We conducted a retrospective cohort study of pregnant patients who tested positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection by RNA polymerase chain reaction test or ...home test who were counseled about taking nirmatrelvir-ritonavir if they were within 5 days of symptom onset. Obstetric and coronavirus disease 2019 (COVID-19) outcomes were compared between patients who did and did not take the medication. Overall, 114 individuals took nirmatrelvir-ritonavir and 323 did not. The cohorts were comparable, including high rates of vaccination in both groups. Nirmatrelvir-ritonavir was well-tolerated, with no patients discontinuing medication due to side effects. There were no intensive care unit admissions in either group. Most obstetric and medical outcomes were similar between those taking and not taking nirmatrelvir-ritonavir. Patients taking nirmatrelvir-ritonavir had significantly higher rates of surgical site infection (3 2.7% vs 0 0%, P =.02) and preeclampsia (11 9.6% vs 12 3.7%, P =.02). Outcome event numbers were too small for multivariable modeling. These preliminary data may be reassuring to clinicians and patients who would like to use nirmatrelvir-ritonavir in pregnancy.
Background. Conflicting results have been reported among studies of protease inhibitor (PI) use during pregnancy and preterm birth. Uncontrolled confounding by indication may explain some of the ...differences among studies. Methods. In total, 777 human immunodeficiency virus (HIV)–infected pregnant women in a prospective cohort who were not receiving antiretroviral (ARV) treatment at conception were studied. Births <37 weeks gestation were reviewed, and deliveries due to spontaneous labor and/or rupture of membranes were identified. Risk of preterm birth and low birth weight (<2500 g) were evaluated by using multivariable logistic regression. Results. Of the study population, 558 (72%) received combination ARV with PI during pregnancy, and a total of 130 preterm births were observed. In adjusted analyses, combination ARV with PI was not significantly associated with spontaneous preterm birth, compared to ARV without PI (odds ratio OR, 1.22; 95% confidence interval CI, 0.70–2.12). Sensitivity analyses that included women who received ARV prior to pregnancy also did not identify a significant association (OR, 1.34; 95% CI, 0.84–2.16). Low birth weight results were similar. Conclusions. No evidence of an association between use of combination ARV with PI during pregnancy and preterm birth was found. Our study supports current guidelines that promote consideration of combination ARV for all HIV-infected pregnant women.
To examine the microbiology and associated antibiotic resistance patterns among febrile peripartum women with positive blood cultures.
We conducted a retrospective cohort study in which we reviewed ...all bacteremia cases between 2009 and 2016 that occurred between 7 days before and 30 days after delivery. Institutional guidelines include obtaining blood cultures and promptly initiating intravenous antibiotics for all obstetric patients with fever of 100.4°F or higher. We describe antibiotic resistance patterns for the most frequently isolated organisms and perform univariate analyses regarding maternal and neonatal outcomes based on type of bacteremia.
Among 56,835 deliveries, 3,797 (6.7%) obstetric patients had blood cultures drawn and 120 (3.2%) had documented bacteremia. The most commonly cultured organisms were Escherichia coli (17.5%, n=21), Bacteroides species (10.8%, n=13), Enterococcus species (10.8%, n=13), group B streptococci (10.8%, n=13), and group A streptococci (5.0%, n=6). E coli had high rates of resistance to ampicillin (n=17, 81.0%) and extended spectrum beta lactams (n=10, 47.6%). Gram-positive bacteremia was noted in 65/120 patients (54.2%), gram-negative bacteremia in 39/120 (32.5%), and anaerobic bacteremia in 16/120 (13.3%) (P=.02). Neonatal bacteremia was identified in 8/120 cases (6.7%), of which 7/8 (87.5%) were attributable to gram-negative bacteria and 1/8 (12.5%) were attributable to gram-positive bacteremia (P=.004). There were no differences in neonatal death or maternal intensive care unit admission.
Peripartum bacteremia is uncommon, with the most frequently isolated organism being E coli. The evolution of antibiotic resistance patterns in E coli at our institution may be of clinical significance in determining antibiotic choice for peripartum fever.
To investigate the test characteristics of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) criteria for intrauterine inflammation or infection or both ...(triple I) and rates of adverse outcomes in a cohort of febrile intrapartum women.
This retrospective cohort study included women at 24 weeks of gestation or greater from June 2015 to September 2017 at a single tertiary hospital with a temperature 100.4°F or greater (38.0°C) during labor or within 1 hour postpartum, all of whom had blood culture data. Women with a fetal demise, expectantly managed preterm prelabor rupture of membranes, or nonobstetric infections were excluded. Documented fever was defined as a single temperature 102.2°F or greater (39.0°C) or a temperature 100.4°F or greater (38.0°C) but less than 102.2°F (39.0°C) on two measurements 45 minutes apart. We defined two analysis groups: 1) suspected triple I, defined as women with documented fever with clinical signs of infection; and 2) isolated maternal fever, defined as women with at least one temperature 100.4°F or greater (38.0°C) who did not meet criteria for suspected triple I. We assessed test characteristics of suspected triple I to predict 1) confirmed triple I, defined as suspected triple I with placental pathology diagnostic of infection; and 2) adverse clinical infectious outcome, defined as a composite of maternal and neonatal adverse infectious outcomes. We also calculated the incidence of adverse clinical infectious outcomes for both groups.
