<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/NCT04421053</url>
  </required_header>
  <id_info>
    <org_study_id>JS-2333</org_study_id>
    <nct_id>NCT04421053</nct_id>
  </id_info>
  <brief_title>Weight Gain Recommendations for Chinese Women With Gestational Diabetes Mellitus</brief_title>
  <official_title>Gestational Weight Gain (GWG) Recommendations for Chinese Women With Gestational Diabetes Mellitus (GDM)</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The 2009 IOM recommendation value for weight gain during pregnancy is widely used. Due to the&#xD;
      unclear relationship between gestational diabetes mellitus and weight gain during pregnancy&#xD;
      when formulating this recommendation value, pregnant women with gestational diabetes mellitus&#xD;
      were excluded from the study population. Control of appropriate weight gain and control of&#xD;
      blood glucose stability is an important part of GDM management in pregnant women. The&#xD;
      incidence of GDM in China is about 15%-20%, and the number of pregnant women with GDM ranks&#xD;
      first in the world. For the sake of the current and long-term health of maternal and infant,&#xD;
      it is of great significance to explore the appropriate weight gain range and formulate the&#xD;
      recommended value for GDM pregnant women as an independent population. This project intends&#xD;
      to use prospective cohort study of combining the observation of pregnant women with&#xD;
      gestational diabetes blood sugar and weight changes, through the comparison of normal&#xD;
      pregnant women suitable scope of weight gain, analyzes its influence on adverse pregnancy&#xD;
      outcomes, increased the weight of gestational diabetes women recommended value is put&#xD;
      forward, and combined with the Delphi expert consultation method for evaluation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This project is a prospective cohort study designed to investigated the changes in blood&#xD;
      glucose and body weight in women with gestational diabetes during pregnancy. The study aimed&#xD;
      to enroll 4000 participants, using health management app in addition to routine prenatal&#xD;
      care. Researchers screen subjects strictly according to the exclusion and inclusion criteria&#xD;
      and those who interested sign the informed consent. participants completed baseline&#xD;
      questionnaire and dietary questionnaire at app under the instruction of researchers. Pregnant&#xD;
      women come back for follow up-visit every 2 weeks until delivery. If anyone doesn't upload&#xD;
      the weight data for a week and doesn't respond to the phone call from the researchers, she&#xD;
      will be regarded as lost follow-up,the number of lost follow-up cases are supplemented by&#xD;
      increasing the enrollment. Data analysis and result output finally.&#xD;
&#xD;
      Besides, part of the study conducted in Beijing has some special points which don't exsit in&#xD;
      large cohort study: participants equipment dynamic blood glucose monitor for glycemic control&#xD;
      and their blood samples and stool samples will be collected at 24-28, 32 and 36 gestational&#xD;
      weeks,respectively.&#xD;
&#xD;
      Based on the description of weight gain range of pregnant women with normal blood glucose,&#xD;
      the influence of weight gain on adverse pregnancy outcome was analyzed, and the recommended&#xD;
      weight gain value for women with gestational diabetes was proposed in combination with Delphi&#xD;
      expert consultation method.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 24, 2020</start_date>
  <completion_date type="Anticipated">June 30, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The incidence rate of pregnancy outcomes</measure>
    <time_frame>delivery</time_frame>
    <description>pregnancy outcomes including preeclampsia, gestational hypertension.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The incidence rate of infant outcomes</measure>
    <time_frame>delivery</time_frame>
    <description>infant outcomes including SGA,neonatal hypoglycemia.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>the value of gestational weight gain during third trimester</measure>
    <time_frame>from enrollment to delivery</time_frame>
    <description>pregnant women with diabetes mellitus type 2,children with hypertension,obesity,diabetes,cardiovascular disease,etc.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">4050</enrollment>
  <condition>Gestational Diabetes</condition>
  <condition>Gestational Weight Gain</condition>
  <arm_group>
    <arm_group_label>women with GDM</arm_group_label>
    <description>After participants enrollment, we conducted follow-up visit every two weeks. Blood glucose values, body weight, life style record and clinical information are collected. Blood samples and stool samples are collected from participants in Beijing.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>prenatal care for women with GDM</intervention_name>
    <description>we conduct prenatal care for GDM pregnancies through both prenatal clinic and app.</description>
    <arm_group_label>women with GDM</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      blood samples and stool samples are collected from participants in Beijing.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        pregnancies with gestational diabetes mellitus&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pregnant women who have regular labor inspection and delivery in the labor inspection&#xD;
             hospital;&#xD;
&#xD;
          -  Pregnant women with gestational diabetes diagnosed by OGTT at 24 to 28 weeks of&#xD;
             pregnancy;&#xD;
&#xD;
          -  Singleton pregnancy;&#xD;
&#xD;
          -  Those who can skillfully use mobile phones and other electronic devices for scientific&#xD;
             follow-up and voluntarily record their daily weight;&#xD;
&#xD;
          -  Voluntary signing of informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with pre-pregnancy diabetes mellitus or abnormal OGTT screening in early&#xD;
             pregnancy;&#xD;
&#xD;
          -  diabetic ketoacidosis,high blood sugar of high permeability anemia,leukemia, and&#xD;
             lymphoma without clinical control.&#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>Liangkun Ma</last_name>
