Clinical trial NCT00290173: Ritodrine in Oral Maintenance of Tocolysis After Active Preterm Labor
Official title: Ritodrine in Oral Maintenance of Tocolysis After Active Preterm Labor: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Keywords: pre term labor
therapy
maintenance
Lead sponsor: University of Zagreb
Sponsor class: OTHER
Collaborators: name: Ministry of Science, Education and Sport, Republic of Croatia
First posted: 2006-02-10
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 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.

Primary outcomes:
measure: the recurrence of preterm labor within 72 hours after discontinuation of IV treatment
Secondary outcomes:
measure: 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
Other outcomes:
Locations:
city: Zagreb
country: Croatia
facility: Department of Obstetrics and Gynecology, University of Zagreb
Study officials:
affiliation: Sveti Duh Hospital
name: Ozren Grgic, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sveti Duh Hospital
name: Ratko Matijevic, MD,PhD
role: STUDY_CHAIR
References:
citation: 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.