1. There was no significant difference in the rate of spontaneous delivery before 34 weeks between women who received pessary placement vs expectant management.
2. There were no significant between-group differences in the incidence of perinatal death, adverse neonatal events, or neonatal special care.
Evidence Rating Level: 2 (Good)
Study Rundown: Preterm birth is implicated in greater than seventy percent of neonatal and infant deaths and is a leading cause of disability among survivors. Transvaginal placement of a silicone pessary around the cervix has been thought to support the cervix and reduce the pressure from the uterine contents on the cervical canal, thereby acting as a prophylaxis against preterm birth.
In this open-label, randomized trial, girls and women with singleton pregnancies were randomized in a 1:1 ratio to receive pessary placement or expectant management. There was no difference in the rate of spontaneous delivery before 34 weeks could be demonstrated between women who received pessary placement vs expectant management. There were no significant between-group differences in the rates of perinatal death, adverse neonatal events, and neonatal special care.
This study draws strength from its detailed characterization of baseline between-group characteristics. However, it is limited by a much lower than anticipated recruitment and the open-label nature of the study possibly affecting medical decision making, such as removal of the pessary at different intervals when patients presented with contractions.
Click to read the study in NEJM
Relevant Reading: An overview of mortality and sequelae of preterm birth from infancy to adulthood
In-Depth [randomized controlled trial]: In this open-label, randomized trial, girls and women with singleton pregnancies were randomized in a 1:1 ratio to receive pessary placement or expectant management. The primary outcome was spontaneous delivery before 34 weeks of gestation. Secondary outcomes were birth weight, adverse neonatal events before discharge (intraventricular hemorrhage, respiratory distress syndrome, retinopathy of prematurity, or necrotizing enterocolitis), neonatal special care (NICU admission, mechanical ventilation, phototherapy, treatment for proven or suspected sepsis, or blood transfusion), and major maternal complications attributable to the pessary (death, serious cervical or vaginal trauma, or chorioamnionitis).
Spontaneous delivery before 34 weeks of gestation occurred in 55 of the 460 pessary group patients (12.0%) and 50 of the 464 control group patients (10.8%) (OR=1.12; 95% [CI], 0.75 to 1.69; p=0.57). The percentage of participants who did not give birth spontaneously before 34 weeks demonstrated no significant between-group difference (95% [CI], 0.77 to 1.65; p=0.54). There was no significant difference in mean birth weight (p=0.84), perinatal death (p=0.40), composite adverse neonatal events (p=0.55), or neonatal special care (p=0.43).
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