<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/NCT03801252</url>
  </required_header>
  <id_info>
    <org_study_id>APPOINT</org_study_id>
    <nct_id>NCT03801252</nct_id>
  </id_info>
  <brief_title>Antibiotic Prophylaxis to Prevent Obesity-Related Induction Complications in Nulliparae at Term</brief_title>
  <acronym>APPOINT</acronym>
  <official_title>Antibiotic Prophylaxis to Prevent Obesity-Related Induction Complications in Nulliparae at Term (APPOINT): A Pilot Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Oklahoma</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Oklahoma</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</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>
      Obesity increases the risk of pregnancy complications, including among others puerperal&#xD;
      infections and cesarean delivery, and risk rises with increasing body mass index (BMI). Class&#xD;
      III obesity is an indication for delivery by 39 weeks, and these patients have a high rate of&#xD;
      labor induction. In nulliparous women from the general population (obese and non-obese),&#xD;
      labor induction at 39 weeks (compared to expectant management) is associated with less&#xD;
      morbidity and a lower cesarean rate. Antibiotic prophylaxis, standard before cesarean&#xD;
      delivery, is associated with less post-cesarean infection if azithromycin is added to the&#xD;
      standard cefazolin. In this placebo-controlled pilot trial, investigators will estimate the&#xD;
      parameters necessary to calculate the sample size for a planned multicenter clinical trial of&#xD;
      prophylactic antibiotics administered at the start of labor inductions of morbidly obese&#xD;
      nulliparous women at term.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Investigators will enroll consenting women delivering at The Children's Hospital at OU&#xD;
      Medical Center who meet enrollment criteria. Flyers will be distributed to providers to give&#xD;
      to women who may be eligible for the study at prenatal visits, so that they may review the&#xD;
      information prior to presenting for their induction of labor. Labor induction may be a&#xD;
      scheduled procedure. However, many inductions occur in an unscheduled fashion due to medical&#xD;
      or obstetric indications. Therefore, it is difficult to predict which women will ultimately&#xD;
      require labor induction and at what gestational age they will require it, so it is not&#xD;
      feasible to approach and consent all women during a clinic visit prior to labor induction.&#xD;
      Distribution of flyers will allow patients to have information about the study prior to&#xD;
      presenting for labor induction. Furthermore, unlike women in spontaneous labor, women being&#xD;
      consented just prior to a labor induction are not vulnerable in the same way as one might&#xD;
      consider a patient in labor, since they will not have the distraction and discomfort of&#xD;
      uterine contractions that are presenting in laboring patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 12, 2018</start_date>
  <completion_date type="Actual">June 1, 2021</completion_date>
  <primary_completion_date type="Actual">June 1, 2021</primary_completion_date>
  <phase>Early Phase 1</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>Randomized controlled clinical trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
    <masking_description>One arm includes double placebo drugs that will be blinded from the investigator and participant</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Cesarean delivery rate</measure>
    <time_frame>30 days after delivery</time_frame>
    <description>Rate at which women give birth via cesarean section</description>
  </primary_outcome>
  <primary_outcome>
    <measure>puerperal infection rate</measure>
    <time_frame>30 days after delivery</time_frame>
    <description>chorioamnionitis, endometritis and/or cesarean wound infection</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">183</enrollment>
  <condition>Obesity</condition>
  <condition>Induction of Labor Affected Fetus / Newborn</condition>
  <arm_group>
    <arm_group_label>Cefazolin + Azithromycin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Women will be randomized 1:1 to receive cefazolin 2 grams intravenously at the start of the labor induction and every 8 hours thereafter for a maximum of three doses and azithromycin 500 mg intravenously once at the start of the labor induction</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo + Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Women will be randomized 1:1 to receive placebo intravenously at the start of the labor induction and every 8 hours thereafter for a maximum of three doses and placebo intravenously once at the start of the labor induction</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cefazolin</intervention_name>
    <description>intravenous drugs used as prophylactic antibiotics</description>
    <arm_group_label>Cefazolin + Azithromycin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Intravenous saline</description>
    <arm_group_label>Placebo + Placebo</arm_group_label>
    <other_name>Saline</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Azithromycin</intervention_name>
    <description>prophylactic antibiotic</description>
    <arm_group_label>Cefazolin + Azithromycin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  BMI ≥30&#xD;
&#xD;
          -  No prior deliveries at or beyond 20 weeks gestation&#xD;
&#xD;
          -  Undergoing induction of labor&#xD;
&#xD;
          -  Gestational age 37 weeks or more&#xD;
&#xD;
          -  Age 15-45&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Fetal death prior to labor induction&#xD;
