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Double-blind, placebo controlled study of ranitidine (Zantac®) for gastroesophageal reflux symptoms during pregnancy
SPO Abstracts
Volume 176, N u m b e r 1, Part 2 A m J Obstet Gynecol
51
52
S23
INDUCTION OF LABOR: A PROSPECTIVE RANDOMIZED TRIAL OF TWO VERSUS THREE DAYS. KFee, ~ C Brees,~J Spinnato. Dept. of O B / GYN, University of Louisville, Louisville, KY. OBJECTIVE: To compare the outcomes ot inductions of labor when restricting the duration of the attempt to two versus three days. STUDY DESIGN: Patients presenting for induction of labor at term were randomized to either Group 1 or Group 2 with a maximum allowable duration for induction of labor set at two and three days respectively. Patients were at least 37 weeks gestation and were committed to delivery (induction of obligation). Patients were excluded if they had ruptured membranes, non-reassuring antenatal testing, severe preeclampsia, multiple gestation, non-vertex presentation, death in utero or pre-existing labor. Intrapartum management including oxymcin use, tinting of amniotomy, and the decision for overnight rest was at the discretion of the resident physician. The physician and nursing staff on Labor and Delivery were aware of the study- arm to which each patient was assigned. RESULTS: 160 patients were initially randomized to this study, of whom 21 were excluded due to protocol violations. No significant dit~brences were noted between groups for maternal age, intmwal from anmiotomy to delivery, birth weight or estimated gestadonal age. The cesarean section rate was 20.9% in Group 1 and 25;8% in Group 2 (NS). Maternal complications were not ditfbrent between groups. The total maternal hospital days (mean 4.3 versus 4.6 days) was not significantly greater in Group 2. CONCLUSIONS: No advantage is gained by extending the permitable intmwal for induction of labor from two to three days. Successful vaginal delivery is equally likely in each group. The availability of a third day lessens the aggressiveness with which induction of labor is attempted.
53
INSULIN RESISTANCE IN GESTATIONAL DIABETES: EFFECT OF OBESITY. M. Carpenter, S. Car~; .]. Hogan ~, B. Haydon ~, M. Somers~, L. Robbins-~, R. Cowett". Depts. Ob/Gyn and Pediatrics, Brown Univ., Providence, RI OBJECTIVE: Obesity is more prevalent in gravidas with gestational diabetes (GDM) cmnpared to those with normal glucose tolerance (ND). We examined whether degree of obesity accounts for the augmented insulin resistance tound in GDM or has the same effect as in ND gravidas. STUDY DESIGN: Hepatic and peripheral insulin-mediated effects during the postabsorptive state and during steady-state hyperinsulinemia using a euglycemic hyperinsulinemic clamp were measured in 10 gestational diabetic women (GDM) and in 30 pregnant patients with normal glucose tolerance (ND). RESULTS: Gestational age (28.6+_1.7 v 28.3+1.6 weeks, P 0.60, mean+_s.d.) and percent body fat estimated by skinfold thicknesses (%BF) (26.0+6.1, range - 15.5 to 35.7% v 27.8+7.0, range = 15.5 to 36.0%, P=0.45,) were comparable in GDM and ND groups, respectively. GDM had higher fa.sting plasma insulin (23.3+-13.9v 14.0+12.1 b~U/ml, P .059) and glucose (84.7+7.1 v 77.9-+5.3 m g / d L , P<.003) and lower insulin-mediated clamp glucose infitsion (AM) (2.7+0.7 v 4.1-+1.4 m g / k g / m i n , P<0.005) and glucose disposal rate (AR,1) (0.94+0.7 v 1.90+1.02 m g / k g / m i n , P<0.009) than ND subjects. Regression of %BF on ARd demonstrated no significant difference in slope in GDM versus ND subjects ( 0.053 v -0.089 m g / k g / m i n / % B F , P-0.45), though the difference in intercept at the mean %BF for all subjects (26.4%) was significantly lower in GDM (A = 1.86 m g / k g / m i n , P<0.001). CONCLUSIONS: These observations suggest that the degree of obesity does not account for the increased insulin resistance found in GDM compared to non-diabetic pregnancy. Obesity appears to affect insulin resistance cmnparably in GDM and nonmliabetic pregnancy.
