Status:
COMPLETED
Ritodrine in Oral Maintenance of Tocolysis After Active Preterm Labor
Lead Sponsor:
University of Zagreb
Collaborating Sponsors:
Ministry of Science, Education and Sport, Republic of Croatia
Conditions:
Pregnancy
Eligibility:
FEMALE
18-45 years
Phase:
NA
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 la...
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 s...
Eligibility Criteria
Inclusion
- Pregnancy between completed 24 to 24 weeks
- Successfully treated episode of threatened preterm labour by intravenous preparations
- No uterine contractions
Exclusion
- 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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
August 1 2005
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00290173
End Date
August 1 2005
Last Update
May 4 2006
Active Locations (1)
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1
Department of Obstetrics and Gynecology, University of Zagreb
Zagreb, Croatia, 10000