<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/NCT02231398</url>
  </required_header>
  <id_info>
    <org_study_id>NHLBI-nuMoM2b-HHS-001</org_study_id>
    <secondary_id>1U10HL119991</secondary_id>
    <nct_id>NCT02231398</nct_id>
  </id_info>
  <brief_title>nuMoM2b Heart Health Study</brief_title>
  <acronym>nuMoM2b-HHS</acronym>
  <official_title>Pregnancy as a Window to Future Cardiovascular Health: Adverse Pregnancy Outcomes as Predictors of Increased Risk Factors for Cardiovascular Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>RTI International</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Heart, Lung, and Blood Institute (NHLBI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>RTI International</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is looking at the relationship between experiences during pregnancy and&#xD;
      cardiovascular health 2 to 3½ years later. The investigators are recruiting women from the&#xD;
      approximately 10,000 women who were enrolled and followed over the course of their first&#xD;
      pregnancy in another study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The National Heart, Lung, and Blood Institute (NHLBI), in collaboration with the Eunice&#xD;
      Kennedy Shriver National Institute of Child Health and Human Development, is funding this&#xD;
      follow-up study of the nuMoM2b cohort to evaluate the association between adverse pregnancy&#xD;
      outcomes (APOs) and cardiovascular health approximately 2 to 3½ years postpartum. The study,&#xD;
      called the nuMoM2b Heart Health Study or nuMoM2b HHS, utilizes the extensive database and&#xD;
      tissue bank developed for nuMoM2b in which nulliparous women are evaluated over the course of&#xD;
      pregnancy to study the mechanisms for and prediction of APOs. Women enrolled in the nuMoM2b&#xD;
      cohort are extremely well phenotyped through prospective data collection, clinical&#xD;
      evaluations, and ultrasound assessments, as well as through the use of standardized&#xD;
      definitions. Demographic, psychosocial, dietary, physiologic, and outcome information were&#xD;
      collected through maternal interviews, self-administered questionnaires, clinical&#xD;
      measurements, ultrasounds, and medical record abstraction. Samples of maternal blood, urine,&#xD;
      and cervico-vaginal fluid over pregnancy and cord blood and placenta at delivery were&#xD;
      collected and banked. All women completed two sleep questionnaires and over 3,600 had&#xD;
      objective overnight sleep studies at two times during pregnancy.&#xD;
&#xD;
      Women participating in the nuMoM2b are assessed in nuMoM2b HHS for evidence of cardiovascular&#xD;
      disease risk (CVDR), including sleep disordered breathing (SDB), at 2 to 3½ years postpartum.&#xD;
      APOs in subsequent pregnancies also are assessed. This study characterizes the relationship&#xD;
      between APOs and CVDR, identify first pregnancy profiles that portend subsequent CVDR,&#xD;
      determine associations between SDB during the first pregnancy and subsequent CVDR, and&#xD;
      identify modifiable factors that mediate the associations between CVDR and APOs in the first&#xD;
      and subsequent pregnancy. This follow-up study will allow for the development of strategies&#xD;
      to modify these CVDR factors and to improve the health of women suffering APOs.&#xD;
&#xD;
      The nuMoM2b Heart Health Study is a prospective observational study that includes interval&#xD;
      contacts and a detailed cardiovascular assessment 2 to 3½ years after delivery of the index&#xD;
      pregnancy. At the cardiovascular assessment, potentially eligible women are invited to attend&#xD;
      a cardiovascular screening visit. After informed consent, a urine pregnancy test is performed&#xD;
      to confirm eligibility. The visit includes clinical and laboratory measurements as well as a&#xD;
      structured interview to assess domains that were measured in the nuMoM2b pregnancy: physical&#xD;
      activity, depression, social support, psychological stress, and nutritional status. Women&#xD;
      with sleep breathing assessments during their nuMoM2b pregnancy are offered another overnight&#xD;
      sleep study.&#xD;
&#xD;
      The overarching goal is to better define the relation between outcomes of pregnancy and long&#xD;
      term health of the mother. The specific aims are as follows:&#xD;
&#xD;
      Aim 1: Define the incidence of hypertension and the cardiovascular disease risk (CVDR)&#xD;
      profile of women approximately 2 to 3½ years after a first pregnancy complicated by&#xD;
      preeclampsia or other adverse pregnancy outcomes (APOs: stillbirth, small for gestational age&#xD;
      at birth [SGA], preterm birth, preeclampsia, pregnancy-associated hypertension, gestational&#xD;
