PEPPER-trial

INTERVENTION: Product Code: SCP145363,Pharmaceutical Form: ,Other descriptive name: CONDITION: Placenta previa, preterm birth Therapeutic area: Diseases [C] ‐ Female Urogenital Diseases and Pregnancy Complications [C13] PRIMARY OUTCOME: Main Objective:1. To assess the effectiveness of progesterone ‐ started between 18‐ and 24‐weeks of gestation, compared to no treatment ‐ in the prevention of preterm birth in women with a placenta previa. We will assess total preterm birth rates and rates subdivided in spontaneous and iatrogenic preterm birth at different gestational age cut‐offs, duration of pregnancy, neonatal mortality and morbidity, and maternal side effects. 2. The primary outcome measure will be the relative risk of preterm birth before 37 weeks of gestation. Primary end point(s):Number of PTB before 37 weeks of gestation Secondary Objective:Secondary outcomes will be the relative risk of preterm birth before 34 weeks of gestation, and preterm births will also be assessed as spontaneous and indicated separately for different cut‐offs (28, 32, 34 and 37 weeks of gestation). Neonatal outcomes will be a composite adverse neonatal outcome for neonatal morbidity and neonatal mortality, and components will also be assessed separately. Maternal outcomes will be maternal morbidity and side effects, and (indication for chosen) mode of birth. SECONDARY OUTCOME: Secondary end point(s):1. sPTB/iPTB <37wks, 2. PTB >24wks, 3. Total PTB, sPTB, iPTB <28/32/34wks, 4. Mean gestational age, 5. Incidence of <10th/3rd percentile birthweight, 6. Umbilical cord blood pH (arterial/venous), 7. Apgar <7 at 5 mins, 8. NICU admissions (>24 hrs, hrs in NICU), 9. Components of composite outcome, 10. Planned/unplanned CS, 11. Admission for antenatal blood loss (incidence), 12. Threatened preterm birth (incidence). INCLUSION CRITERIA: Women pregnant of a singleton – without any other high‐risk factor for preterm birth ‐ diagnosed with a placenta previa diagnosed between 18‐ and 24 weeks of gestation.