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499: Effect of antenatal tocolysis, on neonatal outcomes
Fetus, Prematurity
www.AJOG.org 499 Effect of antenatal tocolysis, on neonatal outcomes Chad K. Klauser1, Sharon Keiser2, Rick Martin3, Ledon Langston4, Everett F. Magann5, Suneet Chauhan6, Mary Kosek3, John Morrison3 1 Maternal Fetal Medicine Associates, New York, New York, 2University of Mississippi Medical Center, Madison, Mississippi, 3University of Mississippi Medical Center, Jackson, Mississippi, 4Mississippi State Department of Health, Mississippi, 5University of Mississippi Medical Center, Obstetrics and Gynecology, Jackson, Mississippi, 6Aurora Health Care, Ob/Gyn Department, West Allis, Wisconsin
OBJECTIVE: To detail any adverse neonatal effects occurring after delivery in pregnancies treated with indomethacin (I), magnesium sulfate (M), or nifedipine (N). STUDY DESIGN: The study was approved by the IRB (0249) at a single site and registered by ClinicalTrials.gov (NCT00811057). Over a four year period, women in preterm labor with cervical dilatation 1-6cm were randomized to receive one of three treatments for acute first line tocolysis RESULTS: There were 317 evaluable neonates (I⫽103, M⫽95, N⫽119) whose mothers were treated with tocolytic therapy. There was no difference in gestational age at randomization (average 28.6 weeks’ gestation) or at delivery (average approximately 31 weeks’ gestation – p⫽.551), birth weight at delivery (1750g, p⫽.871), or ventilator days (approximately 7, p⫽.089) between the three groups. In addition, neonatal morbidity was not different between the three groups; RDS (p⫽.086), PDA (p⫽.592), sepsis (p⫽.590), NEC (p⫽.770), IVH (p⫽.669), and PVL (p⫽.124). Neonatal deaths (p⫽.504) and NICU days (p⫽.672) were also similar. However, both cases of PVL occurred in the Indomethacin group. CONCLUSION: While there were no statistical significant differences between the three tocolytics as far as serious neonatal morbidity or mortality was concerned, the two cases of PVL occurred in the indomethacin group thus possibly representing a risk of such treatment to patients in preterm labor. Serious Neonatal Morbidity Indomethacin (Nⴝ103)
MgSO4 (Nⴝ95)
Nifedipine (Nⴝ119)
P Value
Neonatal Morbidity
..........................................................................................................................................................................................
RDS 42 (41%) 39 (41%) 34 (28%) .086 .......................................................................................................................................................................................... PDA 12 (11%) 13 (13%) 11 (9%) .592 .......................................................................................................................................................................................... Sepsis 13 (13%) 10 (10%) 10 (8%) .590 .......................................................................................................................................................................................... NEC 5 (5%) 5 (5%) 4 (3%) .770 .......................................................................................................................................................................................... IVH 14 (14%) 11 (11%) 10 (8%) .669 .......................................................................................................................................................................................... PVL 2 (2%) 0 0 .124 .......................................................................................................................................................................................... 0002-9378/$ – see front matter • doi:10.1016/j.ajog.2009.10.665
500 Racial disparities in late preterm birth Ryan Loftin1, Katherine Wolfe1, Snyder Candice1, Sammy Tabbah1, David Jones2, David Lewis1, Emily Defranco1 1
University of Cincinnati, Cincinnati, Ohio, 2Cincinnati Children’s Hospital Medical Center, Division of Neonatology, Cincinnati, Ohio
