Effectiveness of double cervical cerclage in women with at least one previous pregnancy loss in the second trimester: A randomized controlled trial

Aim: To evaluate the effect of double cervical cerclage on the prevention of preterm delivery, and perinatal and maternal outcomes in women with previous fetal loss in the second trimester. Methods: Between January 2001 and December 2006 we conducted a prospective study in which patients with a previous preterm delivery at the second trimester who met clinical criteria for the diagnosis of cervical incompetence were randomly allocated to receive double cervical cerclage or traditional single cervical cerclage at a ratio of 1:2. Results: The perinatal and maternal outcomes of the two groups were compared. A total of 17 women were allocated to the double cervical cerclage group, and 34 to the traditional single cervical cerclage group. The single cervical cerclage group had a higher incidence of preterm delivery at <28 weeks than the double cerclage group (29.4 vs 5.9%, respectively, P = 0.0528). The mean gestational age and birth weight in the double cervical cerclage group were significantly higher than in the traditional single cervical cerclage group (35.9 +/- 5.4 vs 32.9 +/- 7.5 weeks, respectively for gestational age, P = 0.045; 2696 +/- 911 vs 2242 +/- 1119 g, respectively for birth weight, P = 0.048). No significant differences in rates of neonatal survival (P = 0.241) and neonatal admission to the intensive care unit were found between the two groups. Conclusion: Our results demonstrated that double cervical cerclage may significantly improve perinatal outcome in women with at least one previous pregnancy loss in the second trimester.