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77: Pregnancy and long-term neurodevelopmental outcome in monochorionic diamniotic twin pregnancies: A multi-center prospective cohort study
SMFM Abstracts 75
EXTERNAL CEPHALIC VERSION AT TERM IN MULTIPAROUS WOMEN WITH OR WITHOUT SPINAL ANALGESIA: RANDOMIZED CONTROLLED TRIAL CAROLYN WEINIGER1, YEHUDA GINOSAR1, HEN Y SELA2, URIEL ELCHALAL2, CHARLES WEISSMAN1, YOSSEF EZRA2, 1Hadassah Hebrew University Medical Center, Department of Anesthesiology and Critical Care Medicine, Jerusalem, Israel, 2Hadassah Hebrew University Medical Center, Department of Obstetrics & Gynecology, Jerusalem, Israel OBJECTIVE: Neuraxial analgesia positively impacts the chance of delivering vaginally a fetus previously lying in a breech position, by significantly increasing the success of external cephalic version (ECV) in nulliparas. We sought to measure the success rate of ECV with spinal analgesia versus no analgesia among multiparas. STUDY DESIGN: A prospective randomized controlled trial with ethical approval was performed in a tertiary referral center delivery suite. Multiparous women at term requesting ECV for breech presentation were randomized to receive spinal analgesia (7.5 mg bupivacaine) or no analgesia prior to the ECV. An experienced obstetrician performed the ECV. The sample size was calculated to reveal an 85% power when 64 subjects were enrolled with a one-sided alpha level of 5%. Primary outcome was successful conversion to vertex presentation. Pain score was evaluated by using the visual analogue, adverse outcomes were recorded. RESULTS: Sixty-five women were enrolled, and sixty-four analyzed (31 spinal, 33 no analgesia). Successful ECV occurred among 27/31 (87.1%) women randomized to receive spinal analgesia versus 19/33 (57.5%) without, p⫽0.012 (95% CI of the difference: 0.0954 to 0.5513). The power of this result is 85%. ECV with spinal analgesia resulted in lower visual analogue pain score, 1.7⫾2.4 versus 5.5⫾2.9 without, p ⬍ 0.0001. Higher parity was not a significant factor in the success rate. There were no adverse outcomes following ECV (placental abruption or emergency cesarean section). CONCLUSION: Administration of spinal analgesia significantly increases the chance of successful ECV among multiparous women at term.
www.AJOG.org 77
0002-9378/$ - see front matter doi:10.1016/j.ajog.2008.09.100
76
A RANDOMIZED CONTROLLED TRIAL OF METFORMIN AND GLYBURIDE IN GESTATIONAL DIABETES LISA MOORE1, DIANA CLOKEY1, LUIS CURET2, 1University of New Mexico, Obstetrics and Gynecology, Albuquerque, New Mexico, 2University of New Mexico, Obstetrics & Gynecology, Albuquerque, NM OBJECTIVE: To compare metformin to glyburide in the management of gestational diabetes. STUDY DESIGN: Gestational diabetic patients attending the University of New Mexico diabetes-in-pregnancy clinic who did not achieve blood glucose control with diet and exercise were randomized to either metformin (n⫽63) or glyburide(n⫽61). Patients were between 11 and 33 weeks gestation at randomization. The primary outcome was glycemic control. Secondary outcomes were drug failure rate, macrosomia, admission to NICU, 5- minute APGAR ⬍ 7, birth trauma, preeclampsia, maternal and neonatal hypoglycemia, and route of delivery. RESULTS: Demographics were similar in both groups. In the patients who achieved glycemic control on medication, the mean fasting and two hour postprandial blood glucose was not statistically different between groups. However, 26 patients on metformin (41.2%) and 12 patients on glyburide (19.6%) did not achieve adequate glycemic control and required insulin therapy (P⫽.01 ). Macrosomia occurred in 4 patients (6.6%) on glyburide and in 1 patient (1.6%) on metformin (P⫽ .2). There were 4 NICU admissions in the metformin group and 1 NICU admission in the glyburide group (P⫽.37). One infant in the metformin group experienced hypoglycemia. Two patients on metformin and 1 patient on glyburide experienced hypoglycemia defined as blood glucose ⬍60 mg/dl. (P⫽1.0). One shoulder dystocia occurred in the glyburide group. Three patients (4.9%) in the glyburide group and 2 patients (3.1%) in the metformin group developed severe preeclampsia (P ⬎ 0.5). There were 11 non-elective cesarean deliveries in the metformin group: 3 for breech presentation and 8 for nonreassuring fetal status; compared to 2 non-elective cesarean deliveries in the glyburide group for failure to progress and nonreassuring fetal status ( P⫽.02). There were no 5 min APGAR scores ⬍ 7 in either group. CONCLUSION: In this study the failure rate of metformin was 2.87 times higher than the failure rate of glyburide when used in the management of gestational diabetes. (95% CI ⫽ 1.28 - 6.4).