DOUBLE-BLIND, PLACEBO CONTROLLED STUDY OF RANITIDINE (ZANTAC| FOR GASTROESOPHAGEAL REFLUX SYMPTOMS DURING PREGNANCY. ~ Lawson, E. Patatanian, ~ P. Miner, ~ W. Raybu~w, M. Robinson, ~ Dept. Ob/Gyn, Univ. of Okla., Okla. City, OK. OBJECTIVE: To deternaine whether ranitidine (Zantac| taken mace or twice daily" is effective for relieving symptoms of gastroesophageal reflux among pregnant wmnen who had failed conservative measures and antacid therapy. STUDY DESIGN: Volunteers at --> 20 weeks gestation were sought among our obstetric clinic population tot this double-blind, placebo controlled, triple cross-over triaL After a baseline week of characterizing symptoms and taking antacids only, patients were assigned to receive, in a randomized order, the three following weekly regimens: r~mitidine 150 nag AM and PM; placebo AM and ranitidine 150 mg PM; placebo AM and PM. Symptom scores, global assessments, and number of antacids taken were compared. RESULTS: The twice-daily dosage of ranitidine was the only regimen found to significantly reduced heartburn symptoms when cmnpared to the baseline (p < 0.001) or a placebo (p < 0.01). Compared with the placebo group, fewer antacid tablets were necessary when ranifidine was taken twice rather than once daily (p < .05 versus p - .24). The average reduction of heartburn scores for the twice-daily ranitidine was 55.6% when compared to baseline (95% C.I. 34.8-76.5%), and 44.2% when colnpared to placebo (95% C.h 15.4-72.9%). CONCLUSIONS: Ranitidine is effective, when taken as 150 lug taken twice rather than once daily, for relief of gastroesophageal reflux symptoms during pregnancy.
84
PREGNANCY O U T C O M E AFTER LIVER T R A N S P L A N T A T I O N . H. Casele,XD. Woelkers, x S. Lai~er. University of Pittsburgh School of Medicine, Magee-Womens Hospital, Pittsburgh, Pennsylvania. OBJECTIVE: To describe maternal and fVtal risks for an ongoing series of pregnant women who have undergone orthotopic liver transplantation. STUDY DESIGN: Hospital records frmn fourteen pregnancies in thirteen women from a single center in whom a liver had been transplanted betore pregnancy were reviewed. Data regarding the primary liver disease, allograft status, liver function at conception and during pregnancy, immunosuppressive medications, associated medical conditions, time from transplant to conception, and maternal and fetal outconm was collected and analyzed. RESULTS: Liver allograft function as assessed by liver transaminases remained stable in 12/14; one patient experienced acute rejection and one experienced chronic rejection. All patients were on a combination of immunosuppressants which included cyclosporine, prednisone, azathioprine, or tacrolimus. Eight patients had evidence of renal insutficienW (creatinine 1.1-2.0 mg/dl) and five were hypertensive at their first prenatal visit. Antepartum complications which developed included preeclampsia (4/14), worsening hypertension (2/14), pyelonephritis (2/14), anemia (4/14), PPROM (3/14) and CMV infection (3/14). The nman gestational age at deliveW was 32.6 weeks and the mean birthweight was 1913 grams. MI three neonatal deaths were associated with CIVW infection and premature delivery. Two of these wmnen had transplant to conception intm~,als of less than six months (three weeks and two months). The other conceived during chronic allograft rejection. CONCLUSION: Pregnancy in recipients of hepatic allografts does not appear to alter graft fnnction and is associated with good maternal OUtcome. However, a short transplant to pregnancy intmwal was associated with a high risk of CMV infection and subsequent preterm deliveW and neonatal death. Pregnancy in these women also appears to be associated with an increased risk of preterin delivel), due to preeclampsia or premature rupture of nlenrbranes.
