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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00290173 |
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Date of registration:
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08/02/2006 |
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Primary sponsor: |
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Public title:
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Ritodrine in Oral Maintenance of Tocolysis After Active Preterm Labor
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Scientific title:
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Ritodrine in Oral Maintenance of Tocolysis After Active Preterm Labor: Randomized Controlled Trial |
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Date of first enrolment:
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December 2002 |
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Target sample size:
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00290173 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Croatia
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Contacts
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Name:
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Ozren Grgic, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Sveti Duh Hospital |
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Name:
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Ratko Matijevic, MD,PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Sveti Duh Hospital |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
45 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Pregnancy
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Intervention(s)
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Drug: efficacy of oral ritodrine in maintaining uterine quiescence
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Primary Outcome(s)
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the recurrence of preterm labor within 72 hours after discontinuation of IV treatment
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Secondary Outcome(s)
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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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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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