PREGNANCY AND LONG-TERM NEURODEVELOPMENTAL OUTCOME IN MONOCHORIONIC DIAMNIOTIC TWIN PREGNANCIES: A MULTI-CENTER PROSPECTIVE COHORT STUDY LIESBETH LEWI1, ELS ORTIBUS2, ENRICO LOPRIORE3, ELISE DONE1, JACQUES JANI1, TIM VAN MIEGHEM1, ANKE DIEMERT4, LÉONARDO GUCCIARDO1, PHILLIP KLARITSCH1, KURT HECHER4, PAUL DE COCK2, LIEVEN LAGAE2, JAN DEPREST1, 1University Hospitals Leuven, Obstetrics and Gynaecology, Leuven, Belgium, 2University Hospitals Leuven, Pediatrics, Leuven, Belgium, 3Leiden University Medical Center, Leiden, Netherlands, 4University Medical Center Hamburg-Eppendorf, OB/GYN, Hamburg, Germany OBJECTIVE: To document pregnancy and long-term neurodevelopmental outcome and to determine the risk factors for death or neurodevelopmental impairment in monochorionic diamniotic (MCDA) twins. STUDY DESIGN: A prospective series of MCDA twin pregnancies recruited in the first trimester in 3 European countries (Jan2002-Oct2005). Information on conception, pregnancy and neonatal outcome was collected and surviving infants were assessed in the 3 study centers by the Bayley scales of infant development at 2 years of age. Death was defined as intra-uterine or neonatal death. Neurodevelopmental impairment (NDI) was defined as the occurrence of cerebral palsy (CP), a Bayley motor or mental score of ⬍ 2 SD, deafness or blindness. Multivariate logistic regression analysis was performed to identify the risk factors for death or NDI. RESULTS: 136 pregnancies (272 fetuses) were recruited. 11/136 (8%) were conceived by artificial reproductive technology (ART). 122/136 (90%) resulted in 2 survivors, 6/136 in 1 survivor (4%) and 8/136 without survivors (6%). Twin-totwin transfusion syndrome (TTTS) occurred in 12/136 (9%) and discordant growth without TTTS in 24/136 (18%). Early-onset discordant growth diagnosed 20 weeks occurred in 16/136 pregnancies (12%). 230/250 surviving infants (92%) were assessed at a median age of 42 months. 22/230 (10%) infants had NDI; either CP (5; 2%); isolated motor delay (11; 5%); isolated mental delay (3; 1.5%); motor and mental delay (3; 1.5%). 166 infants resulted from pregnancies not complicated by TTTS, discordant growth, birth prior to 32 weeks or death of 1 twin. From these, 12 (7%) had NDI of whom 1 had CP (0.6%). Death or NDI occurred in 28/126 pregnancies (22%). TTTS (OR: 39; P ⬍ .0001), early-onset discordant growth (OR: 7; P ⬍ .001) and ART (OR: 5; P ⫽ .024) were significant risk factors for the occurrence of death or NDI. CONCLUSION: In this prospective cohort of MC twins, the mortality rate was 8% (22/272) and NDI occurred in 10% (22/230) of survivors. TTTS was the most important risk factor for death or neurodevelopmental impairment. 0002-9378/$ - see front matter doi:10.1016/j.ajog.2008.09.102
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0002-9378/$ - see front matter doi:10.1016/j.ajog.2008.09.101
NEONATAL ADIPOSITY FOLLOWING MATERNAL TREATMENT OF GESTATIONAL DIABETES WITH GLYBURIDE COMPARED TO INSULIN KRISTINE LAIN1, MATTHEW GARABEDIAN1, ASHI DAFTARY2, ARUNDHATHI JEYABALAN2, 1University of Kentucky, Lexington, Kentucky, 2University of Pittsburgh, Obstetrics and Gynecology, Pittsburgh, Pennsylvania OBJECTIVE: Glyburide is widely used in the treatment of gestational diabetes (GDM). We hypothesized that measures of neonatal body composition would be similar in insulin and glyburide treated patients. STUDY DESIGN: Women with GDM requiring medical therapy were randomized to insulin or glyburide. The primary outcome was fetal fat mass as measured by total body electrical conductance (TOBEC). Secondary outcomes included neonatal anthropometrics and other measures of fetal adiposity. Statistics included t-test, chi-square, and regression