Ritodrine in Oral Maintenance of Tocolysis After Active Preterm Labor - Full Text View

Sponsors and Collaborators:	University of Zagreb Ministry of Science, Education and Sport, Republic of Croatia
Information provided by:	University of Zagreb
ClinicalTrials.gov Identifier:	NCT00290173

Purpose

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.

Condition	Intervention
Pregnancy	Drug: efficacy of oral ritodrine in maintaining uterine quiescence

Drug Information available for: Ritodrine Ritodrine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
Official Title:	Ritodrine in Oral Maintenance of Tocolysis After Active Preterm Labor: Randomized Controlled Trial

Further study details as provided by University of Zagreb:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

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.

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00290173

Locations

Croatia
Department of Obstetrics and Gynecology, University of Zagreb
Zagreb, Croatia, 10000

Sponsors and Collaborators

University of Zagreb

Ministry of Science, Education and Sport, Republic of Croatia

Investigators

Principal Investigator:	Ozren Grgic, MD	Sveti Duh Hospital
Study Chair:	Ratko Matijevic, MD,PhD	Sveti Duh Hospital

More Information

Publications of Results:

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.

Study ID Numbers:	0129111
Study First Received:	February 8, 2006
Last Updated:	May 3, 2006
ClinicalTrials.gov Identifier:	NCT00290173
Health Authority:	Croatia: Ministry of Science, Education and Sports

Keywords provided by University of Zagreb:

pre term labor
therapy
maintenance

Study placed in the following topic categories:

Pregnancy Complications
Obstetric Labor, Premature
Ritodrine
Obstetric Labor Complications

Additional relevant MeSH terms:

Neurotransmitter Agents
Adrenergic beta-Agonists
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Sympathomimetics
Physiological Effects of Drugs
Reproductive Control Agents

Adrenergic Agonists
Pharmacologic Actions
Tocolytic Agents
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009