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

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.

Study Overview

• Status: Completed
• Conditions: Labor, Premature
• Intervention / Treatment: Procedure: cervical cerclage

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.

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35249
      • University of Alabama at Birmingham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of preterm birth less than 35 weeks' gestation	Birth

Secondary Outcome Measures

Outcome Measure	Time Frame
Gestational age at birth	birth

Collaborators and Investigators

• Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Collaborators: University of Alabama at Birmingham
• Investigators: Principal Investigator: John Owen, MD, University of Alabama at Birmingham

Publications and helpful links

General Publications

• Owen J, Hankins G, Iams JD, Berghella V, Sheffield JS, Perez-Delboy A, Egerman RS, Wing DA, Tomlinson M, Silver R, Ramin SM, Guzman ER, Gordon M, How HY, Knudtson EJ, Szychowski JM, Cliver S, Hauth JC. Multicenter randomized trial of cerclage for preterm birth prevention in high-risk women with shortened midtrimester cervical length. Am J Obstet Gynecol. 2009 Oct;201(4):375.e1-8. doi: 10.1016/j.ajog.2009.08.015.

Study record dates

Study Major Dates

• Study Start: January 1, 2003
• Primary Completion (ACTUAL): November 1, 2007
• Study Completion (ACTUAL): October 1, 2009

Study Registration Dates

• First Submitted: May 1, 2003
• First Submitted That Met QC Criteria: May 2, 2003
• First Posted (ESTIMATE): May 5, 2003

Study Record Updates

• Last Update Posted (ESTIMATE): September 30, 2014
• Last Update Submitted That Met QC Criteria: September 29, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Keywords: Premature Birth; Preterm Birth; Cervical length; Cervical cerclage; Vaginal ultrasound
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Premature Birth; Obstetric Labor, Premature
• Other Study ID Numbers: U01HD039939-01A1 (NIH)