Ritodrine in Oral Maintenance of Tocolysis After Active Preterm Labor

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Completion Date

2005-08-31

Brief Summary

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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

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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.

Conditions

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Pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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efficacy of oral ritodrine in maintaining uterine quiescence

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Principal Investigators

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Ozren Grgic, MD

Role: PRINCIPAL_INVESTIGATOR

Sveti Duh Hospital

Ratko Matijevic, MD,PhD

Role: STUDY_CHAIR

Sveti Duh Hospital

Locations

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Department of Obstetrics and Gynecology, University of Zagreb

Zagreb, , Croatia

Site Status

Countries

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Croatia

References

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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.

Reference Type RESULT

PMID: 16489694 (View on PubMed)

Other Identifiers

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0129111

Identifier Type: -

Identifier Source: org_study_id