title: Vaginal progesterone combined with cervical pessary: A chance for pregnancies at risk for preterm birth?
abstract: Precocious cervical ripening, as defined by cervical shortening on transvaginal sonography, has prompted a broad evaluation of secondary strategies (such as cerclage, vaginal progesterone, or a cervical pessary) to prevent preterm delivery. However, there is still a lack of direct comparisons between individual treatments or their combinations.
  
  
  
  We sought to compare at-risk patients and screening patients who had been treated with cervical pessary alone with patients who had been treated with pessary plus vaginal progesterone.
  
  
  
  This is a pre- and postintervention cohort study from a preterm labor clinic where placement of a cervical pessary has been the standard treatment since 2008 for at-risk women defined by (1) a history of spontaneous preterm birth at <37 weeks of gestation, (2) conization, or (3) a cerclage because of a previous short cervical length of <3rd percentile and, additionally, with a cervical length of <10th percentile in the ongoing pregnancy. Patients who did not meet the criteria for the "at risk" group, but who had a cervical length of <3rd percentile comprised the screening group. From July 2011 onward, vaginal progesterone (200 mg, suppositories) was prescribed in addition to the pessary. Both at-risk patients (n = 55) and screening patients (n = 51) were treated at the time of diagnosis. The primary outcome was the rate of preterm deliveries at <34 weeks of gestation. Secondary outcomes included deliveries at <28, <32, and <37 weeks of gestation, the days from start of therapy until delivery, a composite index of neonatal outcome, and the number of days in the neonatal intensive care unit. Primary and secondary outcomes were compared between groups with the use of multivariable models to adjust for possible confounders.
  
  
  
  Delivery at <34 weeks of gestation occurred in 17 of 53 patients (32.1%) who were treated with pessary plus progesterone, compared with 13 of 53 patients (24.5%) who were treated with pessary alone (P = .57). Similarly, there was no difference in the rate of preterm delivery at <28, <32, or <37 weeks of gestation. The composite poor neonatal outcome was 15.1% in the pessary group vs 18.9% in the combined group (P = .96). The mean duration of stay in the neonatal intensive care unit was 46.5 days (range, 9-130 days) in the combined vs 52.0 days (range, 3-151 days) in the pessary group (P < .001).
  
  
  
  In this cohort study, treatment of precocious cervical ripening with cervical pessary plus vaginal progesterone did not reduce the rates of preterm delivery at <28, <32, <34, or <37 weeks of gestation compared with pessary alone. The neonatal intensive care use was shorter in patients who received additional vaginal progesterone, although there was no difference in composite poor neonatal outcome. These preliminary results may serve as a pilot for future trials and provide a basis for treatment until larger trials are completed.
authors.affiliation: Department of Obstetrics and Gynecology, Philipps-University Marburg, Germany. Electronic address: stricker.nathanael@gmail.com.
authors.forename: Nathanael
authors.initials: N
authors.lastname: Stricker
authors.affiliation: Department of Medical Biometry, Philipps-University Marburg, Germany.
authors.forename: Nina
authors.initials: N
authors.lastname: Timmesfeld
authors.affiliation: Department of Obstetrics and Gynecology, Philipps-University Marburg, Germany.
authors.forename: Ioannis
authors.initials: I
authors.lastname: Kyvernitakis
authors.affiliation: Department of Obstetrics and Gynecology, Philipps-University Marburg, Germany.
authors.forename: Janina
authors.initials: J
authors.lastname: Goerges
authors.affiliation: Department of Obstetrics and Gynecology, Philipps-University Marburg, Germany; Clara-Angela Foundation, Berlin, Germany.
authors.forename: Birgit
authors.initials: B
authors.lastname: Arabin
mesh_terms: D000282:Administration, Intravaginal; D000328:Adult; D020070:Cervical Ripening / Q000187:drug effects; D015331:Cohort Studies; D003131:Combined Modality Therapy; D005260:Female; D005865:Gestational Age; D006801:Humans; D007231:Infant, Newborn; D007363:Intensive Care Units, Neonatal; D007902:Length of Stay / Q000706:statistics & numerical data; D010570:Pessaries; D011247:Pregnancy; D047928:Premature Birth / Q000517:prevention & control*; D011374:Progesterone / Q000008:administration & dosage*; D011372:Progestins / Q000008:administration & dosage*; D013488:Suppositories
chemical_list: D011372:Progestins; D013488:Suppositories; D011374:Progesterone
keywords: cerclage; cervical pessary; precocious cervical ripening; prematurity; preterm birth; preterm delivery; short cervix; transvaginal sonography; vaginal progesterone