<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/NCT02967016</url>
  </required_header>
  <id_info>
    <org_study_id>20160001283</org_study_id>
    <nct_id>NCT02967016</nct_id>
  </id_info>
  <brief_title>Physical Activity After a Normal Spontaneous or Cesarean Delivery</brief_title>
  <official_title>A Pilot Study: To Compare Physical Activity After a Normal Spontaneous or Cesarean Delivery by Use of a Actigraph GT3X</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rutgers, The State University of New Jersey</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>George Washington University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Rutgers, The State University of New Jersey</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>
      To the best of the investigators knowledge the average level of physical activity (PA) of&#xD;
      parturients recovering from a cesarean delivery or after a normal spontaneous vaginal&#xD;
      delivery (NSVD) remains unknown. Taking in consideration that parturients are in a&#xD;
      hypercoagulable state and that obstetric venous thromboembolism (VT) is one of the most&#xD;
      common causes of maternal morbidity and mortality, ambulation is of utmost importance to&#xD;
      anesthesiologists as well as obstetricians. In order to promote mobility, first the&#xD;
      investigators need to learn the average parturients level of physical activity in the&#xD;
      immediate post-partum period and up to 48 hours after delivery. This information may help us&#xD;
      promote mobility in the immediate postpartum period, particularly for those that underwent a&#xD;
      cesarean delivery since they are at higher risk of VT.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Cesarean delivery is the most common surgery performed in the United States. Despite this&#xD;
      fact, there is a paucity of literature looking into the implementation of enhanced recovery&#xD;
      after surgery (ERAS) for patients undergoing this type of surgery. ERAS protocols have shown&#xD;
      to improve recovery from surgery, decreasing complication and hospital length of stay. The&#xD;
      pathway for enhanced recovery targets improving 3 factors that have been associated with&#xD;
      increased hospital length of stay and complications. These factors are pain, immobilization&#xD;
      and postoperative ileus. These factors, many times are inter-related. A patient in pain would&#xD;
      tend not to ambulate as this may exacerbate the pain and discomfort. In order to alleviate&#xD;
      pain, the patient would most likely receive an opioid for pain management and these&#xD;
      medications are known to have undesirable side effects such as nausea, vomiting, sedation,&#xD;
      respiratory depression, constipation and urinary retention. All of these adverse effects&#xD;
      (AEs) may lead to complications or increased hospital length of stay.&#xD;
&#xD;
      To the best of the investigators knowledge the average level of physical activity (PA) of&#xD;
      parturients recovering from a cesarean delivery or after a normal spontaneous vaginal&#xD;
      delivery (NSVD) remains unknown. Taking in consideration that parturients are in a&#xD;
      hypercoagulable state and that obstetric venous thromboembolism (VT) is one of the most&#xD;
      common causes of maternal morbidity and mortality, ambulation is of utmost importance to&#xD;
      anesthesiologists as well as obstetricians. In order to promote mobility, first we need to&#xD;
      learn the average parturients level of physical acuity in the immediate post-partum period&#xD;
      and up to 48 hours after delivery. This information may help us promote mobility in the&#xD;
      immediate postpartum period, particularly for those that underwent a cesarean delivery since&#xD;
      they are at higher risk of VT.&#xD;
&#xD;
      Given the lack of knowledge regarding the physical activity level of parturients in the&#xD;
      postpartum period, the investigators have designed a pilot study to objectively measure their&#xD;
      PA. Patients having a normal spontaneous vaginal delivery will serve as our control group.&#xD;
      These patients are going through the same physiologic changes that their counterparts (CD&#xD;
      patients) are going through, the only difference being the stress of surgery in the CD&#xD;
      group.The use of Fitness trackers (i.e Fitbit(R), Actigraph GT3X +) has been used to measure&#xD;
      and promote physical activity in a cardiac rehabilitation population, as well as in&#xD;
      parturients self-identified as inactive. The investigators intend to use the Actigraph GT3X+&#xD;
      to measure the level of physical activity of 50 parturients (25 NSVD and 25 post CD). The&#xD;
      information obtained, will help us tailor the anesthetic/analgesic management of parturients&#xD;
      in such a way that promotes early ambulation and recovery. The investigators estimate that we&#xD;
      need approximately a total of 50 patients, 25 per group to assess if there is a difference in&#xD;
      the level of PA between parturients after a NSVD or CD. We will aim to recruit 60 patients 30&#xD;
      per group to account for missing data, protocol violations, equipment malfunction or patients&#xD;
      drop outs.This will be a pilot, prospective study aimed at measuring the physical activity&#xD;
      (PA) of American Society of Anesthesiologists (ASA) Classification I and II women aged 18&#xD;
      years and older, after a normal spontaneous vaginal (NSVD) or cesarean delivery (CD).&#xD;
      Subjects will be ASA I and II women aged 18 years and older, knowing to have had either a&#xD;
      NSVD or CD (under neuraxial anesthesia). After delivery, and assuring that mother and baby&#xD;
      are stable, patients will be approached by a member of the study team to discuss the study&#xD;
      and obtain informed consent. After obtaining informed consent, patients will be divided into&#xD;
      Two (2) groups depending on the mode of delivery. Group 1 will be NSVD and group 2 will be CD&#xD;
      patients. Patients will be provided with a fitbit- based Actigraph GT3X + hardware, 3 hours&#xD;
      after delivery. Patients will be evaluated every 12 hours after delivery for a period of 48&#xD;
      hours. During these evaluation points, pain (visual analogue scores), factors affecting&#xD;
      mobility, and level of satisfaction with their analgesia will be assessed. After 48 hours the&#xD;
      Actigraph GT3X + will be interrogated and objective data, such as mean daily steps, will be&#xD;
      obtained using the aforementioned software.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2017</start_date>
  <completion_date type="Actual">August 30, 2019</completion_date>
  <primary_completion_date type="Actual">July 30, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Steps</measure>
    <time_frame>from 6 hours the after delivery until discharge or 48 hours whatever happens first</time_frame>
    <description>This will be measured in the numbers of steps registered by the accelerometer</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain Score at Rest</measure>
    <time_frame>6 hours following delivery until 48 hours</time_frame>
    <description>This outcome will be measured using a visual analogue score (VAS). Patient will mark their pain on a 0-100 mm line with 0 been no pain and 100 mm worst pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction Scores</measure>
    <time_frame>6 hours following delivery until 48 hours</time_frame>
    <description>This outcome will be measured using a visual analogue score (VAS). Patient will mark their satisfaction on a 0-100 mm line with 0 been not satisfied at all and 100 mm extremely satisfied.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Postpartum Disorder</condition>
  <arm_group>
    <arm_group_label>normal spontaneous vaginal delivery</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Both groups will be asked to wear a fitness tracker (Actigraph GT3X+).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cesarean Delivery</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Both groups will be asked to wear a fitness tracker (Actigraph GT3X+).</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Actigraph</intervention_name>
    <description>following delivery a ActiGraph will be offered to patients to track their steps</description>
    <arm_group_label>Cesarean Delivery</arm_group_label>
    <arm_group_label>normal spontaneous vaginal delivery</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women 18-45 years old giving birth after receiving a neuraxial analgesia/anesthesia&#xD;
             technique. American Society of Anesthesiologists classification 1-2.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of chronic pain&#xD;
&#xD;
          -  Recent use of opioids (other than postpartum)&#xD;
&#xD;
          -  Emergency case requiring general anesthesia (GA) or conversion to GA&#xD;
&#xD;
          -  BMI &gt; 45&#xD;
&#xD;
          -  Need to perform more extensive surgery (i.e Hysterectomy) Need for the neonate to be&#xD;
             admitted to NICU (This will prompt mothers to walk more frequently, and longer&#xD;
             distances to visit the baby)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Antonio Gonzalez-Fiol, MD</last_name>
    <role>Study Director</role>
    <affiliation>Yale New Haven Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>George Washington University</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20037</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital</name>
      <address>
        <city>Newark</city>
        <state>New Jersey</state>
        <zip>07103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>October 28, 2016</study_first_submitted>
  <study_first_submitted_qc>November 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 17, 2016</study_first_posted>
  <results_first_submitted>May 12, 2020</results_first_submitted>
  <results_first_submitted_qc>June 18, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">June 19, 2020</results_first_posted>
  <last_update_submitted>June 18, 2020</last_update_submitted>
  <last_update_submitted_qc>June 18, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 19, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Rutgers, The State University of New Jersey</investigator_affiliation>
    <investigator_full_name>Dongchen Li, MD</investigator_full_name>
    <investigator_title>Assistant Professor Director of Obstetric Anesthesia Department of Anesthesiology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Puerperal Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>May 12, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/16/NCT02967016/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Normal Spontaneous Vaginal Delivery</title>
          <description>Both groups will be asked to wear a fitness tracker (Actigraph GT3X+).&#xD;
Actigraph: following delivery a ActiGraph will be offered to patients to track their steps</description>
        </group>
        <group group_id="P2">
          <title>Cesarean Delivery</title>
          <description>Both groups will be asked to wear a fitness tracker (Actigraph GT3X+).&#xD;
Actigraph: following delivery a ActiGraph will be offered to patients to track their steps</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
                <participants group_id="P2" count="25"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
                <participants group_id="P2" count="25"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Cesarean Delivery</title>
          <description>Patients delivered via cesarean section</description>
        </group>
        <group group_id="B2">
          <title>Vaginal Delivery</title>
          <description>Patients delivery via cesarean delivery</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="25"/>
            <count group_id="B2" value="25"/>
