<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03040752</url>
  </required_header>
  <id_info>
    <org_study_id>157</org_study_id>
    <nct_id>NCT03040752</nct_id>
  </id_info>
  <brief_title>Comparative Study Between Nifedipine and Ritodrine as Maintenance Tocolytic Therapy in Preterm Labor</brief_title>
  <official_title>Comparative Study Between Nifedipine and Ritodrine as Maintenance Tocolytic Therapy in Preterm Labor: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      A randomized controlled double blinded study included 200 women with preterm contractions.&#xD;
      After successful arrest of contractions women were randomized into 2 equal groups: GI women&#xD;
      received nifedipine 20 mg tablets twice daily and GII women received Ritodrine 5 mg tablets&#xD;
      every 6 hours. The primary outcome was gestational age at delivery and the secondary outcomes&#xD;
      include episodes of recurrent preterm labor, mode of delivery, maternal side effects and&#xD;
      neonatal outcome&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Women included in the study were diagnosed as preterm labor defined according to American&#xD;
      Academy of Pediatrics and the American College of Obstetricians and Gynecologists (2012) with&#xD;
      regular contractions before 37 weeks that are associated with cervical change [12].&#xD;
&#xD;
      Regular uterine contractions means at least 4 in 20 minutes or 8 in 60 minutes) and cervical&#xD;
      changes are either cervical dilation more than 1 cm, and/or cervical effacement ≥ 80%.&#xD;
      Threatened preterm labour was defined as contractions without any appreciable cervical&#xD;
      changes. Women included were between 18 and 40 years old at gestational age between 28 and 34&#xD;
      weeks. Women with failed tocolytic treatment to stop uterine contractions, those with&#xD;
      established preterm labor (cervical dilatation ≥ 4 cm), with multifetal pregnancy, fetal&#xD;
      anomalies or those with contraindication of continuation of pregnancy (antepartum hemorrhage,&#xD;
      premature rupture of membranes, evidence of intrauterine infections or non reassuring fetal&#xD;
      heart rate tracing) were excluded from the study.&#xD;
&#xD;
      During the pre-selection visit, exclusion and inclusion criteria were applied; with recording&#xD;
      of full medical history, findings on abdominal ,local and ultrasound examination.&#xD;
&#xD;
      When the patient's consent was obtained, digital vaginal examination was done prior to start&#xD;
      of medication Treatment of TPL was achieved through Indomethacin administered rectally. A&#xD;
      dose of 50 to 100 mg is followed at 8-hour intervals not to exceed a total 24-hour dose of&#xD;
      200 mg for a maximum of 48 hours [4].&#xD;
&#xD;
      After successful arrest of contractions women were randomized using automated web based&#xD;
      randomization system ensuring allocation concealment into 2 equal groups: GI women received&#xD;
      nifedipine 20 mg tablets (Epilat Retard®, EIPICO, Egypt) twice daily, starting 12 hours after&#xD;
      arrest of threatened preterm labor(The cost is 20 tab=5.20 LE) and GII women received&#xD;
      Ritodrine 5 mg tablets (Yutopar®, PHARCO, Alexandria) every 6 hours, starting 12 hours after&#xD;
      arrest of threatened preterm labor.(The cost is 20 tab=20LE Treatment was maintained till 37&#xD;
      weeks of gestation unless established preterm delivery commence&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2015</start_date>
  <completion_date type="Actual">January 2017</completion_date>
  <primary_completion_date type="Actual">January 2017</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>gestational age at delivery</measure>
    <time_frame>8 weeks</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">200</enrollment>
  <condition>Preterm Birth</condition>
  <arm_group>
    <arm_group_label>Nifedipine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>nifedipine 20 mg tablets (Epilat Retard®, EIPICO, Egypt) twice daily, starting 12 hours after arrest of threatened preterm labor</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ritodrine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Ritodrine 5 mg tablets (Yutopar®, PHARCO, Alexandria) every 6 hours, starting 12 hours after arrest of threatened preterm labor.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nifedipine 20 Mg</intervention_name>
    <description>nifedipine 20 mg tablets (Epilat Retard®, EIPICO, Egypt) twice daily, starting 12 hours after arrest of threatened preterm labor</description>
