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Completed

NCT Number: NCT00290173

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.

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Key information

Conditions

Pregnancy

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Obstetrics and Gynecology, University of Zagreb

Zagreb, 10000, Croatia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

efficacy of oral ritodrine in maintaining uterine quiescence

Drug

Primary outcomes

  1. the recurrence of preterm labor within 72 hours after discontinuation of IV treatment

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of Zagreb

Other

Collaborators

  • Ministry of Science, Education and Sport, Republic of Croatia

Registry information

Official study title

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

Important dates

Study completion
2005
First posted
Feb 10, 2006
Registry last updated
May 4, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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