Efficacy of Combined Cervical Pessary and Progesterone in Women at High-Risk of Preterm Birth.

Objective: This study assessed the efficacy of the cervical pessary combined with progesterone to prevent preterm birth in pregnant women with short cervix and previous preterm birth. Methods: This post hoc analysis of the randomized, multicenter P5 trial examined the efficacy of the cervical pessary associated with vaginal progesterone versus progesterone alone for preventing recurrent preterm birth in 155 pregnant women with cervical length ≤30 mm and prior spontaneous preterm birth (sPPTB) (main subgroup), and in 85 women with cervical length ≤25 mm and sPPTB (higher-risk population). The primary outcome was spontaneous preterm birth (sPTB) before 34 weeks; secondary outcomes included sPTB rates before 37, 32, and 28 weeks, analyzed using Odds Ratio (OR) and Kaplan-Meier curves. A secondary objective was to identify predictive factors for sPTB recurrence in the cohort with prior preterm birth (n = 479), irrespective of treatment allocation. Results: Demographic profiles were balanced between groups. The addition of a cervical pessary to progesterone did not result in a significant reduction in sPTB before 34 weeks: to cervix ≤30 mm, OR 1.169 (95% CI 0.524-2.609; p = 0.703) and 1.167 (95% CI 0.466-2.921; p = 0.742) for ≤25 mm; similar null findings were observed across all gestational age thresholds. Kaplan-Meier survival curves demonstrated no significant differences between groups (p > 0.05). Secondary analysis (n = 479) identified principal predictors of sPTB recurrence, regardless of the cervical length: higher education (OR 2.37; 95% CI 0.99-5.63; p = 0.024), previous cervical conization (OR 4.78; 95% CI 1.08-21.19; p = 0.039) previous low birth weight < 2.5 kg (OR 2.43; 95% CI 1.22-4.85; p = 0.051), prior miscarriages (OR 1.36; 95% CI 1.10-1.69; p = 0.005), current twin pregnancy (OR 14.86; 95% CI 4.35-50.68; p < 0.001) and cervical funneling (OR 3.60; 95% CI 1.79-7.24; p < 0.001). Predictive models achieved an AUC of 0.719, with 87.0% sensitivity and 58.8% specificity. Conclusions: These findings do not support the routine use of cervical pessary combined with progesterone in women with dual risk factors. In this Brazilian population, specific clinical and obstetric characteristics-including higher education, cervical funneling, prior low birth weight delivery, previous conization, current twin gestation, and prior miscarriage-could identify women at increased risk for recurrent preterm birth.