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Am J Perinatol ; 36(11): 1097-1105, 2019 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-30822800


OBJECTIVE: Our objective was to evaluate the efficacy of perioperative multimodal pain management in reducing opioid use after elective cesarean delivery (CD). STUDY DESIGN: A single-center, double-blinded, placebo-controlled randomized trial of women undergoing elective CD. Participants were allocated 1:1 to receive the multimodal protocol or matching placebos. The multimodal protocol consisted of a preoperative dose of intravenous acetaminophen, preincision injection of subcutaneous bupivacaine, and intraoperative injection of intramuscular ketorolac. Primary outcome was total opioid intake at 48 hours postoperatively. Secondary outcomes were pain scores, time to first opioid intake, neonatal outcomes, and total outpatient opioid intake on postoperative day (POD) 7. Data were analyzed using parametric and nonparametric tests and quantile regression as appropriate. RESULTS: A total of 242 women were screened with 120 randomized, 60 to the multimodal group and 60 to control group. There was no significant difference in the primary outcome of opioid use nor in the secondary outcomes. Smokers and patients with a history of drug use had higher median postoperative opiate use and earlier administration. On POD 7, only 40% of prescribed opioids had been used, and there was no difference between the groups. CONCLUSION: This perioperative multimodal pain regimen did not reduce opioid use in 48 hours after CD. Patients who smoke or with a history of drug use required more opioids in the postoperative period. Providers significantly overprescribed opioids after CD.

Am J Obstet Gynecol ; 220(3): 275.e1-275.e9, 2019 03.
Artigo em Inglês | MEDLINE | ID: mdl-30790569


OBJECTIVE: The objective of the study was to test the hypothesis that Dilapan-S is not inferior to the Foley balloon for preinduction cervical ripening at term. STUDY DESIGN: Pregnant women ≥37 weeks scheduled for induction with unfavorable cervix (≤3 cm dilated and ≤60% effaced) were randomly assigned to 12 hours of either Foley balloon inflated with 60 mL saline or Dilapan-S for cervical ripening. If the cervix remained unfavorable, then 1 more round of the assigned dilator was used. Management following ripening was left up to the clinical providers. The primary outcome was vaginal delivery. A satisfaction survey was also obtained after the preinduction period. Sample size was based on a noninferiority margin of 10%, 90% power, and an estimated frequency of vaginal delivery of 71% in Foley balloon and 76% in Dilapan-S. RESULTS: From November 2016 through February 2018, 419 women were randomized (209 to Foley balloon; 210 to Dilapan-S). In the intent-to-treat analysis, vaginal delivery was more common in Dilapan-S vs Foley balloon (81.3% vs 76.1%), with an absolute difference with respect to the Foley balloon of 5.2% (95% confidence interval, -2.7% to 13.0%) indicating noninferiority for the prespecified margin. The difference was not large enough to show superiority. Noninferiority was confirmed in the per-protocol population (n = 204 in the Foley balloon, n = 188 in Dilapan-S), supporting the robustness of the results. Secondary outcomes were not different between groups, except for a longer time the device remained in place in Dilapan-S compared with the Foley balloon. Maternal and neonatal adverse events were not significantly different between groups. A priori interaction analyses showed no difference in the effect on vaginal delivery by cervical dilation at randomization, parity, or body mass index >30 kg/m2. Patients with Dilapan-S were more satisfied than patients with the Foley balloon as far as sleep (P = .01), relaxing time (P = .001), and performance of desired daily activities (P = .001). CONCLUSION: Dilapan-S is not inferior to the Foley balloon for preinduction cervical ripening at term. Advantages of Dilapan-S over Foley include Food and Drug Administration approval, safe profile, no protrusion from the introitus, no need to keep under tension, and better patient satisfaction.

