Pessary Plus Progesterone to Prevent Preterm Birth in Women With Short Cervixes: A Randomized Controlled Trial.

OBJECTIVE: To test the effectiveness of cervical pessary in addition to vaginal progesterone for the prevention of preterm birth in women with midpregnancy short cervixes. METHODS: We performed a multicenter, open-label, randomized controlled trial in 17 perinatal centers. Asymptomatic women with singleton or twin pregnancies and cervical lengths of 30 mm or less, measured at 18 0/7-22 6/7 weeks of gestation, were randomized to cervical pessary plus vaginal progesterone (pessary plus progesterone group) or vaginal progesterone only (progesterone-only group) (200 mg/day). Treatments were used from randomization to 36 weeks of gestation or delivery. The primary outcome was a composite of neonatal mortality and morbidity. Secondary outcomes were delivery before 37 weeks and before 34 weeks of gestation. Analysis was performed according to intention to treat. RESULTS: Between July 9, 2015, and March 29, 2019, 8,168 women were screened, of whom 475 were randomized to pessary and 461 to progesterone only. The composite perinatal outcome occurred in 19.2% (89/463) of the women in the pessary group compared with 20.9% (91/436) of the women in the progesterone-only group (adjusted risk ratio [aRR] 0.88, 95% CI 0.69-1.12). Delivery rates before 37 weeks of gestation were 29.1% compared with 31.4% (aRR 0.86, 95% CI 0.72-1.04); delivery rates before 34 weeks were 9.9% compared with 13.9% (aRR 0.66, 95% CI 0.47-0.93). Women in the pessary group had more vaginal discharge (51.6% [245/476] vs 25.4% [117/479] [P<.001]), pain (33.1% [157/476] vs 24.1% [111/479] [P=.002]), and vaginal bleeding (9.7% [46/476] vs 4.8% [22/479] [P=.004]). CONCLUSION: In asymptomatic women with short cervixes, the combination of pessary and progesterone did not decrease rates of neonatal morbidity or mortality when compared with progesterone only. CLINICAL TRIAL REGISTRATION: Brazilian Clinical Trial Registry (ReBec), UTN:U1111-1164-2636.

Cervical length distribution among Brazilian pregnant population and risk factors for short cervix: A multicenter cross-sectional study.

OBJECTIVE: Since there are populational differences and risk factors that influence the cervical length, the aim of the study was to construct a populational curve with measurements of the uterine cervix of pregnant women in the second trimester of pregnancy and to evaluate which variables were related to cervical length (CL) ≤25 mm. MATERIALS AND METHODS: This was a multicenter cross-sectional study performed at 17 hospitals in several regions of Brazil. From 2015 to 2019, transvaginal ultrasound scan was performed in women with singleton pregnancies at 18 0/7 to 22 6/7 weeks of gestation to measure the CL. We analyzed CL regarding its distribution and the risk factors for CL ≤25 mm using logistic regression. RESULTS: The percentage of CL ≤ 25mm was 6.67%. Shorter cervices, when measured using both straight and curve techniques, showed similar results: range 21.0-25.0 mm in straight versus 22.6-26.0 mm in curve measurement for the 5th percentile. However, the difference between the two techniques became more pronounced after the 75th percentile (range 41.0-42.0 mm straight x 43.6-45.0 mm in curve measurement). The risk factors identified for short cervix were low body mass index (BMI) (OR: 1.81 CI: 1.16-2.82), higher education (OR: 1.39 CI: 1.10-1.75) and personal history ([one prior miscarriage OR: 1.41 CI: 1.11-1.78 and ≥2 prior miscarriages OR: 1.67 CI: 1.24-2.25], preterm birth [OR: 1.70 CI: 1.12-2.59], previous low birth weight <2500 g [OR: 1.70 CI: 1.15-2.50], cervical surgery [OR: 4.33 CI: 2.58-7.27]). By contrast, obesity (OR: 0.64 CI: 0.51-0.82), living with a partner (OR: 0.76 CI: 0.61-0.95) and previous pregnancy (OR: 0.46 CI: 0.37-0.57) decreased the risk of short cervix. CONCLUSIONS: The CL distribution showed a relatively low percentage of cervix ≤25 mm. There may be populational differences in the CL distribution and this as well as the risk factors for short CL need to be considered when adopting a screening strategy for short cervix.