NCT00290173

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Completion

Last participant's last visit for all outcomes

August 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 8, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 10, 2006

Completed
Last Updated

May 4, 2006

Status Verified

February 1, 2006

First QC Date

February 8, 2006

Last Update Submit

May 3, 2006

Conditions

Pregnancy

Keywords

pre term labortherapymaintenance

Outcome Measures

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

Interventions

efficacy of oral ritodrine in maintaining uterine quiescenceDRUG

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Pregnancy between completed 24 to 24 weeks
  • Successfully treated episode of threatened preterm labour by intravenous preparations
  • No uterine contractions

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Obstetrics and Gynecology, University of Zagreb

Zagreb, 10000, Croatia

Location

Related 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.

    PMID: 16489694RESULT

Study Officials

  • Ozren Grgic, MD

    Sveti Duh Hospital

    PRINCIPAL INVESTIGATOR

  • Ratko Matijevic, MD,PhD

    Sveti Duh Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 8, 2006

First Posted

February 10, 2006

Study Completion

August 1, 2005

Last Updated

May 4, 2006

Record last verified: 2006-02

Locations

CR(1)