<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/NCT03298191</url>
  </required_header>
  <id_info>
    <org_study_id>TPL</org_study_id>
    <nct_id>NCT03298191</nct_id>
  </id_info>
  <brief_title>Tocolysis in Prevention of Preterm Labor</brief_title>
  <official_title>Comparative Study on Tocolysis in Prevention of Preterm Labour</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Preterm birth is defined as birth before 37 completed weeks of gestation .it occurs in&#xD;
      11.1%of birth globally affecting an estimated 14.9 million babies every year . It is&#xD;
      generally accepted that approximately 65%-70%of preterm births are spontaneous,40%-45% of&#xD;
      them due to spontaneous preterm labor and 25%-30%following preterm rupture of&#xD;
      membranes.preterm birth represents the single largest cause of morbidity and mortality for&#xD;
      newborn and is estimated for 29%of deaths in the first four weeks of life and also is&#xD;
      estimated for of major cause of morbidity for pregnant women .&#xD;
&#xD;
      Tocolytic agents include a wide range of drugs that can slow or suppress uterine contractions&#xD;
      . Tocolytic are considered advantages in spontaneous preterm labor to : (a) allow time for&#xD;
      the fetus to mature ,potentially avoiding deleterious effects of pre-maturity . (b)allow time&#xD;
      for antenatal corticosteroids to be administered and have clinical effect. (c) allow time for&#xD;
      intrauterine transfer to higher-care center where neonatal intensive care facilities are&#xD;
      available . the ideal Tocolytic agent should be effective , easy to administer , without&#xD;
      significant material ,fetal or neonatal side effects and permit time for antenatal&#xD;
      corticosteroids to be administered and take effect . a variety of Tocolytic treatments have&#xD;
      been used to inhibit uterine activity in women in spontaneous preterm labor , including&#xD;
      betamimetics , calcium channel blockers , magnesium sulfate , prostaglandin inhibitors and&#xD;
      oxytocin receptor antagonists however there is considerable global variation in types , doses&#xD;
      and regimens of tocolytic agents uses to manage preterm labor .&#xD;
&#xD;
      A comparison study between Ritodrine, magnesium sulfate and Nifedipine in terms of effect and&#xD;
      morbidity will be conducted.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">October 25, 2017</start_date>
  <completion_date type="Anticipated">May 25, 2018</completion_date>
  <primary_completion_date type="Anticipated">April 25, 2018</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>
    <intervention_model_description>complications ofthe drugs good response to drugs</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>false preterm labour</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>The time of delivery</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Preterm Labor Without Delivery</condition>
  <arm_group>
    <arm_group_label>Magnesium sulphate</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Ritodrine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Calcium channel blocker</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Magnesium Sulfate</intervention_name>
    <description>Those women will be given Magnesium Sulfate for tocolysis</description>
    <arm_group_label>Magnesium sulphate</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ritodrine</intervention_name>
    <description>Those women will be given Ritodrine for tocolysis</description>
    <arm_group_label>Ritodrine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Calcium Channel Blockers</intervention_name>
    <description>Those women will be given Calcium Channel Blockers for tocolysis</description>
    <arm_group_label>Calcium channel blocker</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  . Gestational age between 24-37weeks&#xD;
&#xD;
               -  Symptoms such as low backache , cramping ,pelvic pressure, excessive vaginal&#xD;
                  discharge and vaginal spotting .&#xD;
&#xD;
               -  Regular uterine contractions at least of 30 seconds duration at a rate of more&#xD;
                  than 4/30 minutes&#xD;
&#xD;
               -  Cervical changes dilatation less than 3cm,effacement lessthan50%.&#xD;
&#xD;
               -  Intact membranes.&#xD;
&#xD;
        Exclusion criteria&#xD;
&#xD;
          -  Active vaginal bleeding and placental abruption.&#xD;
&#xD;
          -  Chorioamnionitis and intrauterine infection&#xD;
&#xD;
          -  Fetal conditions : fetal death or distress, lethal congenital or chromosomal&#xD;
             abnormalities and intra uterine growth restriction&#xD;
&#xD;