            <count group_id="B3" value="50"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="31.6" spread="5.9"/>
                    <measurement group_id="B2" value="28.3" spread="6.0"/>
                    <measurement group_id="B3" value="30.0" spread="6.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="50"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Black</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not available</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass index</title>
          <units>Kg/m2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="32" spread="6.3"/>
                    <measurement group_id="B2" value="31.4" spread="6.0"/>
                    <measurement group_id="B3" value="31.7" spread="6.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Steps</title>
        <description>This will be measured in the numbers of steps registered by the accelerometer</description>
        <time_frame>from 6 hours the after delivery until discharge or 48 hours whatever happens first</time_frame>
        <population>steps</population>
        <group_list>
          <group group_id="O1">
            <title>Cesarean Delivery</title>
            <description>Patients delivered via cesarean section</description>
          </group>
          <group group_id="O2">
            <title>Vaginal Delivery</title>
            <description>Patients delivery via cesarean delivery</description>
          </group>
        </group_list>
        <measure>
          <title>Steps</title>
          <description>This will be measured in the numbers of steps registered by the accelerometer</description>
          <population>steps</population>
          <units>Steps</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="968" spread="920"/>
                    <measurement group_id="O2" value="1771" spread="660"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1652" spread="1206"/>
                    <measurement group_id="O2" value="3165" spread="1266"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3421" spread="2314"/>
                    <measurement group_id="O2" value="5911" spread="2162"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>36</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4919" spread="3678"/>
                    <measurement group_id="O2" value="8841" spread="3113"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>48</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6306" spread="5835"/>
                    <measurement group_id="O2" value="9813" spread="3916"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Cumulative Steps 6 h</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.002</p_value>
            <method>Kruskal-Wallis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Cumulative steps 12 h</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>.0002</p_value>
            <method>Kruskal-Wallis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Cumulative steps 24 h</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>.0006</p_value>
            <method>Kruskal-Wallis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Cumulative steps 36 h</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.0006</p_value>
            <method>Kruskal-Wallis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Cumulative steps 48 h</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.03</p_value>
            <method>Kruskal-Wallis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pain Score at Rest</title>
        <description>This outcome will be measured using a visual analogue score (VAS). Patient will mark their pain on a 0-100 mm line with 0 been no pain and 100 mm worst pain.</description>
        <time_frame>6 hours following delivery until 48 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cesarean Delivery</title>
            <description>Patients delivered via cesarean section</description>
          </group>
          <group group_id="O2">
            <title>Vaginal Delivery</title>
            <description>Patients delivery via cesarean delivery</description>
          </group>
        </group_list>
        <measure>
          <title>Pain Score at Rest</title>
          <description>This outcome will be measured using a visual analogue score (VAS). Patient will mark their pain on a 0-100 mm line with 0 been no pain and 100 mm worst pain.</description>
          <units>score on a scale (0-100)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25" spread="24"/>
                    <measurement group_id="O2" value="14" spread="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27" spread="23"/>
                    <measurement group_id="O2" value="22" spread="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28" spread="22"/>
                    <measurement group_id="O2" value="13" spread="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>36</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36" spread="22"/>
                    <measurement group_id="O2" value="15" spread="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>48</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23" spread="19"/>
                    <measurement group_id="O2" value="12" spread="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Pain at rest 6 h</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.06</p_value>
            <method>Kruskal-Wallis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Pain at rest 12 h</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>.30</p_value>
            <method>Kruskal-Wallis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Pain at rest 24 h</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>.002</p_value>
            <method>Kruskal-Wallis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Pain at rest 36 h</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.003</p_value>
            <method>Kruskal-Wallis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Pain at rest at 48 h</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>.02</p_value>
