Vaginal progesterone combined with cervical pessary – a chance for pregnancies at risk for preterm birth?

Objective: We sought to compare patients treated with cervical pessary alone to patients treated with pessary plus vaginal progesterone.

Study design: This is a pre- and post- intervention cohort study from a Preterm Labor Clinic where placement of a cervical pessary has been the standard treatment since 2008 for women at risk. From July 2011 onwards, vaginal progesterone (200 mg, suppositories) was prescribed in addition to the pessary whereby at risk patients (n = 55) and screening patients (n = 51) were treated at the time of diagnosis.

Results: Delivery < 34 weeks occurred in 17/53 patients (32.1%) treated with pessary plus progesterone compared to 13/53 patients (24.5%) with pessary alone (p = 0.57). Similarly, there was no difference in the rate of preterm delivery < 28, < 32 or < 37 weeks. The composite poor neonatal outcome was 15.1% in the pessary group versus 18.9% in the combined group (p = 0.96). The mean duration of stay in the neonatal intensive care unit was 46.5 (9 – 130) days in the combined versus 52.0 (3 – 151) days in the pessary group (p < 0.001).

Conclusions: Treatment with cervical pessary plus vaginal progesterone did not reduce the rates of preterm delivery and composite outcome compared to pessary alone. The neonatal intensive care utilization was shorter in patients who received additional vaginal progesterone. These findings are in accordance with the recent results of the OPPTIMUM trial, in which vaginal progesterone could not reduce preterm birth rates before 34 weeks or neonatal morbidity in opposite to previous studies.