Table 2.
Primary and secondary outcomes
| Primary | Composite of fetal death or preterm delivery before 32 wk gestation |
|---|---|
| Secondary fetal/neonatal | • Fetal death (at any time after randomization) • Neonatal death up to 28 d after estimated delivery date • Serious neonatal morbidity up to 28 d after estimated delivery date. This is defined by intraventricular hemorrhage grades 3 or 4, periventricular leukomalacia grades III or IV, chronic lung disease, retinopathy of prematurity requiring treatment, necrotizing enterocolitis (Bell Stage II or above), proven early sepsis <72 h, patent ductus arteriosus requiring treatment • Major fetal anomaly • Seizures requiring treatment • Gestational age at fetal death or delivery • Small for gestational age by World Health Organization standards (<5th and 10th percentiles) • Admission to special care nursery • Length of stay in hospital (total including other institutions if transferred) |
| Secondary maternal | • Reasons for removal of the pessary • Vaginal discharge • Vaginal bleeding • Type of labor (no labor, spontaneous, induced) • Maternal complications including genital infection, urinary infection, postpartum infection • Preterm premature rupture of membranes (pPROM) • Type of membrane rupture • Type of delivery, use of tocolysis, use of magnesium sulfate, use of corticosteroids • Maternal death up to 28 d after estimated delivery date • Maternal length of stay in hospital |