&#xD;
          -  Known fetal anomaly&#xD;
&#xD;
          -  Multiple gestation&#xD;
&#xD;
          -  Ruptured membranes for more than 12 hours&#xD;
&#xD;
          -  Chorioamnionitis or other infection requiring antibiotics at the start of the labor&#xD;
             induction&#xD;
&#xD;
          -  Previous myometrial surgery&#xD;
&#xD;
          -  Allergy to either drug used in the protocol (cefazolin or azithromycin)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Women of child-bearing age</gender_description>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stephanie Pierce, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Oklahoma</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Oklahoma Health Sciences Center</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>January 9, 2019</study_first_submitted>
  <study_first_submitted_qc>January 10, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 11, 2019</study_first_posted>
  <last_update_submitted>September 27, 2021</last_update_submitted>
  <last_update_submitted_qc>September 27, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 29, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Azithromycin</mesh_term>
    <mesh_term>Cefazolin</mesh_term>
  </intervention_browse>
  <pending_results>
    <submitted>January 9, 2023</submitted>
  </pending_results>
  <!-- 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/NCT03801252
org study id: APPOINT
nct id: NCT03801252
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
Obesity increases the risk of pregnancy complications, including among others puerperal
      infections and cesarean delivery, and risk rises with increasing body mass index (BMI). Class
      III obesity is an indication for delivery by 39 weeks, and these patients have a high rate of
      labor induction. In nulliparous women from the general population (obese and non-obese),
      labor induction at 39 weeks (compared to expectant management) is associated with less
      morbidity and a lower cesarean rate. Antibiotic prophylaxis, standard before cesarean
      delivery, is associated with less post-cesarean infection if azithromycin is added to the
      standard cefazolin. In this placebo-controlled pilot trial, investigators will estimate the
      parameters necessary to calculate the sample size for a planned multicenter clinical trial of
      prophylactic antibiotics administered at the start of labor inductions of morbidly obese
      nulliparous women at term.
Investigators will enroll consenting women delivering at The Children's Hospital at OU
      Medical Center who meet enrollment criteria. Flyers will be distributed to providers to give
      to women who may be eligible for the study at prenatal visits, so that they may review the
      information prior to presenting for their induction of labor. Labor induction may be a
      scheduled procedure. However, many inductions occur in an unscheduled fashion due to medical
      or obstetric indications. Therefore, it is difficult to predict which women will ultimately
      require labor induction and at what gestational age they will require it, so it is not
      feasible to approach and consent all women during a clinic visit prior to labor induction.
      Distribution of flyers will allow patients to have information about the study prior to
      presenting for labor induction. Furthermore, unlike women in spontaneous labor, women being
      consented just prior to a labor induction are not vulnerable in the same way as one might
      consider a patient in labor, since they will not have the distraction and discomfort of
      uterine contractions that are presenting in laboring patients.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized controlled clinical trial
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
masking description: One arm includes double placebo drugs that will be blinded from the investigator and participant
measure: Cesarean delivery rate
time frame: 30 days after delivery
description: Rate at which women give birth via cesarean section
measure: puerperal infection rate
time frame: 30 days after delivery
description: chorioamnionitis, endometritis and/or cesarean wound infection
arm group label: Cefazolin + Azithromycin
arm group type: Experimental
description: Women will be randomized 1:1 to receive cefazolin 2 grams intravenously at the start of the labor induction and every 8 hours thereafter for a maximum of three doses and azithromycin 500 mg intravenously once at the start of the labor induction
arm group label: Placebo + Placebo
arm group type: Placebo Comparator
description: Women will be randomized 1:1 to receive placebo intravenously at the start of the labor induction and every 8 hours thereafter for a maximum of three doses and placebo intravenously once at the start of the labor induction
intervention type: Drug
intervention name: Cefazolin
description: intravenous drugs used as prophylactic antibiotics
arm group label: Cefazolin + Azithromycin
intervention type: Drug
intervention name: Placebo
description: Intravenous saline
arm group label: Placebo + Placebo
other name: Saline
intervention type: Drug
intervention name: Azithromycin
description: prophylactic antibiotic
arm group label: Cefazolin + Azithromycin
criteria: 
gender: Female
gender based: Yes
gender description: Women of child-bearing age
minimum age: 15 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Stephanie Pierce, MD
role: Principal Investigator
affiliation: University of Oklahoma
facility: 
country: United States
responsible party type: Sponsor
mesh term: Obesity
mesh term: Azithromycin
mesh term: Cefazolin
submitted: January 9, 2023