Back to resultsRitodrine in Oral Maintenance of Tocolysis After Active Preterm Labor
Primary Purpose
Pregnancy
Status
Completed
Phase
Not Applicable
Locations
Croatia
Study Type
Interventional
Intervention
efficacy of oral ritodrine in maintaining uterine quiescence
Sponsored by
About this trial
This is an interventional treatment trial for Pregnancy focused on measuring pre term labor, therapy, maintenance
Eligibility 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.
Sites / Locations
- Department of Obstetrics and Gynecology, University of Zagreb
Outcomes
Primary Outcome Measures
the recurrence of preterm labor within 72 hours after discontinuation of IV treatment
Secondary Outcome Measures
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
Full Information
NCT ID
NCT00290173
First Posted
February 8, 2006
Last Updated
May 3, 2006
Sponsor
University of Zagreb
Collaborators
Ministry of Science, Education and Sport, Republic of Croatia
1. Study Identification
Unique Protocol Identification Number
NCT00290173
Brief Title
Ritodrine in Oral Maintenance of Tocolysis After Active Preterm Labor
Official Title
Ritodrine in Oral Maintenance of Tocolysis After Active Preterm Labor: Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2006
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University of Zagreb
Collaborators
Ministry of Science, Education and Sport, Republic of Croatia
4. Oversight
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy
Keywords
pre term labor, therapy, maintenance
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
efficacy of oral ritodrine in maintaining uterine quiescence
Primary Outcome Measure Information:
Title
the recurrence of preterm labor within 72 hours after discontinuation of IV treatment
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ozren Grgic, MD
Organizational Affiliation
Sveti Duh Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ratko Matijevic, MD,PhD
Organizational Affiliation
Sveti Duh Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Obstetrics and Gynecology, University of Zagreb
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
12. IPD Sharing Statement
Citations:
PubMed Identifier
16489694
Citation
Matijevic R, Grgic O, Vasilj O. Ritodrine in oral maintenance of tocolysis after active preterm labor: randomized controlled trial. Croat Med J. 2006 Feb;47(1):25-31.
Results Reference
result
Learn more about this trial
Ritodrine in Oral Maintenance of Tocolysis After Active Preterm Labor
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