loading page

CERVICAL PESSARY PLUS VAGINAL PROGESTERONE IN A SINGLETON PREGNANCY WITH A SHORT CERVIX: AN ANALYSIS OF EFFICACY BASED ON THE LEARNING CURVE AND CUMULATIVE SUM ANALYSIS (LC-CUSUM) IN A QUASI-RANDOMIZED CLINICAL TRIAL
  • +7
  • Marcelo Franca,
  • Alan Hatanaka,
  • Jader Cruz,
  • Valter Andrade Jr.,
  • Tatiana Hamamoto,
  • Stephanno Sarmento,
  • Julio Elito Jr.,
  • David Pares,
  • Rosiane Mattar,
  • Antonio Moron
Marcelo Franca
Federal University of Sao Paulo
Author Profile
Alan Hatanaka
Federal University of Sao Paulo
Author Profile
Jader Cruz
Centro Hospitalar de Lisboa Central EPE
Author Profile
Valter Andrade Jr.
Impacta Certification Training
Author Profile
Tatiana Hamamoto
Federal University of Sao Paulo
Author Profile
Stephanno Sarmento
Faculdade de Medicina de Jundiai
Author Profile
Julio Elito Jr.
Federal University of Sao Paulo
Author Profile
David Pares
Federal University of Sao Paulo
Author Profile
Rosiane Mattar
Federal University of Sao Paulo
Author Profile
Antonio Moron
Federal University of Sao Paulo
Author Profile

Abstract

Objective This study aims to determine the performance of cervical pessary in singleton pregnancies with a short cervix based on the learning curve. Design, Settings, Population, and Methods Between 2011 and 2018, 128 singleton gestation between 18th to 24th weeks with a short cervix (<25mm) were referred to our quasi-randomized trial. All cases were treated with progesterone, and, when available, cervical pessary was also offered. Three groups were created for statistical analysis: Group 1 (n=33), treated with progesterone-only; Group 2 and Group 3, treated with cervical pessary plus progesterone. Group 2, included the first cases (n=30), defined by the learning curve and cumulative sum analysis (LC-CUSUM), while Group 3, included the subsequent (n=65). Our outcome was delivery before 34 weeks. Main outcome measures and Results LC-CUSUM demonstrated that 30 patients achieved learning. The preterm birth rate before 34 weeks was 27.3% in Group 1, 20% in Group 2, and 4.6% in Group 3. There was no significant difference in the Group 1/Group 2 comparison (OR 1.10, P=0.945); the Group 1/Group 3 comparison, the difference was significant (OR 0.08, P=0.003). Conclusion LC-CUSUM determined 30 pessaries to achieve the best pessary performance. Cervical pessary plus progesterone can reduce the preterm birth before 34 weeks in patients with a short cervix. Funding This study was financed in part by the Coordenação de Aperfeiçoamento de Pessoal de Nível Superior - Brazil (CAPES) - Finance Code 001 Keywords Preterm birth; learning curve; cervical pessary; vaginal progesterone; singleton pregnancy; short cervix; transvaginal ultrasound.