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

Completed · Not applicable

Conditions studied: Labor, Premature

In brief

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.

Key facts

Study ID

NCT00059683

Run by

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

People needed

300

Starts

2003-01-01

Expected to finish

2009-10-01

Last updated by the study team

2014-09-30

Who can join

Age: 16 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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