Preventing Preterm Birth With a Pessary

Preventing Preterm Birth With a Pessary

The primary objective of this study, is to determine the effect of a Cup pessary, a device that is currently readily available in the USA and similar in design to the Arabin pessary, on the incidence of delivery prior to 37 weeks in women with a history of prior spontaneous birth (before 37 weeks) and incidentally found to have a cervix less than 25 mm in length prior to 23 weeks.

Inclusion Criteria:

• Singleton pregnancies in patients with a history of spontaneous preterm birth (previous delivery between 17 0/7 weeks and 36 6/7 weeks).
• Women ages 18 to 45 years of age

Exclusion Criteria:

• Major fetal abnormalities (defined as those that are lethal or require prenatal or postnatal surgery), fetal death, or fetal growth restriction diagnosed before randomization.
• Presence of prophylactic cervical cerclage
• Significant maternal-fetal complications (treated chronic hypertension, insulin dependant diabetes mellitus, red cell isoimmunization)
• Painful regular uterine contractions, or ruptured membranes
• Visual cervical dilation of 2cm or greater and visible membranes.
• Patients with a pregnancy dated by an ultrasound after 20 weeks gestation.