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

NCT06103227 | Completed Phase 2

• 1 other identifier: 1236/23
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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 prednisone prolongs singleton pregnancy in threatened preterm birth and reduces mortality and morbidity of newborns without harmful consequences for the mother and the foetus. Participants will be:

• administered low dose of prednisone in a period of a total of 3 weeks on top of standard therapy
• drown blood for standard laboratory tests
• cervical swab and urine for urine culture will be taken, and
• asked to sign Informed Consent The researcher will compare a low dose of prednisone to standard therapy.

Conditions

Preterm Birth

Keywords

Premature birth, sterile inflammation, prednisone

Outcome Measures

Primary Outcomes (1)

• Number of days by which singleton pregnancies with threatened preterm birth are prolonged

  Prolongation of singleton pregnancy in threatened preterm birth

  10 weeks (from 24th till 34th week of pregnancy)

Secondary Outcomes (1)

• Change of mortality and morbidity

  10 weeks (from 24th till 34th week of pregnancy)

Study Arms (2)

Low dose of prednisone group

EXPERIMENTAL

Low-dose prednisone was used for a total of three weeks from the initiation of RDS prophylaxis, following two-day tocolysis and magnesium sulphate for neuroprotection.

Drug: Prednisone 5Mg

Standard therapy group

ACTIVE COMPARATOR

Two-day tocolysis and RDS prophylaxis, plus neuroprotection with magnesium sulphate.

Drug: Prednisone 5Mg

Interventions

Prednisone 5Mg DRUG

Prednisone administered for three weeks. If pregnant women weighs less than 90 kg , she will receive prednisone on altering days instead of every morning for pregnant women weighing more than 90 kg.

Low dose of prednisone group; Standard therapy group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Pregnant women
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \- 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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• University of Mostar: lead

Study Sites (1)

University Clinical Hospital

Mostar, 88000, Bosnia and Herzegovina

Location

MeSH Terms

Conditions

Premature Birth

Interventions

Prednisone

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Maternal-fetal medicine specialist

Study Record Dates

• First Submitted: October 21, 2023
• First Posted: October 26, 2023
• Study Start: November 8, 2023
• Primary Completion: November 25, 2024
• Study Completion: December 2, 2024
• Last Updated: February 19, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

BO (1)