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348: Randomized trial of glyburide plus diet compared to placebo plus diet in women with gestational diabetes
www.AJOG.org
Hypertension, Diabetes, Prematurity, Physiology
Poster Session II
in the Table. When comparing 135 mg/dL vs 130 mg/dL GCT cutoff utilization 6.3% less patients tested positive at the same 100% sensitivity. CONCLUSION: In twin pregnancies universal screening for GDM is routinely performed. As the recent NIH Consensus Panel concluded (March 4-6, 2013) the current two-step approach to screening and diagnosis for gestational diabetes should be maintained. In twin pregnancies our analysis suggests optimal GCT screening cut-off to be at 135 mg/dL.
Testing characteristics of a one-hour GCT at 24-28 weeks for the diagnosis of GDM in twin pregnancies
348 Randomized trial of glyburide plus diet compared to placebo plus diet in women with gestational diabetes Mina Abbassi-Ghanavati1, Brian Casey1, Stephan Shivvers1, Carmen Tudela1, Donald McIntire1, Kenneth Leveno1 1
University of Texas Southwestern Medical Center, Obstetrics and Gynecology, Dallas, TX
OBJECTIVE: To determine if the addition of glyburide to diet ther-
apy modifies pregnancy outcome in women with gestational diabetes. STUDY DESIGN: Women with at least 2 abnormal values on a 3-hour, 100 gm oral glucose tolerance test according to NDDG criteria and fasting values less than 105 mg/dL between 24 and 30 weeks gestation were randomized to blinded glyburide or placebo study drug. All women underwent monitored diet with weekly dietary logs as well as 4 X daily capillary glucose measurements recorded in memory-based glucose meters. Starting dose for glyburide was 2.5 mg and was titrated to a maximum of 20 mg per day based on weekly maternal capillary glucose values. Target values were less than 95 mg/dL and 120 mg/dL for fasting and 2-hour postprandial glucose measurements respectively. The primary study outcome chosen based on an apriori sample size analysis, was a 200 gm birthweight decrement in infants of women treated with glyburide. The sample size estimate for this outcome was 334 randomized women. RESULTS: A total of 395 women were enrolled in this trial at a single center between September 2008 and October 2012. Twenty women were lost to followup at delivery. As shown in the figure, women treated with glyburide had a greater decline in fasting glucose values over the course of therapy. As shown in the table of selected outcomes, the difference in the mean birthweight was 33 gms (p ¼ 0.52). CONCLUSION: Though the addition of glyburide to diet therapy significantly impacted maternal glycemic control, it did not modify infant size.
349 Gestational prehypertensioneadditional category of hypertensive disease of pregnancy Vivian Adum1, Steve Buyske5, Amen Ness1, Yali Xiong3, Eliezer Holtzman4, Ed Guzman1, Ossie Geifman-Holtzman2 1
Saint Peters University Hospital, Obstetrics & Gynecology, New Brunswick, NJ, 2Drexel College of Medicine, Obstetrics & Gynecology, Philadelphia, PA, 3 Temple School of Medicine, Fels Institute, Philadelphia, PA, 4Sheba Medical Center, Tel-Aviv University, Nephrology Institute, Tel-Aviv, Israel, 5Rutgers University, Department of Statistics & Biostatistics, Piscataway, NJ
OBJECTIVE: The joint national committee on high blood pressure (JNC7) determined blood pressure of 120-139/80-89 in adults to be Prehypertension associate with increased risk of cardiovascular disease. We hypothesize that gestational prehypertension is associated with increased risk of anterpartum and peripartum complications. STUDY DESIGN: A retrospective case control study consists of pregnant patients at our clinic during the year of 2010. The study group consists of pregnant patients with blood pressure of 120-139/80-89 at <15 weeks. The control group consists of pregnant patients with blood pressure <120/80 at <15 weeks. Outcome measures included development of hypertensive disease: Gestational hypertension and/ or Preeclampsia as the primary outcome and preterm delivery (PTL), lower birth weight (LBW), APGARS & admission to NICU as a secondary outcome. Comparisons between the two groups were accomplished using Fisher exact test & two-sample t-tests for comparing birth weight means. Logistic regression was used to obtain Odd Ratios while linear regression was used for adjusting of confounding variants. RESULTS: A total of 346 patients were eligible to be included in the study with 108 cases and 111 in the control group. The outcome measures analyzed resulted in poorer results being associated with the study group compared with control as follows: 15.9% vs. 0.9% (p<0.0001) for gestational hypertension, respectively, 19.4% vs. 10% (P¼0.0043) for gestational diabetes, 12% vs. 5% (P¼0.3567) for preterm labor, 30% vs. 13 % (P¼0.0031) for admission to the NICU, 7.4 % vs. 0.9% (P¼0.001), for APGARS less than 9 at 5 minutes On
Supplement to JANUARY 2014 American Journal of Obstetrics & Gynecology
S179
Hypertension, Diabetes, Prematurity, Physiology
Poster Session II
in the Table. When comparing 135 mg/dL vs 130 mg/dL GCT cutoff utilization 6.3% less patients tested positive at the same 100% sensitivity. CONCLUSION: In twin pregnancies universal screening for GDM is routinely performed. As the recent NIH Consensus Panel concluded (March 4-6, 2013) the current two-step approach to screening and diagnosis for gestational diabetes should be maintained. In twin pregnancies our analysis suggests optimal GCT screening cut-off to be at 135 mg/dL.
Testing characteristics of a one-hour GCT at 24-28 weeks for the diagnosis of GDM in twin pregnancies
348 Randomized trial of glyburide plus diet compared to placebo plus diet in women with gestational diabetes Mina Abbassi-Ghanavati1, Brian Casey1, Stephan Shivvers1, Carmen Tudela1, Donald McIntire1, Kenneth Leveno1 1
University of Texas Southwestern Medical Center, Obstetrics and Gynecology, Dallas, TX
OBJECTIVE: To determine if the addition of glyburide to diet ther-
apy modifies pregnancy outcome in women with gestational diabetes. STUDY DESIGN: Women with at least 2 abnormal values on a 3-hour, 100 gm oral glucose tolerance test according to NDDG criteria and fasting values less than 105 mg/dL between 24 and 30 weeks gestation were randomized to blinded glyburide or placebo study drug. All women underwent monitored diet with weekly dietary logs as well as 4 X daily capillary glucose measurements recorded in memory-based glucose meters. Starting dose for glyburide was 2.5 mg and was titrated to a maximum of 20 mg per day based on weekly maternal capillary glucose values. Target values were less than 95 mg/dL and 120 mg/dL for fasting and 2-hour postprandial glucose measurements respectively. The primary study outcome chosen based on an apriori sample size analysis, was a 200 gm birthweight decrement in infants of women treated with glyburide. The sample size estimate for this outcome was 334 randomized women. RESULTS: A total of 395 women were enrolled in this trial at a single center between September 2008 and October 2012. Twenty women were lost to followup at delivery. As shown in the figure, women treated with glyburide had a greater decline in fasting glucose values over the course of therapy. As shown in the table of selected outcomes, the difference in the mean birthweight was 33 gms (p ¼ 0.52). CONCLUSION: Though the addition of glyburide to diet therapy significantly impacted maternal glycemic control, it did not modify infant size.
349 Gestational prehypertensioneadditional category of hypertensive disease of pregnancy Vivian Adum1, Steve Buyske5, Amen Ness1, Yali Xiong3, Eliezer Holtzman4, Ed Guzman1, Ossie Geifman-Holtzman2 1
Saint Peters University Hospital, Obstetrics & Gynecology, New Brunswick, NJ, 2Drexel College of Medicine, Obstetrics & Gynecology, Philadelphia, PA, 3 Temple School of Medicine, Fels Institute, Philadelphia, PA, 4Sheba Medical Center, Tel-Aviv University, Nephrology Institute, Tel-Aviv, Israel, 5Rutgers University, Department of Statistics & Biostatistics, Piscataway, NJ
OBJECTIVE: The joint national committee on high blood pressure (JNC7) determined blood pressure of 120-139/80-89 in adults to be Prehypertension associate with increased risk of cardiovascular disease. We hypothesize that gestational prehypertension is associated with increased risk of anterpartum and peripartum complications. STUDY DESIGN: A retrospective case control study consists of pregnant patients at our clinic during the year of 2010. The study group consists of pregnant patients with blood pressure of 120-139/80-89 at <15 weeks. The control group consists of pregnant patients with blood pressure <120/80 at <15 weeks. Outcome measures included development of hypertensive disease: Gestational hypertension and/ or Preeclampsia as the primary outcome and preterm delivery (PTL), lower birth weight (LBW), APGARS & admission to NICU as a secondary outcome. Comparisons between the two groups were accomplished using Fisher exact test & two-sample t-tests for comparing birth weight means. Logistic regression was used to obtain Odd Ratios while linear regression was used for adjusting of confounding variants. RESULTS: A total of 346 patients were eligible to be included in the study with 108 cases and 111 in the control group. The outcome measures analyzed resulted in poorer results being associated with the study group compared with control as follows: 15.9% vs. 0.9% (p<0.0001) for gestational hypertension, respectively, 19.4% vs. 10% (P¼0.0043) for gestational diabetes, 12% vs. 5% (P¼0.3567) for preterm labor, 30% vs. 13 % (P¼0.0031) for admission to the NICU, 7.4 % vs. 0.9% (P¼0.001), for APGARS less than 9 at 5 minutes On
Supplement to JANUARY 2014 American Journal of Obstetrics & Gynecology
S179