<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/NCT03748576</url>
  </required_header>
  <id_info>
    <org_study_id>JS-1012</org_study_id>
    <nct_id>NCT03748576</nct_id>
  </id_info>
  <brief_title>A Prospective Randomized Controlled Trial of Mobile Medical Used for Management of Pregnant Women</brief_title>
  <official_title>Clinical Research on Mobile Medical Used for the Management of Pregnant Women: a Randomized Control Trail</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking Union Medical College Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking Union Medical College Hospital</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>
      A multicenter, randomized controlled trial was conducted to investigate whether health&#xD;
      education and life style management through WeChat group chat was: 1. more effective in&#xD;
      improving pregnancy outcomes in normal pregnant women. 2. more effective in controlling blood&#xD;
      glucose (BG) than standard clinic prenatal care in women with GDM.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. Mobile technology and equipment based on Internet and communications technology have&#xD;
           revolutionized the content and manner of social interaction and services. Mobile medical&#xD;
           care has just started, the relevant platform and service is still immature, not&#xD;
           standardized, poor satisfaction, low efficiency, its value and effectiveness of health&#xD;
           management lack of clear theoretical support and data description. In this study, based&#xD;
           on the multi-center prospective randomized controlled study, we constructed a&#xD;
           large-scale maternal health service platform and a systematic standardized maternal&#xD;
           health management model to carry out personalized maternal health management and mobile&#xD;
           health services. Mobile medical effects validation, and further improve the mobile&#xD;
           medical platform.&#xD;
&#xD;
           This study will verify the value of mobile health care for maternal health management,&#xD;
           to establish a standardized standard mobile medical model, to further improve the level&#xD;
           of domestic maternal health management and improve the quality of maternal and child&#xD;
           health management.&#xD;
&#xD;
        2. Most gestational diabetes mellitus (GDM) can be well controlled by health education and&#xD;
           life style management, expecting a better pregnancy outcome. But standard clinic&#xD;
           prenatal care which consist of clinic visit every two weeks may not give full play to&#xD;
           the effects of GDM management. Telemedicine shows its potential to fill this gap. A&#xD;
           multicenter, randomized controlled trial was designed to investigate whether health&#xD;
           education and life style management through WeChat group chat was more effective in&#xD;
           controlling blood glucose (BG) than standard clinic prenatal care in women with GDM.&#xD;
           Women with GDM diagnosed by oral glucose tolerance test between 23-30+6 gestational&#xD;
           weeks were randomized to a WeChat group chat-based blood glucose management group or&#xD;
           routine clinic prenatal care. In PUMCH, investigators also equip CGM for m-health group&#xD;
           allowing a more detailed BG information. The primary outcome was change of glycemic&#xD;
           qualification rate during follow up period in both groups. The second outcome was&#xD;
           pregnancy outcomes. Also, a case control study is designed to compare the glucose&#xD;
           control status between rice-richen meal and wheaten-richen meal, and all other&#xD;
           macronutrients and micronutrients are all calculated and same between two groups, which&#xD;
           may provide more clues for type of carbohydrate recommendation for Chinese women with&#xD;
           GDM.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2017</start_date>
  <completion_date type="Actual">May 31, 2020</completion_date>
  <primary_completion_date type="Actual">December 31, 2019</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>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>weight gain during pregnancy</measure>
    <time_frame>up to 40 gestatinal weeks</time_frame>
    <description>Participants record their body weight twice a month. Weight gain from third-trimester and the whole pregnancy period are calculated.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Glycemic qualification rate in women with GDM</measure>
    <time_frame>From enrollment to 42 days postpartum</time_frame>
    <description>Glycemic qualification rate was calculated by the number of BG within the control range /30*100%. BG control range were fasting BG (fasting and before-sleep BG)#95 mg/dL (5.3 mmol/L) and two-hour postprandial BG (post-breakfast, post-lunch, post-dinner BG)#120 mg/dL (6.7 mmol/L)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The incidence rate of specific pregnant outcomes in both normal pregnant women and women with GDM</measure>
    <time_frame>at delivery</time_frame>
    <description>pregnancy outcomes include delivery mode, premature rupture of the membranes, preterm birth, SGA, LGA and postpartum hemorrhage</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">640</enrollment>
  <condition>Maternal Behavior</condition>
  <condition>Mobile Health</condition>
  <condition>Pregnancy Outcome</condition>
  <condition>GDM</condition>
  <condition>Blood Glucose</condition>
  <condition>Diet Habit</condition>
  <condition>Compliance, Patient</condition>
  <arm_group>
    <arm_group_label>Mobile technologies group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>m-health group (Intervention Group) participants were managed continuously through WeChat group chat during prenatal clinic interval.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Standard Clinic Prenatal Care (Control Group): regular routine prenatal care following Chinese standard.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>telemedicine: management through WeChat group chat</intervention_name>
    <description>Patients in intervention group received additional WeChat group management when conducted standard clinic prenatal care</description>
    <arm_group_label>Mobile technologies group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged between 18 and 45 years.&#xD;