      diabetes [GDM]) compared to women having no APOs in the first pregnancy.&#xD;
&#xD;
      Aim 2: Identify a profile in early pregnancy that portends subsequent CVDR approximately 2 to&#xD;
      3½ years postpartum.&#xD;
&#xD;
      Aim 3: Determine whether pregnancy and postpartum sleep disordered breathing (SDB) is&#xD;
      associated with increased CVDR and identify specific patterns of pregnancy and postpartum SDB&#xD;
      that increase CVDR.&#xD;
&#xD;
      Aim 4: Identify modifiable factors during and after pregnancy that mediate the associations&#xD;
      between APOs and the CVDR during pregnancy and approximately 2 to 3½ years postpartum.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">October 30, 2020</completion_date>
  <primary_completion_date type="Actual">October 30, 2017</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>Hypertension, defined as systolic blood pressure above 140 mm Hg or diastolic blood pressure above 90 mm Hg</measure>
    <time_frame>Blood pressures taken at study clinic visit between 2 and 3.5 years postpartum</time_frame>
    <description>Will exclude participants with chronic hypertension or pregestational diabetes during or just prior to the index pregnancy.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Systolic blood pressure in mm Hg</measure>
    <time_frame>Blood pressures taken at study clinic visit between 2 and 3.5 years postpartum</time_frame>
    <description>Will exclude participants with chronic hypertension or pregestational diabetes during or just prior to the index pregnancy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diastolic blood pressures in mm Hg</measure>
    <time_frame>Blood pressures taken at study clinic visit between 2 and 3.5 years postpartum</time_frame>
    <description>Will exclude participants with chronic hypertension or pregestational diabetes during or just prior to the index pregnancy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HDL cholesterol in mg/dL from blood sample following overnight fast of at least 8 hours</measure>
    <time_frame>Blood sample taken at study clinic visit between 2 and 3.5 years postpartum</time_frame>
    <description>Will exclude participants with chronic hypertension or pregestational diabetes during or just prior to the index pregnancy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>LDL cholesterol in mg/dL from blood sample following overnight fast of at least 8 hours</measure>
    <time_frame>Blood sample taken at study clinic visit between 2 and 3.5 years postpartum</time_frame>
    <description>Will exclude participants with chronic hypertension or pregestational diabetes during or just prior to the index pregnancy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Triglycerides in mg/dL from blood sample following overnight fast of at least 8 hours</measure>
    <time_frame>Blood sample taken at study clinic visit between 2 and 3.5 years postpartum</time_frame>
    <description>Will exclude participants with chronic hypertension or pregestational diabetes during or just prior to the index pregnancy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) from glucose and insulin measured from blood sample following overnight fast of at least 8 hours</measure>
    <time_frame>Blood sample taken at study clinic visit between 2 and 3.5 years postpartum</time_frame>
    <description>Will exclude participants with chronic hypertension or pregestational diabetes during or just prior to the index pregnancy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>High sensitivity C-reactive protein (hs-CRP) in mg/L measured from blood sample following overnight fast of at least 8 hours</measure>
    <time_frame>Taken at study clinic visit between 2 and 3.5 years postpartum</time_frame>
    <description>Will exclude participants with chronic hypertension or pregestational diabetes during or just prior to the index pregnancy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hemoglobin A1c (%) measured from blood sample following overnight fast of at least 8 hours</measure>
    <time_frame>Taken at study clinic visit between 2 and 3.5 years postpartum</time_frame>
    <description>Will exclude participants with chronic hypertension or pregestational diabetes during or just prior to the index pregnancy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep disordered breathing, defined as apnea-hypopnea index (AHI) of 3 or more</measure>
    <time_frame>Taken at study clinic visit between 2 and 3.5 years postpartum</time_frame>
    <description>AHI calculated for apnea-hypopnea events with 3% desaturation.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>N-terminal of the Prohormone Brain Natriuretic peptide (NT-proBNP) in pg/mL from blood sample following overnight fast of at least 8 hours</measure>
    <time_frame>Blood sample taken at study clinic visit between 2 and 3.5 years postpartum</time_frame>
