Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Oxidative Stress in Women Treated With Atosiban for Impending Preterm Birth

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03570294
Recruitment Status : Completed
First Posted : June 26, 2018
Last Update Posted : June 14, 2019
Sponsor:
Information provided by (Responsible Party):
Polish Mother Memorial Hospital Research Institute

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.

Condition or disease Intervention/treatment Phase
Premature Birth Drug: Atosiban Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Oxidative and Antioxidative Status of Pregnant Women Suffering From Threatened Preterm Birth During Tocolytic Treatment With Atosiban
Actual Study Start Date : February 1, 2014
Actual Primary Completion Date : June 10, 2018
Actual Study Completion Date : December 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Atosiban
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.
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.
Other Name: Tractocile




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03570294


Locations
Layout table for location information
Poland
Department of Obstetrics, Perinatology and Gynecology, Polish Mother's Memorial Hospital-Research Institute
Łódź, Poland, 93-338
Sponsors and Collaborators
Polish Mother Memorial Hospital Research Institute
Investigators
Layout table for investigator information
Principal Investigator: Mariusz Grzesiak, Ph.D. MD Department of Obstetrics, Perinatology and Gynecology, Polish Mother's Memorial Hospital-Research Institute

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Polish Mother Memorial Hospital Research Institute
ClinicalTrials.gov Identifier: NCT03570294     History of Changes
Other Study ID Numbers: 2015/I/17-GW
First Posted: June 26, 2018    Key Record Dates
Last Update Posted: June 14, 2019
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Study protocol, statistical analysis plan, informed consent form, clinical study report

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Vasotocin
Atosiban
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Tocolytic Agents
Reproductive Control Agents
Oxytocics
Vasoconstrictor Agents