Vincenzo Berghella1, Anthony O Odibo, Jorge E Tolosa. 1. Department of Gynecology and Obstetrics, Division of Maternal-Fetal Medicine, Jefferson Medical College of Thomas Jefferson University, Philadelphia, PA, USA.
Abstract
OBJECTIVE: The purpose of this study was to determine the efficacy of cerclage and bed rest versus bed rest-only for the prevention of preterm birth in women with a short cervix found on transvaginal ultrasound examination. STUDY DESIGN:Women with > or =1 of high-risk factors for preterm birth (> or =1preterm birth at < 35 weeks of gestation, > or =2 curettages, diethylstilbestrol exposure, cone biopsy, Mullerian anomaly, or twin gestation) were screened with transvaginal ultrasonography of the cervix every 2 weeks from 14 weeks of gestation to 23 weeks 6 days of gestation. Enrollment was offered to both asymptomatic women who were at high risk and who were identified to have short cervix (< 25 mm) or significant funneling (>25%) and nonscreened women who were at low risk and who were identified incidentally. The women who gave written consent were assigned randomly to receive either McDonald cerclage or bed rest-only. Both groups received similar counseling and treatment. Primary outcome was preterm birth at < 35 weeks of gestation. RESULTS:Sixty-one women were assigned randomly. Forty-seven pregnancies (77%) were high-risk singleton gestations. Thirty-one women (51%) were allocated to cerclage, and 30 women (49%) were allocated to bed rest. There were no differences between the groups in demographic characteristics, risk factors, and cervical variables. Preterm birth at < 35 weeks of gestation occurred in 14 women (45%) in the cerclage group and in 14 women (47%) in the bed rest group (relative risk, 0.94; 95% CI, 0.34-2.58). There was no difference in any obstetric or neonatal outcomes. A subanalysis of singleton pregnancies with previous preterm birth at < 35 weeks of gestation and a short cervix of < 25 mm (n = 31 women) also revealed no significant difference in recurrent preterm birth at < 35 weeks of gestation (40% vs 56%; relative risk, 0.52; 95% CI, 0.12-2.17). CONCLUSION:Cerclage did not prevent preterm birth in women with a short cervix. These results should be confirmed by larger trials.
RCT Entities:
OBJECTIVE: The purpose of this study was to determine the efficacy of cerclage and bed rest versus bed rest-only for the prevention of preterm birth in women with a short cervix found on transvaginal ultrasound examination. STUDY DESIGN:Women with > or =1 of high-risk factors for preterm birth (> or =1 preterm birth at < 35 weeks of gestation, > or =2 curettages, diethylstilbestrol exposure, cone biopsy, Mullerian anomaly, or twin gestation) were screened with transvaginal ultrasonography of the cervix every 2 weeks from 14 weeks of gestation to 23 weeks 6 days of gestation. Enrollment was offered to both asymptomatic women who were at high risk and who were identified to have short cervix (< 25 mm) or significant funneling (>25%) and nonscreened women who were at low risk and who were identified incidentally. The women who gave written consent were assigned randomly to receive either McDonald cerclage or bed rest-only. Both groups received similar counseling and treatment. Primary outcome was preterm birth at < 35 weeks of gestation. RESULTS: Sixty-one women were assigned randomly. Forty-seven pregnancies (77%) were high-risk singleton gestations. Thirty-one women (51%) were allocated to cerclage, and 30 women (49%) were allocated to bed rest. There were no differences between the groups in demographic characteristics, risk factors, and cervical variables. Preterm birth at < 35 weeks of gestation occurred in 14 women (45%) in the cerclage group and in 14 women (47%) in the bed rest group (relative risk, 0.94; 95% CI, 0.34-2.58). There was no difference in any obstetric or neonatal outcomes. A subanalysis of singleton pregnancies with previous preterm birth at < 35 weeks of gestation and a short cervix of < 25 mm (n = 31 women) also revealed no significant difference in recurrent preterm birth at < 35 weeks of gestation (40% vs 56%; relative risk, 0.52; 95% CI, 0.12-2.17). CONCLUSION: Cerclage did not prevent preterm birth in women with a short cervix. These results should be confirmed by larger trials.
Authors: J M Szychowski; J Owen; G Hankins; J D Iams; J S Sheffield; A Perez-Delboy; V Berghella; D A Wing; E R Guzman Journal: Ultrasound Obstet Gynecol Date: 2016-05-29 Impact factor: 7.299
Authors: Vincenzo Berghella; Dana Figueroa; Jeff M Szychowski; John Owen; Gary D V Hankins; Jay D Iams; Jeanne S Sheffield; Annette Perez-Delboy; Deborah A Wing; Edwin R Guzman Journal: Am J Obstet Gynecol Date: 2010-04 Impact factor: 8.661
Authors: J M Szychowski; J Owen; G Hankins; J Iams; J Sheffield; A Perez-Delboy; V Berghella; D A Wing; E R Guzman Journal: Ultrasound Obstet Gynecol Date: 2009-01 Impact factor: 7.299