CLINICAL TRIALS PROFILE FOR RITODRINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER
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All Clinical Trials for RITODRINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00137501 ↗ | Two Dose Regimens of Nifedipine for the Management of Preterm Labor | Terminated | American University of Beirut Medical Center | Phase 3 | 2003-05-01 | Preterm birth is one of the most important causes of perinatal morbidity and mortality worldwide. Prevention and treatment of preterm labor is important, not as an end in itself, but as a means of reducing adverse events for the neonate. A wide range of tocolytics, drugs used to suppress uterine contractions, have been tried. Magnesium sulfate (MgSO4) is the most widely used tocolytic at the American University of Beirut Medical Center despite the fact that an effective tocolytic role of MgSO4 has never been established. Moreover, the currently available data are suggestive of deleterious fetal effects of MgSO4 in the setting of preterm labor to the extent that some authorities are recommending abandoning it for routine use as a tocolytic therapy. Calcium channel blockers have the ability to inhibit contractility in smooth muscle cells. Consequently, nifedipine has emerged as an effective and rather safe alternative tocolytic agent for the management of preterm labor after several studies have shown that the use of nifedipine in comparison with other tocolytics is associated with a more frequent successful prolongation of pregnancy, resulting in significantly fewer admissions of newborns to the neonatal intensive care unit, and is associated with a lower incidence of respiratory distress syndrome. The unequivocal impact of this method of tocolysis on short term postponement of delivery and the opportunity that this provides for affecting in-utero transfer and steroid administration has prompted many investigators to recommend focusing future trials on testing different dose regimens of nifedipine. To the best of the investigators' knowledge, no study comparing two different dose regimens of nifedipine has been previously published in the literature. The objective of their study is to compare the effectiveness of a high versus a low dose regimen in a total of 200 patients admitted with the diagnosis of preterm labor between 24 and 34 weeks of gestation. In addition, the investigators' study will try to assess the safety profile of the 2 dose regimens on the mother and the neonate by assessing a selected number of outcome variables. The data generated will be used to change their protocol for managing patients presenting with threatened preterm delivery and will fill the existing gap regarding the most effective and safest dose regimen of nifedipine in such patients. |
| NCT00290173 ↗ | Ritodrine in Oral Maintenance of Tocolysis After Active Preterm Labor | Completed | Ministry of Science, Education and Sport, Republic of Croatia | N/A | 1969-12-31 | This is a trial comparing the efficacy of oral ritodrine in the form of sustained release capsules for the maintenance of uterine quiescence after successfully treated episode of threatened preterm labor. |
| NCT00290173 ↗ | Ritodrine in Oral Maintenance of Tocolysis After Active Preterm Labor | Completed | University of Zagreb | N/A | 1969-12-31 | This is a trial comparing the efficacy of oral ritodrine in the form of sustained release capsules for the maintenance of uterine quiescence after successfully treated episode of threatened preterm labor. |
| NCT00679705 ↗ | Influence of Tocolytical Medications on Hemodynamics (Central and Peripheral) and Vascular Function in a Pilot Study to Determine the Design of the Final Study and the Final Study Itself | Completed | University Hospital, Ghent | Phase 1 | 2008-05-01 | This trial will consist of two parts: A pilot study in a three-way cross over trial to determine the highest well tolerated dose of Ritodrine (Pre-Par®), the impact of Atosiban (Tractocile®) on the hemodynamics and hence the design of the final study. The final study is planned as a three-way crossover trial to investigate and compare the cardiovascular effects of Ritodrine, Atosiban and placebo to relate those effects to the pharmacokinetics of Ritodrine and Atosiban (PK/PD modelling). |
| NCT01429545 ↗ | Single Versus Combination Therapy in Acute Tocolysis | Completed | Tawam Hospital | Phase 2 | 2007-04-01 | The purpose of this study is to compare the tocolytic efficacy, effectiveness and safety of Atosiban in comparison with the combination of Atosiban and Nifedipine together. |
| NCT02115256 ↗ | Study to Evaluate is ECV Success is Improved and the Side Effects Reduced With the Use of IV NTGL Versus Terbutaline | Terminated | Yaakov Beilin | Phase 2/Phase 3 | 2014-07-01 | Breech presentation of a term pregnancy is a common occurrence. A procedure known as external cephalic version (ECV) is frequently used by obstetricians to turn the baby into the vertex position prior to delivery in order to avoid a cesarean section and the associated risks. Medications to relax the uterus, known as tocolytics, are used in conjunction with the procedure as they have been shown to improve the success rate of ECV, but with inconsistent, varying results. |
| NCT02538718 ↗ | Efficacy and Safety of MgSO4 as Tocolytics Compared to Ritodrine in Preterm Labor | Completed | Seoul National University Hospital | N/A | 2015-09-22 | Ritodrine is the conventional and the only approved tocolytics in Korea(by KFDA), although it was withdrawn from the US market more than 10 years ago. As already known well, ritodrine has many side effects such as tachycardia, hyperglycemia, pulmonary edema and so on. When such complications of ritodrine appears, clinicians consider of using MgSO4 as substitute, but its use is off-the-label yet in Korea. Facing this discrepancy, the investigators want to compare the efficacy and safety of MgSO4 with ritodrine and prove that MgSO4 is not inferior to ritodrine as tocolytics. For the singleton and twin pregnancies between 24+0weeks and 34 completed weeks whose uterine contraction is more than 4 during 20 minutes period with their cervical ripening is more than 25%, the investigators randomise them in Ritodrine group or MgSO4 group. Then, the investigators will check the change of their interval of uterine contraction, degree of pain and the appearance of any side effects or treatment failure sign. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
Clinical Trial Conditions for RITODRINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER
Condition Name
Condition MeSH
| Condition MeSH for RITODRINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER | |
| Intervention | Trials |
| Obstetric Labor, Premature | 7 |
| Premature Birth | 4 |
| Respiratory Distress Syndrome, Newborn | 1 |
| Respiratory Distress Syndrome | 1 |
| [disabled in preview] | 0 |
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