Cateterismo/instrumentação , Maturidade Cervical , Trabalho de Parto Induzido/instrumentação , Polímeros , Adolescente , Adulto , Cateterismo/métodos , Parto Obstétrico/métodos , Parto Obstétrico/estatística & dados numéricos , Feminino , Humanos , Trabalho de Parto Induzido/métodos , Satisfação do Paciente , Gravidez , Método Simples-Cego , Adulto Jovem
Am J Perinatol ; 35(5): 515-520, 2018 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-29183096


OBJECTIVE: This article aims to compare the composite maternal and neonatal morbidities (CMM and CNM, respectively) between macrosomic (≥4,000 g) and nonmacrosomic (<4,000 g) newborns among women with diabetes mellitus (DM). METHODS: Maternal demographic and peripartum outcome data (N = 1,260) were collected from a retrospective cohort. CMM included chorioamnionitis/endometritis, wound infection, shoulder dystocia, eclampsia, pulmonary edema, admission for hypoglycemia, 3rd/4th degree perineal laceration, and death. CNM included 5-minute Appearance, Pulse, Grimace, Activity and Respiration (APGAR) score of <4, neonatal intensive care unit (NICU) admission, respiratory distress syndrome, mechanical ventilation, intraventricular hemorrhage grade III/IV, necrotizing enterocolitis stage II/III, hypoglycemia, hypocalcemia, bronchopulmonary dysplasia, sepsis, seizures, hyperbilirubinemia, and death. Multivariable Poisson regression models with robust error variance were used to calculate adjusted relative risk (aRR) and 95% confidence interval (CI). RESULTS: The study population consisted of 967 subjects, including 854 (88.3%) nonmacrosomic and 113 (11.7%) macrosomic infants. After adjustment, the risk of CMM was higher among macrosomic deliveries (aRR = 4.08, 95% CI = 2.45-6.80). The risk of CNM was also higher among macrosomic deliveries (aRR = 1.77, 95% CI = 1.39-2.24). Macrosomia was associated with an increased risk in NICU admission, hypoglycemia, and hyperbilirubinemia. CONCLUSION: Among DM deliveries, macrosomia was associated with a fourfold higher risk of CMM and almost twofold higher risk of CNM.

Macrossomia Fetal/epidemiologia , Doenças do Recém-Nascido/epidemiologia , Unidades de Terapia Intensiva Neonatal/estatística & dados numéricos , Complicações do Trabalho de Parto/epidemiologia , Gravidez em Diabéticas/epidemiologia , Adulto , Distocia/etiologia , Feminino , Humanos , Hiperbilirrubinemia/etiologia , Hipoglicemia/etiologia , Recém-Nascido , Troca Materno-Fetal , Morbidade , Análise Multivariada , Gravidez , Análise de Regressão , Estudos Retrospectivos , Texas/epidemiologia , Adulto Jovem
AJP Rep ; 7(2): e128-e133, 2017 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-28674636


Objective This study aims to compare composite maternal and neonatal morbidities (MM, NM) among pregnant women with diabetes mellitus whose body mass index (BMI) at delivery was < 30 (group 1), 30.0 to 39.9 (group 2), and ≥ 40 kg/m 2 (group 3). We hypothesized that increased BMI class at delivery would be associated with worsening maternal and neonatal outcomes. Methods This is a retrospective cohort study. MM was defined as: chorioamnionitis, wound infection, eclampsia, diabetic ketoacidosis, hypoglycemia admission, third/fourth degree laceration, and/or death. NM was defined as umbilical arterial pH < 7.0, 5 minute Apgar < 4, respiratory distress syndrome, mechanical ventilation, neonatal sepsis, stillbirth, and/or death. Odds ratios were adjusted for possible confounders. Results MM was noted in 8, 13, and 24% of groups 1, 2, and 3, respectively, and significantly more common in group 2 versus 1 (adjusted odds ratio [aOR]: 1.66) and group 3 versus 1 (aOR: 3.06). NM was noted in 7, 8, and 15% of each BMI group, respectively, and differed significantly between group 3 vs. 2 (aOR: 1.77). Conclusions The increased rate of morbidities between the BMI groups is useful to inform diabetic women and highlights the need for further investigation of diabetes and obesity as comorbidities in pregnancy.