Status
Completed
Phase
Not applicable
Enrollment
64
Locations
1
Results
Not posted
Publications
1
Study 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.
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
DRUG
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
First posted
Jun 26, 2018
Study start
Feb 1, 2014
Primary completion
Jun 10, 2018
Study completion
Dec 30, 2018
Results posted
Not reported
Registry updated
Jun 14, 2019
Outcomes
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
Eligibility
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
Study locations
Poland. Showing up to 24 locations stored in the fast local snapshot.
Department of Obstetrics, Perinatology and Gynecology, Polish Mother's Memorial Hospital-Research Institute
Lodz, Poland
Publications
Related trials
Northwest Women's and Children's Hospital, Xi'an, Shaanxi · Infertility
Not applicable
Recruiting
792
2025-12
University of Electronic Science and Technology of China · Healthy Adult Male
Early Phase 1
Recruiting
250
2025-09
University of Electronic Science and Technology of China · Healhty
Early Phase 1
Recruiting
250
2025-07
Children's Hospital of Chongqing Medical University · Cervical Cerclage · Premature Birth
Not applicable
Completed
334
2025-05
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Preterm Birth
Phase 4
Completed
760
2024-07
University of Sao Paulo General Hospital · Myelomeningocele · Terbutaline Adverse Reaction
Not applicable
Completed
25
2022-06
Radboud University Medical Center · Endometriosis
Phase 2
Unknown
10
2022-05
Al Baraka Fertility Hospital · Recurrent Implantation Failure
Not applicable
Unknown
150
2021-09
Related PeptideStat pages
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.