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

Detail Information

Publications3

  1. ncbi 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...
  2. ncbi 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...
  3. ncbi 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...