Ritodrine in Oral Maintenance of Tocolysis After Active Preterm Labor
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Outcome Measures
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 []
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Pregnancy between completed 24 to 24 weeks
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Successfully treated episode of threatened preterm labour by intravenous preparations
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No uterine contractions
Exclusion Criteria:
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Uterine contractions (painful, clinically palpable, or present on cardiotocography)
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Cervical dilatation of ≥5 cm
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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
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Positive findings of microorganisms rather than normal vaginal flora on high vaginal swab
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Any signs of fetal distress according to cardiotocography, Doppler assessment of blood flow in umbilical artery, and biophysical profile of <8.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 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
- Principal Investigator: Ozren Grgic, MD, Sveti Duh Hospital
- Study Chair: Ratko Matijevic, MD,PhD, Sveti Duh Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 0129111