Volume 176, N u m b e r 1, Part 2 A m J Obstet Gynecol
51
52
S23
INDUCTION OF LABOR: A PROSPECTIVE RANDOMIZED TRIAL OF TWO VERSUS THREE DAYS. KFee, ~ C Brees,~J Spinnato. Dept. of O B / GYN, University of Louisville, Louisville, KY. OBJECTIVE: To compare the outcomes ot inductions of labor when restricting the duration of the attempt to two versus three days. STUDY DESIGN: Patients presenting for induction of labor at term were randomized to either Group 1 or Group 2 with a maximum allowable duration for induction of labor set at two and three days respectively. Patients were at least 37 weeks gestation and were committed to delivery (induction of obligation). Patients were excluded if they had ruptured membranes, non-reassuring antenatal testing, severe preeclampsia, multiple gestation, non-vertex presentation, death in utero or pre-existing labor. Intrapartum management including oxymcin use, tinting of amniotomy, and the decision for overnight rest was at the discretion of the resident physician. The physician and nursing staff on Labor and Delivery were aware of the study- arm to which each patient was assigned. RESULTS: 160 patients were initially randomized to this study, of whom 21 were excluded due to protocol violations. No significant dit~brences were noted between groups for maternal age, intmwal from anmiotomy to delivery, birth weight or estimated gestadonal age. The cesarean section rate was 20.9% in Group 1 and 25;8% in Group 2 (NS). Maternal complications were not ditfbrent between groups. The total maternal hospital days (mean 4.3 versus 4.6 days) was not significantly greater in Group 2. CONCLUSIONS: No advantage is gained by extending the permitable intmwal for induction of labor from two to three days. Successful vaginal delivery is equally likely in each group. The availability of a third day lessens the aggressiveness with which induction of labor is attempted.
53
INSULIN RESISTANCE IN GESTATIONAL DIABETES: EFFECT OF OBESITY. M. Carpenter, S. Car~; .]. Hogan ~, B. Haydon ~, M. Somers~, L. Robbins-~, R. Cowett". Depts. Ob/Gyn and Pediatrics, Brown Univ., Providence, RI OBJECTIVE: Obesity is more prevalent in gravidas with gestational diabetes (GDM) cmnpared to those with normal glucose tolerance (ND). We examined whether degree of obesity accounts for the augmented insulin resistance tound in GDM or has the same effect as in ND gravidas. STUDY DESIGN: Hepatic and peripheral insulin-mediated effects during the postabsorptive state and during steady-state hyperinsulinemia using a euglycemic hyperinsulinemic clamp were measured in 10 gestational diabetic women (GDM) and in 30 pregnant patients with normal glucose tolerance (ND). RESULTS: Gestational age (28.6+_1.7 v 28.3+1.6 weeks, P 0.60, mean+_s.d.) and percent body fat estimated by skinfold thicknesses (%BF) (26.0+6.1, range - 15.5 to 35.7% v 27.8+7.0, range = 15.5 to 36.0%, P=0.45,) were comparable in GDM and ND groups, respectively. GDM had higher fa.sting plasma insulin (23.3+-13.9v 14.0+12.1 b~U/ml, P .059) and glucose (84.7+7.1 v 77.9-+5.3 m g / d L , P<.003) and lower insulin-mediated clamp glucose infitsion (AM) (2.7+0.7 v 4.1-+1.4 m g / k g / m i n , P<0.005) and glucose disposal rate (AR,1) (0.94+0.7 v 1.90+1.02 m g / k g / m i n , P<0.009) than ND subjects. Regression of %BF on ARd demonstrated no significant difference in slope in GDM versus ND subjects ( 0.053 v -0.089 m g / k g / m i n / % B F , P-0.45), though the difference in intercept at the mean %BF for all subjects (26.4%) was significantly lower in GDM (A = 1.86 m g / k g / m i n , P<0.001). CONCLUSIONS: These observations suggest that the degree of obesity does not account for the increased insulin resistance found in GDM compared to non-diabetic pregnancy. Obesity appears to affect insulin resistance cmnparably in GDM and nonmliabetic pregnancy.
