Oxidative Stress in Women Treated With Atosiban for Impending Preterm Birth
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|ClinicalTrials.gov Identifier: NCT03570294|
Recruitment Status : Completed
First Posted : June 26, 2018
Last Update Posted : June 14, 2019
|Condition or disease||Intervention/treatment||Phase|
|Premature Birth||Drug: Atosiban||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||64 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of Oxidative and Antioxidative Status of Pregnant Women Suffering From Threatened Preterm Birth During Tocolytic Treatment With Atosiban|
|Actual Study Start Date :||February 1, 2014|
|Actual Primary Completion Date :||June 10, 2018|
|Actual Study Completion Date :||December 30, 2018|
Total oxidant status (TOS), total antioxidant status (TAS) and oxidative stress index (OSI) values as well as 3-nitrotyrosine, carbonyl and thiol groups levels weill be measure using ELISA test in serum and plasma of 64 pregnant women before and after 48 hours of continuous administration of 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.
Other Name: Tractocile
- Delay preterm delivery for 48 hours [ Time Frame: 48 hours ]Delay preterm delivery for 48 hours, thus allowing administration of corticosteroids to induce surfactant production in fetal lungs and improve neonatal outcome
- Apgar score [ Time Frame: At birth ]Apgar score
- Weight [ Time Frame: At birth ]Weight
- Incidence of duration of hospitalization [ Time Frame: Up to 28 days after birth ]Incidence of duration of hospitalization
- Time to delivery measured from start of Atosiban administration [ Time Frame: Up to 15 weeks from start of Atosiban administration ]Time to delivery measured from start of Atosiban administration
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03570294
|Department of Obstetrics, Perinatology and Gynecology, Polish Mother's Memorial Hospital-Research Institute|
|Łódź, Poland, 93-338|
|Principal Investigator:||Mariusz Grzesiak, Ph.D. MD||Department of Obstetrics, Perinatology and Gynecology, Polish Mother's Memorial Hospital-Research Institute|