494: Scheduled timing of and patient compliance with longitudinal sonographic cervical length (CL)...

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6/7 weeks exposed to ACS 34 weeks (2003-2008). Case status was defined by adverse respiratory outcomes including need for CPAP or ventilator prior to discharge (RESP). Pertinent maternal information and neonatal outcomes were recorded. Significant associations be- tween dichotomous maternal variables and RESP were determined with chi-square analyses. MVLR was performed to estimate the odds of RESP controlling for confounders. RESULTS: We enrolled 148 infants (black: 84.5%, non-black: 15.5%). Non-black race was associated with RESP (p0.04) independent of medical co-morbidities, age, insurance, prenatal care, chorioamnio- nitis, delivery type, and infant gender. Controlling for gestational age at delivery, time between ACS and delivery, and birth weight, non- black infants had 3.4-fold (95%CI 1.2-9.6) greater odds of RESP and 8.1-fold (95%CI 1.2-53.0) greater odds of ventilator use than black infants. CONCLUSIONS: Despite ACS, the prevalence of RESP in late PTB re- mains high with non-black infants at significantly greater risk. Some studies have shown that non-black infants have decreased surfactant synthesis compared to black infants. Whether this biological differ- ence is responsible for increased respiratory complications is not known. It is plausible that non-black infants have a less potent re- sponse to ACS or that genetic and/or environmental factors modify response to ACS in non-black women and fetuses. Understanding these racial differences may lead to modifications in ACS therapy and improved outcomes. 493 Cerclage retention versus removal in the setting of preterm premature rupture of membranes: a systematic review and meta-analysis of neonatal sepsis and mortality Joel Larma 1 , Cynthia Shellhaas 2 1 The Ohio State University, Department of Obstetrics & Gynecology, Division of Maternal Fetal Medicine, Columbus, OH, 2 The Ohio State University, Columbus, OH OBJECTIVE: When PPROM occurs in patients with a cerclage, there is no consensus regarding its removal or retention. The objective of this study was to perform a meta-analysis of the neonatal effects associated with cerclage retention versus removal in the setting of PPROM. STUDY DESIGN: PubMed was indexed for cerclage, premature, rupture and membranes to identify studies for inclusion. A QUOROM meth- odology was employed & only comparative studies were included. The difference in neonatal sepsis between groups was the primary out- come. Secondary outcomes involved neonatal mortality and birth- weight. A Bayesian inference utilizing Markov chain Monte Carlo modeling was used to perform a random effects meta-analysis model with the WinBugs 1.4.3 program. Continuous variables were com- pared using Cohen’s d and dichotomous variables were compared using log OR. Each outcome was reported as a standardized effect. A one-way exclusion sensitivity analysis was performed to assess the effect on final outcomes. Publication bias was assessed using a stan- dard funnel plot, heterogeneity with the Q statistic and graphical out- put was done with MIX 1.7. An alpha of 0.05 indicated a statistically significant result. RESULTS: Five studies were included in the final analysis. Values of standardized effects greater than zero indicate an outcome (i.e. sepsis) was increased in the retained-cerclage group while values less than zero indicate the outcome was increased in the group where the cer- clage was removed. Values in parentheses indicate a 95% CI. The overall effect for sepsis was 1.22 (0.45, 1.99), p 0.01. The difference in mortality was 0.79 (0.90, 2.49), p 0.36 and for birthweight was 0.05 (0.26, 0.35), p 0.75. The sensitivity analysis did not alter any outcome and the funnel plot revealed no evidence of publication bias. Heterogeneity was not seen. CONCLUSIONS: Retention of a cerclage in the setting of PPROM signif- icantly increases the risk for neonatal sepsis with no significant differ- ence in neonatal mortality or birthweight. Figure 1 – Forest plot of neonatal sepsis with and without cerclage removal 494 Scheduled timing of and patient compliance with longitudinal sonographic cervical length (CL) measurement in a multicenter randomized trial of ultrasound-indicated cerclage John Owen 1 , Jeff Szychowski 1 , for the Vaginal Ultrasound Trial Consortium 2 1 University of Alabama at Birmingham, Birmingham, AL, 2 Multicenter OBJECTIVE: To assess the timing of CL measurement and compliance with scheduled visits in women at high risk for recurrent preterm birth (PTB). STUDY DESIGN: Women with 1 prior spontaneous PTB 17-33 6/7 wks had an initial scan at 16-21 wks. Unless randomization occurred at the initial scan, follow-up visits were scheduled biweekly if CL 30 mm, increased to weekly if 25-29 mm. Women were randomized: cerclage or no-cerclage if CL25 mm. The final scan was scheduled by 22 6/7 wks. Birth in the prescribed scanning window 16-22 6/7 wks and ges- tational age (GA) at birth were evaluated. RESULTS: Of 674 non-randomized women, only 11 (1.6%) delivered in the GA window 23 wks. The rate of birth 23 wks was 1.6% in 379 women with perfect compliance and 1.7% in 295 women who were either late for any visit or who missed their final scan (p1.00). 183 (27.2%) did not present for their final scan 23 wks, and these non- compliant women delivered at a mean (SD) GA of 37.0 (4.0) as com- pared to 37.2 (3.8) wks for those who were compliant (p0.66). Women who missed their final 1-week follow-up (last observed CL 25-29 mm), delivered at 36.4 (4.4) wks compared to 37.1 (3.9) wks in those whose missed scan was a 2-week follow-up (last observed CL 30 mm; p0.55). Of 189 women randomized after the initial scan, 91 were assigned to cerclage and 98 to no-cerclage. In the cerclage group the rates of birth 23 weeks were 4% in 78 with perfect com- pliance and 0 (0%) in 13 who missed 1 scheduled visit (p1.00). In the no-cerclage group the rates of birth 23 weeks were 7.5% in 80 with perfect compliance and 0 (0%) in 18 who were non-compliant (p0.59). CONCLUSIONS: Women at high-risk for recurrent PTB followed with serial CL measurement using a defined scanning interval based on CL, with an intent for ultrasound-indicated cerclage, have a low, 1.8% risk of birth 23 wks. The effect of non compliance with scheduled scans was null. For non-randomized women who missed their final scan, mean birth GA did not depend on whether the last observed CL was 25-29 vs. 30 mm. 495 Can the optimal cervical length for placing ultrasound-indicated cerclage be identified? John Owen 1 , Jeff Szychowski 1 , for the Vaginal Ultrasound Trial Consortium 2 1 University of Alabama at Birmingham, Birmingham, AL, 2 Multicenter OBJECTIVE: To define an optimal cervical length (CL) for cerclage in women with prior spontaneous preterm birth (PTB) and short cervix 25 mm. Poster Session III Doppler Assessment, Fetus, Neonatology, Prematurity www.AJOG.org S198 American Journal of Obstetrics & Gynecology Supplement to JANUARY 2011

