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484: Transplacental passage of clindamycin from mother to neonate
ajog.org
Poster Session III
CONCLUSION: Our data provide reassurance that patients selected for home management have lower risk for adverse outcomes. However, studies of groups with more similar risk profiles managed at home vs. in the hospital are warranted.
significant findings except the lowest paired values (maternal level of 0.7 mcg/mL and fetal level of < 0.5 mcg/mL) had a single dose with a time from administration to delivery of 5 hours and 49 minutes. CONCLUSION: These data show that the current dosing recommendation of 900 mg IV every 8 hrs produces therapeutic maternal and cord blood levels. There were no study patients delivered that had a time from last dose to delivery of > 6 hours but < 8 hours to determine if dosing frequency should change to every 6 hours in laboring patients. With the high rate of GBS resistance, therapeutic clindamycin levels may help minimize further contribution of GBS resistance to clindamycin.
485 Low birth weight (LBW) in the Antiretroviral Pregnancy Registry (APR)
Karen P. Beckerman1, Jessica Albano2, Conway Gee2, D. H. Watts3, Hugh Tilson4 1 Albert Einstein College of Medicine, Bronx, NY, 2INC Research, LLC, Wilmington, NC, 3Office of the Global AIDS Coordinator, Washington, DC, 4 UNC School of Public Health, Chapel Hill, NC
OBJECTIVE: We investigated the potential impact of combination
484 Transplacental passage of clindamycin from mother to neonate
Craig V. Towers1, Daniele Wear1, Suzanne Bryant1, Beth Weitz1, Stephanie Porter1, Lynlee Wolfe1 1
University of Tennessee Medical Center, Knoxville, Knoxville, TN
OBJECTIVE: The current dosing recommendation for group B
streptococcal (GBS) prophylaxis in pregnancy for clindamycin is 900 mg IV every 8 hrs. A few studies have analyzed maternal clindamycin levels and transplacental passage, but these involved the use of oral treatment at the time of abortion, administration 30 minutes prior to C-section, or in treating chorioamnionitis. No study has evaluated the 900 mg IV dosing regimen. The study purpose was to analyze a large number of patients receiving treatment for GBS prophylaxis at the recommended dose of 900 mg IV every 8 hrs. STUDY DESIGN: Every mother that entered labor and delivery with a positive GBS culture and a high risk penicillin allergy with GBS sensitivity to clindamycin was prospectively consented to be in the study. Maternal clindamycin levels were obtained at delivery and correlated with neonatal cord blood levels. RESULTS: 23 total patients were consented and evaluated. The MIC for clindamycin is > 0.5 mcg/mL. All maternal clindamycin values were above this level with a mean concentration of 4.46 mcg/mL (range of 0.7 to 8.4 mcg/mL). 22 of 23 cord blood samples were also above this value with a mean concentration of 3.35 mcg/mL (range of 1.0 to 6.4 mcg/mL). There was one cord blood sample that was < 0.5 mcg/mL. Patient BMI did not affect the levels obtained. The cord blood values were higher than maternal in 5 (22%) of the cases. 14 patients received a single dose; 8 received 2 doses and 1 received 3 doses. Time from last dose to delivery also did not demonstrate any
antiretroviral (ARV) use, with and without protease inhibitors (PI), on the prevalence of LBW <2500g and very LBW <1500g (VLBW) in the APR primary prospective cohort. STUDY DESIGN: APR is an ongoing, pregnancy exposure registry designed to detect potential signals of birth defects associated with ARV use in pregnancy. No such signal has been identified. Health care providers register ARV exposed pregnant women who are followed prospectively to birth outcome. We analyzed BW among live birth(LB) outcomes reported through July 2011. We excluded multiple gestations and LB with birth defects. Univariate, bivariate and multivariate logistic regressions were performed and included risk factors for LBW: maternal age, race/ethnicity, CD4 count, and earliest trimester of exposure. RESULTS: Of 11,105 LB, 1764 were LBW <2500g (16%) and 233 were VLBW <1500g (2%). The prevalence of LBW ranged between 15% and 20% for individual PI. US population prevalence of LBW and VLBW in 2010 was 8.1% and 1.4%, respectively. Stratified analyses by individual risk factors (Table) showed significantly increased risk of LBW associated with maternal use of PI-based combination ARV, but no difference between PI-based combinations with and without ritonavir. Bivariate analyses suggested that increasing maternal age, decreasing CD4 and race/ethnicity might enhance PI-associated LBW risk (Figure). Multivariate adjusted logistic-regression showed PI-based combinations were associated with increased risk of LBW (RR 1.3, 95% CI 1.1-1.4, p<0.001) and VLBW (RR 1.6, 95% CI 1.1-2.2, p¼0.008) compared with non-PI combination ARV exposure. Ritonavir had no increased risk vs PI without ritonavir for LBW (RR 1.1,p¼0.209) or VLBW (RR 0.9,p¼0.621). CONCLUSION: Overall prevalence of LBW in APR was higher than in the general population. We found increased risk of LBW after maternal PI exposure compared to combination ARV without PI and this increase persisted after adjusting for LBW risk factors in multivariate analyses. Presence or absence of ritonavir in PI-based combinations did not affect LBW risk. Our findings warrant careful consideration as combination ARV therapy both with and without PI offers substantial benefits to maternal health and survival, as well as highly effective prevention of vertical transmission of HIV.
