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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00059683
Recruitment Status : Completed
First Posted : May 5, 2003
Last Update Posted : September 30, 2014
University of Alabama at Birmingham
Information provided by (Responsible Party):
John Owen, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Brief Summary:
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 or disease Intervention/treatment Phase
Labor, Premature Procedure: cervical cerclage Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Vaginal Ultrasound Cerclage Trial
Study Start Date : January 2003
Actual Primary Completion Date : November 2007
Actual Study Completion Date : October 2009

Arm Intervention/treatment
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

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00059683

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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
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Principal Investigator: John Owen, MD University of Alabama at Birmingham
Publications of Results:
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Responsible Party: John Owen, Professor Ob/Gyn-Maternal Fetal medicine, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Identifier: NCT00059683    
Other Study ID Numbers: U01HD039939-01A1 ( U.S. NIH Grant/Contract )
First Posted: May 5, 2003    Key Record Dates
Last Update Posted: September 30, 2014
Last Verified: September 2014
Keywords provided by John Owen, 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:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications