Ritodrine in Oral Maintenance of Tocolysis After Active Preterm Labor

Study Overview
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Brief Summary
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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
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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.

Official Title
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Ritodrine in Oral Maintenance of Tocolysis After Active Preterm Labor: Randomized Controlled Trial

Conditions
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Pregnancy

Intervention / Treatment
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* Drug: efficacy of oral ritodrine in maintaining uterine quiescence


Participation Criteria
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Eligibility 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: efficacy of oral ritodrine in maintaining uterine quiescence|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the recurrence of preterm labor within 72 hours after discontinuation of IV treatment |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pre term labor, therapy, maintenance