title: Combined treatment with cervical pessary and vaginal progesterone for the prevention of preterm birth: A randomized clinical trial.
abstract: OBJECTIVE
  We compared the effectiveness of a combined treatment involving cervical pessary plus vaginal progesterone to vaginal progesterone alone in decreasing the rate of preterm birth in women with short cervix in the second gestational trimester.
  
  
  METHODS
  This prospective, open-label, randomized clinical trial was conducted on 144 pregnant women with singleton pregnancy who had a cervical length ≤ 25 mm, at 18-22 gestational weeks (GW). Seventy-three patients were assigned to receive 400 mg of daily vaginal progesterone (group A), and 73 to receive cervical pessary plus 400 mg of daily vaginal progesterone (group B), until the 37th GW. The patients were then followed until delivery.
  
  
  RESULTS
  The rates of preterm birth were 16.4% in group A and 19.7% in group B, which were not statistically different (P = 0.6). There were no statistically significant differences in the rates of preterm birth at <37, <34, <32, and ≤26 GW between participants randomized to each group (P = 0.55). The rates of low-birthweight delivery were 17.8% in group A, and 23.9% in group B, which were not statistically different (P = 0.36). The rates of premature rupture of membranes, chorioamnionitis, the requirement for neonatal intensive care unit admission, and fetal and neonatal deaths were similar between the two groups.
  
  
  CONCLUSIONS
  In pregnancies with short cervix at mid-pregnancy, combination therapy of cervical pessary plus daily vaginal progesterone does not have any additional benefit over daily vaginal progesterone alone in reducing the rate of preterm birth and adverse pregnancy outcomes.
authors.affiliation: Breastfeeding Research Center, Tehran University of Medical Sciences, Tehran, Iran.
authors.forename: Niloofar
authors.initials: N
authors.lastname: Karbasian
authors.affiliation: Maternal, Fetal and Neonatal Research Center, Tehran University of Medical Sciences, Tehran, Iran.
authors.forename: Mahdi
authors.identifier: http://orcid.org/0000-0003-3972-7824
authors.initials: M
authors.lastname: Sheikh
authors.affiliation: Arash Women's Hospital, Tehran University of Medical Sciences, Tehran, Iran.
authors.forename: Reihaneh
authors.initials: R
authors.lastname: Pirjani
authors.affiliation: Maternal, Fetal and Neonatal Research Center, Tehran University of Medical Sciences, Tehran, Iran.
authors.forename: Shahla
authors.initials: S
authors.lastname: Hazrati
authors.affiliation: Breastfeeding Research Center, Tehran University of Medical Sciences, Tehran, Iran.
authors.forename: Fatemeh
authors.initials: F
authors.lastname: Tara
authors.affiliation: Maternal, Fetal and Neonatal Research Center, Tehran University of Medical Sciences, Tehran, Iran.
authors.forename: Sedigheh
authors.initials: S
authors.lastname: Hantoushzadeh
mesh_terms: D000328:Adult; D054791:Cervical Length Measurement; D003131:Combined Modality Therapy; D005260:Female; D006801:Humans; D011247:Pregnancy; D011256:Pregnancy Outcome; D047928:Premature Birth / Q000188:drug therapy / Q000517:prevention & control* / Q000601:surgery; D011374:Progesterone / Q000008:administration & dosage / Q000627:therapeutic use*; D011446:Prospective Studies; D016896:Treatment Outcome; D002581:Uterine Cervical Incompetence / Q000601:surgery*
chemical_list: D011374:Progesterone
keywords: delivery; high risk; premature; second trimester; short cervix