Three hundred thirty-nine women were analyzed: 212 with suspected triple I and 127 with isolated maternal fever. Baseline demographic and obstetric characteristics were similar between groups. The incidence of adverse clinical infectious outcomes was 11.8% among women with suspected triple I and 9.5% among women with isolated maternal fever (P=.50). The sensitivity and specificity of suspected triple I for confirmed triple I were 71.4% (95% CI 61.4-80.1%) and 40.5% (95% CI 33.6-47.8%), respectively, and for an adverse clinical infectious outcome were 67.6% (95% CI 50.2-82.0%) and 38.1% (95% CI 32.6-43.8%), respectively.
Applying the NICHD criteria to guide clinical diagnosis and management of intrauterine infection or inflammation may overlook an important proportion of laboring febrile women at risk for adverse infectious outcomes.
Some studies suggest that combination antiretroviral therapy in pregnant women with human immunodeficiency virus type 1 (HIV-1) infection increases the risk of premature birth and other adverse ...outcomes of pregnancy.
We studied pregnant women with HIV-1 infection who were enrolled in seven clinical studies and delivered their infants from 1990 through 1998. The cohort comprised 2123 women who received antiretroviral therapy during pregnancy (monotherapy in 1590, combination therapy without protease inhibitors in 396, and combination therapy with protease inhibitors in 137) and 1143 women who did not receive antiretroviral therapy.
After standardization for the CD4+ cell count and use or nonuse of tobacco, alcohol, and illicit drugs, the rate of premature delivery (<37 weeks of gestation) was similar among the women who received antiretroviral therapy and those who did not (16 percent and 17 percent, respectively); the rate of low birth weight (<2500 g) was 16 percent among the infants born to both groups; and the rate of very low birth weight (<1500 g) was 2 percent for the group that received antiretroviral therapy and 1 percent for the group that did not. The rates of low Apgar scores (<7) and stillbirth were also similar or the same in the two groups. After adjustment for multiple risk factors, combination antiretroviral therapy was not associated with an increased risk of premature delivery as compared with monotherapy (odds ratio, 1.08; 95 percent confidence interval, 0.71 to 1.62) or delivery of an infant with low birth weight (odds ratio, 1.03; 95 percent confidence interval, 0.64 to 1.63). Seven of the women who received combination therapy with protease inhibitors (5 percent) had infants with very low birth weight, as compared with nine women who received combination therapy without protease inhibitors (2 percent) (adjusted odds ratio, 3.56; 95 percent confidence interval, 1.04 to 12.19).
As compared with no antiretroviral therapy or monotherapy, combination therapy for HIV-1 infection in pregnant women is not associated with increased rates of premature delivery or with low birth weight, low Apgar scores, or stillbirth in their infants. The association between combination therapy with protease inhibitors and an increased risk of very low birth weight requires confirmation.
To evaluate the frequency and associated characteristics of chronic comorbid conditions and obstetrical complications among pregnant women with human immunodeficiency virus (HIV) and receiving ...antiretroviral therapy (ART) in comparison to those without HIV.
We compared 2 independent concurrent US pregnancy cohorts: (1) with HIV (International Maternal Pediatric Adolescent AIDS Clinical Trials Protocol P1025, 2002-2013) and (2) without HIV (Consortium for Safe Labor Study, 2002-2007). Outcomes were ≥2 chronic comorbid conditions and obstetrical complications. For women with HIV, we assessed whether late prenatal care (≥14 weeks), starting ART in an earlier era (2002-2008), and a detectable viral load at delivery (≥400 copies/mL) were associated with study outcomes.
We assessed 2868 deliveries (n = 2574 women) with HIV and receiving ART and 211 910 deliveries (n = 193 170 women) without HIV. Women with HIV were more likely to have ≥2 chronic comorbid conditions versus those without HIV (10 vs 3%; adjusted OR AOR: 2.96; 95% CI: 2.58-3.41). Women with HIV were slightly less likely to have obstetrical complications versus those without HIV (both 17%; AOR: .84; 95% CI: .75-.94), but secondarily, higher odds of preterm birth <37 weeks. Late entry to prenatal care and starting ART in an earlier era were associated with a lower likelihood of ≥2 chronic comorbidities and obstetrical complications; detectable viral load at delivery was associated with a higher likelihood of obstetric complications.
Pregnant women with HIV receiving ART have more chronic comorbid conditions, but not necessarily obstetrical complications, than their peers without HIV.
To define the microbial epidemiology and clinical risk factors associated with peripartum bacteremia in the era of group B streptococcus prophylaxis.
We identified all cases of maternal bacteremia ...occurring during the peripartum time period (defined as from 7 days before delivery until 30 days after delivery) in a large maternity center from 2000 to 2008. Chart review was performed to determine the clinical factors associated with bacteremia.
During the study period, blood cultures were obtained from 1,295 febrile peripartum women (1.6% of all parturients); 172 of 1,295 febrile peripartum women (13.3%) had bacteremia (2.2 cases per 1,000 deliveries) with 194 microbial isolates and 1 yeast. The most frequent bacterial isolates were Escherichia coli (35.9%), enterococci (23.6%), and anaerobic species (9.2%); group B streptococcus was isolated in only eight cases (4.1%). Clinical diagnoses among infected women included endometritis (56%), chorioamnionitis (21%), and urosepsis (8%). Among women with endometritis, 77% underwent cesarean delivery (compared with vaginal delivery; relative risk RR 10.85, 95% confidence interval CI 6.75-17.45) and 39% delivered at less than 37 weeks of gestation (compared with 37 weeks or more; RR 3.21, 95% CI 2.42-4.25). Severe maternal complications of bacteremia were noted; six women required intensive care unit admission, five women had development of ileus, and one death occurred because of urosepsis.
In the era of group B streptococcus prophylaxis, E coli and enterococci are the most frequent bacteria isolated in peripartum bacteremia. Group B streptococcus accounted for only 4% of cases.
III.
To describe patterns and factors associated with mode of delivery among pregnant women with human immunodeficiency virus (HIV) infection in the United States in relation to evolving HIV-in-pregnancy ...guidelines.
We conducted an analysis of two observational studies, Pediatric AIDS Clinical Trials Group and International Maternal Pediatric Adolescent AIDS Clinical Trials Network Protocol P1025, which enrolled pregnant women with HIV infection from 1998 to 2013 at more than 60 U.S. acquired immunodeficiency syndrome clinical research sites. Multivariable analyses of factors associated with an HIV-indicated cesarean delivery (ie, for prevention of mother-to-child transmission) compared with other indications were conducted and compared according to prespecified time periods of evolving HIV-in-pregnancy guidelines: 1998-1999, 2000-2008, and 2009-2013.
Among 6,444 pregnant women with HIV infection, 21% delivered in 1998-1999, 58% in 2000-2008, and 21% in 2009-2013; 3,025 (47%) delivered by cesarean. Cesarean delivery increased from 30% in 1998 to 48% in 2013. Of all cesarean deliveries, repeat cesarean deliveries increased from 16% in 1998 to 42% in 2013; HIV-indicated cesarean deliveries peaked at 48% in 2004 and then dropped to 12% by 2013. In multivariable analyses, an HIV diagnosis during pregnancy, initiation of antiretroviral therapy in the third trimester, a plasma viral load 500 copies/mL or greater, and delivery between 37 and 40 weeks of gestation increased the likelihood of an HIV-indicated cesarean delivery. In analyses by time period, an HIV diagnosis during pregnancy, initiation of antiretroviral therapy in the third trimester, and a plasma viral load of 500 copies/mL or greater were progressively more likely to be associated with an HIV-indicated cesarean delivery over time.
Almost 50% of pregnant women with HIV infection underwent cesarean delivery. Over time, the rate of repeat cesarean deliveries increased, whereas the rate of HIV-indicated cesarean deliveries decreased; cesarean deliveries were more likely to be performed in women at high risk of mother-to-child transmission. These findings reinforce the need for both early diagnosis and treatment of HIV infection in pregnancy and the option of vaginal delivery after cesarean among pregnant women with HIV infection.
To investigate complications of cesarean section in a cohort of HIV-infected pregnant women.
IMPAACT P1025 is a prospective cohort study of HIV-1-infected women and infants, enrolled 2002-2013, at ...clinical sites in the United States and Puerto Rico. Demographic, medical, and obstetric data were collected and analyzed including cesarean indications. The delivery route was categorized as elective cesarean (ECS) (before labor and <5 minutes before membrane rupture), nonelective cesarean (NECS) (all other cesareans) or vaginal delivery. Logistic regression models evaluated associations between delivery route and maternal intrapartum/postpartum morbidities. Composite morbidity of vaginal delivery was compared with ECS and NECS.
This study included 2297 women. Of note, 99% used antiretroviral medication and 89% were on a combination antiretroviral therapy regimen; 84% had a HIV-1 viral load ≤400 copies per milliliter before delivery; 46% (1055) delivered vaginally, 35% (798) by ECS, and 19% (444) by NECS. Although interruption of HIV-1 infection was the second most frequent indication for cesarean after repeat cesarean, it decreased as an indication over time. There were no delivery-related maternal mortalities. Overall, 19% of women had ≥1 complication(s)-primarily wound complications (14%) or other infections (11%). Vaginal delivery had the lowest complication rate (13%), followed by ECS (23%), and highest NECS (28%) with an overall P < 0.001. HIV-1 mother-to-child transmission rates were low and did not differ by delivery mode group.
HIV interruption as cesarean indicator declined during the study. Morbidity was more common in HIV-infected women delivering by NECS than ECS and lowest with vaginal delivery.
Prenatal and Postnatal Studies of Interventions for Prevention of Mother-To-Child Transmission https://clinicaltrials.gov/ct2/show/NCT00028145?term=impaact+1025&rank=2 NCT00028145.
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