Trials / Completed
CompletedNCT00290173
Ritodrine in Oral Maintenance of Tocolysis After Active Preterm Labor
Ritodrine in Oral Maintenance of Tocolysis After Active Preterm Labor: Randomized Controlled Trial
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- —
- Sponsor
- University of Zagreb · Academic / Other
- Sex
- Female
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | efficacy of oral ritodrine in maintaining uterine quiescence |
Timeline
- Completion
- 2005-08-01
- First posted
- 2006-02-10
- Last updated
- 2006-05-04
Locations
1 site across 1 country: Croatia
Source: ClinicalTrials.gov record NCT00290173. Inclusion in this directory is not an endorsement.