1
STUDY DESIGN: This is a retrospective cohort study including 502,186 singleton, nonanomalous pregnancies recorded in the 2008 California Birth Registry, of which 125 were complicated by chronic kidney dis- ease. Outcomes recorded included preeclampsia, preterm delivery, neonatal death, intrauterine fetal demise, small for gestational age, low birthweight, and mode of delivery stratified for nulliparous and multiparous patients. Chi squared tests and multivariable logistic re- gression analyses were used for statistical analysis. RESULTS: The rate of preterm delivery was 50.4% in patients with chronic kidney disease (CKD) compared to 8.4% (p.001) in the controls. The rate of preeclampsia was 40.0% in CKD patients with a control group rate of 2.9% (p.001). Neonatal death was rated at 3.5% in CKD versus 0.2% in controls (p.001) and intrauterine fetal demise at 6.4% in CKD and 0.3% in the control group (p.001). Moreover, the overall rate of cesar- ean sections were greater in women with CKD (51.2%) versus those with- out (30.3%, p.001) which differed by parity as well (Table). CONCLUSION: Chronic kidney disease (CKD) is associated with an in- creased risk of preterm delivery, preeclampsia, gestational hypertension, neonatal death, intrauterine fetal demise, small for gestational age babies, low birthweight at term, and significantly increased rates of cesarean de- livery. These risks can be utilized to counsel patients with this chronic illness. 347 Recombinant human antithrombin (rhAT) for prevention of venous thromboembolism (VTE) in pregnant patients with hereditary antithrombin deficiency (HD) Michael Paidas 1 , Elizabeth Triche 2 , Andra James 3 , Trina Ballard 4 , Simon Lowry 5 1 Yale University School of Medicine, Obstetrics, Gynecology and Reproductive Sciences, New Haven, CT, 2 Brown University School of Medicine, Epidemiology, Providence, RI, 3 National Institutes of Health, Division of Blood Diseases and Resources, National; Heart, Lung, and Blood Institute, Bethesda, MD, 4 GTC Biotherapeutics, Inc., GTC Biotherapeutics, Inc., Framingham, MA, 5 GTC Biotherapeutics, Inc., GTC Biotherapeutics, Inc., Framingham, MA OBJECTIVE: HD is the most thrombogenic, and rarest, of inherited thrombotic disorders. Management of these patients require anti- thrombin replacement when anticoagulation (AC) is withheld, such as during surgery or delivery. In 2 studies that included pregnant and surgical HD patients, rhAT therapy prevented VTE. A retrospective analysis was conducted to assess rhAT safety and efficacy in a large cohort of pregnant HD patients. STUDY DESIGN: Data from all pregnant HD patients in these two phase three studies were pooled. rhAT dosing, based on weight and AT ac- tivity, began up to 24 hrs before scheduled cesarean delivery or at labor and continued for 3-14 days. Adverse events (AEs) were characterized. Frequency tabulations comprised the statistical analysis. RESULTS: Among 21 patients, 19 had a VTE history. Mean (range) rhAT therapy duration, loading dose, and infusion rate were 4.3 d (0.9-14.0), 34.9 IU/kg (13.0-81.4), and 140.6 IU/kg/d (7.2-451.7), re- spectively. All patients achieved target mean AT activity (80%-120% of normal) during rhAT therapy. There were no confirmed VTEs dur- ing rhAT treatment or within 7 (1) d post dosing. Two VTE events [1 deep venous thrombosis (DVT) and 1 pulmonary embolism (PE)] occurred 11 and 14 days after rhAT discontinuation, respectively. Four patients (19.0%) reported 6 serious AEs:DVT, PE, enterobacter sepsis, pyrexia, wound hematoma, intra-abdominal hemorrhage (IAH), but only the IAH was considered probably related to rhAT. Importantly, the IAH was directly related to reinstitution of AC. CONCLUSION: This study, representing the largest cohort of pregnant HD patients in the world, found no VTEs during rhAT therapy or within 7 (1) days post dosing. rhAT was safe and effective in preg- nant HD patients peripartum, the period of highest VTE risk and when AC is normally withheld. Pregnant HD patients may benefit from therapeutic, rather than prophylactic, AC post delivery to pro- tect against remote postpartum VTE events. 348 Pregnancy outcomes in women with 10, 20, and 30 pound weight gain Roxane Holt 1 , Jeanne Sheffield 1 , Donald McIntire 1 , Kenneth Leveno 1 1 UTSW Medical Center, Obstetrics and Gynecology, Dallas, TX OBJECTIVE: To evaluate the risk of incremental weight gain during pregnancy in all four WHO weight categories. STUDY DESIGN: Retrospective cohort study from a single institution in- volving a primarily Hispanic indigent population. From January 1, 2002 to April 30, 2011, women presenting with a BMI recorded in the 1st trimester and a subsequent delivery weight were included. The study co- hort included singleton infants, excluding preexisting maternal hyper- tension, overt and gestational DM, and anomalies. Women were catego- rized according to WHO weight categories. Pregnancy outcomes were assessed for each weight category by race and 10 pound weight gain in- crements. Standard methods were used for statistical analysis. RESULTS: During the study period, 44,084 women were identified with 903 (2%) underweight, 17,537 (40%) normal weight, 15,283 (35%) over- weight, and 10,361 (24%) obese. In Hispanic women, for every ten pounds of weight gain, there was a significant decrease in fetal growth restriction, preterm birth, and stillbirth. In contrast, there was a signifi- cant increase in macrosomia, preeclampsia, labor induction, primary Ce- sarean delivery, and shoulder dystocia (Example shown in Table). This was true across all weight categories though the incremental differences varied. Black and non-Hispanic white women also show similar absolute differences though the incremental differences varied. CONCLUSION: There are disadvantages to weight gain in pregnancy (e.g. macrosomia, primary Cesarean delivery); however, the benefits of decreasing preterm birth, fetal growth restriction, and stillbirth are significant. The data presented as risk of increasing weight per ten pound increment in the four weight categories are useful for counsel- ing women regarding weight gain recommendations in pregnancy. Pregnancy outcomes in chronic kidney disease: singleton pregnancies Risk of primary cesarean delivery and growth restriction with weight gain Poster Session II Clinical Obstetrics, Diabetes, Labor, Medical-Surgical-Disease, Physiology/Endocrinology, Prematurity www.AJOG.org S154 American Journal of Obstetrics & Gynecology Supplement to JANUARY 2013

