Comparative Study Between Nifedipine and Ritodrine as Maintenance Tocolytic Therapy in Preterm Labor

• Status: Completed
• Trial end date: 2017-01-01
• Target enrollment: 0
• Participant gender: Female

Summary

A randomized controlled double blinded study included 200 women with preterm contractions. After successful arrest of contractions women were randomized into 2 equal groups: GI women received nifedipine 20 mg tablets twice daily and GII women received Ritodrine 5 mg tablets every 6 hours. The primary outcome was gestational age at delivery and the secondary outcomes include episodes of recurrent preterm labor, mode of delivery, maternal side effects and neonatal outcome

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cairo University
• Treatments: Nifedipine; Ritodrine; Tocolytic Agents

Criteria

Inclusion Criteria:

• Women included in the study were diagnosed as preterm labor defined according to American Academy of Pediatrics and the American College of Obstetricians and Gynecologists (2012) with regular contractions before 37 weeks that are associated with cervical change .

Regular uterine contractions means at least 4 in 20 minutes or 8 in 60 minutes) and cervical changes are either cervical dilation more than 1 cm, and/or cervical effacement ≥ 80%. Threatened preterm labour was defined as contractions without any appreciable cervical changes. Women included were between 18 and 40 years old at gestational age between 28 and 34 weeks

Exclusion Criteria:

• Women with failed tocolytic treatment to stop uterine contractions,

• those with established preterm labor (cervical dilatation ≥ 4 cm),

• multifetal pregnancy

• fetal anomalies

• those with contraindication of continuation of pregnancy (antepartum hemorrhage, premature rupture of membranes, evidence of intrauterine infections or non reassuring fetal heart rate tracing)