Vaginal Ultrasound Cerclage Trial

Summary

Principal Investigator: J Owen
Affiliation: University of Alabama at Birmingham
Country: USA
Abstract: The Vaginal Ultrasound Cerclage Trial is a multicenter, randomized clinical trial, designed to determine the efficacy of cerclage (a purse- string suture placed around the uterine cervix) for the prevention of spontaneous preterm birth prior to 35 weeks' gestation. We propose to study women at significant risk for recurrent spontaneous preterm birth (those with a prior spontaneous birth at 17-32 weeks' gestation) and who also have an increased risk based on midtrimester ultrasonographic findings of a cervical length <25mm. A consortium of 7 perinatal centers, recognized nationally for their expertise in the conduct of clinical trials, will identify approximately 1000 women with a history of a spontaneous preterm birth at 17-32 weeks' gestation. These women will undergo biweekly vaginal sonography beginning at 16-18 weeks, and ending by 22 weeks. Based on our pilot data, approximately one- third of these women will either have or develop a cervix <25mm and be eligible for randomization to cerclage or no cerclage (control group). The proposed efficacy and sample size for this trial is based on many reports in the literature and particularly on two prospective observational studies of vaginal ultrasonographic data from the multicenter NICHD Maternal Fetal Medicine Units Network. The following specific aims will be addressed: 1. To determine if placement of a cervical cerclage reduces spontaneous birth prior to 35 weeks' gestation in women with a prior early spontaneous preterm birth and with a cervix <25mm in length, as determined by serial midtrimester vaginal sonographic evaluation. 2. To determine the safety of cervical cerclage placement at 16-22 weeks' gestation in the patient population described in Aim#1. 3. (Ancillary Aim) To measure vaginal pH and perform Gram stains of vaginal flora and to collect and store maternal serum and cervicovaginal fluid for later analysis of selected markers to predict preterm delivery in order to: A. correlate these markers with the success of failure of cerclage B. further define possible mechanisms of early spontaneous preterm birth.
Funding Period: 2002-05-16 - 2009-01-31
more information: NIH RePORT

Top Publications

  1. doi Association between body mass index and pregnancy outcome in a randomized trial of cerclage for short cervix
    C K Farinelli
    Department of Obstetrics and Gynecology, University of California, Irvine, CA 92869, USA
    Ultrasound Obstet Gynecol 40:669-73. 2012
  2. doi Suture type and ultrasound-indicated cerclage efficacy
    Vincenzo Berghella
    Division of Maternal Fetal Medicine, Department of Obstetrics and Gynecology, Thomas Jefferson University, Philadelphia, PA 19107, USA
    J Matern Fetal Neonatal Med 25:2287-90. 2012
  3. pmc Midtrimester bacterial vaginosis and cervical length in women at risk for preterm birth
    Melissa S Mancuso
    Division of Maternal Fetal Medicine, Department of Obstetrics and Gynecology, University of Alabama at Birmingham School of Medicine, Birmingham, AL, USA
    Am J Obstet Gynecol 204:342.e1-5. 2011
  4. doi Does midtrimester Nugent score or high vaginal pH predict gestational age at delivery in women at risk for recurrent preterm birth?
    Dana Figueroa
    Department of Obstetrics and Gynecology, University of Alabama at Birmingham, USA
    Am J Obstet Gynecol 204:46.e1-4. 2011
  5. pmc Cervical funneling: effect on gestational length and ultrasound-indicated cerclage in high-risk women
    Melissa S Mancuso
    Division of Maternal Fetal Medicine, Department of Obstetrics and Gynecology, University of Alabama, Birmingham, AL, USA
    Am J Obstet Gynecol 203:259.e1-5. 2010
  6. pmc Does midtrimester cervical length ≥25 mm predict preterm birth in high-risk women?
    John Owen
    Division of Maternal Fetal Medicine, Department of Obstetrics and Gynecology, University of Alabama, Birmingham, AL, USA
    Am J Obstet Gynecol 203:393.e1-5. 2010
  7. pmc Gestational age at previous preterm birth does not affect cerclage efficacy
    Deborah A Wing
    Department of Obstetrics and Gynecology, University of California, Irvine, Irvine, CA, USA
    Am J Obstet Gynecol 203:377.e1-4. 2010
  8. pmc 17-alpha-hydroxyprogesterone caproate for the prevention of preterm birth in women with prior preterm birth and a short cervical length
    Vincenzo Berghella
    Division of Maternal Fetal Medicine, Department of Obstetrics and Gynecology, Jefferson Medical College, Thomas Jefferson University, Philadelphia, PA, USA
    Am J Obstet Gynecol 202:351.e1-6. 2010
  9. pmc Prevention of preterm birth based on a short cervix: cerclage
    Melissa S Mancuso
    Department of Obstetrics and Gynecology, University of Alabama at Birmingham, Birmingham, AL 35249, USA
    Semin Perinatol 33:325-33. 2009
  10. pmc Multicenter randomized trial of cerclage for preterm birth prevention in high-risk women with shortened midtrimester cervical length
    John Owen
    Department of Obstetrics and Gynecology, University of Alabama at Birmingham, Birmingham, AL 35249 7333, USA
    Am J Obstet Gynecol 201:375.e1-8. 2009

