Oxidative Stress in Women Treated With Atosiban for Impending Preterm Birth

NCT03570294 | Completed DMC

• 1 other identifier: 2015/I/17-GW
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Premature Birth

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Apgar score

  At birth

• Weight

  At birth

• Incidence of duration of hospitalization

  Up to 28 days after birth

• Time to delivery measured from start of Atosiban administration

  Up to 15 weeks from start of Atosiban administration

Study Arms (1)

Atosiban

OTHER

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

Interventions

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.

Also known as: Tractocile

Atosiban

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Polish Mother Memorial Hospital Research Institute: lead

Study Sites (1)

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

Lodz, 93-338, Poland

Location

Related Publications (1)

• 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.

  PMID: 30622667 DERIVED

MeSH Terms

Conditions

Premature Birth

Interventions

atosiban

Condition Hierarchy (Ancestors)

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

Study Officials

• Mariusz Grzesiak, Ph.D. MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2018
• First Posted: June 26, 2018
• Study Start: February 1, 2014
• Primary Completion: June 10, 2018
• Study Completion: December 30, 2018
• Last Updated: June 14, 2019

Record last verified: 2018-06

Locations

PL (1)