    <description>project funds permitting</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">4509</enrollment>
  <condition>Pregnancy Complicated by Cardiovascular Disorders as Postpartum Condition, Delivered During Previous Episode</condition>
  <condition>Breathing-Related Sleep Disorder</condition>
  <arm_group>
    <arm_group_label>Women who participated in nuMoM2b</arm_group_label>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood Samples: A research or clinical staff member collects a fasting blood draw from the&#xD;
      participant: 2 SST (tiger top) 10 mL tubes for serum; 2 EDTA (purple top) 10 mL tubes for&#xD;
      plasma, and 1 (light blue top) 2.7 mL tube for citrated plasma. Less than 3 tablespoons of&#xD;
      blood are collected. A 0.5 mL aliquot of whole blood from the EDTA tube is reserved. The rest&#xD;
      of the blood is processed and as many 0.5 mL aliquots of serum, EDTA plasma, and citrated&#xD;
      plasma as possible are collected. In addition, a 1.5 mL aliquot of buffy coat is collected&#xD;
      from one of the EDTA tubes.&#xD;
&#xD;
      Urine Sample: A research or clinical staff member collects about 20 mL of clean catch urine&#xD;
      from the participant and 2 urine aliquots (1.8 mL each).&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Eligible women are recruited from the cohort enrolled to nuMoM2b. For nuMom2b a convenience&#xD;
        sample was recruited through 8 primary clinical sites that NIH selected because they could&#xD;
        each demonstrate access to more than 4,500 deliveries per year. As a group, sites were&#xD;
        geographically dispersed and ethically diverse. All nulliparous women aged 13 years or&#xD;
        greater with a singleton pregnancy less than 13 weeks 6 days gestation who presented at&#xD;
        recruitment clinics or practices and planned to deliver at a study hospital were&#xD;
        potentially eligible for participation. A clinical or research ultrasound, performed by a&#xD;
        study certified sonographer, confirmed viability of a singleton gestation with no obvious&#xD;
        malformations and estimated gestational age less than or equal to 13 weeks 6 days before&#xD;
        the woman was allowed enrollment. The first visit was scheduled and completed within a&#xD;
        window of 6 weeks 0 days and 13 weeks 6 days estimated gestational age.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Interval Contact:&#xD;
&#xD;
          -  Agreed to contact for future studies during nuMoM2b and not subsequently withdrawn&#xD;
             from the cohort.&#xD;
&#xD;
          -  Have pregnancy outcome data from the nuMoM2b study.&#xD;
&#xD;
          -  At least 18 years of age (to begin interval contact attempts once nuMoM2b participant&#xD;
             reaches age 18).&#xD;
&#xD;
          -  Provision of verbal consent for telephone interview or acknowledgement of consent with&#xD;
             completion of the web-based self-administered questionnaire.&#xD;
&#xD;
        In-clinic Visit:&#xD;
&#xD;
          -  Consented for participation in interval contacts and not subsequently withdrawn&#xD;
&#xD;
          -  Between 2 and 3.5 years after the nuMoM2b pregnancy ended&#xD;
&#xD;
          -  Self-report at least 6 months postpartum from any subsequent pregnancy&#xD;
&#xD;
          -  Self-report not currently pregnant&#xD;
&#xD;
          -  Able to provide informed consent&#xD;
&#xD;
          -  Provision of written, signed, informed consent for the 2 to 3.5 year in-clinic&#xD;
             assessment&#xD;
&#xD;
          -  Not currently pregnant by urine pregnancy test administered in the clinic following&#xD;
             consent&#xD;
&#xD;
        In-home Sleep Breathing Assessment after the In-Clinic Visit:&#xD;
&#xD;
          -  Participation in the in-clinic visit&#xD;
&#xD;
          -  Participation in the sleep breathing substudy of nuMoM2b with at least one sleep&#xD;
             breathing assessment providing valid data&#xD;
&#xD;
          -  Not currently using positive airway pressure (PAP) therapy or other approved&#xD;
             treatments for sleep apnea such as oral appliances and nasal therapy patch (Provent)&#xD;
&#xD;
          -  Not currently on continuous oral steroid therapy for 14 days or more to treat asthma&#xD;
&#xD;
          -  Not currently using oxygen supplementation to treat a medical condition&#xD;
&#xD;
          -  Able to provide informed consent and deemed likely to return equipment in a reasonable&#xD;
             period&#xD;
&#xD;
          -  Provision of written, signed, informed consent for the sleep breathing assessment for&#xD;
             the nuMoM2b Heart Health Study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability or refusal to provide informed consent for the study component.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>George Saade, M.D.</last_name>
    <role>Study Chair</role>
    <affiliation>University of Texas Medical Branch at Galveston</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Brian M. Mercer, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Case Western Reserve University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ronald Wapner, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Columbia University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>David M. Haas, M.D., M.S.,</last_name>
    <role>Principal Investigator</role>
    <affiliation>Indiana University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Hyagriv N. Simhan, MD, MSCR</last_name>
    <role>Principal Investigator</role>
    <affiliation>Magee Womens Hospital - University of Pittsburgh</affiliation>
  </overall_official>
  <overall_official>
    <last_name>William Grobman, M.D., M.B.A.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Northwestern University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Judith Chung, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University CA Irvine</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Samuel Parry, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Pennsylvania</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Robert M. Silver, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Utah</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Fountain Valley Regional Hospital and Medical Center- UCI MFM private practice</name>
      <address>
        <city>Fountain Valley</city>
        <state>California</state>
        <zip>92708</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Long Beach Memorial Medical Center, Women's and Children's Hospital - Women's Perinatal Group, OB Clinic</name>
      <address>
        <city>Long Beach</city>
        <state>California</state>
        <zip>90801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California, Irvine, Medical Center - Prenatal care clinics and private practice</name>
      <address>
        <city>Orange</city>
        <state>California</state>
        <zip>92868</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Christiana Care Health Systems</name>
      <address>
        <city>Newark</city>
        <state>Delaware</state>
        <zip>19718</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwestern University</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Indiana University School of Medicine OB/GYN</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Columbia University Medical Center- Department of OB/GYN Division of Maternal Fetal Medicine</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Case Western Reserve University, MetroHealth Medical Center</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Magee Womens Hospital</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>McKay Dee Hospital</name>
      <address>
        <city>Ogden</city>
        <state>Utah</state>
        <zip>84403</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Utah Valley Regional Medical Center</name>
      <address>
        <city>Provo</city>
        <state>Utah</state>
        <zip>84604</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Utah</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Intermountain Medical Center</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LDS Hospital</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84143</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Haas DM, Ehrenthal DB, Koch MA, Catov JM, Barnes SE, Facco F, Parker CB, Mercer BM, Bairey-Merz CN, Silver RM, Wapner RJ, Simhan HN, Hoffman MK, Grobman WA, Greenland P, Wing DA, Saade GR, Parry S, Zee PC, Reddy UM, Pemberton VL, Burwen DR; National Heart, Lung, and Blood Institute nuMoM2b Heart Health Study Network. Pregnancy as a Window to Future Cardiovascular Health: Design and Implementation of the nuMoM2b Heart Health Study. Am J Epidemiol. 2016 Mar 15;183(6):519-30. doi: 10.1093/aje/kwv309. Epub 2016 Jan 28.</citation>
    <PMID>26825925</PMID>
  </reference>
  <reference>
    <citation>Catov JM, Parker CB, Gibbs BB, Bann CM, Carper B, Silver RM, Simhan HN, Parry S, Chung JH, Haas DM, Wapner RJ, Saade GR, Mercer BM, Bairey-Merz CN, Greenland P, Ehrenthal DB, Barnes SE, Shanks AL, Reddy UM, Grobman WA; NICHD NuMoM2b and NHLBI NuMoM2b Heart Health Study Network. Patterns of leisure-time physical activity across pregnancy and adverse pregnancy outcomes. Int J Behav Nutr Phys Act. 2018 Jul 11;15(1):68. doi: 10.1186/s12966-018-0701-5.</citation>
    <PMID>29996930</PMID>
  </reference>
  <reference>
    <citation>Facco FL, Parker CB, Hunter S, Reid KJ, Zee PC, Silver RM, Haas DM, Chung JH, Pien GW, Nhan-Chang CL, Simhan HN, Parry S, Wapner RJ, Saade GR, Mercer BM, Torres C, Knight J, Reddy UM, Grobman WA; NICHD NuMoM2b and NHLBI NuMoM2b Heart Health Study Networks. Association of Adverse Pregnancy Outcomes With Self-Reported Measures of Sleep Duration and Timing in Women Who Are Nulliparous. J Clin Sleep Med. 2018 Dec 15;14(12):2047-2056. doi: 10.5664/jcsm.7534.</citation>
    <PMID>30518449</PMID>
  </reference>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>August 28, 2014</study_first_submitted>
  <study_first_submitted_qc>August 30, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 4, 2014</study_first_posted>
  <last_update_submitted>January 31, 2022</last_update_submitted>
  <last_update_submitted_qc>January 31, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 16, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>RTI International</investigator_affiliation>
    <investigator_full_name>Becky McNeil</investigator_full_name>
    <investigator_title>Senior Research Statistician</investigator_title>
  </responsible_party>
  <keyword>Cardiovascular disease</keyword>
  <keyword>Pregnant women</keyword>
  <keyword>Nulliparity</keyword>
  <keyword>Pregnancy outcomes</keyword>
  <keyword>Pregnancy complications</keyword>
  <keyword>Sleep disordered breathing</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Aspiration</mesh_term>
    <mesh_term>Sleep Wake Disorders</mesh_term>
    <mesh_term>Cardiovascular Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>De-identified data will be made available through an NIH data repository.</ipd_description>
  </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/NCT02231398
org study id: NHLBI-nuMoM2b-HHS-001
secondary id: 1U10HL119991
nct id: NCT02231398
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
This study is looking at the relationship between experiences during pregnancy and
      cardiovascular health 2 to 3½ years later. The investigators are recruiting women from the
      approximately 10,000 women who were enrolled and followed over the course of their first
      pregnancy in another study.
The National Heart, Lung, and Blood Institute (NHLBI), in collaboration with the Eunice
      Kennedy Shriver National Institute of Child Health and Human Development, is funding this
      follow-up study of the nuMoM2b cohort to evaluate the association between adverse pregnancy
      outcomes (APOs) and cardiovascular health approximately 2 to 3½ years postpartum. The study,
      called the nuMoM2b Heart Health Study or nuMoM2b HHS, utilizes the extensive database and
      tissue bank developed for nuMoM2b in which nulliparous women are evaluated over the course of
      pregnancy to study the mechanisms for and prediction of APOs. Women enrolled in the nuMoM2b
      cohort are extremely well phenotyped through prospective data collection, clinical
      evaluations, and ultrasound assessments, as well as through the use of standardized
      definitions. Demographic, psychosocial, dietary, physiologic, and outcome information were
      collected through maternal interviews, self-administered questionnaires, clinical
      measurements, ultrasounds, and medical record abstraction. Samples of maternal blood, urine,
      and cervico-vaginal fluid over pregnancy and cord blood and placenta at delivery were
      collected and banked. All women completed two sleep questionnaires and over 3,600 had
      objective overnight sleep studies at two times during pregnancy.

      Women participating in the nuMoM2b are assessed in nuMoM2b HHS for evidence of cardiovascular
      disease risk (CVDR), including sleep disordered breathing (SDB), at 2 to 3½ years postpartum.
      APOs in subsequent pregnancies also are assessed. This study characterizes the relationship
      between APOs and CVDR, identify first pregnancy profiles that portend subsequent CVDR,
      determine associations between SDB during the first pregnancy and subsequent CVDR, and
      identify modifiable factors that mediate the associations between CVDR and APOs in the first
      and subsequent pregnancy. This follow-up study will allow for the development of strategies
      to modify these CVDR factors and to improve the health of women suffering APOs.

      The nuMoM2b Heart Health Study is a prospective observational study that includes interval
      contacts and a detailed cardiovascular assessment 2 to 3½ years after delivery of the index
      pregnancy. At the cardiovascular assessment, potentially eligible women are invited to attend
      a cardiovascular screening visit. After informed consent, a urine pregnancy test is performed
      to confirm eligibility. The visit includes clinical and laboratory measurements as well as a
      structured interview to assess domains that were measured in the nuMoM2b pregnancy: physical
      activity, depression, social support, psychological stress, and nutritional status. Women
      with sleep breathing assessments during their nuMoM2b pregnancy are offered another overnight
      sleep study.

