Status and phase
Conditions
Treatments
About
Assess the efficacy of 2 Cervical Pessaries containing 6.3 g and 7.7 g micronized progesterone for the prevention of preterm delivery, established through spontaneous birth before gestation weeks 32 (31 weeks and 6 days) and 34 (33 weeks and 6 days), when the pessary is inserted during weeks 16th and 24th and removed at 36 weeks and 6 days in pregnant women at high risk of premature birth.
Full description
Participant selection will be performed by screening the general population of pregnant women with single fetus monitored by the Hospital Healthcare Network, to investigate by serial transvaginal ultrasound performed between gestation weeks 16 (0 day to 7 days) and 24 (0 day to 7 days) those patients who have a cervical length between 10 mm and 25 mm, and/or women with a single fetus and cervical length ≥10 mm presenting one or more of the following risk factors:
After insertion of the pessary or beginning of the administration with vaginal progesterone capsules and until 28 weeks of gestation, participants in the 3 treatment groups will be monitored every 4 weeks at the most or more often, if the site has established so as a control standard. After 28 weeks, patients should be monitored every 2 weeks.
The proportions of spontaneous preterm delivery before gestation weeks 32 and 34 will be compared between the control group and the 2 groups with the pessaries containing different doses of progesterone.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
Pregnancies with:
Cervical or vaginal injuries prior to insertion of the pessary (e.g., cervical erosion secondary to trauma, infection, or carcinoma; vesicovaginal or rectovaginal fistulas).
Unconscious, severely ill or mentally disabled patients, or under 16 years of age.
Patients for whom use of progesterone is contraindicated.
Patients with history of thrombosis.
Primary purpose
Allocation
Interventional model
Masking
271 participants in 3 patient groups
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal