Premature BirthNCT03570294
Oxidative Stress in Women Treated With Atosiban for Impending Preterm Birth
A study testing Atosiban in people with Premature Birth, run by Polish Mother Memorial Hospital Research Institute at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Premature Birth
- What is being tested?
- Atosiban
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 sitePoland
- Study dates
- 1 Feb 2014to 30 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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,
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- 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
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of Obstetrics, Perinatology and Gynecology, Polish Mother's Memorial Hospital-Research Institute
Lodz, 93-338
About this study
Official title: Evaluation of Oxidative and Antioxidative Status of Pregnant Women Suffering From Threatened Preterm Birth During Tocolytic Treatment With Atosiban
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.
Read the 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.
- Conditions
- Premature Birth
- Being tested
- Atosiban
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtosibanDrug
Also called Tractocile
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Atosiban |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 48 hours
Secondary outcomes (4)
Apgar score
Apgar score
Measured: At birth
Weight
Weight
Measured: At birth
Incidence of duration of hospitalization
Incidence of duration of hospitalization
Measured: Up to 28 days after birth
Time to delivery measured from start of Atosiban administration
Time to delivery measured from start of Atosiban administration
Measured: Up to 15 weeks from start of Atosiban administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2018
- Study start1 Feb 2014
- Primary completion10 Jun 2018
- Study completion30 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Premature BirthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Polish Mother Memorial Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mariusz Grzesiak, Ph.D. MD, Principal investigator, Department of Obstetrics, Perinatology and Gynecology, Polish Mother's Memorial Hospital-Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03570294
- Sponsor's protocol ID
- 2015/I/17-GW
- Status last verified
- Jun 2018
- First submitted
- 15 Jun 2018
- Last updated
- 14 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Study protocol, statistical analysis plan, informed consent form, clinical study report
Publications
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.
PubMed 30622667
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Oxidative and Antioxidative Status of Pregnant Women Suffering From Threatened Preterm Birth During Tocolytic Treatment With Atosiban
- ClinicalTrials.gov ID
- NCT03570294
- Acronym / sponsor ID
- 2015/I/17-GW
- Conditions
- Premature Birth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Polish Mother Memorial Hospital Research InstituteUniversity, hospital or other
- Study start
- 1 Feb 2014 (actual)
- Primary completion
- 10 Jun 2018 (actual)
- Study completion
- 30 Dec 2018 (actual)
- First posted
- 26 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Atosiban | Other | Drug: AtosibanTotal 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (11 listed)
- acute fetal distress
- other conditions requiring immediate delivery (eclampsia and severe pre-eclampsia, placenta previa, abruptio placenta)
- vaginal bleeding,
- premature rupture of membranes
- chorioamnionitis,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AtosibanAlso: TractocileThe 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. | Drug | Atosiban |
Primary outcome
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
4 secondary outcomes
Apgar score
Time frame: At birth
Weight
Time frame: At birth
Incidence of duration of hospitalization
Time frame: Up to 28 days after birth
Time to delivery measured from start of Atosiban administration
Time frame: Up to 15 weeks from start of Atosiban administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2019.
- Derived from this study: PubMed 30622667Grzesiak 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.
- Individual participant dataSharing planned: Undecided. Study protocol, statistical analysis plan, informed consent form, clinical study report
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mariusz Grzesiak, Ph.D. MD principal investigator
Department of Obstetrics, Perinatology and Gynecology, Polish Mother's Memorial Hospital-Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Atosiban in people with Premature Birth, run by Polish Mother Memorial Hospital Research Institute at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delay preterm delivery for 48 hours (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03570294, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2019.