Clinical trial NCT03570294: 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
Overall status: COMPLETED
Phase: NA
Conditions: Premature Birth
Lead sponsor: Polish Mother Memorial Hospital Research Institute
Sponsor class: OTHER
First posted: 2018-06-26
Enrollment: 64
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Delay preterm delivery for 48 hours
timeFrame: 48 hours
Secondary outcomes:
measure: Apgar score
timeFrame: At birth
measure: Weight
timeFrame: At birth
measure: Incidence of duration of hospitalization
timeFrame: Up to 28 days after birth
measure: Time to delivery measured from start of Atosiban administration
timeFrame: Up to 15 weeks from start of Atosiban administration
Other outcomes:
Locations:
city: Łódź
country: Poland
facility: Department of Obstetrics, Perinatology and Gynecology, Polish Mother's Memorial Hospital-Research Institute
Study officials:
affiliation: Department of Obstetrics, Perinatology and Gynecology, Polish Mother's Memorial Hospital-Research Institute
name: Mariusz Grzesiak, Ph.D. MD
role: PRINCIPAL_INVESTIGATOR
References:
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.