DOUBLE-BLIND, PLACEBO CONTROLLED STUDY OF RANITIDINE (ZANTAC| FOR GASTROESOPHAGEAL REFLUX SYMPTOMS DURING PREGNANCY. ~ Lawson, E. Patatanian, ~ P. Miner, ~ W. Raybu~w, M. Robinson, ~ Dept. Ob/Gyn, Univ. of Okla., Okla. City, OK. OBJECTIVE: To deternaine whether ranitidine (Zantac| taken mace or twice daily" is effective for relieving symptoms of gastroesophageal reflux among pregnant wmnen who had failed conservative measures and antacid therapy. STUDY DESIGN: Volunteers at --> 20 weeks gestation were sought among our obstetric clinic population tot this double-blind, placebo controlled, triple cross-over triaL After a baseline week of characterizing symptoms and taking antacids only, patients were assigned to receive, in a randomized order, the three following weekly regimens: r~mitidine 150 nag AM and PM; placebo AM and ranitidine 150 mg PM; placebo AM and PM. Symptom scores, global assessments, and number of antacids taken were compared. RESULTS: The twice-daily dosage of ranitidine was the only regimen found to significantly reduced heartburn symptoms when cmnpared to the baseline (p < 0.001) or a placebo (p < 0.01). Compared with the placebo group, fewer antacid tablets were necessary when ranifidine was taken twice rather than once daily (p < .05 versus p - .24). The average reduction of heartburn scores for the twice-daily ranitidine was 55.6% when compared to baseline (95% C.I. 34.8-76.5%), and 44.2% when colnpared to placebo (95% C.h 15.4-72.9%). CONCLUSIONS: Ranitidine is effective, when taken as 150 lug taken twice rather than once daily, for relief of gastroesophageal reflux symptoms during pregnancy.
84
PREGNANCY O U T C O M E AFTER LIVER T R A N S P L A N T A T I O N . H. Casele,XD. Woelkers, x S. Lai~er. University of Pittsburgh School of Medicine, Magee-Womens Hospital, Pittsburgh, Pennsylvania. OBJECTIVE: To describe maternal and fVtal risks for an ongoing series of pregnant women who have undergone orthotopic liver transplantation. STUDY DESIGN: Hospital records frmn fourteen pregnancies in thirteen women from a single center in whom a liver had been transplanted betore pregnancy were reviewed. Data regarding the primary liver disease, allograft status, liver function at conception and during pregnancy, immunosuppressive medications, associated medical conditions, time from transplant to conception, and maternal and fetal outconm was collected and analyzed. RESULTS: Liver allograft function as assessed by liver transaminases remained stable in 12/14; one patient experienced acute rejection and one experienced chronic rejection. All patients were on a combination of immunosuppressants which included cyclosporine, prednisone, azathioprine, or tacrolimus. Eight patients had evidence of renal insutficienW (creatinine 1.1-2.0 mg/dl) and five were hypertensive at their first prenatal visit. Antepartum complications which developed included preeclampsia (4/14), worsening hypertension (2/14), pyelonephritis (2/14), anemia (4/14), PPROM (3/14) and CMV infection (3/14). The nman gestational age at deliveW was 32.6 weeks and the mean birthweight was 1913 grams. MI three neonatal deaths were associated with CIVW infection and premature delivery. Two of these wmnen had transplant to conception intm~,als of less than six months (three weeks and two months). The other conceived during chronic allograft rejection. CONCLUSION: Pregnancy in recipients of hepatic allografts does not appear to alter graft fnnction and is associated with good maternal OUtcome. However, a short transplant to pregnancy intmwal was associated with a high risk of CMV infection and subsequent preterm deliveW and neonatal death. Pregnancy in these women also appears to be associated with an increased risk of preterin delivel), due to preeclampsia or premature rupture of nlenrbranes.