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29: Neonatal morbidities in a multicenter randomized trial of ultrasound-indicated cerclage for shortened cervical length (CL)

      Objective

      To estimate the effect of ultrasound-indicated cerclage on neonatal (NN) morbidities.

      Study Design

      Planned secondary analysis of the NICHD-sponsored multicenter cerclage trial. Women with ≥1 prior spontaneous preterm birth 17-33 wks underwent serial CL measurements and randomized to cerclage or no cerclage for CL<25 mm between 16-226/7 wks. The primary outcome was a composite, any of: severe RDS, chronic lung disease, confirmed sepsis, NEC, or grades 3-4 IVH. Since perinatal death was previously reported it was excluded from morbidity assessment. Outcomes were compared by intent to treat.

      Results

      Of 302 maternal-fetal dyads randomized, 300 cases had sufficient NN information for analysis; 38 experienced a perinatal death (13, cerclage; 25, no-cerclage, p=0.046). Of the 262 survivors, the mean birth GA for the cerclage group, 36.2, was similar to the no-cerclage group, 35.7 (p=0.3), and 87 were admitted to the NICU. The remaining 175 went to a continuing care nursery, and none experienced any components of the NN composite. Of those admitted to NICU, the mean birth GA for the cerclage and no-cerclage groups were 32.3 and 31.5 wks respectively (p=0.35). Rates of composite morbidity, NICU admission and components of the composite morbidity are shown in the Table.
      Tabled 1
      Outcome (N=262)Cerclage (52%)No-cerclage (48%)p
      Composite Morbidity13 (10%)15 (12%)0.57
      Severe RDS10 (7%)10 (8%)0.89
      Chronic lung Disease7 (5%)6 (5%)0.86
      Sepsis4 (3%)8 (6%)0.20
      NEC1 (1%)1 (1%)1.00
      Grades 3-4 IVH0 (0)1 (1%)0.48
      NICU admission34%33%0.76
      Mean NICU Stay (days)31.7 (35.4)37.1 (31.9)0.46

      Conclusions

      Ultrasound-indicated cerclage for CL<25 mm was associated with a null effect on NN composite morbidity in surviving infants.