Pregnancy
Conditions
Keywords
pre term labor, therapy, maintenance
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.
Interventions
DRUGefficacy of oral ritodrine in maintaining uterine quiescence
Sponsors
Ministry of Science, Education and Sport, Republic of Croatia
University of Zagreb
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the recurrence of preterm labor within 72 hours after discontinuation of IV treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Croatia
Outcome results
None listed