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Cerclage for short cervix on ultrasound: A meta-analysis of the randomized trials
S106 SMFM Abstracts 357
LONG-TERM FOLLOW-UP OF CHILDREN EXPOSED IN UTERO TO NIFEDIPINE OR RITODRINE IN THE MANAGEMENT OF PRETERM LABOR D. N. M. PAPATSONIS1, S. M. HOGENDOORN2, B. A. HOUTZAGER2, A. G. WASSENAER VAN2, J. F. SAMSOM3, 1 Free University Hospital Amsterdam, Obstetrics and Gynecology, Amsterdam, Netherlands, 2Academisch Medisch Centrum Amsterdam, Neonatology, Amsterdam, Netherlands, 3Free University Hospital Amsterdam, Neonatology, Amsterdam, Netherlands OBJECTIVE: Comparison of long-term psychosocial and motor function of children exposed in utero to nifedipine or ritodrine in the management of preterm labor. STUDY DESIGN: Long-term follow-up of children 9-12 years old from mothers who were given nifedipine or ritodrine during pregnancy. Questionnaires were sent for the parents, child and teacher to assess the child’s behaviour-emotional problems, quality of life, education and motor function. Parenting distress, social demographic data and life events were also assessed. Multivariate and logistic regression analysis were performed in combination with perinatal outcome variables. RESULTS: Of the 185 patients who were previously randomized 167 children survived (90%). Questionnaires of 102 children (61%) were completed. Children in the nifedipine group (n = 48) had a higher gestational age at birth compared to the ritodrine group(n = 54) (34.2 vs. 32.4 wks, P = .03). Neonatal morbidity in the nifedipine group was lower regarding RDS (n = 5 vs.16 P = .03) and mean Apgar scores at 5 minutes compared with the ritodrine group (9.3 vs. 8.8, P = .04). There were no significant differences in mean scores between the groups regarding behaviour-emotional outcome, quality of life, education and motor function. However, in the ritodrine group the number of children with clinical behaviour-emotional and motor scores was higher compared with the nifedipine group (NS). CONCLUSION: Long-term follow-up results did not show any siginifant adverse psycho-social or developmental effects on children exposed to nifedipine compared to ritodrine at 9-12 years of age. Nifedipine is a safe tocolytic agent with respect to long-term outcome.
359
CERCLAGE FOR SHORT CERVIX ON ULTRASOUND: A META-ANALYSIS OF THE RANDOMIZED TRIALS VINCENZO BERGHELLA1, ANTHONY ODIBO2, 1Thomas Jefferson University, Department of Obstetrics and Gynecology, Philadelphia, Pennsylvania, 2University of Pennsylvania, Obstetrics and Gynecology, Philadelphia, Pennsylvania OBJECTIVE: To determine if cerclage prevents preterm birth (PTB) in women with a short cervical length (CL) on transvaginal ultrasound (TVU). STUDY DESIGN: MEDLINE, PUBMED, EMBASE, and the Cochrane Library were searched for ‘cerclage’, ‘short cervix’, ‘ultrasound’, ‘randomized trial’, and combinations thereof. Selection included asymptomatic pregnant women, screened by TVU for a short CL on TVU, then randomized to cerclage vs no cerclage, and followed for the primary outcome of PTB. Trials were reviewed for study design, assuring proper randomization. Authors were contacted for missing information. Characteristics examined were singleton vs multiple gestation, CL and gestational age at diagnosis, and risk factors for PTB, including prior PTB, multiple D&Es, cone biopsy, mu¨llerian anomaly, and DES exposure. QUORUM guidelines for meta-analysis were followed. Fixed or random effects models were used to pool both dichotomous and continuous outcomes where appropriate.Sensitivity analyses were used to assess the impact of each trial on outcomes. RESULTS: Of 9 randomized trials identified, 4 met our inclusion criteria (Rust et al AJOG 2001; Althuisius et al AJOG 2001; To Lancet et al 2004; Berghella et al AJOG 2004). Of 462 women with short cervical length randomized, 232 received cerclage and 230 did not. There were 133/462 (29%) PTB !34 weeks, 60/232 (26%) in the cerclage group and 73/230 (32%) in the no cerclage group (OR 0.75, 95% CI 0.50-1.13). There was no significant heterogeneity between the trials (fixed-effect model, P = .16). There were 31/458 (7%) perinatal deaths (PNM) in the singleton pregnancies, 17/229 (7%) in the cerclage and 24/229 (10%) in the no cerclage group (OR 0.74, 95% CI 0.37-1.42). In women with a prior PTB !34 weeks and a short cervix, 25/83 delivered !34 weeks in the cerclage group compared with 32/73 controls (OR 0.57, 95% CI 0.28-1.17, P = .13). CONCLUSION: In women with a short cervical length on ultrasound, cerclage was associated with a 25% reduction of PTB !34 weeks and 26% reduction in PNM. These reductions were however, not significant statistically.
