NCT03570294

Oxidative Stress in Women Treated With Atosiban for Impending Preterm Birth

Evaluation of Oxidative and Antioxidative Status of Pregnant Women Suffering From Threatened Preterm Birth During Tocolytic Treatment With Atosiban

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Polish Mother Memorial Hospital Research Institute · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Premature Birth

Interventions

Type	Name	Description
DRUG	Atosiban	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.

Timeline

• Start date: 2014-02-01
• Primary completion: 2018-06-10
• Completion: 2018-12-30
• First posted: 2018-06-26
• Last updated: 2019-06-14

Locations

1 site across 1 country: Poland