetal distress (aRR: 2.67, 95% CI: 1.18-3.58). Obesity was also associated with increased rates of neonatal (aRR: 1.38, 95% CI: 1.05-1.80), but not maternal morbidity (aRR: 1.06, 95% CI: 0.90-1.25). Neonatal morbidity risk was not modified by prolonged second stage. Conclusion: Obesity is associated with increased risk of neonatal morbidity, which is not modified by prolonged second stage of labor.Item Perinatal outcomes after intrauterine growth restriction and umbilical artery Doppler pulsatility index of less than the fifth percentile(Taylor & Francis, 2021-03) Lewkowitz, Adam K.; Tuuli, Methodius G.; Cahill, Alison G.; Macones, George A.; Dicke, Jeffrey M.; Obstetrics and Gynecology, School of MedicineObjective: To analyze perinatal morbidity and stillbirth after intrauterine growth restriction (IUGR) with an umbilical artery Doppler pulsatility index (UA PI) less than the fifth centile.Study design: This retrospective cohort study included nonanomalous singleton, IUGR pregnancies receiving UA PI testing at a tertiary-care prenatal diagnostic center. Women with persistently elevated UA PI, absent or reversed end-diastolic flow on UA PI, or who had only one UA PI result were excluded. Low UA PI was defined as having ≥1 UA PI <5%. Women with low UA PI were matched by gestational age at IUGR diagnosis in a random 1 case: 4 control computer-generated algorithm to those with normal UA PI (≤95% and ≥5%). The primary outcome was composite neonatal morbidity and mortality (stillbirth, mechanical ventilation, sepsis, intraventricular hemorrhage, and necrotizing enterocolitis). Secondary outcomes included 5-minute Apgar, umbilical artery pH, delivery type, and interval from IUGR diagnosis to delivery. We compared outcomes after low UA PI to those after normal UA PI with multivariable logistic regression, adjusting for gestational age at delivery, betamethasone use, infant gender, and maternal factors.Results: Of the 1893 IUGR pregnancies, 25 (1.3%) had low UA PI <5% and were randomly matched via computer algorithm to 100 controls. There were no stillbirths in either group; the odds of composite neonatal morbidity was similar among IUGR pregnancies with UA PI <5% versus normal (adjusted odds ratio 0.89 (95% confidence interval 0.27-2.75)). There was no difference in 5-minute Apgars, umbilical artery pH, rate of cesarean delivery for fetal distress, or interval from IUGR diagnosis to delivery between the two groups.Conclusion: Among IUGR pregnancies, UA PI <5% is uncommon and not associated with improved neonatal outcomes compared to normal UA PI. These findings suggest low UA PI can continue to be managed as normal UA PI.Item Pilot Randomized Controlled Trial of Diabetes Group Prenatal Care(Thieme, 2022) Carter, Ebony B.; Barbier, Kate; Hill, Pamela K.; Cahill, Alison G.; Colditz, Graham A.; Macones, George A.; Tuuli, Methodius G.; Mazzoni, Sara E.; Obstetrics and Gynecology, School of MedicineObjective: This study aimed to determine the feasibility and effectiveness of Diabetes Group Prenatal Care to increase patient engagement in diabetes self-care activities. Study design: A pilot randomized controlled trial was conducted at two sites. Inclusion criteria were English or Spanish speaking, type 2 or gestational diabetes, 22 to 34 weeks of gestational age at first study visit, ability to attend group care at specified times, and willingness to be randomized. Exclusion criteria included type 1 diabetes, multiple gestation, major fetal anomaly, serious medical comorbidity, and serious psychiatric illness. Women were randomized to Diabetes Group Prenatal Care or individual prenatal care. The primary outcome was completion of diabetes self-care activities, including diet, exercise, blood sugar testing, and medication adherence. Secondary outcomes included antenatal care characteristics, and maternal, neonatal, and diabetes management outcomes. Analysis followed the intention-to-treat principle. Results: Of 159 eligible women, 84 (53%) consented to participate in the study and were randomized to group (n = 42) or individual (n = 42) prenatal care. Demographic characteristics were similar between study arms. Completion of diabetes self-care activities was similar overall, but women in group care ate the recommended amount of fruits and vegetables on more days per week (5.1 days/week ± 2.0 standard deviation [SD] in group care vs. 3.4 days ± 2.6 SD in individual care; p < 0.01) and gained less weight per week during the study period (0.2 lbs/week [interquartile range: 0-0.7] vs. 0.5 lbs/week [interquartile range: 0.2-0.9]; p = 0.03) than women in individual care. Women with gestational diabetes randomized to group care were 3.5 times more likely to have postpartum glucose tolerance testing than those in individual care (70 vs. 21%; relative risk: 3.5; 95% confidence interval: 1.4-8.8). Other maternal, neonatal, and pregnancy outcomes were similar between study arms. Conclusion: Diabetes group care is feasible and shows promise for decreasing gestational weight gain, improving diet, and increasing postpartum diabetes testing among women with pregnancies complicated by diabetes.Item Risk of Maternal Morbidity with Increasing Number of Cesareans(Thieme Publishing, 2019-03) Sondgeroth, Kristina E.; Wan, Leping; Rampersad, Roxane M.; Stout, Molly J.; Macones, George A.; Cahill, Alison G.; Tuuli, Methodius G.; Department of Obstetrics and Gynecology, School of MedicineObjective To estimate the risk of perioperative morbidity with increasing number of cesareans. Study Design We conducted a retrospective cohort study from 2004 to 2010. Patients delivered by cesarean were included. Outcome measures were a composite organ injury (bowel or bladder), hysterectomy, hemorrhage requiring transfusion, severe morbidity, or surgical site complications. The Cochran–Armitage's test of trend was used to assess increasing incidence of each morbidity with number of prior cesareans. Multivariable logistic regression was used to estimate adjusted risks for each morbidity with increasing number of cesareans compared with primary cesarean. Results Of the 15,872 women in the cohort, 5,144 had cesarean delivery: 3,113 primary, 1,310 one prior, 510 two prior, and 211 three or more prior cesareans. There was a significant increase in organ injury, hysterectomy, and surgical site complications with increasing number of cesareans. In multivariable analysis, the risk of organ injury and hysterectomy was increased compared with primary cesarean after two prior cesareans, and after three or more cesareans for hemorrhage requiring transfusion and surgical site complications. Conclusion The risks of organ injury and hysterectomy are increased after two or more prior cesareans, and risks of hemorrhage and surgical site complications are increased after three or more cesareans.