Effectiveness of Double Cervical Cerclage in Women With at Least One Previous Pregnancy Loss in the Second Trimester: A Randomized Controlled Trial

Abstract

Cervical cerclage is widely used to prevent preterm birth in women at moderate or high risk of prematurity due to a history of preterm birth in the second trimester. Several studies reported, however, that cerclage is not effective; one study found no difference in the risk of preterm birth between cerclage and bed rest alone. Many of these studies, however, can be criticized because of deficiencies in design. A number of authors believe that placement of the suture close to the internal os may improve perinatal outcomes. Most studies investigating cerclage have used a single purse-string cerclage suture. The investigators in the present study suggest that use of a single suture is inadequate, no matter where it is placed in the cervix. This prospective randomized controlled pilot study compared the effect of double cervical cerclage with traditional single cervical cerclage on the frequency of preterm birth, perinatal outcomes, and maternal side effects in 51 singleton women with a history of pregnancy loss in the second trimester and suspected cervical incompetence. The participants were randomized into 2 groups: double cervical cerclage (n = 17) and traditional single cervical cerclage (n = 34). The effect of using double or single cervical sutures on a number of outcomes was compared. Outcomes examined included the duration of pregnancy, perinatal outcomes, maternal hospital stay, neonatal death, and neonatal admission to the intensive care unit. At less than 34 weeks of gestation, there was a nonsignificant difference in the rate of preterm delivery between the 2 groups favoring double cerclage, 12% versus 41%. At less than 28 weeks of gestation, the incidence of preterm delivery was lower (but not significantly) in the double cervical cerclage group compared to the single cerclage group, 6% versus 29%. The mean birth weight in the double cerclage group was higher (double suture: 2696 ± 911 vs. single suture: 2242 ± 1119 g, P = 0.048). The rates of neonatal survival and admission to the intensive care unit were not significantly different in the 2 groups. Few neonatal complications and no intraoperative maternal complications were associated with use of double cervical cerclage. The findings of this pilot study suggest that double cervical cerclage is effective and may be more effective than traditional single cervical cerclage in preventing preterm delivery and improving perinatal outcome among women with a prior history of premature delivery in the second trimester.