Status:
COMPLETED
The Effect of Low Doses of Prednisone on the Prolongation of Pregnancy in Threatened Preterm Birth
Lead Sponsor:
University of Mostar
Conditions:
Preterm Birth
Eligibility:
FEMALE
18-50 years
Phase:
PHASE2
PHASE3
Brief Summary
The goal of this clinical trial is to test the effect of a low dose of prednisone in the prevention of preterm labour in singleton pregnancies. The main question it aims to answer is whether prednison...
Detailed Description
Prematurity is the leading cause of infant mortality and is associated with an increased risk of respiratory, neurological and metabolic disorders in survivors. Approximately 15 million babies are bor...
Eligibility Criteria
Inclusion
- \- primiparity, singleton pregnancy between 24+0 and 34+0 weeks, and signs of threatened PTB at admission. Threatened PTB was defined as regular uterine contractions (\>4 in 20 minutes or \>8 in 60 minutes), with or without bleeding, along with cervical dilation greater than 2 cm or cervical length less than 20 mm, confirmed by transvaginal ultrasound or clinical progression.
Exclusion
- \- contraindications to tocolysis or systemic corticosteroid (CS) therapy, such as intrauterine fetal death, lethal fetal anomaly, abnormal CTG recording, severe preeclampsia or eclampsia, hemodynamically significant bleeding, infection, uncontrolled diabetes, ongoing CS therapy for underlying conditions, severe liver impairment, or preterm prelabour rupture of membranes.
Key Trial Info
Start Date :
November 8 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 2 2024
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT06103227
Start Date
November 8 2023
End Date
December 2 2024
Last Update
February 19 2025
Active Locations (1)
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1
University Clinical Hospital
Mostar, Bosnia and Herzegovina, 88000