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Ultrasound-indicated Cerclage to Prevent Premature Birth in High-risk Women

This study has been completed.
University of Alabama at Birmingham
Information provided by (Responsible Party):
John Owen, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Identifier:
First received: May 1, 2003
Last updated: September 29, 2014
Last verified: September 2014
Pregnant women who have a shortened cervix and have previously had a premature baby are at increased risk for having another premature baby. This study will determine whether reinforcing the cervix with a surgical stitch can reduce the chance of a premature birth.

Condition Intervention
Labor, Premature
Procedure: cervical cerclage

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Vaginal Ultrasound Cerclage Trial

Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:
  • Incidence of preterm birth less than 35 weeks' gestation [ Time Frame: Birth ]

Secondary Outcome Measures:
  • Gestational age at birth [ Time Frame: birth ]

Estimated Enrollment: 300
Study Start Date: January 2003
Study Completion Date: October 2009
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cervical Cerclage Group
Women randomized to receive cerclage should receive cervical cerclage
Procedure: cervical cerclage
Cerclage is a circumferential stitch of non-absorbable suture placed around the cervix
No Intervention: Control Group
Women randomized to not receive cerclage represent the control arm

Detailed Description:

Women with a prior early spontaneous preterm birth and a shortened mid-trimester cervical length (less than 25 mm) are at very high risk for having another premature baby. 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. The study will evaluate women at significant risk for recurrent spontaneous preterm birth (those with a prior spontaneous birth at 17 to 32 weeks' gestation) and who have an increased risk based on mid-trimester ultrasound findings of a cervical length less than 25 mm.

The trial will have an observational portion and an interventional portion. In the observational portion, 1,000 women with a history of a spontaneous preterm birth at 17 to 32 weeks' gestation will undergo biweekly vaginal ultrasounds beginning at 16 to 18 weeks' gestation and ending by 22 weeks. Prior research indicates that one third of these women will either have or develop a cervix less than 25 mm long. Women will be seen at a frequency determined by the cervical length (as determined by ultrasound examination starting at 16 weeks' gestation). If cervical length remains greater than 30 mm, the next visits will occur in 2 week intervals until 22.6 weeks' gestation. If the cervical length is 25 mm to 29 mm, the visits will be scheduled weekly. If the cervical length shortens to less than 25 mm, the woman is eligible for randomization, and will undergo one more study visit.

In the interventional portion of the trial, women will be randomized to either cerclage or no cerclage (control group). Randomized women will have weekly contact with a nurse either by phone or in person, whichever is convenient for the woman, until delivery occurs. The woman is followed during the course of her pregnancy and delivery of her infant. Her infant is followed until discharge from the hospital.


Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria

  • Pregnant with a singleton gestation
  • History of at least 1 prior spontaneous preterm birth at or before 32 weeks' gestation

Exclusion Criteria

  • Cervical cerclage planned for this pregnancy
  • Clinical history of cervical incompetence
  • Untreated C. trachomatis or N. gonorrhoeae infection or symptomatic vaginitis
  • Unable to obtain mid-trimester ultrasound to confirm no major fetal anomaly (i.e., aneuploidy, major organ system defect) or fetal demise prior to enrollment
  • Multiple gestation
  • Prolapsed or ruptured membranes noted on initial speculum examination
  • Cervical os dilation > 2 cm noted on initial speculum examination
  • Oligohydramnios
  • Complete placenta previa
  • Chronic hypertension or vascular disease requiring therapy
  • Maternal red cell alloimmunization
  • Insulin dependent diabetes
  • Significant renal or cardiopulmonary disease
  • Delivery or prenatal care outside clinical center
  • Enrolled in this study in a previous pregnancy
  • Participation in a randomized trial with interventions or endpoints in conflict with the cerclage randomized trial
  Contacts and Locations
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Please refer to this study by its identifier: NCT00059683

United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35249
Sponsors and Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of Alabama at Birmingham
Principal Investigator: John Owen, MD University of Alabama at Birmingham
  More Information

Responsible Party: John Owen, Professor Ob/Gyn-Maternal Fetal medicine, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Identifier: NCT00059683     History of Changes
Other Study ID Numbers: U01HD039939-01A1 ( US NIH Grant/Contract Award Number )
Study First Received: May 1, 2003
Last Updated: September 29, 2014

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
Preterm Birth
Premature Birth
Cervical cerclage
Vaginal ultrasound
Cervical length

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications processed this record on May 24, 2017