Oxidative Stress in Women Treated With Atosiban for Impending Preterm Birth

Polish Mother Memorial Hospital Research Institute64 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Premature Birth

Interventions

AtosibanDRUG

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.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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

Locations (1)

Department of Obstetrics, Perinatology and Gynecology, Polish Mother's Memorial Hospital-Research Institute

Lodz, Poland

Outcomes

Primary Outcomes

Delay preterm delivery for 48 hours

Delay preterm delivery for 48 hours, thus allowing administration of corticosteroids to induce surfactant production in fetal lungs and improve neonatal outcome

Time frame: 48 hours

Secondary Outcomes

Apgar score

Time frame: At birth

Weight

Time frame: At birth

Incidence of duration of hospitalization

Time frame: Up to 28 days after birth

Time to delivery measured from start of Atosiban administration

Time frame: Up to 15 weeks from start of Atosiban administration

Data from ClinicalTrials.gov

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