The Effect of Low Doses of Prednisone on the Prolongation of Pregnancy in Threatened Preterm Birth

• Status: Not yet recruiting
• Trial end date: 2025-10-01
• Target enrollment: 0
• Participant gender: Female

Summary

The goal of this clinical trial is to test the effect of low dose of prednisone in prevention of preterm labour in single pregnancies. The main question it aims to answer is does prednisone prolong singleton pregnancy in threatened preterm birth and reduce mortality and morbidity of newborns, without harmful consequences for mother and the foetus. Participants will be:

• administered low dose of prednisone in a period of total 3 weeks on top of standard therapy

• drown blood for standard laboratory tests

• cervical swab and urine for urinoculture will be taken and

• asked to sign Informed Consent Researcher will compare low dose of prednisone to standard therapy

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Mostar
• Treatments: Prednisone

Criteria

Inclusion Criteria:

• Singleton pregnancies in 24th until 34th week of gestation with a sign of threatening preterm birth at the time of admission: uterine contractions more than 4 in 20 minutes or more than 8 in 60 minutes with concomitant bleeding accompanied by cervical dilation more than 2 cm, cervical effacement less than 20 mm using transvaginal probe, progression in gynecological findings at the time of admission.

Exclusion Criteria:

• Contraindications for tocolysis and continuation of systemic CS administration that include all conditions in which prolongation of the pregnancy increases the risk for foetus or/and the mother (i.e. intrauterine growth restriction, lethal foetal anomaly, non/reassuring foetal status, preeclampsia with severe features or eclampsia, maternal hemorrhage with haemodynamic instability, intraamniotic infections/chorioamnionitis), uncontrolled diabetes, severe liver impairment and preterm prelabour rupture of membranes.