Pessary plus progesterone to prevent preterm birth in women with short cervixes. A randomized controlled trial
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2022-01-01
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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 (progesteroneonly
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] [P5.002]), and vaginal bleeding (9.7%
[46/476] vs 4.8% [22/479] [P5.004]).
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.
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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):p.41-51. doi: 10.1097/AOG.0000000000004634. PMID: 34856583.