&#xD;
          -  With singleton pregnancy&#xD;
&#xD;
          -  Diagnosed or not diagnosed as GDM by 75g oral glucose tolerance test (OGTT) and&#xD;
             insulin treatment is not required assessed by multi-disciplinary consultation.&#xD;
&#xD;
          -  Be able to use smart phone for chatting, read and write basic Chinese.&#xD;
&#xD;
          -  Volunteer for research.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Pregnancies with diagnosed chronic disease&#xD;
&#xD;
          -  Pregnancies with other pregnancy complications except GDM&#xD;
&#xD;
          -  Pregnancies had recent trauma and treatment of glucocorticoids&#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>
  <overall_official>
    <last_name>liangkun ma</last_name>
    <role>Study Director</role>
    <affiliation>Peking union medical college hosiptal</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of ob gyn, Peking Union Medical College Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100730</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>October 31, 2018</study_first_submitted>
  <study_first_submitted_qc>November 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 21, 2018</study_first_posted>
  <last_update_submitted>July 22, 2020</last_update_submitted>
  <last_update_submitted_qc>July 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 24, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT03748576
org study id: JS-1012
nct id: NCT03748576
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
A multicenter, randomized controlled trial was conducted to investigate whether health
      education and life style management through WeChat group chat was: 1. more effective in
      improving pregnancy outcomes in normal pregnant women. 2. more effective in controlling blood
      glucose (BG) than standard clinic prenatal care in women with GDM.
1. Mobile technology and equipment based on Internet and communications technology have
           revolutionized the content and manner of social interaction and services. Mobile medical
           care has just started, the relevant platform and service is still immature, not
           standardized, poor satisfaction, low efficiency, its value and effectiveness of health
           management lack of clear theoretical support and data description. In this study, based
           on the multi-center prospective randomized controlled study, we constructed a
           large-scale maternal health service platform and a systematic standardized maternal
           health management model to carry out personalized maternal health management and mobile
           health services. Mobile medical effects validation, and further improve the mobile
           medical platform.

           This study will verify the value of mobile health care for maternal health management,
           to establish a standardized standard mobile medical model, to further improve the level
           of domestic maternal health management and improve the quality of maternal and child
           health management.

        2. Most gestational diabetes mellitus (GDM) can be well controlled by health education and
           life style management, expecting a better pregnancy outcome. But standard clinic
           prenatal care which consist of clinic visit every two weeks may not give full play to
           the effects of GDM management. Telemedicine shows its potential to fill this gap. A
           multicenter, randomized controlled trial was designed to investigate whether health
           education and life style management through WeChat group chat was more effective in
           controlling blood glucose (BG) than standard clinic prenatal care in women with GDM.
           Women with GDM diagnosed by oral glucose tolerance test between 23-30+6 gestational
           weeks were randomized to a WeChat group chat-based blood glucose management group or
           routine clinic prenatal care. In PUMCH, investigators also equip CGM for m-health group
           allowing a more detailed BG information. The primary outcome was change of glycemic
           qualification rate during follow up period in both groups. The second outcome was
           pregnancy outcomes. Also, a case control study is designed to compare the glucose
           control status between rice-richen meal and wheaten-richen meal, and all other
           macronutrients and micronutrients are all calculated and same between two groups, which
           may provide more clues for type of carbohydrate recommendation for Chinese women with
           GDM.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: weight gain during pregnancy
time frame: up to 40 gestatinal weeks
description: Participants record their body weight twice a month. Weight gain from third-trimester and the whole pregnancy period are calculated.
measure: Glycemic qualification rate in women with GDM
time frame: From enrollment to 42 days postpartum
description: Glycemic qualification rate was calculated by the number of BG within the control range /30*100%. BG control range were fasting BG (fasting and before-sleep BG)#95 mg/dL (5.3 mmol/L) and two-hour postprandial BG (post-breakfast, post-lunch, post-dinner BG)#120 mg/dL (6.7 mmol/L)
measure: The incidence rate of specific pregnant outcomes in both normal pregnant women and women with GDM
time frame: at delivery
description: pregnancy outcomes include delivery mode, premature rupture of the membranes, preterm birth, SGA, LGA and postpartum hemorrhage
arm group label: Mobile technologies group
arm group type: Experimental
description: m-health group (Intervention Group) participants were managed continuously through WeChat group chat during prenatal clinic interval.
arm group label: control group
arm group type: No Intervention
description: Standard Clinic Prenatal Care (Control Group): regular routine prenatal care following Chinese standard.
intervention type: Behavioral
intervention name: telemedicine: management through WeChat group chat
description: Patients in intervention group received additional WeChat group management when conducted standard clinic prenatal care
arm group label: Mobile technologies group
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: liangkun ma
role: Study Director
affiliation: Peking union medical college hosiptal
facility: 
country: China
responsible party type: Sponsor
sharing ipd: No