347: Recombinant human antithrombin (rhAT) for prevention of venous thromboembolism (VTE) in pregnant patients with hereditary antithrombin deficiency (HD)

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Poster Session II Clinical Obstetrics, Diabetes, Labor, Medical-Surgical-Disease, Physiology/Endocrinology, Prematurity www.AJOG.org

STUDY DESIGN: This is a retrospective cohort study including 502,186singleton, nonanomalous pregnancies recorded in the 2008 CaliforniaBirth Registry, of which 125 were complicated by chronic kidney dis-ease. Outcomes recorded included preeclampsia, preterm delivery,neonatal death, intrauterine fetal demise, small for gestational age,low birthweight, and mode of delivery stratified for nulliparous andmultiparous patients. Chi squared tests and multivariable logistic re-gression analyses were used for statistical analysis.RESULTS: The rate of preterm delivery was 50.4% in patients with chronic

idney disease (CKD) compared to 8.4% (p�.001) in the controls. Theate of preeclampsia was 40.0% in CKD patients with a control group ratef 2.9% (p�.001). Neonatal death was rated at 3.5% in CKD versus 0.2%

n controls (p�.001) and intrauterine fetal demise at 6.4% in CKD and.3% in the control group (p�.001). Moreover, the overall rate of cesar-an sections were greater in women with CKD (51.2%) versus those with-ut (30.3%, p�.001) which differed by parity as well (Table).

CONCLUSION: Chronic kidney disease (CKD) is associated with an in-creased risk of preterm delivery, preeclampsia, gestational hypertension,neonatal death, intrauterine fetal demise, small for gestational age babies,low birthweight at term, and significantly increased rates of cesarean de-livery. These risks can be utilized to counsel patients with this chronicillness.