          -  Maternal conditions indicate that pregnancy shouldn't be continued: eclampsia , severe&#xD;
             preeclampsia and cardiac diseases&#xD;
&#xD;
          -  Drug specific contraindications(contraindication of tocolysis)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>pregnancy</gender_description>
    <minimum_age>17 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Mohamed Atef Mohamed</name>
      <address>
        <city>Sohag</city>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>mohamed mohamed</last_name>
      <phone>+01005537951</phone>
      <email>mohammedelksoy@yahoo.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>August 26, 2017</study_first_submitted>
  <study_first_submitted_qc>September 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 2, 2017</study_first_posted>
  <last_update_submitted>September 26, 2017</last_update_submitted>
  <last_update_submitted_qc>September 26, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 2, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>mohamed atef mohamed</investigator_full_name>
    <investigator_title>principal investigator</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>Magnesium Sulfate</mesh_term>
    <mesh_term>Calcium Channel Blockers</mesh_term>
    <mesh_term>Ritodrine</mesh_term>
    <mesh_term>Calcium</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03298191
org study id: TPL
nct id: NCT03298191
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Preterm birth is defined as birth before 37 completed weeks of gestation .it occurs in
      11.1%of birth globally affecting an estimated 14.9 million babies every year . It is
      generally accepted that approximately 65%-70%of preterm births are spontaneous,40%-45% of
      them due to spontaneous preterm labor and 25%-30%following preterm rupture of
      membranes.preterm birth represents the single largest cause of morbidity and mortality for
      newborn and is estimated for 29%of deaths in the first four weeks of life and also is
      estimated for of major cause of morbidity for pregnant women .

      Tocolytic agents include a wide range of drugs that can slow or suppress uterine contractions
      . Tocolytic are considered advantages in spontaneous preterm labor to : (a) allow time for
      the fetus to mature ,potentially avoiding deleterious effects of pre-maturity . (b)allow time
      for antenatal corticosteroids to be administered and have clinical effect. (c) allow time for
      intrauterine transfer to higher-care center where neonatal intensive care facilities are
      available . the ideal Tocolytic agent should be effective , easy to administer , without
      significant material ,fetal or neonatal side effects and permit time for antenatal
      corticosteroids to be administered and take effect . a variety of Tocolytic treatments have
      been used to inhibit uterine activity in women in spontaneous preterm labor , including
      betamimetics , calcium channel blockers , magnesium sulfate , prostaglandin inhibitors and
      oxytocin receptor antagonists however there is considerable global variation in types , doses
      and regimens of tocolytic agents uses to manage preterm labor .

      A comparison study between Ritodrine, magnesium sulfate and Nifedipine in terms of effect and
      morbidity will be conducted.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: complications ofthe drugs good response to drugs
primary purpose: Prevention
masking: Single (Participant)
masking description: false preterm labour
measure: The time of delivery
time frame: 6 months
arm group label: Magnesium sulphate
arm group type: Experimental
arm group label: Ritodrine
arm group type: Experimental
arm group label: Calcium channel blocker
arm group type: Experimental
intervention type: Drug
intervention name: Magnesium Sulfate
description: Those women will be given Magnesium Sulfate for tocolysis
arm group label: Magnesium sulphate
intervention type: Drug
intervention name: Ritodrine
description: Those women will be given Ritodrine for tocolysis
arm group label: Ritodrine
intervention type: Drug
intervention name: Calcium Channel Blockers
description: Those women will be given Calcium Channel Blockers for tocolysis
arm group label: Calcium channel blocker
criteria: 
gender: Female
gender based: Yes
gender description: pregnancy
minimum age: 17 Years
maximum age: 40 Years
healthy volunteers: No
facility: 
status: Recruiting
contact: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: mohamed atef mohamed
investigator title: principal investigator
mesh term: Premature Birth
mesh term: Obstetric Labor, Premature
mesh term: Magnesium Sulfate
mesh term: Calcium Channel Blockers
mesh term: Ritodrine
mesh term: Calcium
sharing ipd: No