A Trial of Pessary and Progesterone for Preterm Prevention in Twin Gestation With a Short Cervix

Inclusion Criteria

• Twin gestation with cardiac activity in both fetuses. Higher order multifetal gestations reduced to twins, either spontaneously or therapeutically, are not eligible unless the reduction occurred by 13 weeks 6 days project gestational age.
• Gestational age at randomization between 16 weeks 0 days and 23 weeks 6 days based on clinical information and evaluation of the earliest ultrasound.
• Cervical length on transvaginal examination of less than 30 mm by a study certified sonographer.

Exclusion Criteria

• Cervical dilation (internal os) 3 cm or greater on digital examination or evidence of prolapsed membranes beyond the external cervical os either at the time of the qualifying cervical ultrasound examination or at a cervical exam immediately before randomization. There is no lower threshold of cervical length measurement threshold on ultrasound that is an exclusion criterion.
• Monoamniotic gestation, due to increased risk of adverse pregnancy outcome
• Twin-twin transfusion syndrome, due to increased risk of adverse pregnancy outcome
• Evidence of severe IUGR (intrauterine growth restriction) ( 1.4 mg/dL, carcinoma of the breast, conditions treated with chronic oral glucocorticoid therapy. Specifically, patients with seizure disorders, HIV, and other medical conditions not specifically associated with an increased risk of indicated preterm birth are not excluded. Prior cervical cone/LOOP/LEEP is not an exclusion criterion.
• Planned cerclage or cerclage already in place since it would preclude placement of a pessary
• Planned indicated delivery prior to 35 weeks
• Planned or actual progesterone treatment of any type or form after 15 weeks 6 days during the current pregnancy
• Allergy to progesterone, silicone, or excipients in the study drug, including peanuts or peanut oil in the study drug or placebo
• Known, suspected or history of breast cancer because breast cancer is a contraindication to the active study medication.
• Known liver dysfunction or disease because liver disease is a contraindication to the active study medication.
• Participation in another interventional study that influences gestational age at delivery or neonatal morbidity or mortality
• Participation in this trial in a previous pregnancy. Patients who were screened in a previous pregnancy, but not randomized, do not have to be excluded.
• Prenatal care or delivery planned elsewhere unless the study visits can be made as scheduled and complete outcome information can be obtained