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

University of Mostar

Status and phase

Completed

Phase 3

Phase 2

Conditions

Preterm Birth

Treatments

Drug: Prednisone 5Mg

Study type

Interventional

Funder types

Other

Identifiers

NCT06103227

1236/23

Details and patient eligibility

About

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.

Full 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 born preterm annually worldwide. Despite the rapid development of pharmacotherapy, there was no significant decline in 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 the 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. NSAIDs 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 periods. 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 outcomes in threatening PTB. Today, CS is a part of standard therapy for treating systemic autoimmune diseases and acts as a suppressor 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.

Enrollment

26 patients

Sex

Female

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

26 participants in 2 patient groups

Low dose of prednisone group

Experimental group

Description:

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.

Treatment:

Drug: Prednisone 5Mg

Standard therapy group

Active Comparator group

Description:

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

Treatment:

Drug: Prednisone 5Mg