Ritodrine in Oral Maintenance of Tocolysis After Active Preterm Labor

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00290173
• Other study ID #: 0129111
• Status: Completed
• Phase: N/A
• First received: February 8, 2006
• Last updated: May 3, 2006
• Est. completion date: August 2005

Study information

• Verified date: February 2006
• Source: University of Zagreb
• Contact: n/a
• Is FDA regulated: No
• Health authority: Croatia: Ministry of Science, Education and Sports
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: August 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obstetric Labor, Premature
• Pregnancy

Intervention

Drug:
• efficacy of oral ritodrine in maintaining uterine quiescence

Locations

Country	Name	City	State
Croatia	Department of Obstetrics and Gynecology, University of Zagreb	Zagreb

Sponsors (2)

Lead Sponsor	Collaborator
University of Zagreb	Ministry of Science, Education and Sport, Republic of Croatia

Country where clinical trial is conducted

Croatia, 

References & Publications (1)

Matijevic R, Grgic O, Vasilj O. Ritodrine in oral maintenance of tocolysis after active preterm labor: randomized controlled trial. Croat Med J. 2006 Feb;47(1):25-31. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the recurrence of preterm labor within 72 hours after discontinuation of IV treatment
Secondary	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