Table 1 Inclusion and exclusion criteria for PESAPRO
Inclusion criteria | Exclusion criteria |
|---|---|
• Women older than 18 years old | • Major fetal and/ or uterine abnormalities |
• Pregnant women with a short cervix (<25 mm) identified by the use of routine transvaginal ultrasonography at 19 to 22 weeks of gestation | • Placenta previa during current pregnancy |
• Gestational age at randomization between 20 weeks + 1 and 23 weeks +6 | • Vaginal bleeding or ruptured membranes in the moment of randomization |
• Single pregnancy | • Cervical cerclage in situ |
• Women sign informed consent according to the GCP and local legislation | • History of cone biopsy |
• History of three or more premature labor | |
• Allergic to peanut | |
• Contraindication for progesterone usage | |
• Active treatment with progesterone at randomization | |
• If in an investigator’s opinion, there are findings on physical examination, abnormalities in the results of clinical analyzes or other medical factors, social or psychosocial that could negatively influence | |
• Women unable to give the informed consent |