Problem:We evaluated eculizumab, a complement protein C5 inhibitor, for treatment of severe COVID-19 in pregnant and postpartum individuals.
Method ofStudy: Protocol ECU-COV-401 (clinicaltrials.gov NCT04355494) is an open label, multicenter, Expanded Access Program (EAP), evaluating eculizumab for treatment of severe COVID-19. Participants enrolled at our center from August 2020 to February 2021. Hospitalized patients were eligible if they had severe COVID-19 with bilateral pulmonary infiltrates and oxygen requirement. Eculizumab was administered on day 1 (1200 mg IV) with additional doses if still hospitalized (1200 mg IV on Days 4 and 8; 900 mg IV on Days 15 and 22; optional doses on Days 12 and 18). The primary outcome was survival at Day 15. Secondary outcomes included survival at Day 29, need for mechanical ventilation, and duration of hospital stay. We evaluated pharmacokinetic and pharmacodynamic data, safety, and adverse outcomes. Results: Eight participants were enrolled at the Cedars-Sinai Medical Center, six during pregnancy (mean 30 ± 4.0 weeks) and two in the postpartum period. Baseline oxygen requirement ranged from 2 L/min nasal cannula to 12 L/min by non-rebreather mask. The median number of doses of eculizumab was 2 (range 1-3); the median This is an open access article under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made.
Objective To evaluate whether prophylactic antibiotics at the time of placement of an intrauterine balloon tamponade (IBT) is associated with a reduction in postpartum endometritis.
Study Design Retrospective cohort study of patients who received an IBT from January 1, 2012, to December 12, 2016. Patients were included if the IBT remained in place at least 2 hours and excluded if chorioamnionitis was present. Patients who received prophylactic antibiotics at the time of IBT placement were compared with those who did not.
Results A total of 149 subjects received an IBT; 36 were excluded due to early removal or chorioamnionitis. Of the remaining, 59 received prophylactic antibiotics and 54 did not. Baseline characteristics were similar between the groups except mode of delivery. The majority (65%) of those who did not receive prophylactic antibiotics had a cesarean delivery (p = 0.03). The overall incidence of endometritis was 15%. The incidence of endometritis was greater among those patients who did not receive prophylactic antibiotics compared with those who did (5 vs. 26%; p < 0.002; odds ratio [OR]: 6.53; 95% confidence interval [CI]: 1.76–24.25). This association remained after adjustment for mode of delivery and receiving group B Streptococcus antibiotics prior to delivery (adjusted OR: 5.9; 95% CI: 1.58–22.35).
Conclusion Prophylactic antibiotics were associated with a reduction in postpartum endometritis among patients receiving an IBT.
Prelude clinical performance is consistent with the NIPS literature, and is achieved without a FF failure threshold. Our results demonstrate that Prelude achieves high accuracy and a low test-failure rate in a large general obstetric population.
OBJECTIVE:To evaluate the incidence of postpartum depression in mothers who endured maternal-neonatal separation at delivery and in the postpartum period due to their SARS-CoV-2 positive PCR status. STUDY DESIGN: We conducted a retrospective cohort study of women who delivered during the height of the COVID-19 pandemic from March 18th to May 12th 2020, when maternal-neonatal separation was recommended for SARS-CoV-2 positive mothers by the American Academy of Pediatrics. We excluded women who were less than 18 years of age at the time of delivery and those who experienced an IUFD or neonatal death. We investigated the difference in postpartum depression rates between SARS-CoV-2 positive and SARS-CoV-2 negative mothers. SARS-CoV-2 status was determined using a nasopharyngeal PCR swab upon admission to labor and delivery. We conducted analyses using Fischer Exact Tests, where a p-value of less than 0.05 was considered to be statistically significant. RESULTS: The incidence of postpartum depression was 2.4% in SARS-CoV-2 negative mothers versus 10.3% in SARS-COV-2 positive mothers with a p-value of 0.02. The relative risk of developing PPD in SARS-CoV-2 positive mothers was 3.73 with a 95% confidence interval of 1.03-13.4 with a p-value of 0.04. CONCLUSION: There was increased incidence and relative risk of postpartum depression in patients who were positive for SARS-CoV-2. Patients and providers should be made aware of this possible association. One possible contributing factor to the increased incidence of postpartum depression may have been maternal-neonatal separation. Current CDC evidence demonstrates low risk of neonatal acquisition of SARS-CoV-2 from asymptomatic positive mothers. The results of this study suggest another reason to follow the updated American Academy of Pediatrics SARS-CoV-2 recommendation, that asymptomatic mothers positive for SARS-CoV-2 should be allowed to room in with their neonate and not endure maternalneonatal separation.
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