CompletedNot Applicable

Oxidative Stress in Women Treated With Atosiban for Impending Preterm Birth

Poland64 participantsStarted 2014-02-01

Plain-language 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.

Who can participate

Age range

18 Years – 45 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Delay preterm delivery for 48 hours

Timeframe: 48 hours

Trial details

NCT IDNCT03570294

SponsorPolish Mother Memorial Hospital Research Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-06-10

View on ClinicalTrials.gov More Premature Birth trials