Cervical pessary plus vaginal progesterone versus long‐term tocolysis for the prevention of preterm birth: An observational retrospective study

Abstract

Objective To compare cervical pessaries plus vaginal progesterone versus long‐term tocolysis for preventing preterm birth for women with a short cervix. Methods Retrospective evaluation of women with singleton pregnancy who received cervical pessaries plus vaginal progesterone (combined group) or ritodrine hydrochloride (tocolysis group) for short cervix (≤25 mm at 20–24 weeks, or ≤20 mm at 25–34 weeks) at a general hospital in Kagoshima, Japan, 2015–2019. The primary outcome was rate of preterm birth (<36 weeks); secondary outcomes were maternal hospital admittance and treatment complications. Results Data were evaluated from 95 women (combined group, n=43; tocolysis group, n=52). There was no significant difference in cervical length or gestational age at intervention between the groups. Overall, 3/43 (7.0%) women delivered before 36 weeks in the combined group versus 16/52 (30.8%) in the tocolysis group (relative risk, 0.56; 95% confidence interval, 0.41–0.76; P=0.004). Median maternal admittance was shorter in the combined group (6.6 vs 41.0 days, P<0.001). Although 36/43 (83.7%) women in the combined group reported increased vaginal discharge, no major complications occurred. Conclusion A combination of pessaries and vaginal progesterone reduced the rate of preterm birth (<36 weeks) for women with short cervix as compared with long‐term tocolysis.

Prevention of Preterm Birth by Cervical Pessary Combined with Vaginal Progesterone: a Systematic Review and Meta-analysis with Trial Sequential Analysis

“…Of 16 studies, 12 studies [ 8 , 10 – 12 , 18 – 22 , 25 – 27 ] involved women with a singleton pregnancy and the other four [ 9 , 17 , 24 , 27 ] included women with multiple pregnancies. Five RCT [ 10 – 12 , 19 , 25 ] and four non-RCT [ 18 , 21 , 26 , 27 ] singleton studies included a control group receiving treatment with vaginal progesterone alone; two non-RCT singleton studies compared with a group receiving the combination of cervical cerclage and vaginal progesterone [ 18 , 20 ]; only one non-RCT singleton study used the group receiving vaginal progesterone + cervical cerclage + cervical pessary [ 18 ], tocolysis (ritodrine hydrochloride and magnesium sulfate) [ 22 ] or cervical pessary alone [ 8 ] as the control, respectively. Two non-RCT [ 9 , 23 ] multiple pregnancy studies included a control group receiving vaginal progesterone alone treatment; only one non-RCT multiple pregnancy used the group receiving conservative treatment [ 24 ] or no treatment [ 17 ] as the control, respectively.…”

“…Thus, ten studies with patients in singleton gestations [ 10 – 12 , 18 – 21 , 25 – 27 ] and two studies [ 9 , 23 ] with patients in multiple gestations were used for meta-analysis. The RR (or SMD) with 95% CI was calculated for other studies that could not be synthesized with others due to different controls [ 8 , 17 , 22 , 24 ] to serve as a literature systematic review.…”

“…Tajima et al compared the effects of cervical pessary + vaginal progesterone with ritodrine hydrochloride and magnesium sulfate-based tocolysis [ 22 ]. The results showed cervical pessary + vaginal progesterone may be more effective in preventing PTB < 37 weeks of gestation (RR = 0.23, 95% CI: 0.07–0.74, p = 0.01) and composite adverse neonatal outcomes (RR = 0.11, 95% CI: 0.03–0.45, p = 0.002), increasing GA at delivery (SMD = 0.61, 95% CI: 0.20–1.03, p = 0.004) and birth weight (SMD = 0.64, 95% CI: 0.23–1.05, p = 0.002) (Table 3 ).…”

“…According to the TSA results, the RIS was not reached for all our therapeutic outcomes in meta-analysis. Only one study was included to explore the therapeutic difference of cervical pessary plus vaginal progesterone compared with pessary alone [ 8 ], tocolysis [ 22 ], conservative [ 24 ], or no treatment [ 17 ], leading to meta-analysis inexecutable and only a preliminary systematic review for them. If the sample size was larger, the conclusions of these systematic review articles may be different and should be cautiously interpreted.…”

Pessary Plus Progesterone to Prevent Preterm Birth in Women With Short Cervixes

“…Some cohort studies have demonstrated possible benefits from this combination of pessary and progesterone. 12,[26][27][28] Few RCTs, however, included information of the use of progesterone in the pessary group, as was done in the earlier studies. 10,14,24 Our RCT has several strengths.…”