Scientific Experts

  • Tsivgoulis Georgios
  • John Owen
  • Vincenzo Berghella
  • Jeff M Szychowski
  • Melissa S Mancuso
  • Edwin R Guzman
  • Deborah A Wing
  • Jay D Iams
  • Jeanne S Sheffield
  • Annette Perez-Delboy
  • Gary Hankins
  • Richard Silver
  • Mark Tomlinson
  • Dana Figueroa
  • J M Szychowski
  • Eric Knudtson
  • Mike Gordon
  • Helen How
  • Robert Egerman
  • Susan Ramin
  • John C Hauth
  • C K Farinelli
  • Merri Maddox Paden
  • G Hankins
  • V Berghella
  • A Perez-Delboy
  • D A Wing
  • J Owen
  • E R Guzman
  • Susan M Ramin
  • Helen Y How
  • Robert S Egerman
  • Michael Gordon
  • Suzanne Cliver
  • Eric J Knudtson
  • G Tsivgoulis
  • J D Iams
  • J S Sheffield
  • Gary D V Hankins
  • Debora A Wing
  • Jeff Szychowski
  • C S Moy
  • V G Wadley
  • B Kissela
  • J Iams
  • A V Alexandrov
  • F W Unverzagt
  • R C P Go
  • J Sheffield
  • G Howard

