Ritodrine in Oral Maintenance of Tocolysis After Active Preterm Labor
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Purpose
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 | Intervention |
|---|---|
|
Pregnancy |
Drug: efficacy of oral ritodrine in maintaining uterine quiescence |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Ritodrine in Oral Maintenance of Tocolysis After Active Preterm Labor: Randomized Controlled Trial |
- the recurrence of preterm labor within 72 hours after discontinuation of IV treatment
- 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
| Estimated Study Completion Date: | August 2005 |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| Croatia | |
| Department of Obstetrics and Gynecology, University of Zagreb | |
| Zagreb, Croatia, 10000 | |
| Principal Investigator: | Ozren Grgic, MD | Sveti Duh Hospital |
| Study Chair: | Ratko Matijevic, MD,PhD | Sveti Duh Hospital |
More Information
Publications:
| ClinicalTrials.gov Identifier: | NCT00290173 History of Changes |
| Other Study ID Numbers: | 0129111 |
| Study First Received: | February 8, 2006 |
| Last Updated: | May 3, 2006 |
| Health Authority: | Croatia: Ministry of Science, Education and Sports |
Keywords provided by University of Zagreb:
|
pre term labor therapy maintenance |
Additional relevant MeSH terms:
|
Obstetric Labor, Premature Obstetric Labor Complications Pregnancy Complications Ritodrine Adrenergic beta-2 Receptor Agonists Adrenergic beta-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Sympathomimetics Autonomic Agents Peripheral Nervous System Agents Tocolytic Agents Reproductive Control Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 21, 2013