Oxidative Stress in Women Treated With Atosiban for Impending Preterm Birth
Primary Purpose
Premature Birth
Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Atosiban
Sponsored by

About this trial
This is an interventional treatment trial for Premature Birth
Eligibility Criteria
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
Sites / Locations
- Department of Obstetrics, Perinatology and Gynecology, Polish Mother's Memorial Hospital-Research Institute
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Atosiban
Arm Description
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Apgar score
Apgar score
Weight
Weight
Incidence of duration of hospitalization
Incidence of duration of hospitalization
Time to delivery measured from start of Atosiban administration
Time to delivery measured from start of Atosiban administration
Full Information
NCT ID
NCT03570294
First Posted
June 15, 2018
Last Updated
June 13, 2019
Sponsor
Polish Mother Memorial Hospital Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT03570294
Brief Title
Oxidative Stress in Women Treated With Atosiban for Impending Preterm Birth
Official Title
Evaluation of Oxidative and Antioxidative Status of Pregnant Women Suffering From Threatened Preterm Birth During Tocolytic Treatment With Atosiban
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
February 1, 2014 (Actual)
Primary Completion Date
June 10, 2018 (Actual)
Study Completion Date
December 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Polish Mother Memorial Hospital Research Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Birth
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Atosiban
Arm Type
Other
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Atosiban
Other Intervention Name(s)
Tractocile
Intervention Description
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.
Primary Outcome Measure Information:
Title
Delay preterm delivery for 48 hours
Description
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 Outcome Measure Information:
Title
Apgar score
Description
Apgar score
Time Frame
At birth
Title
Weight
Description
Weight
Time Frame
At birth
Title
Incidence of duration of hospitalization
Description
Incidence of duration of hospitalization
Time Frame
Up to 28 days after birth
Title
Time to delivery measured from start of Atosiban administration
Description
Time to delivery measured from start of Atosiban administration
Time Frame
Up to 15 weeks from start of Atosiban administration
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mariusz Grzesiak, Ph.D. MD
Organizational Affiliation
Department of Obstetrics, Perinatology and Gynecology, Polish Mother's Memorial Hospital-Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Obstetrics, Perinatology and Gynecology, Polish Mother's Memorial Hospital-Research Institute
City
Łódź
ZIP/Postal Code
93-338
Country
Poland
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Study protocol, statistical analysis plan, informed consent form, clinical study report
Citations:
PubMed Identifier
30622667
Citation
Grzesiak M, Gaj Z, Kocylowski R, Suliburska J, Oszukowski P, Horzelski W, von Kaisenberg C, Banach M. Oxidative Stress in Women Treated with Atosiban for Impending Preterm Birth. Oxid Med Cell Longev. 2018 Dec 2;2018:3919106. doi: 10.1155/2018/3919106. eCollection 2018.
Results Reference
derived
Learn more about this trial
Oxidative Stress in Women Treated With Atosiban for Impending Preterm Birth
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