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Sponsors and Collaborators: |
University of Zagreb Ministry of Science, Education and Sport, Republic of Croatia |
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Information provided by: | University of Zagreb |
ClinicalTrials.gov Identifier: | NCT00290173 |
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.
Condition | Intervention |
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Pregnancy |
Drug: efficacy of oral ritodrine in maintaining uterine quiescence |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study |
Official Title: | Ritodrine in Oral Maintenance of Tocolysis After Active Preterm Labor: Randomized Controlled Trial |
Estimated Study Completion Date: | August 2005 |
We randomized 120 women with singleton pregnancy who were successfully treated for threatened preterm labor before 34 completed weeks to receive either maintenance tocolysis with two 40 mg ritodrine sustained release capsules three times a day (study group, n=62) or no treatment (control group, n=58) for three days. The primary outcome measure was the recurrent episode of threatened preterm labor within 72 hours, which was defined as regular palpable uterine contractions and change in cervical effacement and/or cervical dilatation on clinical examination. Secondary outcome measures included the incidence of preterm birth, neonatal adverse outcomes, and maternal side effects.
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Croatia | |
Department of Obstetrics and Gynecology, University of Zagreb | |
Zagreb, Croatia, 10000 |
Principal Investigator: | Ozren Grgic, MD | Sveti Duh Hospital |
Study Chair: | Ratko Matijevic, MD,PhD | Sveti Duh Hospital |
Study ID Numbers: | 0129111 |
Study First Received: | February 8, 2006 |
Last Updated: | May 3, 2006 |
ClinicalTrials.gov Identifier: | NCT00290173 History of Changes |
Health Authority: | Croatia: Ministry of Science, Education and Sports |
pre term labor therapy maintenance |
Neurotransmitter Agents Pregnancy Complications Adrenergic beta-Agonists Adrenergic Agents Obstetric Labor, Premature |
Ritodrine Obstetric Labor Complications Peripheral Nervous System Agents Adrenergic Agonists |
Neurotransmitter Agents Pregnancy Complications Adrenergic beta-Agonists Adrenergic Agents Molecular Mechanisms of Pharmacological Action Sympathomimetics Obstetric Labor, Premature Physiological Effects of Drugs Obstetric Labor Complications |
Ritodrine Reproductive Control Agents Adrenergic Agonists Pharmacologic Actions Tocolytic Agents Autonomic Agents Therapeutic Uses Peripheral Nervous System Agents |