modeling and were performed by intention to treat and actual therapy received. RESULTS: TOBEC measurements were completed in 82 neonates. Birth weight and chest circumference were increased in the glyburide group (3358 vs 3603g, p⫽0.03; 32.8 vs 32.0 cm; p⫽0.03). Arm, thigh, abdominal, and skin fold measurements were not different between groups. Differences in birth weight and chest circumference did not remain in multivariate analysis. Percent body fat measured by TOBEC was not different between the two groups (11.1 vs 12.9%; p⫽0.13). Other measures of neonatal adiposity (BMI, skin fold sum, arm fat area, and ponderal index) were also similar. Percent fat mass was correlated to head circumference (p⬍0.01) and birth weight (p⬍0.01). Percent fat mass correlated with all anthropometrics and other measures of adiposity. The strongest correlations were with thigh skin fold thickness (r⫽0.8, p⬍0.001) and skin fold sum (r⫽0.8, p⬍0.001). The rate of large for gestational age was increased among women taking glyburide (8 vs 29%; p⫽0.02). Three women in the glyburide group failed oral therapy and were transitioned to insulin. The data was reanalyzed by actual therapy and no differences were present. CONCLUSION: We measured fetal adiposity as a surrogate of fetal metabolism in women treated with glyburide compared to insulin. Similarities in growth outcomes add to the neonatal safety profile for the use of glyburide during pregnancy. 0002-9378/$ - see front matter doi:10.1016/j.ajog.2008.09.103
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American Journal of Obstetrics & Gynecology Supplement to DECEMBER 2008
EXTERNAL CEPHALIC VERSION AT TERM IN MULTIPAROUS WOMEN WITH OR WITHOUT SPINAL ANALGESIA: RANDOMIZED CONTROLLED TRIAL CAROLYN WEINIGER1, YEHUDA GINOSAR1, HEN Y SELA2, URIEL ELCHALAL2, CHARLES WEISSMAN1, YOSSEF EZRA2, 1Hadassah Hebrew University Medical Center, Department of Anesthesiology and Critical Care Medicine, Jerusalem, Israel, 2Hadassah Hebrew University Medical Center, Department of Obstetrics & Gynecology, Jerusalem, Israel OBJECTIVE: Neuraxial analgesia positively impacts the chance of delivering vaginally a fetus previously lying in a breech position, by significantly increasing the success of external cephalic version (ECV) in nulliparas. We sought to measure the success rate of ECV with spinal analgesia versus no analgesia among multiparas. STUDY DESIGN: A prospective randomized controlled trial with ethical approval was performed in a tertiary referral center delivery suite. Multiparous women at term requesting ECV for breech presentation were randomized to receive spinal analgesia (7.5 mg bupivacaine) or no analgesia prior to the ECV. An experienced obstetrician performed the ECV. The sample size was calculated to reveal an 85% power when 64 subjects were enrolled with a one-sided alpha level of 5%. Primary outcome was successful conversion to vertex presentation. Pain score was evaluated by using the visual analogue, adverse outcomes were recorded. RESULTS: Sixty-five women were enrolled, and sixty-four analyzed (31 spinal, 33 no analgesia). Successful ECV occurred among 27/31 (87.1%) women randomized to receive spinal analgesia versus 19/33 (57.5%) without, p⫽0.012 (95% CI of the difference: 0.0954 to 0.5513). The power of this result is 85%. ECV with spinal analgesia resulted in lower visual analogue pain score, 1.7⫾2.4 versus 5.5⫾2.9 without, p ⬍ 0.0001. Higher parity was not a significant factor in the success rate. There were no adverse outcomes following ECV (placental abruption or emergency cesarean section). CONCLUSION: Administration of spinal analgesia significantly increases the chance of successful ECV among multiparous women at term.