    <arm_group_label>Nifedipine</arm_group_label>
    <other_name>Epilate retard</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ritodrine Oral Tablet</intervention_name>
    <description>Ritodrine 5 mg tablets (Yutopar®, PHARCO, Alexandria) every 6 hours, starting 12 hours after arrest of threatened preterm labor</description>
    <arm_group_label>Ritodrine</arm_group_label>
    <other_name>Yutopar</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women included in the study were diagnosed as preterm labor defined according to&#xD;
             American Academy of Pediatrics and the American College of Obstetricians and&#xD;
             Gynecologists (2012) with regular contractions before 37 weeks that are associated&#xD;
             with cervical change .&#xD;
&#xD;
        Regular uterine contractions means at least 4 in 20 minutes or 8 in 60 minutes) and&#xD;
        cervical changes are either cervical dilation more than 1 cm, and/or cervical effacement ≥&#xD;
        80%. Threatened preterm labour was defined as contractions without any appreciable cervical&#xD;
        changes. Women included were between 18 and 40 years old at gestational age between 28 and&#xD;
        34 weeks&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women with failed tocolytic treatment to stop uterine contractions,&#xD;
&#xD;
          -  those with established preterm labor (cervical dilatation ≥ 4 cm),&#xD;
&#xD;
          -  multifetal pregnancy&#xD;
&#xD;
          -  fetal anomalies&#xD;
&#xD;
          -  those with contraindication of continuation of pregnancy (antepartum hemorrhage,&#xD;
             premature rupture of membranes, evidence of intrauterine infections or non reassuring&#xD;
             fetal heart rate tracing)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>39 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ahmed Maged</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kasr Alainy medical school</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kasr Alainy medical school</name>
      <address>
        <city>Cairo</city>
        <zip>12151</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>January 31, 2017</study_first_submitted>
  <study_first_submitted_qc>January 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 2, 2017</study_first_posted>
  <last_update_submitted>September 20, 2019</last_update_submitted>
  <last_update_submitted_qc>September 20, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 24, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Ahmed M Maged, MD</investigator_full_name>
    <investigator_title>Assistant professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Premature Birth</mesh_term>
    <mesh_term>Obstetric Labor, Premature</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nifedipine</mesh_term>
    <mesh_term>Ritodrine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03040752
org study id: 157
nct id: NCT03040752
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
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
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
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: gestational age at delivery
time frame: 8 weeks
arm group label: Nifedipine
arm group type: Active Comparator
description: nifedipine 20 mg tablets (Epilat Retard®, EIPICO, Egypt) twice daily, starting 12 hours after arrest of threatened preterm labor
arm group label: Ritodrine
arm group type: Active Comparator
description: Ritodrine 5 mg tablets (Yutopar®, PHARCO, Alexandria) every 6 hours, starting 12 hours after arrest of threatened preterm labor.
intervention type: Drug
intervention name: Nifedipine 20 Mg
description: nifedipine 20 mg tablets (Epilat Retard®, EIPICO, Egypt) twice daily, starting 12 hours after arrest of threatened preterm labor
arm group label: Nifedipine
other name: Epilate retard
intervention type: Drug
intervention name: Ritodrine Oral Tablet
description: Ritodrine 5 mg tablets (Yutopar®, PHARCO, Alexandria) every 6 hours, starting 12 hours after arrest of threatened preterm labor
arm group label: Ritodrine
other name: Yutopar
criteria: 
gender: Female
gender based: Yes
minimum age: 18 Years
maximum age: 39 Years
healthy volunteers: No
last name: Ahmed Maged
role: Principal Investigator
affiliation: Kasr Alainy medical school
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Ahmed M Maged, MD
investigator title: Assistant professor
mesh term: Premature Birth
mesh term: Obstetric Labor, Premature
mesh term: Nifedipine
mesh term: Ritodrine
sharing ipd: Undecided