358
INTRAVENOUS INTERLEUKIN-10 MINIMALLY CROSSES THE PLACENTA IN THE PREGNANT EWE CHAD KLAUSER1, KEESLA MOULTON2, SHERYL RODTS-PALENIK1, PETER RYAN2, SCOTT WILLARD2, CARL ROSE1, JOHN MORRISON1, DAWN TUCKER3, ANNA CHROMIAK2, WILLIAM BENNETT1, 1University of Mississippi Medical Center, Obstetrics & Gynecology, Jackson, Mississippi, 2Mississippi State University, Animal and Dairy Sciences, Mississippi State, Mississippi, 3Mississippi State University, CVM Animal Health Center, Mississippi State, Mississippi OBJECTIVE: The anti-inflammatory cytokine Interleukin-10 (IL-10) is efficacious in delaying delivery, reducing fetal wastage, and increasing birth weight, independent of gestational age when administered to pregnant rats experimentally infected with Escherichia coli. Radiolabeled IL-10 rapidly crosses the rat placenta, suggesting that maternal infusion of IL-10 may dampen the fetal immune response. This study was designed to evaluate characteristics of transplacental passage of IL-10 in the pregnant ewe, with intent to replicate the established preterm labor rat model in a larger animal. STUDY DESIGN: On day 115 of a 146 day gestation, two pregnant dated Suffolk ewes received an intravenous bolus of 50 mg of recombinant IL-10 commercially radiolabeled with I125 to a specific activity of 3 mCi/50 mg. Sacrifice was performed at one and two hours following injection and maternal and fetal blood and tissue specimens were collected. The presence of radiolabeled IL-10 was quantified with a gamma counter. RESULTS: Maternal whole blood demonstrated radioactivity levels of 379,500 cpm/mL and 101,760 cpm/mL at 1 and 2 hours post-infusion, respectively. Fetal blood counts were 6940 cpm/mL at one hour, rising to 8878 cpm/mL at two hours. The caruncle (maternal portion) of the cotyledonary placenta registered 37,113 cpm/g at 1 hour and 17,664 cpm/g at 2 hours, while the cotyledon (fetal portion) radiated 18,300 cpm/g and 12,450 cpm/g at identical time intervals. Amniotic fluid counts were 440 cpm/mL at 1 hour and !40 at 2 hours, while the fetal brain emitted 750 cpm/g 1 hour and 1615 cpm/g 2 hours following the infusion. CONCLUSION: Interleukin-10 administered intravenously to pregnant ewes crosses the placenta to a lesser degree than in the previously established rat model. Alternative methods of administration may be required to exert therapeutic effects on the fetal inflammatory response.
360
EFFECT OF MATERNAL BMI, NUMBER OF COURSES AND TIMING OF ANTENATAL CORTICOSTEROIDS: ASSOCIATION WITH NEONATAL ANTHROPOMETRIC MEASUREMENTS YORAM SOROKIN1, 1for the NICHD, MFMU Network, Bethesda, Maryland OBJECTIVE: Infants exposed to four or more courses of antenatal corticosteroids (AC) in utero have been shown to have lower birth weight. Maternal body mass index (BMI) has been shown to affect fetal size. We sought to investigate further the relationship between anthropometric measurements and the number of courses or timing of AC, adjusting for maternal BMI. STUDY DESIGN: This is a secondary analysis of patients assigned to weekly courses of antenatal corticosteroids (AC) in a multicenter randomized trial of repeat versus a single course of AC in women at high risk for preterm birth. The relationships between the number and timing of courses of AC and four neonatal anthropometric measurements, birth weight (BW), length (L), head circumference (HC), and arm circumferences (ACM), were analyzed, adjusting for maternal BMI, race and gestational age. A multivariable regression model was used, accounting for correlations between twins. Multiples of the median for birth weight (MOM BW) by gestational age were also calculated and analyzed similarly. RESULTS: 495 patients were randomized with 252 in the repeat AC group (296 infants). Increasing maternal BMI was significantly associated with higher MOM BW (P = .026). After adjustment for BMI, neonates born after 4 or more courses still had a lower MOM BW than neonates born after 1-3 courses (0.86 vs. 0.94) (P = .0006). The interval from last dose to delivery (INTERVAL) was inversely associated with L (P = .006), HC (P = .022), and ACM (P = .003). CONCLUSION: After controlling for BMI and other factors, patients that received 4 repeat doses of AC have smaller babies than those receiving 1-3 courses. Neonates born after a longer INTERVAL have smaller L, HC, and ACM. We speculate that there may be a time lag in the impact of repeat AC on fetal growth.
