Surgical Procedure to Prevent 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.

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