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Grand Rounds

Cervical Pessary or Vaginal Progesterone for Preterm Birth Prevention?

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BACKGROUND AND PURPOSE: 

  • Cruz-Melguizo et al. (Obstetrics & Gynecology, 2018) compared the effectiveness of a cervical pessary and vaginal progesterone for preterm birth prevention

METHODS: 

  • Multicenter, open-label, randomized, noninferiority trial (RCT)  
  • Participants 
    • Singleton pregnancies  
    • Cervical length ≤25 mm  
      • transvaginal ultrasonography at 19-22 weeks  
  • Subjects were randomized to receive either 
    • Cervical pessary placement  
    • Vaginal progesterone  
      • 200 mg micronized progesterone per day  
      • Vaginal route 
      • Self-administered, preferably before going to bed 
  • Treatments  
    • Initiated between 20w1d and 23w6d 
    • Stopped between 37w0d and 37w4d 
  • Primary outcome: Proportion of spontaneous preterm delivery <34 weeks  
  • Secondary outcomes  
    • Proportion of spontaneous preterm births <37 and <28 weeks | Rate of PROM <34 and <37 weeks | Need of tocolysis and corticosteroid | Vaginal side effects | Maternal outcomes such as rate of chorioamnionitis etc.| Newborn outcomes such as birthweight and adverse events (e.g., perinatal death etc.)  
  • Sample size: 254 women were required to show noninferiority of the pessary to progesterone 
    • Noninferiority margin of 4% with a 0.025 one-sided α level (i.e., if the 95% CI upper bound exceeds 4%, the pessary could not be deemed noninferior) 
    • Statistical power of 80% 
    • Assumed dropout rate of 5%

RESULTS: 

  • 254 patients were enrolled and 246 included in the intention-to-treat analysis 
  • The rate of spontaneous delivery before 34 weeks of gestation was 
    • 14% (n=18/127) in the pessary group 
    • 14% (n=17/119) in the progesterone group 
    • Risk difference: −0.11% (95% CI −8.85% to 8.62%; P=.99) 
    • Noninferiority was not shown for the pessary 
  • Adverse events were higher in the pessary group compared to progesterone  
    • Incidence of increased vaginal discharge: 87% vs 71% (P=.002) 
    • Discomfort: 27% vs 3% (P<.001)

CONCLUSION: 

  • Cervical pessary was not noninferior to vaginal progesterone 
    • 95% CI of the difference exceeded the 4% prespecified non-inferiority margin of 4%  
  • Cervical pessary was associated with increased vaginal discharge and discomfort  
  • Authors recommend vaginal progesterone as the first line treatment as a “first option” but 

…the pessary could be considered a similar effective alternative and could be a preferred choice for women reluctant to use daily medication

Learn More – Primary Sources: 

Cervical Pessary Compared With Vaginal Progesterone for Preventing Early Preterm Birth: A Randomized Controlled Trial

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Related ObG Topics:

SMFM Statement: Choice of Progestogen for Preterm Birth Prevention
Short Cervix and Risk for Preterm Birth: Do Pessaries Work? 
Can Cervical Pessaries Prevent Preterm Birth?
PoPPS Study: Does Pessary Use In Women with a Short Cervical Length Prevent Preterm Birth?

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