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Ritodrine in Oral Maintenance of Tocolysis After Active Preterm Labor

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ClinicalTrials.gov Identifier: NCT00290173
Recruitment Status : Completed
First Posted : February 10, 2006
Last Update Posted : May 4, 2006
Sponsor:
Collaborator:
Ministry of Science, Education and Sport, Republic of Croatia
Information provided by:
University of Zagreb

Brief Summary:
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 or disease Intervention/treatment Phase
Pregnancy Drug: efficacy of oral ritodrine in maintaining uterine quiescence Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ritodrine in Oral Maintenance of Tocolysis After Active Preterm Labor: Randomized Controlled Trial
Study Completion Date : August 2005



Primary Outcome Measures :
  1. the recurrence of preterm labor within 72 hours after discontinuation of IV treatment

Secondary Outcome Measures :
  1. Secondary outcome measures were incidence of preterm delivery before 37 weeks of gestation, incidence of early preterm delivery before completed 34 weeks of gestation, prolongation of pregnancy, birth weight, perinatal mortality and perinatal morbidity


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pregnancy between completed 24 to 24 weeks
  • Successfully treated episode of threatened preterm labour by intravenous preparations
  • No uterine contractions

Exclusion Criteria:

  • Uterine contractions (painful, clinically palpable, or present on cardiotocography)
  • Cervical dilatation of ≥5 cm
  • Clinical and laboratory signs of infection defined as offensive vaginal discharge on clinical examination, vaginal pH ≥5, white blood cell (WBC) count >16×109/L, and C-reactive protein (CRP) >10 mg/L
  • Positive findings of microorganisms rather than normal vaginal flora on high vaginal swab
  • Any signs of fetal distress according to cardiotocography, Doppler assessment of blood flow in umbilical artery, and biophysical profile of <8.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00290173


Locations
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Croatia
Department of Obstetrics and Gynecology, University of Zagreb
Zagreb, Croatia, 10000
Sponsors and Collaborators
University of Zagreb
Ministry of Science, Education and Sport, Republic of Croatia
Investigators
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Principal Investigator: Ozren Grgic, MD Sveti Duh Hospital
Study Chair: Ratko Matijevic, MD,PhD Sveti Duh Hospital
Publications of Results:
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ClinicalTrials.gov Identifier: NCT00290173    
Other Study ID Numbers: 0129111
First Posted: February 10, 2006    Key Record Dates
Last Update Posted: May 4, 2006
Last Verified: February 2006
Keywords provided by University of Zagreb:
pre term labor
therapy
maintenance
Additional relevant MeSH terms:
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Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Ritodrine
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action