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

This study has been completed.
Sponsor:
Collaborator:
University of Alabama at Birmingham
Information provided by (Responsible Party):
John Owen, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00059683
First received: May 1, 2003
Last updated: September 29, 2014
Last verified: September 2014
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Vaginal Ultrasound Cerclage Trial

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Gestational age at birth [ Time Frame: birth ] [ Designated as safety issue: No ]

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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00059683

Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35249
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
Principal Investigator: John Owen, MD University of Alabama at Birmingham
  More Information

Publications:
Responsible Party: John Owen, Professor Ob/Gyn-Maternal Fetal medicine, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier: NCT00059683     History of Changes
Other Study ID Numbers: U01HD39939-01A1
Study First Received: May 1, 2003
Last Updated: September 29, 2014
Health Authority: United States: Federal Government

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:
Obstetric Labor, Premature
Premature Birth
Obstetric Labor Complications
Pregnancy Complications

ClinicalTrials.gov processed this record on October 20, 2014