Detail Information

Publications12

  1. doi Association between body mass index and pregnancy outcome in a randomized trial of cerclage for short cervix
    C K Farinelli
    Department of Obstetrics and Gynecology, University of California, Irvine, CA 92869, USA
    Ultrasound Obstet Gynecol 40:669-73. 2012
    ..To evaluate whether increasing body mass index (BMI) alters the efficacy of ultrasound-directed cerclage in women with a history of preterm birth...
  2. doi Suture type and ultrasound-indicated cerclage efficacy
    Vincenzo Berghella
    Division of Maternal Fetal Medicine, Department of Obstetrics and Gynecology, Thomas Jefferson University, Philadelphia, PA 19107, USA
    J Matern Fetal Neonatal Med 25:2287-90. 2012
    ..To assess whether type of suture material affects cerclage efficacy for preterm birth (PTB) prevention...
  3. pmc Midtrimester bacterial vaginosis and cervical length in women at risk for preterm birth
    Melissa S Mancuso
    Division of Maternal Fetal Medicine, Department of Obstetrics and Gynecology, University of Alabama at Birmingham School of Medicine, Birmingham, AL, USA
    Am J Obstet Gynecol 204:342.e1-5. 2011
    ..The purpose of this study was to estimate the effect of bacterial vaginosis on midtrimester cervical length in women at increased risk for recurrent spontaneous preterm birth...
  4. doi Does midtrimester Nugent score or high vaginal pH predict gestational age at delivery in women at risk for recurrent preterm birth?
    Dana Figueroa
    Department of Obstetrics and Gynecology, University of Alabama at Birmingham, USA
    Am J Obstet Gynecol 204:46.e1-4. 2011
    ..To estimate whether bacterial vaginosis, as defined by either Nugent score or vaginal pH, predicts gestational age at delivery in women at risk for recurrent preterm birth...
  5. pmc Cervical funneling: effect on gestational length and ultrasound-indicated cerclage in high-risk women
    Melissa S Mancuso
    Division of Maternal Fetal Medicine, Department of Obstetrics and Gynecology, University of Alabama, Birmingham, AL, USA
    Am J Obstet Gynecol 203:259.e1-5. 2010
    ..The purpose of this study was to assess funnel type and pregnancy duration in women with previous spontaneous preterm birth and cervical length <25 mm...
  6. pmc Does midtrimester cervical length ≥25 mm predict preterm birth in high-risk women?
    John Owen
    Division of Maternal Fetal Medicine, Department of Obstetrics and Gynecology, University of Alabama, Birmingham, AL, USA
    Am J Obstet Gynecol 203:393.e1-5. 2010
    ..We sought to assess pregnancy outcome along a continuum of cervical lengths (CLs) ≥25 mm...
  7. pmc Gestational age at previous preterm birth does not affect cerclage efficacy
    Deborah A Wing
    Department of Obstetrics and Gynecology, University of California, Irvine, Irvine, CA, USA
    Am J Obstet Gynecol 203:377.e1-4. 2010
    ..The purpose of this study was to evaluate the effect of earliest previous spontaneous preterm birth (SPTB) gestational age on cervical length, pregnancy duration, and ultrasound-indicated cerclage efficacy in a subsequent gestation...
  8. pmc 17-alpha-hydroxyprogesterone caproate for the prevention of preterm birth in women with prior preterm birth and a short cervical length
    Vincenzo Berghella
    Division of Maternal Fetal Medicine, Department of Obstetrics and Gynecology, Jefferson Medical College, Thomas Jefferson University, Philadelphia, PA, USA
    Am J Obstet Gynecol 202:351.e1-6. 2010
    ..We sought to evaluate 17-alpha-hydroxyprogesterone caproate (17P) for prevention of preterm birth (PTB) in women with prior spontaneous PTB (SPTB) and cervical length (CL) <25 mm...
  9. pmc Prevention of preterm birth based on a short cervix: cerclage
    Melissa S Mancuso
    Department of Obstetrics and Gynecology, University of Alabama at Birmingham, Birmingham, AL 35249, USA
    Semin Perinatol 33:325-33. 2009
    ..Cerclage may effectively reduce preterm birth in carefully selected women who have experienced a prior early preterm birth and who have shortened mid-trimester cervical length...
  10. pmc Multicenter randomized trial of cerclage for preterm birth prevention in high-risk women with shortened midtrimester cervical length
    John Owen
    Department of Obstetrics and Gynecology, University of Alabama at Birmingham, Birmingham, AL 35249 7333, USA
    Am J Obstet Gynecol 201:375.e1-8. 2009
    ..The objective of the study was to assess cerclage to prevent recurrent preterm birth in women with short cervix...
  11. pmc Association of higher diastolic blood pressure levels with cognitive impairment
    G Tsivgoulis
    Comprehensive Stroke Center, University of Alabama at Birmingham, RWUH M226, 1530 3rd Avenue S, Birmingham, AL 35294 3280, USA
    Neurology 73:589-95. 2009
    ..We evaluated the cross-sectional relationship of blood pressure (BP) components with cognitive impairment after adjusting for potential confounders...
  12. pmc Timing of mid-trimester cervical length shortening in high-risk women
    J M Szychowski
    University of Alabama at Birmingham, Department of Biostatistics, Birmingham, Alabama 35249 7333, USA
    Ultrasound Obstet Gynecol 33:70-5. 2009
    ..To examine the natural history of cervical length shortening in women who had experienced at least one prior spontaneous preterm birth at between 17+0 and 33+6 weeks' gestation...