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

Preterm Birth Clinical Trial

Official title:

The Effect of Low Doses of Intermediate Acting Corticosteroids on the Prolongation of Pregnancy in Threatened Preterm Birth

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06103227
• Other study ID #: 1236/22
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• Start date: December 1, 2023
• Est. completion date: October 1, 2025

Study information

• Verified date: October 2023
• Source: University of Mostar
• Contact: Nikolina Penava, MD
• Phone: 0038763818875
• Email: npenava[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

Prematurity is the leading causes of infant mortality and is associated with an increased risk of respiratory, neurological and metabolic disorders in survivors. Approximately 15 million babies are born preterm annually worldwide. Despite the rapid development of pharmacotherapy, there was no significant decline in the premature birth (PTB) rates. So far, the most useful intervention for improving neonatal outcomes in premature children has been the antenatal administration of long-acting corticosteroids (CSs). Although the underlying causes of PTB are numerous, it is well established that infection and inflammation represent a highly significant risk factor for spontaneous PTB, characterized by the significant production of inflammatory mediators that lead to weakening of the foetal membranes, cervical stroma and contraction of the myometrium. There is increasing evidence of the presence of sterile inflammation (intra-amniotic inflammation without the presence of microorganisms) in PTB with both intact membranes and preterm premature rupture of membranes (PPROM). CS and non-steroidal anti-inflammatory drugs (NSAID) are used today to treat most inflammatory diseases. NSAID are used as tocolytics. Indomethacin, one of the most commonly used NSAID tocolytics has been associated with oligohydramnios and premature closure of the foetal ductus arteriosus when used for prolonged period. As far back as 1972, Liggins and Howie proved that antenatal administration of CS reduces the incidence and severity of respiratory distress syndrome (RDS) and mortality of premature infants. Meta-analyses have confirmed a lower rate of intraventricular haemorrhage and necrotic enterocolitis in premature infants whose mothers received RDS prophylaxis. Therefore, their application proved to be the most useful intervention for improving neonatal outcome in threatening PTB.Today, a CS is a part of standard therapy for the treatment of systemic autoimmune diseases and act as suppressors of immune response. Long acting CSs cross the placental barrier and are used to treat the foetus (foetal lupus, congenital adrenal hyperplasia, prevention of respiratory distress syndrome), and intermediate acting drugs are used to treat maternal diseases as they have a low affinity for passing through the placenta.The effect of low doses of intermediate acting corticosteroids on the prolongation of pregnancy in threatened preterm birth has not yet been studied.Given that PTB is a syndrome characterized by a strong inflammatory response, we present the hypothesis that low doses of an intermediate acting CS for 3 weeks after tocolysis and RDS prophylaxis help prolong singleton pregnancy in women with threatening PTB, without harmful consequences for mother and child.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 26
• Est. completion date: October 1, 2025
• Est. primary completion date: October 1, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Premature Birth
• Preterm Birth

Intervention

Drug:
• Prednisone 5Mg
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Mostar

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change of mortality and morbidity	Change mortality and morbidity of newborns without harmful consequences for the mother and the foetus.	10 weeks (from 24th till 34th week of pregnancy)