OBJECTIVE: The number of late preterm births (LPTB), 34-36 completed weeks, are increasing, yet no studies have examined the impact of race on the risk of delivery or neonatal outcomes in the late preterm period. Our aim is to quantify the affect of race, independent of other factors, on the risk of LPTB and neonatal outcomes. STUDY DESIGN: We conducted a population-based cohort study using the Ohio Department of Health’s birth certificate database (2006 and 2007) for racial, socioeconomic and maternal medical risk factors associated with the occurrence of LPTB and adverse neonatal outcomes. We examined 289,833 singleton live birth records after excluding major congenital anomalies and births ⬍20 or 42 weeks. We utilized logistic regression modeling to estimate adjusted odds ratios
Poster Session III
(aOR) for the influence of race on LPTB rates and adverse neonatal outcomes, adjusting for significant and biologically plausible covariates (history of preterm birth, low socioceconomic status (Medicaid and WIC) hypertension, diabetes, obesity, parity, and tobacco use). RESULTS: 9.2% of White women (n ⫽ 225,046) delivered LPT, compared to 12.3% of Black women (n ⫽ 45,733) and 10.2% of Hispanic women (n⫽ 12,615), p⬍0.001. Black and Hispanic mothers were more likely to have LPTB compared to White mothers, aOR 1.31 (95% CI 1.26-1.36) and aOR 1.09 (95% CI 1.02-1.16), respectively, after adjustment for covaritates. Composite neonatal morbidity (neonatal seizure, Apgar⬍7 at 5 minutes, neonatal transfer, birth injury, or assisted ventilation ⬎ 6 hours) was less frequent in births to Black mothers (aOR 0 .73; 95% CI 0.64 - 0.83) compared to White mothers, but not for Hispanic mothers. CONCLUSION: Despite the increased occurrence of late preterm birth in Black women, independent of maternal medical and socioeconomic factors, there is an improved composite neonatal morbidity in this population. 0002-9378/$ – see front matter • doi:10.1016/j.ajog.2009.10.666
501 Ethnic variations in cervicovaginal MMP8 and IL-6 levels in preterm birth Jacqueline Ogutha1, Sahar Stephens2, Samuel Parry3, Jerome Strauss4, Iii, Marjorie Jeffcoat3, George Macones1 1
Washington University in St. Louis, St. Louis, Missouri, 2Washington University in St. Louis, , Missouri, 3University of Pennsylvania, Philadelphia, Pennsylvania, 4University of Pennsylvania Health System, Center for Research on Reproduction and Women’s Health, Philadelphia, Pennsylvania
OBJECTIVE: We sought to examine whether patients with preterm
birth (PTB) have elevated levels of mid-pregnancy cervicovaginal MMP8 and IL-6, and if enzyme levels vary by ethnicity, which is a known risk factor for PTB. STUDY DESIGN: This is a secondary analysis of data from a multicenter RCT of treating periodontal disease (PD) to prevent preterm birth. Cervicovaginal specimens were collected on patients with and without PD enrolled in the study. MMP8 and IL-6 levels were assessed using a validated assay. We compared mean MMP8 and IL-6 levels in women who delivered preterm and those who did not, stratified by ethnicity. RESULTS: 1616 pregnant women were included in this study: 83.7% (n⫽1352) were Black, 16.3% (n⫽264) were Non-Black, and 227 had deliveries at less than 37 weeks. There was no statistically significant difference in mean MMP8 levels among Blacks with or without PTB at 20 weeks (p⫽0.67) and at 28 weeks (p⫽0.31), or in IL-6 levels at 20 weeks (p⫽0.76) and 24 weeks (p⫽0.95). Non-significant findings were also noted in MMP8 levels in Non-Blacks (p⫽ 0.82 at 20 weeks; 0.78 at 28 weeks) and in IL-6 levels (p⫽0.10 at both 20 and 24 weeks). CONCLUSION: Cervicovaginal MMP8 and IL-6 levels do not differ significantly in patients who deliver prior to 37 weeks compared to those who deliver at term, and levels of these enzymes are similar across ethnicity. Continued research on the molecular genetics of PROM and PTB is warranted, specifically in a larger cohort of women, to better elucidate the role of proteolytic enzymes in these processes and how they may contribute to racial disparity in preterm birth. Blk.
mmp8 20w
Non-Blk.