            <method>Kruskal-Wallis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Satisfaction Scores</title>
        <description>This outcome will be measured using a visual analogue score (VAS). Patient will mark their satisfaction on a 0-100 mm line with 0 been not satisfied at all and 100 mm extremely satisfied.</description>
        <time_frame>6 hours following delivery until 48 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cesarean Delivery</title>
            <description>Patients delivered via cesarean section</description>
          </group>
          <group group_id="O2">
            <title>Vaginal Delivery</title>
            <description>Patients delivery via cesarean delivery</description>
          </group>
        </group_list>
        <measure>
          <title>Satisfaction Scores</title>
          <description>This outcome will be measured using a visual analogue score (VAS). Patient will mark their satisfaction on a 0-100 mm line with 0 been not satisfied at all and 100 mm extremely satisfied.</description>
          <units>score on a scale (0-100)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="71" spread="34"/>
                    <measurement group_id="O2" value="78" spread="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="69" spread="29"/>
                    <measurement group_id="O2" value="80" spread="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60" spread="32"/>
                    <measurement group_id="O2" value="83" spread="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>36</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="58" spread="29"/>
                    <measurement group_id="O2" value="95" spread="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>48</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57" spread="32"/>
                    <measurement group_id="O2" value="89" spread="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Satisfaction with pain control 6 h</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>.43</p_value>
            <method>Kruskal-Wallis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Satisfaction with pain control 12 h</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>.24</p_value>
            <method>Kruskal-Wallis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Satisfaction with pain control 24 h</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>.012</p_value>
            <method>Kruskal-Wallis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Satisfaction with pain control 36 h</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Kruskal-Wallis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Satisfaction with pain control 48 h</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>.0005</p_value>
            <method>Kruskal-Wallis</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>3 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Normal Spontaneous Vaginal Delivery</title>
          <description>Both groups will be asked to wear a fitness tracker (Actigraph GT3X+).&#xD;
Actigraph: following delivery a ActiGraph will be offered to patients to track their steps</description>
        </group>
        <group group_id="E2">
          <title>Cesarean Delivery</title>
          <description>Both groups will be asked to wear a fitness tracker (Actigraph GT3X+).&#xD;
Actigraph: following delivery a ActiGraph will be offered to patients to track their steps</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Small sample size. No standardized post-delivery ambulation protocol at any of the institutions.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr. Antonio Gonzalez</name_or_title>
      <organization>Rutgers SUNJ</organization>
      <phone>4133869415</phone>
      <email>ajantoni@gmail.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02967016
org study id: 20160001283
nct id: NCT02967016
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To the best of the investigators knowledge the average level of physical activity (PA) of
      parturients recovering from a cesarean delivery or after a normal spontaneous vaginal
      delivery (NSVD) remains unknown. Taking in consideration that parturients are in a
      hypercoagulable state and that obstetric venous thromboembolism (VT) is one of the most
      common causes of maternal morbidity and mortality, ambulation is of utmost importance to
      anesthesiologists as well as obstetricians. In order to promote mobility, first the
      investigators need to learn the average parturients level of physical activity in the
      immediate post-partum period and up to 48 hours after delivery. This information may help us
      promote mobility in the immediate postpartum period, particularly for those that underwent a
      cesarean delivery since they are at higher risk of VT.
Cesarean delivery is the most common surgery performed in the United States. Despite this
      fact, there is a paucity of literature looking into the implementation of enhanced recovery
      after surgery (ERAS) for patients undergoing this type of surgery. ERAS protocols have shown
      to improve recovery from surgery, decreasing complication and hospital length of stay. The
      pathway for enhanced recovery targets improving 3 factors that have been associated with
      increased hospital length of stay and complications. These factors are pain, immobilization
      and postoperative ileus. These factors, many times are inter-related. A patient in pain would
      tend not to ambulate as this may exacerbate the pain and discomfort. In order to alleviate
      pain, the patient would most likely receive an opioid for pain management and these
      medications are known to have undesirable side effects such as nausea, vomiting, sedation,
      respiratory depression, constipation and urinary retention. All of these adverse effects
      (AEs) may lead to complications or increased hospital length of stay.

      To the best of the investigators knowledge the average level of physical activity (PA) of
      parturients recovering from a cesarean delivery or after a normal spontaneous vaginal
      delivery (NSVD) remains unknown. Taking in consideration that parturients are in a
      hypercoagulable state and that obstetric venous thromboembolism (VT) is one of the most
      common causes of maternal morbidity and mortality, ambulation is of utmost importance to
      anesthesiologists as well as obstetricians. In order to promote mobility, first we need to
      learn the average parturients level of physical acuity in the immediate post-partum period
      and up to 48 hours after delivery. This information may help us promote mobility in the
      immediate postpartum period, particularly for those that underwent a cesarean delivery since
      they are at higher risk of VT.

      Given the lack of knowledge regarding the physical activity level of parturients in the
      postpartum period, the investigators have designed a pilot study to objectively measure their
      PA. Patients having a normal spontaneous vaginal delivery will serve as our control group.
      These patients are going through the same physiologic changes that their counterparts (CD
      patients) are going through, the only difference being the stress of surgery in the CD
      group.The use of Fitness trackers (i.e Fitbit(R), Actigraph GT3X +) has been used to measure
      and promote physical activity in a cardiac rehabilitation population, as well as in
      parturients self-identified as inactive. The investigators intend to use the Actigraph GT3X+
      to measure the level of physical activity of 50 parturients (25 NSVD and 25 post CD). The
      information obtained, will help us tailor the anesthetic/analgesic management of parturients
      in such a way that promotes early ambulation and recovery. The investigators estimate that we
      need approximately a total of 50 patients, 25 per group to assess if there is a difference in
      the level of PA between parturients after a NSVD or CD. We will aim to recruit 60 patients 30
      per group to account for missing data, protocol violations, equipment malfunction or patients
      drop outs.This will be a pilot, prospective study aimed at measuring the physical activity
      (PA) of American Society of Anesthesiologists (ASA) Classification I and II women aged 18
      years and older, after a normal spontaneous vaginal (NSVD) or cesarean delivery (CD).
      Subjects will be ASA I and II women aged 18 years and older, knowing to have had either a
      NSVD or CD (under neuraxial anesthesia). After delivery, and assuring that mother and baby
      are stable, patients will be approached by a member of the study team to discuss the study
      and obtain informed consent. After obtaining informed consent, patients will be divided into
      Two (2) groups depending on the mode of delivery. Group 1 will be NSVD and group 2 will be CD
      patients. Patients will be provided with a fitbit- based Actigraph GT3X + hardware, 3 hours
      after delivery. Patients will be evaluated every 12 hours after delivery for a period of 48
      hours. During these evaluation points, pain (visual analogue scores), factors affecting
      mobility, and level of satisfaction with their analgesia will be assessed. After 48 hours the
      Actigraph GT3X + will be interrogated and objective data, such as mean daily steps, will be
      obtained using the aforementioned software.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Steps
time frame: from 6 hours the after delivery until discharge or 48 hours whatever happens first
description: This will be measured in the numbers of steps registered by the accelerometer
measure: Pain Score at Rest
time frame: 6 hours following delivery until 48 hours
description: This outcome will be measured using a visual analogue score (VAS). Patient will mark their pain on a 0-100 mm line with 0 been no pain and 100 mm worst pain.
measure: Satisfaction Scores
time frame: 6 hours following delivery until 48 hours
description: This outcome will be measured using a visual analogue score (VAS). Patient will mark their satisfaction on a 0-100 mm line with 0 been not satisfied at all and 100 mm extremely satisfied.
arm group label: normal spontaneous vaginal delivery
arm group type: Experimental
description: Both groups will be asked to wear a fitness tracker (Actigraph GT3X+).
arm group label: Cesarean Delivery
arm group type: Experimental
description: Both groups will be asked to wear a fitness tracker (Actigraph GT3X+).
intervention type: Behavioral
intervention name: Actigraph
description: following delivery a ActiGraph will be offered to patients to track their steps
arm group label: Cesarean Delivery
arm group label: normal spontaneous vaginal delivery
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: Antonio Gonzalez-Fiol, MD
role: Study Director
affiliation: Yale New Haven Hospital
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Rutgers, The State University of New Jersey
investigator full name: Dongchen Li, MD
investigator title: Assistant Professor Director of Obstetric Anesthesia Department of Anesthesiology
mesh term: Puerperal Disorders
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Small sample size. No standardized post-delivery ambulation protocol at any of the institutions.
point of contact: 