Transcript of 494: Scheduled timing of and patient compliance with longitudinal sonographic cervical length (CL)...

Page 1: 494: Scheduled timing of and patient compliance with longitudinal sonographic cervical length (CL) measurement in a multicenter randomized trial of ultrasound-indicated cerclage

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Poster Session III Doppler Assessment, Fetus, Neonatology, Prematurity www.AJOG.org

6/7 weeks exposed to ACS �34 weeks (2003-2008). Case status wasdefined by adverse respiratory outcomes including need for CPAP orventilator prior to discharge (RESP). Pertinent maternal informationand neonatal outcomes were recorded. Significant associations be-tween dichotomous maternal variables and RESP were determinedwith chi-square analyses. MVLR was performed to estimate the oddsof RESP controlling for confounders.RESULTS: We enrolled 148 infants (black: 84.5%, non-black: 15.5%).

on-black race was associated with RESP (p�0.04) independent ofedical co-morbidities, age, insurance, prenatal care, chorioamnio-

itis, delivery type, and infant gender. Controlling for gestational aget delivery, time between ACS and delivery, and birth weight, non-lack infants had 3.4-fold (95%CI 1.2-9.6) greater odds of RESP and.1-fold (95%CI 1.2-53.0) greater odds of ventilator use than blacknfants.

CONCLUSIONS: Despite ACS, the prevalence of RESP in late PTB re-ains high with non-black infants at significantly greater risk. Some

tudies have shown that non-black infants have decreased surfactantynthesis compared to black infants. Whether this biological differ-nce is responsible for increased respiratory complications is notnown. It is plausible that non-black infants have a less potent re-ponse to ACS or that genetic and/or environmental factors modifyesponse to ACS in non-black women and fetuses. Understandinghese racial differences may lead to modifications in ACS therapy andmproved outcomes.

493 Cerclage retention versus removal in the setting ofreterm premature rupture of membranes: a systematiceview and meta-analysis of neonatal sepsis and mortality

Joel Larma1, Cynthia Shellhaas2

1The Ohio State University, Department of Obstetrics & Gynecology,ivision of Maternal Fetal Medicine, Columbus, OH,

2The Ohio State University, Columbus, OHOBJECTIVE: When PPROM occurs in patients with a cerclage, there is

o consensus regarding its removal or retention. The objective of thistudy was to perform a meta-analysis of the neonatal effects associatedith cerclage retention versus removal in the setting of PPROM.