<37wk
>37wk
p
<37wk
>37wk
p
2.68
2.96
0.67
2.77
2.86
0.82
..........................................................................................................................................................................................
mmp8 28w 2.86 3.57 0.31 2.62 2.77 0.74 .......................................................................................................................................................................................... il-6 20w .007 .007 0.76 .010 .004 0.10 .......................................................................................................................................................................................... il-6 24w .008 .008 0.95 .017 .008 0.10 .......................................................................................................................................................................................... 0002-9378/$ – see front matter • doi:10.1016/j.ajog.2009.10.667
Supplement to DECEMBER 2009 American Journal of Obstetrics & Gynecology
S187
www.AJOG.org 499 Effect of antenatal tocolysis, on neonatal outcomes Chad K. Klauser1, Sharon Keiser2, Rick Martin3, Ledon Langston4, Everett F. Magann5, Suneet Chauhan6, Mary Kosek3, John Morrison3 1 Maternal Fetal Medicine Associates, New York, New York, 2University of Mississippi Medical Center, Madison, Mississippi, 3University of Mississippi Medical Center, Jackson, Mississippi, 4Mississippi State Department of Health, Mississippi, 5University of Mississippi Medical Center, Obstetrics and Gynecology, Jackson, Mississippi, 6Aurora Health Care, Ob/Gyn Department, West Allis, Wisconsin
OBJECTIVE: To detail any adverse neonatal effects occurring after delivery in pregnancies treated with indomethacin (I), magnesium sulfate (M), or nifedipine (N). STUDY DESIGN: The study was approved by the IRB (0249) at a single site and registered by ClinicalTrials.gov (NCT00811057). Over a four year period, women in preterm labor with cervical dilatation 1-6cm were randomized to receive one of three treatments for acute first line tocolysis RESULTS: There were 317 evaluable neonates (I⫽103, M⫽95, N⫽119) whose mothers were treated with tocolytic therapy. There was no difference in gestational age at randomization (average 28.6 weeks’ gestation) or at delivery (average approximately 31 weeks’ gestation – p⫽.551), birth weight at delivery (1750g, p⫽.871), or ventilator days (approximately 7, p⫽.089) between the three groups. In addition, neonatal morbidity was not different between the three groups; RDS (p⫽.086), PDA (p⫽.592), sepsis (p⫽.590), NEC (p⫽.770), IVH (p⫽.669), and PVL (p⫽.124). Neonatal deaths (p⫽.504) and NICU days (p⫽.672) were also similar. However, both cases of PVL occurred in the Indomethacin group. CONCLUSION: While there were no statistical significant differences between the three tocolytics as far as serious neonatal morbidity or mortality was concerned, the two cases of PVL occurred in the indomethacin group thus possibly representing a risk of such treatment to patients in preterm labor. Serious Neonatal Morbidity Indomethacin (Nⴝ103)
MgSO4 (Nⴝ95)
Nifedipine (Nⴝ119)
P Value
Neonatal Morbidity
..........................................................................................................................................................................................
RDS 42 (41%) 39 (41%) 34 (28%) .086 .......................................................................................................................................................................................... PDA 12 (11%) 13 (13%) 11 (9%) .592 .......................................................................................................................................................................................... Sepsis 13 (13%) 10 (10%) 10 (8%) .590 .......................................................................................................................................................................................... NEC 5 (5%) 5 (5%) 4 (3%) .770 .......................................................................................................................................................................................... IVH 14 (14%) 11 (11%) 10 (8%) .669 .......................................................................................................................................................................................... PVL 2 (2%) 0 0 .124 .......................................................................................................................................................................................... 0002-9378/$ – see front matter • doi:10.1016/j.ajog.2009.10.665
500 Racial disparities in late preterm birth Ryan Loftin1, Katherine Wolfe1, Snyder Candice1, Sammy Tabbah1, David Jones2, David Lewis1, Emily Defranco1 1
University of Cincinnati, Cincinnati, Ohio, 2Cincinnati Children’s Hospital Medical Center, Division of Neonatology, Cincinnati, Ohio