Supplement to JANUARY 2016 American Journal of Obstetrics & Gynecology
S265
Poster Session III
CONCLUSION: Our data provide reassurance that patients selected for home management have lower risk for adverse outcomes. However, studies of groups with more similar risk profiles managed at home vs. in the hospital are warranted.
significant findings except the lowest paired values (maternal level of 0.7 mcg/mL and fetal level of < 0.5 mcg/mL) had a single dose with a time from administration to delivery of 5 hours and 49 minutes. CONCLUSION: These data show that the current dosing recommendation of 900 mg IV every 8 hrs produces therapeutic maternal and cord blood levels. There were no study patients delivered that had a time from last dose to delivery of > 6 hours but < 8 hours to determine if dosing frequency should change to every 6 hours in laboring patients. With the high rate of GBS resistance, therapeutic clindamycin levels may help minimize further contribution of GBS resistance to clindamycin.
485 Low birth weight (LBW) in the Antiretroviral Pregnancy Registry (APR)
Karen P. Beckerman1, Jessica Albano2, Conway Gee2, D. H. Watts3, Hugh Tilson4 1 Albert Einstein College of Medicine, Bronx, NY, 2INC Research, LLC, Wilmington, NC, 3Office of the Global AIDS Coordinator, Washington, DC, 4 UNC School of Public Health, Chapel Hill, NC
OBJECTIVE: We investigated the potential impact of combination
484 Transplacental passage of clindamycin from mother to neonate
Craig V. Towers1, Daniele Wear1, Suzanne Bryant1, Beth Weitz1, Stephanie Porter1, Lynlee Wolfe1 1
University of Tennessee Medical Center, Knoxville, Knoxville, TN
OBJECTIVE: The current dosing recommendation for group B
streptococcal (GBS) prophylaxis in pregnancy for clindamycin is 900 mg IV every 8 hrs. A few studies have analyzed maternal clindamycin levels and transplacental passage, but these involved the use of oral treatment at the time of abortion, administration 30 minutes prior to C-section, or in treating chorioamnionitis. No study has evaluated the 900 mg IV dosing regimen. The study purpose was to analyze a large number of patients receiving treatment for GBS prophylaxis at the recommended dose of 900 mg IV every 8 hrs. STUDY DESIGN: Every mother that entered labor and delivery with a positive GBS culture and a high risk penicillin allergy with GBS sensitivity to clindamycin was prospectively consented to be in the study. Maternal clindamycin levels were obtained at delivery and correlated with neonatal cord blood levels. RESULTS: 23 total patients were consented and evaluated. The MIC for clindamycin is > 0.5 mcg/mL. All maternal clindamycin values were above this level with a mean concentration of 4.46 mcg/mL (range of 0.7 to 8.4 mcg/mL). 22 of 23 cord blood samples were also above this value with a mean concentration of 3.35 mcg/mL (range of 1.0 to 6.4 mcg/mL). There was one cord blood sample that was < 0.5 mcg/mL. Patient BMI did not affect the levels obtained. The cord blood values were higher than maternal in 5 (22%) of the cases. 14 patients received a single dose; 8 received 2 doses and 1 received 3 doses. Time from last dose to delivery also did not demonstrate any
antiretroviral (ARV) use, with and without protease inhibitors (PI), on the prevalence of LBW <2500g and very LBW <1500g (VLBW) in the APR primary prospective cohort. STUDY DESIGN: APR is an ongoing, pregnancy exposure registry designed to detect potential signals of birth defects associated with ARV use in pregnancy. No such signal has been identified. Health care providers register ARV exposed pregnant women who are followed prospectively to birth outcome. We analyzed BW among live birth(LB) outcomes reported through July 2011. We excluded multiple gestations and LB with birth defects. Univariate, bivariate and multivariate logistic regressions were performed and included risk factors for LBW: maternal age, race/ethnicity, CD4 count, and earliest trimester of exposure. RESULTS: Of 11,105 LB, 1764 were LBW <2500g (16%) and 233 were VLBW <1500g (2%). The prevalence of LBW ranged between 15% and 20% for individual PI. US population prevalence of LBW and VLBW in 2010 was 8.1% and 1.4%, respectively. Stratified analyses by individual risk factors (Table) showed significantly increased risk of LBW associated with maternal use of PI-based combination ARV, but no difference between PI-based combinations with and without ritonavir. Bivariate analyses suggested that increasing maternal age, decreasing CD4 and race/ethnicity might enhance PI-associated LBW risk (Figure). Multivariate adjusted logistic-regression showed PI-based combinations were associated with increased risk of LBW (RR 1.3, 95% CI 1.1-1.4, p<0.001) and VLBW (RR 1.6, 95% CI 1.1-2.2, p¼0.008) compared with non-PI combination ARV exposure. Ritonavir had no increased risk vs PI without ritonavir for LBW (RR 1.1,p¼0.209) or VLBW (RR 0.9,p¼0.621). CONCLUSION: Overall prevalence of LBW in APR was higher than in the general population. We found increased risk of LBW after maternal PI exposure compared to combination ARV without PI and this increase persisted after adjusting for LBW risk factors in multivariate analyses. Presence or absence of ritonavir in PI-based combinations did not affect LBW risk. Our findings warrant careful consideration as combination ARV therapy both with and without PI offers substantial benefits to maternal health and survival, as well as highly effective prevention of vertical transmission of HIV.
Supplement to JANUARY 2016 American Journal of Obstetrics & Gynecology
S265