Last updated: February 15, 2025
Sponsor: University of Mostar
Overall Status: Completed
Phase
2/3
Condition
Miscarriage
Treatment
Prednisone 5Mg
Clinical Study ID
NCT06103227
1236/23
Ages 18-50 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- primiparity, singleton pregnancy between 24+0 and 34+0 weeks, and signs ofthreatened PTB at admission. Threatened PTB was defined as regular uterinecontractions (>4 in 20 minutes or >8 in 60 minutes), with or without bleeding, alongwith cervical dilation greater than 2 cm or cervical length less than 20 mm,confirmed by transvaginal ultrasound or clinical progression.
Exclusion
Exclusion Criteria:
- contraindications to tocolysis or systemic corticosteroid (CS) therapy, such asintrauterine fetal death, lethal fetal anomaly, abnormal CTG recording, severepreeclampsia or eclampsia, hemodynamically significant bleeding, infection,uncontrolled diabetes, ongoing CS therapy for underlying conditions, severe liverimpairment, or preterm prelabour rupture of membranes.
Study Design
Total Participants: 26
Treatment Group(s): 1
Primary Treatment: Prednisone 5Mg
Phase: 2/3
Study Start date:
November 08, 2023
Estimated Completion Date:
December 02, 2024
Study Description
Connect with a study center
University Clinical Hospital
Mostar, 88000
Bosnia and HerzegovinaSite Not Available
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