OBJECTIVE: The number of late preterm births (LPTB), 34-36 completed weeks, are increasing, yet no studies have examined the impact of race on the risk of delivery or neonatal outcomes in the late preterm period. Our aim is to quantify the affect of race, independent of other factors, on the risk of LPTB and neonatal outcomes. STUDY DESIGN: We conducted a population-based cohort study using the Ohio Department of Health’s birth certificate database (2006 and 2007) for racial, socioeconomic and maternal medical risk factors associated with the occurrence of LPTB and adverse neonatal outcomes. We examined 289,833 singleton live birth records after excluding major congenital anomalies and births ⬍20 or 42 weeks. We utilized logistic regression modeling to estimate adjusted odds ratios
Poster Session III
(aOR) for the influence of race on LPTB rates and adverse neonatal outcomes, adjusting for significant and biologically plausible covariates (history of preterm birth, low socioceconomic status (Medicaid and WIC) hypertension, diabetes, obesity, parity, and tobacco use). RESULTS: 9.2% of White women (n ⫽ 225,046) delivered LPT, compared to 12.3% of Black women (n ⫽ 45,733) and 10.2% of Hispanic women (n⫽ 12,615), p⬍0.001. Black and Hispanic mothers were more likely to have LPTB compared to White mothers, aOR 1.31 (95% CI 1.26-1.36) and aOR 1.09 (95% CI 1.02-1.16), respectively, after adjustment for covaritates. Composite neonatal morbidity (neonatal seizure, Apgar⬍7 at 5 minutes, neonatal transfer, birth injury, or assisted ventilation ⬎ 6 hours) was less frequent in births to Black mothers (aOR 0 .73; 95% CI 0.64 - 0.83) compared to White mothers, but not for Hispanic mothers. CONCLUSION: Despite the increased occurrence of late preterm birth in Black women, independent of maternal medical and socioeconomic factors, there is an improved composite neonatal morbidity in this population. 0002-9378/$ – see front matter • doi:10.1016/j.ajog.2009.10.666
501 Ethnic variations in cervicovaginal MMP8 and IL-6 levels in preterm birth Jacqueline Ogutha1, Sahar Stephens2, Samuel Parry3, Jerome Strauss4, Iii, Marjorie Jeffcoat3, George Macones1 1
Washington University in St. Louis, St. Louis, Missouri, 2Washington University in St. Louis, , Missouri, 3University of Pennsylvania, Philadelphia, Pennsylvania, 4University of Pennsylvania Health System, Center for Research on Reproduction and Women’s Health, Philadelphia, Pennsylvania
OBJECTIVE: We sought to examine whether patients with preterm
birth (PTB) have elevated levels of mid-pregnancy cervicovaginal MMP8 and IL-6, and if enzyme levels vary by ethnicity, which is a known risk factor for PTB. STUDY DESIGN: This is a secondary analysis of data from a multicenter RCT of treating periodontal disease (PD) to prevent preterm birth. Cervicovaginal specimens were collected on patients with and without PD enrolled in the study. MMP8 and IL-6 levels were assessed using a validated assay. We compared mean MMP8 and IL-6 levels in women who delivered preterm and those who did not, stratified by ethnicity. RESULTS: 1616 pregnant women were included in this study: 83.7% (n⫽1352) were Black, 16.3% (n⫽264) were Non-Black, and 227 had deliveries at less than 37 weeks. There was no statistically significant difference in mean MMP8 levels among Blacks with or without PTB at 20 weeks (p⫽0.67) and at 28 weeks (p⫽0.31), or in IL-6 levels at 20 weeks (p⫽0.76) and 24 weeks (p⫽0.95). Non-significant findings were also noted in MMP8 levels in Non-Blacks (p⫽ 0.82 at 20 weeks; 0.78 at 28 weeks) and in IL-6 levels (p⫽0.10 at both 20 and 24 weeks). CONCLUSION: Cervicovaginal MMP8 and IL-6 levels do not differ significantly in patients who deliver prior to 37 weeks compared to those who deliver at term, and levels of these enzymes are similar across ethnicity. Continued research on the molecular genetics of PROM and PTB is warranted, specifically in a larger cohort of women, to better elucidate the role of proteolytic enzymes in these processes and how they may contribute to racial disparity in preterm birth. Blk.
mmp8 20w
Non-Blk.
<37wk
>37wk
p
<37wk
>37wk
p
2.68
2.96
0.67
2.77
2.86
0.82
..........................................................................................................................................................................................
mmp8 28w 2.86 3.57 0.31 2.62 2.77 0.74 .......................................................................................................................................................................................... il-6 20w .007 .007 0.76 .010 .004 0.10 .......................................................................................................................................................................................... il-6 24w .008 .008 0.95 .017 .008 0.10 .......................................................................................................................................................................................... 0002-9378/$ – see front matter • doi:10.1016/j.ajog.2009.10.667
Supplement to DECEMBER 2009 American Journal of Obstetrics & Gynecology
S187