Surgical Procedure to Prevent Premature Birth

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2003 by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00059683
First received: May 1, 2003
Last updated: June 28, 2007
Last verified: April 2003

May 1, 2003
June 28, 2007
January 2003
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Complete list of historical versions of study NCT00059683 on ClinicalTrials.gov Archive Site
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Surgical Procedure to Prevent Premature Birth
Vaginal Ultrasound Cerclage Trial

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.

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.

Interventional
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Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Labor, Premature
Procedure: cervical cerclage
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
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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
Female
16 Years and older
No
United States
 
NCT00059683
U01HD39939-01A1
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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Principal Investigator: John Owen, MD University of Alabama at Birmingham
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
April 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP