Comparative Study Between Nifedipine and Ritodrine as Maintenance Tocolytic Therapy in Preterm Labor
Condition: Preterm Birth
MeSH terms: Premature Birth; Obstetric Labor, Premature
Study type: Interventional
Phase: Phase 4

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
    

Detailed description: 
      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 [12].

      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. Women with failed tocolytic treatment to stop uterine contractions, those with
      established preterm labor (cervical dilatation ≥ 4 cm), with multifetal pregnancy, fetal
      anomalies or those with contraindication of continuation of pregnancy (antepartum hemorrhage,
      premature rupture of membranes, evidence of intrauterine infections or non reassuring fetal
      heart rate tracing) were excluded from the study.

      During the pre-selection visit, exclusion and inclusion criteria were applied; with recording
      of full medical history, findings on abdominal ,local and ultrasound examination.

      When the patient's consent was obtained, digital vaginal examination was done prior to start
      of medication Treatment of TPL was achieved through Indomethacin administered rectally. A
      dose of 50 to 100 mg is followed at 8-hour intervals not to exceed a total 24-hour dose of
      200 mg for a maximum of 48 hours [4].

      After successful arrest of contractions women were randomized using automated web based
      randomization system ensuring allocation concealment into 2 equal groups: GI women received
      nifedipine 20 mg tablets (Epilat Retard®, EIPICO, Egypt) twice daily, starting 12 hours after
      arrest of threatened preterm labor(The cost is 20 tab=5.20 LE) and GII women received
      Ritodrine 5 mg tablets (Yutopar®, PHARCO, Alexandria) every 6 hours, starting 12 hours after
      arrest of threatened preterm labor.(The cost is 20 tab=20LE Treatment was maintained till 37
      weeks of gestation unless established preterm delivery commence
    

Intervention name(s): Nifedipine 20 Mg; Ritodrine Oral Tablet
Intervention type(s): Drug; Drug
Intervention description(s): nifedipine 20 mg tablets (Epilat Retard®, EIPICO, Egypt) twice daily, starting 12 hours after arrest of threatened preterm labor; Ritodrine 5 mg tablets (Yutopar®, PHARCO, Alexandria) every 6 hours, starting 12 hours after arrest of threatened preterm labor
Other intervention name(s): Epilate retard; Yutopar
Intervention MeSH terms: Nifedipine; Ritodrine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention