<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/NCT03796416</url>
  </required_header>
  <id_info>
    <org_study_id>HP-00077208</org_study_id>
    <nct_id>NCT03796416</nct_id>
  </id_info>
  <brief_title>Obesity Study to Assess Induction of Labor</brief_title>
  <acronym>Obtainable</acronym>
  <official_title>Obesity Study to Assess Induction of Labor With Balloon and Cytotec: a Randomized Control Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Maryland, Baltimore</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Maryland, Baltimore</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      There are more and more pregnant women who are obese. It is very difficult for obese women to&#xD;
      get into labor. That is why when women are obese, half are likely to need a Cesarean&#xD;
      delivery(C-section). Unfortunately, C-sections are more dangerous for obese women. There may&#xD;
      be a combination of issues that cause obese women to need C-sections. We believe one of those&#xD;
      reasons is that the womb of obese women respond differently to medications and devices&#xD;
      compared to non-obese women. There are commonly two ways to help women get into labor. One&#xD;
      way is a medication called misoprostol. The second way is a device called Foley balloon. In&#xD;
      most studies, both ways are equally effective in helping women get into labor. However, these&#xD;
      studies included everyone, and didn't focus on obese women.&#xD;
&#xD;
      So far there are no studies in this area that focus only on obese women. Therefore we need to&#xD;
      design this study to focus just on obese women and what is the best way to help them get into&#xD;
      labor and avoid a C-section.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    in error&#xD;
  </why_stopped>
  <start_date type="Actual">December 1, 2019</start_date>
  <completion_date type="Anticipated">July 2025</completion_date>
  <primary_completion_date type="Anticipated">January 2022</primary_completion_date>
  <phase>N/A</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>achieving complete cervical dilation</measure>
    <time_frame>24 hours</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Induction of Labor Affected Fetus / Newborn</condition>
  <arm_group>
    <arm_group_label>misoprostol</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Induction using misoprostol:&#xD;
Insert misoprostol 25 micrograms in the posterior fornix of the vagina digitally Repeat cervical exam every 4 hours</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Misoprostol and foley bulb</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Induction using Foley balloon combined with misoprostol:&#xD;
A 26 French intracervical Foley balloon will be inserted above the internal os at the start of induction, inflated using 80cc of sterile water.&#xD;
If a Foley balloon is not able to be inserted at the time of starting induction of labor, misoprostol 25microgram can be inserted in the posterior fornix of the vagina and the misoprostol protocol followed.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Misoprostol</intervention_name>
    <description>used at a rate of 25 mcg Q4hours for cervical ripening.</description>
    <arm_group_label>Misoprostol and foley bulb</arm_group_label>
    <arm_group_label>misoprostol</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Morbidly obese patient (BMI≥40kg/m2) at admission for induction of labor Speaks&#xD;
             English Gestational age between 37and0 weeks and 41and6 weeks Cervical exam: dilation&#xD;
             &lt;4cm and Bishop score 6 or less Contractions &lt; 2 per 10 minutes&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of cesarean delivery Maternal contraindications to labor Fetal&#xD;
             contraindications to labor Maternal age &lt;18yo Fetal growth restriction with abnormal&#xD;
             umbilical artery Doppler indexes Cervical dilation ≥4cm or Bishop score ≥7&#xD;
             Contractions ≥3 per 10 minutes Non-reassuring fetal status Latex allergy&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>January 4, 2019</study_first_submitted>
  <study_first_submitted_qc>January 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 8, 2019</study_first_posted>
  <last_update_submitted>March 7, 2022</last_update_submitted>
  <last_update_submitted_qc>March 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 22, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Maryland, Baltimore</investigator_affiliation>
    <investigator_full_name>Sarah Crimmins</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>Obesity</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Misoprostol</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/NCT03796416
org study id: HP-00077208
nct id: NCT03796416
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
There are more and more pregnant women who are obese. It is very difficult for obese women to
      get into labor. That is why when women are obese, half are likely to need a Cesarean
      delivery(C-section). Unfortunately, C-sections are more dangerous for obese women. There may
      be a combination of issues that cause obese women to need C-sections. We believe one of those
      reasons is that the womb of obese women respond differently to medications and devices
      compared to non-obese women. There are commonly two ways to help women get into labor. One
      way is a medication called misoprostol. The second way is a device called Foley balloon. In
      most studies, both ways are equally effective in helping women get into labor. However, these
      studies included everyone, and didn't focus on obese women.

      So far there are no studies in this area that focus only on obese women. Therefore we need to
      design this study to focus just on obese women and what is the best way to help them get into
      labor and avoid a C-section.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: achieving complete cervical dilation
time frame: 24 hours
arm group label: misoprostol
arm group type: Active Comparator
description: Induction using misoprostol:
Insert misoprostol 25 micrograms in the posterior fornix of the vagina digitally Repeat cervical exam every 4 hours
arm group label: Misoprostol and foley bulb
arm group type: Experimental
description: Induction using Foley balloon combined with misoprostol:
A 26 French intracervical Foley balloon will be inserted above the internal os at the start of induction, inflated using 80cc of sterile water.
If a Foley balloon is not able to be inserted at the time of starting induction of labor, misoprostol 25microgram can be inserted in the posterior fornix of the vagina and the misoprostol protocol followed.
intervention type: Drug
intervention name: Misoprostol
description: used at a rate of 25 mcg Q4hours for cervical ripening.
arm group label: Misoprostol and foley bulb
arm group label: misoprostol
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: University of Maryland, Baltimore
investigator full name: Sarah Crimmins
investigator title: Assistant Professor
mesh term: Obesity
mesh term: Misoprostol
sharing ipd: Undecided