Oxidative Stress in Women Treated With Atosiban for Impending Preterm Birth

Premature Birth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03570294
• Other study ID #: 2015/I/17-GW
• Status: Completed
• Phase: N/A
• Start date: February 1, 2014
• Est. completion date: December 30, 2018

Study information

• Verified date: June 2018
• Source: Polish Mother Memorial Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: December 30, 2018
• Est. primary completion date: June 10, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

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

Related Conditions & MeSH terms

• Premature Birth

Intervention

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.

Locations

Country	Name	City	State
Poland	Department of Obstetrics, Perinatology and Gynecology, Polish Mother's Memorial Hospital-Research Institute	Lódz

Sponsors (1)

Lead Sponsor	Collaborator
Polish Mother Memorial Hospital Research Institute

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	48 hours
Secondary	Apgar score	Apgar score	At birth
Secondary	Weight	Weight	At birth
Secondary	Incidence of duration of hospitalization	Incidence of duration of hospitalization	Up to 28 days after birth
Secondary	Time to delivery measured from start of Atosiban administration	Time to delivery measured from start of Atosiban administration	Up to 15 weeks from start of Atosiban administration