Ritodrine in Oral Maintenance of Tocolysis After Active Preterm Labor

University of Zagreb

Status

Completed

Conditions

Pregnancy

Treatments

Drug: efficacy of oral ritodrine in maintaining uterine quiescence

Study type

Interventional

Funder types

Other

Identifiers

NCT00290173

0129111

Details and patient eligibility

About

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.

Full 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.

Sex

Female

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

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.