Ritodrine in Oral Maintenance of Tocolysis After Active Preterm Labor

Not Applicable

Completed

• Conditions: Pregnancy

• Registration Number: NCT00290173
• Lead Sponsor: University of Zagreb

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.

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 Timeline

• Study Completion: 2005-08
• Status Verified: 2006-02
• Study First Submitted: 2006-02-08
• Study First Submitted QC: 2006-02-08
• Study First Posted: 2006-02-10
• Last Update Submitted: 2006-05-03
• Last Update Posted: 2006-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
the recurrence of preterm labor within 72 hours after discontinuation of IV treatment

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Department of Obstetrics and Gynecology, University of Zagreb; 🇭🇷 Zagreb, Croatia