Premature Birth
Conditions
Brief summary
Oxidative stress is recognized as a important factor in the pathogenesis premature birth. Preterm birth is defined as delivery before 37 completed weeks of gestation and it is the leading cause of neonatal morbidity and mortality. The investigators conducted this analysis to investigate the safety of administration of Atosiban - a reversible, competitive antagonist of the oxytocin receptor in the treatment of preterm labor and its impact on the level of oxidative stress after 48 hours of tocolytic treatment.
Detailed description
Atosiban (1-(3-mercaptopropanoic acid)-2-(O-ethyl-D-tyrosine)-4-L-threonine-8-L-ornithine-oxytocin) is licensed for clinical use in women suffering from threatened premature birth and is widely used in clinical practice in Europe because of its low side effect profile. The impact of Atosiban on pregnancy outcomes in women has been investigated in recent years and the research has shown its ability to reduce intracytoplasmic calcium release and downregulate prostaglandin synthesis as oxytocin receptor antagonist. While a role of Atosiban in the modulation of myometrial contractility is well-described, its effect on many other functions is not so well known. The serum and plasma samples take for the measurement of total oxidant status (TOS), total antioxidant status (TAS), level of 3-nitrotyrosine (3-NT), and carbonyl and thiol groups will be stored at -70°C in aliquots for subsequent biochemical analysis and processed within two months.
Interventions
DRUGAtosiban
The initial dose of Atosiban (Tractocile, Ferring Pharmaceuticals A/S, Copenhagen, Denmark) will be give as a single intravenous bolus dose (6.75 mg in 0.9 ml isotonic sodium chloride solution). This will be follow immediately by intravenous infusion of 300 μg/min of Atosiban in 5% glucose for 3 hours, and then 100 μg/min for up to 48 hours. Venous blood samples from a forearm vein will take before and after 48 hours of continuous administration tocolytic therapy with Atosiban.
Sponsors
Polish Mother Memorial Hospital Research Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* pregnant women between 24-35 weeks' gestation receiving prenatal care due to the risk of premature birth * intact membranes * evidence of premature labor (regular, painful and persistent uterine contractions; cervical changes)
Exclusion criteria
* acute fetal distress * other conditions requiring immediate delivery (eclampsia and severe pre-eclampsia, placenta previa, abruptio placenta) * vaginal bleeding, * premature rupture of membranes * chorioamnionitis, * fetal congenital malformations, * intrauterine growth restriction, * the use of any tocolytic drugs during pregnancy before admission to the hospital * circulatory system diseases (e.g. heart defects, hypertension), * symptoms of infection * other diseases that may increase oxidative stress
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Delay preterm delivery for 48 hours | 48 hours | Delay preterm delivery for 48 hours, thus allowing administration of corticosteroids to induce surfactant production in fetal lungs and improve neonatal outcome |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Apgar score | At birth | Apgar score |
| Weight | At birth | Weight |
| Incidence of duration of hospitalization | Up to 28 days after birth | Incidence of duration of hospitalization |
| Time to delivery measured from start of Atosiban administration | Up to 15 weeks from start of Atosiban administration | Time to delivery measured from start of Atosiban administration |
Countries
Poland
Outcome results
None listed