LONG-TERM FOLLOW-UP OF CHILDREN EXPOSED IN UTERO TO NIFEDIPINE OR RITODRINE IN THE MANAGEMENT OF PRETERM LABOR D. N. M. PAPATSONIS1, S. M. HOGENDOORN2, B. A. HOUTZAGER2, A. G. WASSENAER VAN2, J. F. SAMSOM3, 1 Free University Hospital Amsterdam, Obstetrics and Gynecology, Amsterdam, Netherlands, 2Academisch Medisch Centrum Amsterdam, Neonatology, Amsterdam, Netherlands, 3Free University Hospital Amsterdam, Neonatology, Amsterdam, Netherlands OBJECTIVE: Comparison of long-term psychosocial and motor function of children exposed in utero to nifedipine or ritodrine in the management of preterm labor. STUDY DESIGN: Long-term follow-up of children 9-12 years old from mothers who were given nifedipine or ritodrine during pregnancy. Questionnaires were sent for the parents, child and teacher to assess the child’s behaviour-emotional problems, quality of life, education and motor function. Parenting distress, social demographic data and life events were also assessed. Multivariate and logistic regression analysis were performed in combination with perinatal outcome variables. RESULTS: Of the 185 patients who were previously randomized 167 children survived (90%). Questionnaires of 102 children (61%) were completed. Children in the nifedipine group (n = 48) had a higher gestational age at birth compared to the ritodrine group(n = 54) (34.2 vs. 32.4 wks, P = .03). Neonatal morbidity in the nifedipine group was lower regarding RDS (n = 5 vs.16 P = .03) and mean Apgar scores at 5 minutes compared with the ritodrine group (9.3 vs. 8.8, P = .04). There were no significant differences in mean scores between the groups regarding behaviour-emotional outcome, quality of life, education and motor function. However, in the ritodrine group the number of children with clinical behaviour-emotional and motor scores was higher compared with the nifedipine group (NS). CONCLUSION: Long-term follow-up results did not show any siginifant adverse psycho-social or developmental effects on children exposed to nifedipine compared to ritodrine at 9-12 years of age. Nifedipine is a safe tocolytic agent with respect to long-term outcome.
359
CERCLAGE FOR SHORT CERVIX ON ULTRASOUND: A META-ANALYSIS OF THE RANDOMIZED TRIALS VINCENZO BERGHELLA1, ANTHONY ODIBO2, 1Thomas Jefferson University, Department of Obstetrics and Gynecology, Philadelphia, Pennsylvania, 2University of Pennsylvania, Obstetrics and Gynecology, Philadelphia, Pennsylvania OBJECTIVE: To determine if cerclage prevents preterm birth (PTB) in women with a short cervical length (CL) on transvaginal ultrasound (TVU). STUDY DESIGN: MEDLINE, PUBMED, EMBASE, and the Cochrane Library were searched for ‘cerclage’, ‘short cervix’, ‘ultrasound’, ‘randomized trial’, and combinations thereof. Selection included asymptomatic pregnant women, screened by TVU for a short CL on TVU, then randomized to cerclage vs no cerclage, and followed for the primary outcome of PTB. Trials were reviewed for study design, assuring proper randomization. Authors were contacted for missing information. Characteristics examined were singleton vs multiple gestation, CL and gestational age at diagnosis, and risk factors for PTB, including prior PTB, multiple D&Es, cone biopsy, mu¨llerian anomaly, and DES exposure. QUORUM guidelines for meta-analysis were followed. Fixed or random effects models were used to pool both dichotomous and continuous outcomes where appropriate.Sensitivity analyses were used to assess the impact of each trial on outcomes. RESULTS: Of 9 randomized trials identified, 4 met our inclusion criteria (Rust et al AJOG 2001; Althuisius et al AJOG 2001; To Lancet et al 2004; Berghella et al AJOG 2004). Of 462 women with short cervical length randomized, 232 received cerclage and 230 did not. There were 133/462 (29%) PTB !34 weeks, 60/232 (26%) in the cerclage group and 73/230 (32%) in the no cerclage group (OR 0.75, 95% CI 0.50-1.13). There was no significant heterogeneity between the trials (fixed-effect model, P = .16). There were 31/458 (7%) perinatal deaths (PNM) in the singleton pregnancies, 17/229 (7%) in the cerclage and 24/229 (10%) in the no cerclage group (OR 0.74, 95% CI 0.37-1.42). In women with a prior PTB !34 weeks and a short cervix, 25/83 delivered !34 weeks in the cerclage group compared with 32/73 controls (OR 0.57, 95% CI 0.28-1.17, P = .13). CONCLUSION: In women with a short cervical length on ultrasound, cerclage was associated with a 25% reduction of PTB !34 weeks and 26% reduction in PNM. These reductions were however, not significant statistically.
