Ritodrine in Oral Maintenance of Tocolysis After Active Preterm Labor
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.
|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.
|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|