www.AJOG.org 77
0002-9378/$ - see front matter doi:10.1016/j.ajog.2008.09.100
76
A RANDOMIZED CONTROLLED TRIAL OF METFORMIN AND GLYBURIDE IN GESTATIONAL DIABETES LISA MOORE1, DIANA CLOKEY1, LUIS CURET2, 1University of New Mexico, Obstetrics and Gynecology, Albuquerque, New Mexico, 2University of New Mexico, Obstetrics & Gynecology, Albuquerque, NM OBJECTIVE: To compare metformin to glyburide in the management of gestational diabetes. STUDY DESIGN: Gestational diabetic patients attending the University of New Mexico diabetes-in-pregnancy clinic who did not achieve blood glucose control with diet and exercise were randomized to either metformin (n⫽63) or glyburide(n⫽61). Patients were between 11 and 33 weeks gestation at randomization. The primary outcome was glycemic control. Secondary outcomes were drug failure rate, macrosomia, admission to NICU, 5- minute APGAR ⬍ 7, birth trauma, preeclampsia, maternal and neonatal hypoglycemia, and route of delivery. RESULTS: Demographics were similar in both groups. In the patients who achieved glycemic control on medication, the mean fasting and two hour postprandial blood glucose was not statistically different between groups. However, 26 patients on metformin (41.2%) and 12 patients on glyburide (19.6%) did not achieve adequate glycemic control and required insulin therapy (P⫽.01 ). Macrosomia occurred in 4 patients (6.6%) on glyburide and in 1 patient (1.6%) on metformin (P⫽ .2). There were 4 NICU admissions in the metformin group and 1 NICU admission in the glyburide group (P⫽.37). One infant in the metformin group experienced hypoglycemia. Two patients on metformin and 1 patient on glyburide experienced hypoglycemia defined as blood glucose ⬍60 mg/dl. (P⫽1.0). One shoulder dystocia occurred in the glyburide group. Three patients (4.9%) in the glyburide group and 2 patients (3.1%) in the metformin group developed severe preeclampsia (P ⬎ 0.5). There were 11 non-elective cesarean deliveries in the metformin group: 3 for breech presentation and 8 for nonreassuring fetal status; compared to 2 non-elective cesarean deliveries in the glyburide group for failure to progress and nonreassuring fetal status ( P⫽.02). There were no 5 min APGAR scores ⬍ 7 in either group. CONCLUSION: In this study the failure rate of metformin was 2.87 times higher than the failure rate of glyburide when used in the management of gestational diabetes. (95% CI ⫽ 1.28 - 6.4).
PREGNANCY AND LONG-TERM NEURODEVELOPMENTAL OUTCOME IN MONOCHORIONIC DIAMNIOTIC TWIN PREGNANCIES: A MULTI-CENTER PROSPECTIVE COHORT STUDY LIESBETH LEWI1, ELS ORTIBUS2, ENRICO LOPRIORE3, ELISE DONE1, JACQUES JANI1, TIM VAN MIEGHEM1, ANKE DIEMERT4, LÉONARDO GUCCIARDO1, PHILLIP KLARITSCH1, KURT HECHER4, PAUL DE COCK2, LIEVEN LAGAE2, JAN DEPREST1, 1University Hospitals Leuven, Obstetrics and Gynaecology, Leuven, Belgium, 2University Hospitals Leuven, Pediatrics, Leuven, Belgium, 3Leiden University Medical Center, Leiden, Netherlands, 4University Medical Center Hamburg-Eppendorf, OB/GYN, Hamburg, Germany OBJECTIVE: To document pregnancy and long-term neurodevelopmental outcome and to determine the risk factors for death or neurodevelopmental impairment in monochorionic diamniotic (MCDA) twins. STUDY DESIGN: A prospective series of MCDA twin pregnancies recruited in the first trimester in 3 European countries (Jan2002-Oct2005). Information on conception, pregnancy and neonatal outcome was collected and surviving infants were assessed in the 3 study centers by the Bayley scales of infant development at 2 years of age. Death was defined as intra-uterine or neonatal death. Neurodevelopmental impairment (NDI) was defined as the occurrence of cerebral palsy (CP), a Bayley motor or mental score of ⬍ 2 SD, deafness or blindness. Multivariate logistic regression analysis was performed to identify the risk factors for death or NDI. RESULTS: 136 pregnancies (272 fetuses) were recruited. 