358
INTRAVENOUS INTERLEUKIN-10 MINIMALLY CROSSES THE PLACENTA IN THE PREGNANT EWE CHAD KLAUSER1, KEESLA MOULTON2, SHERYL RODTS-PALENIK1, PETER RYAN2, SCOTT WILLARD2, CARL ROSE1, JOHN MORRISON1, DAWN TUCKER3, ANNA CHROMIAK2, WILLIAM BENNETT1, 1University of Mississippi Medical Center, Obstetrics & Gynecology, Jackson, Mississippi, 2Mississippi State University, Animal and Dairy Sciences, Mississippi State, Mississippi, 3Mississippi State University, CVM Animal Health Center, Mississippi State, Mississippi OBJECTIVE: The anti-inflammatory cytokine Interleukin-10 (IL-10) is efficacious in delaying delivery, reducing fetal wastage, and increasing birth weight, independent of gestational age when administered to pregnant rats experimentally infected with Escherichia coli. Radiolabeled IL-10 rapidly crosses the rat placenta, suggesting that maternal infusion of IL-10 may dampen the fetal immune response. This study was designed to evaluate characteristics of transplacental passage of IL-10 in the pregnant ewe, with intent to replicate the established preterm labor rat model in a larger animal. STUDY DESIGN: On day 115 of a 146 day gestation, two pregnant dated Suffolk ewes received an intravenous bolus of 50 mg of recombinant IL-10 commercially radiolabeled with I125 to a specific activity of 3 mCi/50 mg. Sacrifice was performed at one and two hours following injection and maternal and fetal blood and tissue specimens were collected. The presence of radiolabeled IL-10 was quantified with a gamma counter. RESULTS: Maternal whole blood demonstrated radioactivity levels of 379,500 cpm/mL and 101,760 cpm/mL at 1 and 2 hours post-infusion, respectively. Fetal blood counts were 6940 cpm/mL at one hour, rising to 8878 cpm/mL at two hours. The caruncle (maternal portion) of the cotyledonary placenta registered 37,113 cpm/g at 1 hour and 17,664 cpm/g at 2 hours, while the cotyledon (fetal portion) radiated 18,300 cpm/g and 12,450 cpm/g at identical time intervals. Amniotic fluid counts were 440 cpm/mL at 1 hour and !40 at 2 hours, while the fetal brain emitted 750 cpm/g 1 hour and 1615 cpm/g 2 hours following the infusion. CONCLUSION: Interleukin-10 administered intravenously to pregnant ewes crosses the placenta to a lesser degree than in the previously established rat model. Alternative methods of administration may be required to exert therapeutic effects on the fetal inflammatory response.
360
EFFECT OF MATERNAL BMI, NUMBER OF COURSES AND TIMING OF ANTENATAL CORTICOSTEROIDS: ASSOCIATION WITH NEONATAL ANTHROPOMETRIC MEASUREMENTS YORAM SOROKIN1, 1for the NICHD, MFMU Network, Bethesda, Maryland OBJECTIVE: Infants exposed to four or more courses of antenatal corticosteroids (AC) in utero have been shown to have lower birth weight. Maternal body mass index (BMI) has been shown to affect fetal size. We sought to investigate further the relationship between anthropometric measurements and the number of courses or timing of AC, adjusting for maternal BMI. STUDY DESIGN: This is a secondary analysis of patients assigned to weekly courses of antenatal corticosteroids (AC) in a multicenter randomized trial of repeat versus a single course of AC in women at high risk for preterm birth. The relationships between the number and timing of courses of AC and four neonatal anthropometric measurements, birth weight (BW), length (L), head circumference (HC), and arm circumferences (ACM), were analyzed, adjusting for maternal BMI, race and gestational age. A multivariable regression model was used, accounting for correlations between twins. Multiples of the median for birth weight (MOM BW) by gestational age were also calculated and analyzed similarly. RESULTS: 495 patients were randomized with 252 in the repeat AC group (296 infants). Increasing maternal BMI was significantly associated with higher MOM BW (P = .026). After adjustment for BMI, neonates born after 4 or more courses still had a lower MOM BW than neonates born after 1-3 courses (0.86 vs. 0.94) (P = .0006). The interval from last dose to delivery (INTERVAL) was inversely associated with L (P = .006), HC (P = .022), and ACM (P = .003). CONCLUSION: After controlling for BMI and other factors, patients that received 4 repeat doses of AC have smaller babies than those receiving 1-3 courses. Neonates born after a longer INTERVAL have smaller L, HC, and ACM. We speculate that there may be a time lag in the impact of repeat AC on fetal growth.