Skip to main content
OpenTrials
Completed

NCT Number: NCT03570294

Oxidative Stress in Women Treated With Atosiban for Impending Preterm Birth

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Premature Birth Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Obstetrics, Perinatology and Gynecology, Polish Mother's Memorial Hospital-Research Institute

Lodz, 93-338, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Atosiban

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.

Other names: Tractocile

Primary outcomes

  1. 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

Secondary outcomes

  1. Apgar score

    Time frame: At birth

    Apgar score

  2. Weight

    Time frame: At birth

    Weight

  3. Incidence of duration of hospitalization

    Time frame: Up to 28 days after birth

    Incidence of duration of hospitalization

  4. 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

Sponsors and collaborators

Lead sponsor

Polish Mother Memorial Hospital Research Institute

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Jun 26, 2018
Registry last updated
Jun 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.