11/136 (8%) were conceived by artificial reproductive technology (ART). 122/136 (90%) resulted in 2 survivors, 6/136 in 1 survivor (4%) and 8/136 without survivors (6%). Twin-totwin transfusion syndrome (TTTS) occurred in 12/136 (9%) and discordant growth without TTTS in 24/136 (18%). Early-onset discordant growth diagnosed 20 weeks occurred in 16/136 pregnancies (12%). 230/250 surviving infants (92%) were assessed at a median age of 42 months. 22/230 (10%) infants had NDI; either CP (5; 2%); isolated motor delay (11; 5%); isolated mental delay (3; 1.5%); motor and mental delay (3; 1.5%). 166 infants resulted from pregnancies not complicated by TTTS, discordant growth, birth prior to 32 weeks or death of 1 twin. From these, 12 (7%) had NDI of whom 1 had CP (0.6%). Death or NDI occurred in 28/126 pregnancies (22%). TTTS (OR: 39; P ⬍ .0001), early-onset discordant growth (OR: 7; P ⬍ .001) and ART (OR: 5; P ⫽ .024) were significant risk factors for the occurrence of death or NDI. CONCLUSION: In this prospective cohort of MC twins, the mortality rate was 8% (22/272) and NDI occurred in 10% (22/230) of survivors. TTTS was the most important risk factor for death or neurodevelopmental impairment. 0002-9378/$ - see front matter doi:10.1016/j.ajog.2008.09.102
78
0002-9378/$ - see front matter doi:10.1016/j.ajog.2008.09.101
NEONATAL ADIPOSITY FOLLOWING MATERNAL TREATMENT OF GESTATIONAL DIABETES WITH GLYBURIDE COMPARED TO INSULIN KRISTINE LAIN1, MATTHEW GARABEDIAN1, ASHI DAFTARY2, ARUNDHATHI JEYABALAN2, 1University of Kentucky, Lexington, Kentucky, 2University of Pittsburgh, Obstetrics and Gynecology, Pittsburgh, Pennsylvania OBJECTIVE: Glyburide is widely used in the treatment of gestational diabetes (GDM). We hypothesized that measures of neonatal body composition would be similar in insulin and glyburide treated patients. STUDY DESIGN: Women with GDM requiring medical therapy were randomized to insulin or glyburide. The primary outcome was fetal fat mass as measured by total body electrical conductance (TOBEC). Secondary outcomes included neonatal anthropometrics and other measures of fetal adiposity. Statistics included t-test, chi-square, and regression modeling and were performed by intention to treat and actual therapy received. RESULTS: TOBEC measurements were completed in 82 neonates. Birth weight and chest circumference were increased in the glyburide group (3358 vs 3603g, p⫽0.03; 32.8 vs 32.0 cm; p⫽0.03). Arm, thigh, abdominal, and skin fold measurements were not different between groups. Differences in birth weight and chest circumference did not remain in multivariate analysis. Percent body fat measured by TOBEC was not different between the two groups (11.1 vs 12.9%; p⫽0.13). Other measures of neonatal adiposity (BMI, skin fold sum, arm fat area, and ponderal index) were also similar. Percent fat mass was correlated to head circumference (p⬍0.01) and birth weight (p⬍0.01). Percent fat mass correlated with all anthropometrics and other measures of adiposity. The strongest correlations were with thigh skin fold thickness (r⫽0.8, p⬍0.001) and skin fold sum (r⫽0.8, p⬍0.001). The rate of large for gestational age was increased among women taking glyburide (8 vs 29%; p⫽0.02). Three women in the glyburide group failed oral therapy and were transitioned to insulin. The data was reanalyzed by actual therapy and no differences were present. CONCLUSION: We measured fetal adiposity as a surrogate of fetal metabolism in women treated with glyburide compared to insulin. Similarities in growth outcomes add to the neonatal safety profile for the use of glyburide during pregnancy. 0002-9378/$ - see front matter doi:10.1016/j.ajog.2008.09.103
S34
American Journal of Obstetrics & Gynecology Supplement to DECEMBER 2008