<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/NCT03290144</url>
  </required_header>
  <id_info>
    <org_study_id>69HCL17_0624</org_study_id>
    <nct_id>NCT03290144</nct_id>
  </id_info>
  <brief_title>Pregnancies and Cystic Fibrosis</brief_title>
  <acronym>MUCOG</acronym>
  <official_title>Occurrence of Pregnancies in Women With Cystic Fibrosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospices Civils de Lyon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospices Civils de Lyon</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>
      There have been substantial advances in care for individuals with CF, including improved&#xD;
      nutrition and respiratory care. Women with CF are now likely to survive into adulthood with a&#xD;
      median predicted survival of 49.7 years in 2012, which have resulted in increasingly normal&#xD;
      lifestyles, including successful pregnancies in women with CF. The number of pregnancies in&#xD;
      CF women has increased as reported by the 2013 Annual Data Report from the French CF Registry&#xD;
      (6 pregnancies in 1992 to 53 in 2012). Pregnancy adds many physiological stresses to the&#xD;
      body, particularly on pulmonary function (decrease in residual volume, expiratory reserve&#xD;
      capacity) and nutritional status (increase in nutritional needs). In women with CF, these&#xD;
      added stresses could theoretically affect survival, with difficulties to maintain adequate&#xD;
      nutrition and an unpredictable effect on lung function. A number of studies published over&#xD;
      the past 15 years have attempted to clarify the risk of pregnancy in women with CF to guide&#xD;
      clinicians and women. Many authors compared the outcomes of pregnant CF women to non-pregnant&#xD;
      CF women regardless of nutritional status, lung function, diabetes mellitus, bacteriological&#xD;
      colonization. In literature, pregnancy was possible and well tolerated in CF women with mild&#xD;
      disease if associated with more intensive monitoring and aggressive treatment during&#xD;
      pregnancy, with particular emphasis on nutrition and weight gain. CF women have an increased&#xD;
      likelihood of receiving treatment for diabetes both during and after pregnancy. Furthermore&#xD;
      diabetes mellitus has been associated with more severe pulmonary disease, more frequent&#xD;
      pulmonary exacerbations, poorer nutritional status and a reduced life expectancy.&#xD;
      Pre-pregnancy diabetes mellitus is associated with a poorer prognosis for pregnancy in&#xD;
      general population. Severe forms of CF, including pre-pregnancy diabetes mellitus might as&#xD;
      well do badly with accelerated decline after pregnancy. To determine the effect of&#xD;
      pre-pregnancy diabetes on maternal decline after pregnancy, we will compare FEV1 and BMI&#xD;
      rates of decline, during a two-years follow-up period after pregnancies, reported in the&#xD;
      French CF Registry, according to their diabetic status.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">February 2, 2015</start_date>
  <completion_date type="Anticipated">September 2, 2018</completion_date>
  <primary_completion_date type="Anticipated">September 2, 2018</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <target_duration>12 Months</target_duration>
  <primary_outcome>
    <measure>Change in FEV1</measure>
    <time_frame>12 months following the pregnancy</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Body Mass Index (BMI)</measure>
    <time_frame>12 months following the pregnancy</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">450</enrollment>
  <condition>Cystic Fibrosis</condition>
  <arm_group>
    <arm_group_label>with diabetes</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>without diabetes</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        All pregnant, Cystic Fibrosis (CF) women attending the CF French Registry between January&#xD;
        1, 2001 and December 31, 2010.&#xD;
      </textblock>
    </study_pop>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Cystic Fibrosis women attending the CF French Registry between January 1, 2001 and&#xD;
             December 31, 2010&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women who had received a pulmonary graft before pregnancy.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 19, 2017</study_first_submitted>
  <study_first_submitted_qc>September 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 21, 2017</study_first_posted>
  <last_update_submitted>September 21, 2017</last_update_submitted>
  <last_update_submitted_qc>September 21, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 25, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cystic fibrosis - Pregnancy - Diabetes</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cystic Fibrosis</mesh_term>
    <mesh_term>Fibrosis</mesh_term>
  </condition_browse>
  <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/NCT03290144
org study id: 69HCL17_0624
nct id: NCT03290144
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
There have been substantial advances in care for individuals with CF, including improved
      nutrition and respiratory care. Women with CF are now likely to survive into adulthood with a
      median predicted survival of 49.7 years in 2012, which have resulted in increasingly normal
      lifestyles, including successful pregnancies in women with CF. The number of pregnancies in
      CF women has increased as reported by the 2013 Annual Data Report from the French CF Registry
      (6 pregnancies in 1992 to 53 in 2012). Pregnancy adds many physiological stresses to the
      body, particularly on pulmonary function (decrease in residual volume, expiratory reserve
      capacity) and nutritional status (increase in nutritional needs). In women with CF, these
      added stresses could theoretically affect survival, with difficulties to maintain adequate
      nutrition and an unpredictable effect on lung function. A number of studies published over
      the past 15 years have attempted to clarify the risk of pregnancy in women with CF to guide
      clinicians and women. Many authors compared the outcomes of pregnant CF women to non-pregnant
      CF women regardless of nutritional status, lung function, diabetes mellitus, bacteriological
      colonization. In literature, pregnancy was possible and well tolerated in CF women with mild
      disease if associated with more intensive monitoring and aggressive treatment during
      pregnancy, with particular emphasis on nutrition and weight gain. CF women have an increased
      likelihood of receiving treatment for diabetes both during and after pregnancy. Furthermore
      diabetes mellitus has been associated with more severe pulmonary disease, more frequent
      pulmonary exacerbations, poorer nutritional status and a reduced life expectancy.
      Pre-pregnancy diabetes mellitus is associated with a poorer prognosis for pregnancy in
      general population. Severe forms of CF, including pre-pregnancy diabetes mellitus might as
      well do badly with accelerated decline after pregnancy. To determine the effect of
      pre-pregnancy diabetes on maternal decline after pregnancy, we will compare FEV1 and BMI
      rates of decline, during a two-years follow-up period after pregnancies, reported in the
      French CF Registry, according to their diabetic status.
observational model: Cohort
time perspective: Other
measure: Change in FEV1
time frame: 12 months following the pregnancy
measure: Change in Body Mass Index (BMI)
time frame: 12 months following the pregnancy
arm group label: with diabetes
arm group label: without diabetes
study pop: 
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Sponsor
mesh term: Cystic Fibrosis
mesh term: Fibrosis
sharing ipd: No