STUDY DESIGN: PubMed was indexed for cerclage, premature, rupturend membranes to identify studies for inclusion. A QUOROM meth-dology was employed & only comparative studies were included. Theifference in neonatal sepsis between groups was the primary out-ome. Secondary outcomes involved neonatal mortality and birth-eight. A Bayesian inference utilizing Markov chain Monte Carloodeling was used to perform a random effects meta-analysis modelith the WinBugs 1.4.3 program. Continuous variables were com-ared using Cohen’s d and dichotomous variables were comparedsing log OR. Each outcome was reported as a standardized effect. Ane-way exclusion sensitivity analysis was performed to assess theffect on final outcomes. Publication bias was assessed using a stan-ard funnel plot, heterogeneity with the Q statistic and graphical out-ut was done with MIX 1.7. An alpha of 0.05 indicated a statisticallyignificant result.

RESULTS: Five studies were included in the final analysis. Values oftandardized effects greater than zero indicate an outcome (i.e. sepsis)as increased in the retained-cerclage group while values less than

ero indicate the outcome was increased in the group where the cer-lage was removed. Values in parentheses indicate a 95% CI. Theverall effect for sepsis was 1.22 (0.45, 1.99), p � 0.01. The difference

n mortality was 0.79 (�0.90, 2.49), p � 0.36 and for birthweight was0.05 (�0.26, 0.35), p � 0.75. The sensitivity analysis did not alter anyoutcome and the funnel plot revealed no evidence of publication bias.Heterogeneity was not seen.CONCLUSIONS: Retention of a cerclage in the setting of PPROM signif-cantly increases the risk for neonatal sepsis with no significant differ-nce in neonatal mortality or birthweight.

S198 American Journal of Obstetrics & Gynecology Supplement to JANUARY 2

Figure 1 – Forest plot of neonatal sepsiswith and without cerclage removal

494 Scheduled timing of and patient complianceith longitudinal sonographic cervical length (CL)easurement in a multicenter randomized

rial of ultrasound-indicated cerclageJohn Owen1, Jeff Szychowski1, for the

aginal Ultrasound Trial Consortium2

1University of Alabama at Birmingham, Birmingham, AL, 2MulticenterOBJECTIVE: To assess the timing of CL measurement and compliance

ith scheduled visits in women at high risk for recurrent pretermirth (PTB).

STUDY DESIGN: Women with �1 prior spontaneous PTB 17-336/7 wksad an initial scan at 16-21 wks. Unless randomization occurred at the

nitial scan, follow-up visits were scheduled biweekly if CL �30 mm,ncreased to weekly if 25-29 mm. Women were randomized: cerclager no-cerclage if CL�25 mm. The final scan was scheduled by 226/7

wks. Birth in the prescribed scanning window 16-226/7 wks and ges-tational age (GA) at birth were evaluated.RESULTS: Of 674 non-randomized women, only 11 (1.6%) deliveredn the GA window �23 wks. The rate of birth �23 wks was 1.6% in 379omen with perfect compliance and 1.7% in 295 women who were

ither late for any visit or who missed their final scan (p�1.00). 18327.2%) did not present for their final scan � 23 wks, and these non-ompliant women delivered at a mean (SD) GA of 37.0 (4.0) as com-ared to 37.2 (3.8) wks for those who were compliant (p�0.66).omen who missed their final 1-week follow-up (last observed CL

5-29 mm), delivered at 36.4 (4.4) wks compared to 37.1 (3.9) wks inhose whose missed scan was a 2-week follow-up (last observed CL

30 mm; p�0.55). Of 189 women randomized after the initial scan,1 were assigned to cerclage and 98 to no-cerclage. In the cerclageroup the rates of birth �23 weeks were 4% in 78 with perfect com-liance and 0 (0%) in 13 who missed �1 scheduled visit (p�1.00). Inhe no-cerclage group the rates of birth �23 weeks were 7.5% in 80ith perfect compliance and 0 (0%) in 18 who were non-compliant

p�0.59).CONCLUSIONS: Women at high-risk for recurrent PTB followed witherial CL measurement using a defined scanning interval based on CL,ith an intent for ultrasound-indicated cerclage, have a low, 1.8% riskf birth �23 wks. The effect of non compliance with scheduled scansas null. For non-randomized women who missed their final scan,ean birth GA did not depend on whether the last observed CL was

5-29 vs. �30 mm.

495 Can the optimal cervical length for placingltrasound-indicated cerclage be identified?

John Owen1, Jeff Szychowski1, for theaginal Ultrasound Trial Consortium2

1University of Alabama at Birmingham, Birmingham, AL, 2MulticenterOBJECTIVE: To define an optimal cervical length (CL) for cerclage in

omen with prior spontaneous preterm birth (PTB) and short cervix

25 mm.

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