347 Recombinant human antithrombin (rhAT) for preventionf venous thromboembolism (VTE) in pregnant patientsith hereditary antithrombin deficiency (HD)

Michael Paidas1, Elizabeth Triche2, Andra James3,rina Ballard4, Simon Lowry5

1Yale University School of Medicine, Obstetrics, Gynecology andeproductive Sciences, New Haven, CT, 2Brown University School of

Medicine, Epidemiology, Providence, RI, 3National Institutes of Health,ivision of Blood Diseases and Resources, National; Heart, Lung, and Blood

nstitute, Bethesda, MD, 4GTC Biotherapeutics, Inc., GTC Biotherapeutics,Inc., Framingham, MA, 5GTC Biotherapeutics, Inc., GTC Biotherapeutics,Inc., Framingham, MAOBJECTIVE: HD is the most thrombogenic, and rarest, of inheritedhrombotic disorders. Management of these patients require anti-hrombin replacement when anticoagulation (AC) is withheld, suchs during surgery or delivery. In 2 studies that included pregnant andurgical HD patients, rhAT therapy prevented VTE. A retrospectivenalysis was conducted to assess rhAT safety and efficacy in a largeohort of pregnant HD patients.

STUDY DESIGN: Data from all pregnant HD patients in these two phasehree studies were pooled. rhAT dosing, based on weight and AT ac-ivity, began up to 24 hrs before scheduled cesarean delivery or at labornd continued for 3-14 days. Adverse events (AEs) were characterized.requency tabulations comprised the statistical analysis.

RESULTS: Among 21 patients, 19 had a VTE history. Mean (range)hAT therapy duration, loading dose, and infusion rate were 4.3 d0.9-14.0), 34.9 IU/kg (13.0-81.4), and 140.6 IU/kg/d (7.2-451.7), re-pectively. All patients achieved target mean AT activity (80%-120%f normal) during rhAT therapy. There were no confirmed VTEs dur-

ng rhAT treatment or within 7 (�1) d post dosing. Two VTE events1 deep venous thrombosis (DVT) and 1 pulmonary embolism (PE)]

Pregnancy outcomes in chronic kidneydisease: singleton pregnancies

ccurred 11 and 14 days after rhAT discontinuation, respectively.

S154 American Journal of Obstetrics & Gynecology Supplement to JANUARY 2

Four patients (19.0%) reported 6 serious AEs:DVT, PE, enterobactersepsis, pyrexia, wound hematoma, intra-abdominal hemorrhage(IAH), but only the IAH was considered probably related to rhAT.Importantly, the IAH was directly related to reinstitution of AC.CONCLUSION: This study, representing the largest cohort of pregnantHD patients in the world, found no VTEs during rhAT therapy orwithin 7 (�1) days post dosing. rhAT was safe and effective in preg-nant HD patients peripartum, the period of highest VTE risk andwhen AC is normally withheld. Pregnant HD patients may benefitfrom therapeutic, rather than prophylactic, AC post delivery to pro-tect against remote postpartum VTE events.

348 Pregnancy outcomes in women with0, 20, and 30 pound weight gain

Roxane Holt1, Jeanne Sheffield1, Donald McIntire1,enneth Leveno1

1UTSW Medical Center, Obstetrics and Gynecology, Dallas, TXOBJECTIVE: To evaluate the risk of incremental weight gain during

regnancy in all four WHO weight categories.STUDY DESIGN: Retrospective cohort study from a single institution in-olving a primarily Hispanic indigent population. From January 1, 2002o April 30, 2011, women presenting with a BMI recorded in the 1strimester and a subsequent delivery weight were included. The study co-ort included singleton infants, excluding preexisting maternal hyper-ension, overt and gestational DM, and anomalies. Women were catego-ized according to WHO weight categories. Pregnancy outcomes weressessed for each weight category by race and 10 pound weight gain in-rements. Standard methods were used for statistical analysis.

RESULTS: During the study period, 44,084 women were identified with03 (2%) underweight, 17,537 (40%) normal weight, 15,283 (35%) over-eight, and 10,361 (24%) obese. In Hispanic women, for every tenounds of weight gain, there was a significant decrease in fetal growthestriction, preterm birth, and stillbirth. In contrast, there was a signifi-ant increase in macrosomia, preeclampsia, labor induction, primary Ce-arean delivery, and shoulder dystocia (Example shown in Table). Thisas true across all weight categories though the incremental differencesaried. Black and non-Hispanic white women also show similar absoluteifferences though the incremental differences varied.

CONCLUSION: There are disadvantages to weight gain in pregnancy(e.g. macrosomia, primary Cesarean delivery); however, the benefitsof decreasing preterm birth, fetal growth restriction, and stillbirth aresignificant. The data presented as risk of increasing weight per tenpound increment in the four weight categories are useful for counsel-ing women regarding weight gain recommendations in pregnancy.

Risk of primary cesarean delivery andgrowth restriction with weight gain

013