Pessary with progesterone fails to improve survival in women with short cervix

Brazil: A new study shows that, when compared to progesterone alone, the combination of pessary and progesterone did not reduce rates of newborn mortality or morbidity in asymptomatic women with short cervixes. The findings of this study were published in the journal Obstetricians and Gynecologists.

Rodolfo C. Pacagnella performed this study with the goal of testing the efficiency of cervical pessary along with the vaginal progesterone for the prevention of preterm delivery in women with mid-pregnancy short cervixes.

This was a multicenter, open-label, randomized controlled experiment that took place at 17 perinatal facilities. Asymptomatic women with singleton or twin pregnancies with cervical lengths of 30 mm or fewer were randomized to either cervical pessary plus vaginal progesterone (pessary plus progesterone group) or vaginal progesterone only (progesterone-only group) (200 mg/day). From the time of randomization until 36 weeks of gestation or delivery, the treatments were employed. The main result was a combination of newborn death and morbidity. Delivery before 37 weeks and before 34 weeks of gestation were secondary outcomes. The analysis was carried out with the purpose of treatment in mind.

The results of this study were stated as follow:

1. In between July 9, 2015, and March 29, 2019, 8,168 women were screened, with 475 assigned to pessary treatment and 461 to progesterone alone.

2. The composite perinatal outcome occurred in 19.2% (89/463) of the women in the pessary group vs 20.9% (91/436) of the women in the progesterone-only group (aRR 0.88).

3. Before 37 weeks of gestation, delivery rates were 29.1% compared to 31.4% (aRR 0.86); before 34 weeks, delivery rates were 9.9% compared to 13.9% (aRR 0.66).

4. Women in the pessary group reported higher rates of vaginal discharge (51.6% [245/476] vs 25.4% [117/479]), discomfort (33.1% [157/476] vs 24.1% [111/479]), and vaginal bleeding (9.7% [46/476] vs 4.8% [22/479]).

In conclusion, adding cervical pessary to vaginal progesterone medication did not lower a composite of newborn morbidity or death among pregnant women with short cervixes, although it did appear to prevent some preterm deliveries. Additional research should be conducted to obtain even more exact results.

Reference:

Pacagnella RC, Silva TV, Cecatti JG, Passini R Jr, Fanton TF, Borovac-Pinheiro A, Pereira CM, Fernandes KG, França MS, Li W, Mol BW; P5 Working Group. Pessary Plus Progesterone to Prevent Preterm Birth in Women With Short Cervixes: A Randomized Controlled Trial. Obstet Gynecol. 2022 Jan 1;139(1):41-51. doi:10.1097/AOG.0000000000004634. PMID: 34856583.