CompletedPhase 2/3

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

Bosnia and Herzegovina26 participantsStarted 2023-11-08

Plain-language 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.

Who can participate

Age range

18 Years – 50 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: \- 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 Criteria: \- 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

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

Trial details

NCT IDNCT06103227

SponsorUniversity of Mostar

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-11-25

View on ClinicalTrials.gov More Preterm Birth trials