    <role>Study Chair</role>
    <affiliation>Chinese Academy of Medical Science &amp; Peking Union Medical College Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Liangkun Ma</last_name>
    <phone>13021961166</phone>
    <email>MaLiangKun@pumch.cn</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ying Tian</last_name>
    <phone>13121591988</phone>
    <email>1220325578@qq.com</email>
  </overall_contact_backup>
  <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>
    <status>Recruiting</status>
    <contact>
      <last_name>Liangkun Ma, MD</last_name>
      <phone>+8613021961166</phone>
      <email>MaLiangKun@pumch.cn</email>
    </contact>
    <contact_backup>
      <last_name>Ying Tian</last_name>
      <phone>15110790115</phone>
      <email>1220325578@qq.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>June 5, 2020</study_first_submitted>
  <study_first_submitted_qc>June 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>October 19, 2021</last_update_submitted>
  <last_update_submitted_qc>October 19, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 21, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>gestational diabetes mellitus</keyword>
  <keyword>gestational weight gain</keyword>
  <keyword>blood glucoes monitoring</keyword>
  <keyword>health management</keyword>
  <keyword>moblie health</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes, Gestational</mesh_term>
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Body Weight</mesh_term>
    <mesh_term>Weight Gain</mesh_term>
    <mesh_term>Gestational Weight Gain</mesh_term>
  </condition_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/NCT04421053
org study id: JS-2333
nct id: NCT04421053
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The 2009 IOM recommendation value for weight gain during pregnancy is widely used. Due to the
      unclear relationship between gestational diabetes mellitus and weight gain during pregnancy
      when formulating this recommendation value, pregnant women with gestational diabetes mellitus
      were excluded from the study population. Control of appropriate weight gain and control of
      blood glucose stability is an important part of GDM management in pregnant women. The
      incidence of GDM in China is about 15%-20%, and the number of pregnant women with GDM ranks
      first in the world. For the sake of the current and long-term health of maternal and infant,
      it is of great significance to explore the appropriate weight gain range and formulate the
      recommended value for GDM pregnant women as an independent population. This project intends
      to use prospective cohort study of combining the observation of pregnant women with
      gestational diabetes blood sugar and weight changes, through the comparison of normal
      pregnant women suitable scope of weight gain, analyzes its influence on adverse pregnancy
      outcomes, increased the weight of gestational diabetes women recommended value is put
      forward, and combined with the Delphi expert consultation method for evaluation.
This project is a prospective cohort study designed to investigated the changes in blood
      glucose and body weight in women with gestational diabetes during pregnancy. The study aimed
      to enroll 4000 participants, using health management app in addition to routine prenatal
      care. Researchers screen subjects strictly according to the exclusion and inclusion criteria
      and those who interested sign the informed consent. participants completed baseline
      questionnaire and dietary questionnaire at app under the instruction of researchers. Pregnant
      women come back for follow up-visit every 2 weeks until delivery. If anyone doesn't upload
      the weight data for a week and doesn't respond to the phone call from the researchers, she
      will be regarded as lost follow-up,the number of lost follow-up cases are supplemented by
      increasing the enrollment. Data analysis and result output finally.

      Besides, part of the study conducted in Beijing has some special points which don't exsit in
      large cohort study: participants equipment dynamic blood glucose monitor for glycemic control
      and their blood samples and stool samples will be collected at 24-28, 32 and 36 gestational
      weeks,respectively.

      Based on the description of weight gain range of pregnant women with normal blood glucose,
      the influence of weight gain on adverse pregnancy outcome was analyzed, and the recommended
      weight gain value for women with gestational diabetes was proposed in combination with Delphi
      expert consultation method.
observational model: Cohort
time perspective: Prospective
measure: The incidence rate of pregnancy outcomes
time frame: delivery
description: pregnancy outcomes including preeclampsia, gestational hypertension.
measure: The incidence rate of infant outcomes
time frame: delivery
description: infant outcomes including SGA,neonatal hypoglycemia.
measure: the value of gestational weight gain during third trimester
time frame: from enrollment to delivery
description: pregnant women with diabetes mellitus type 2,children with hypertension,obesity,diabetes,cardiovascular disease,etc.
arm group label: women with GDM
description: After participants enrollment, we conducted follow-up visit every two weeks. Blood glucose values, body weight, life style record and clinical information are collected. Blood samples and stool samples are collected from participants in Beijing.
intervention type: Behavioral
intervention name: prenatal care for women with GDM
description: we conduct prenatal care for GDM pregnancies through both prenatal clinic and app.
arm group label: women with GDM
blood samples and stool samples are collected from participants in Beijing.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: Liangkun Ma
role: Study Chair
affiliation: Chinese Academy of Medical Science & Peking Union Medical College Hospital
last name: Liangkun Ma
phone: 13021961166
email: MaLiangKun@pumch.cn
last name: Ying Tian
phone: 13121591988
email: 1220325578@qq.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: China
responsible party type: Sponsor
mesh term: Diabetes, Gestational
mesh term: Diabetes Mellitus
mesh term: Body Weight
mesh term: Weight Gain
mesh term: Gestational Weight Gain
sharing ipd: Undecided