      The overarching goal is to better define the relation between outcomes of pregnancy and long
      term health of the mother. The specific aims are as follows:

      Aim 1: Define the incidence of hypertension and the cardiovascular disease risk (CVDR)
      profile of women approximately 2 to 3½ years after a first pregnancy complicated by
      preeclampsia or other adverse pregnancy outcomes (APOs: stillbirth, small for gestational age
      at birth [SGA], preterm birth, preeclampsia, pregnancy-associated hypertension, gestational
      diabetes [GDM]) compared to women having no APOs in the first pregnancy.

      Aim 2: Identify a profile in early pregnancy that portends subsequent CVDR approximately 2 to
      3½ years postpartum.

      Aim 3: Determine whether pregnancy and postpartum sleep disordered breathing (SDB) is
      associated with increased CVDR and identify specific patterns of pregnancy and postpartum SDB
      that increase CVDR.

      Aim 4: Identify modifiable factors during and after pregnancy that mediate the associations
      between APOs and the CVDR during pregnancy and approximately 2 to 3½ years postpartum.
observational model: Cohort
time perspective: Prospective
measure: Hypertension, defined as systolic blood pressure above 140 mm Hg or diastolic blood pressure above 90 mm Hg
time frame: Blood pressures taken at study clinic visit between 2 and 3.5 years postpartum
description: Will exclude participants with chronic hypertension or pregestational diabetes during or just prior to the index pregnancy.
measure: Systolic blood pressure in mm Hg
time frame: Blood pressures taken at study clinic visit between 2 and 3.5 years postpartum
description: Will exclude participants with chronic hypertension or pregestational diabetes during or just prior to the index pregnancy.
measure: Diastolic blood pressures in mm Hg
time frame: Blood pressures taken at study clinic visit between 2 and 3.5 years postpartum
description: Will exclude participants with chronic hypertension or pregestational diabetes during or just prior to the index pregnancy.
measure: HDL cholesterol in mg/dL from blood sample following overnight fast of at least 8 hours
time frame: Blood sample taken at study clinic visit between 2 and 3.5 years postpartum
description: Will exclude participants with chronic hypertension or pregestational diabetes during or just prior to the index pregnancy.
measure: LDL cholesterol in mg/dL from blood sample following overnight fast of at least 8 hours
time frame: Blood sample taken at study clinic visit between 2 and 3.5 years postpartum
description: Will exclude participants with chronic hypertension or pregestational diabetes during or just prior to the index pregnancy.
measure: Triglycerides in mg/dL from blood sample following overnight fast of at least 8 hours
time frame: Blood sample taken at study clinic visit between 2 and 3.5 years postpartum
description: Will exclude participants with chronic hypertension or pregestational diabetes during or just prior to the index pregnancy.
measure: Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) from glucose and insulin measured from blood sample following overnight fast of at least 8 hours
time frame: Blood sample taken at study clinic visit between 2 and 3.5 years postpartum
description: Will exclude participants with chronic hypertension or pregestational diabetes during or just prior to the index pregnancy.
measure: High sensitivity C-reactive protein (hs-CRP) in mg/L measured from blood sample following overnight fast of at least 8 hours
time frame: Taken at study clinic visit between 2 and 3.5 years postpartum
description: Will exclude participants with chronic hypertension or pregestational diabetes during or just prior to the index pregnancy.
measure: Hemoglobin A1c (%) measured from blood sample following overnight fast of at least 8 hours
time frame: Taken at study clinic visit between 2 and 3.5 years postpartum
description: Will exclude participants with chronic hypertension or pregestational diabetes during or just prior to the index pregnancy.
measure: Sleep disordered breathing, defined as apnea-hypopnea index (AHI) of 3 or more
time frame: Taken at study clinic visit between 2 and 3.5 years postpartum
description: AHI calculated for apnea-hypopnea events with 3% desaturation.
measure: N-terminal of the Prohormone Brain Natriuretic peptide (NT-proBNP) in pg/mL from blood sample following overnight fast of at least 8 hours
time frame: Blood sample taken at study clinic visit between 2 and 3.5 years postpartum
description: project funds permitting
arm group label: Women who participated in nuMoM2b
Blood Samples: A research or clinical staff member collects a fasting blood draw from the
      participant: 2 SST (tiger top) 10 mL tubes for serum; 2 EDTA (purple top) 10 mL tubes for
      plasma, and 1 (light blue top) 2.7 mL tube for citrated plasma. Less than 3 tablespoons of
      blood are collected. A 0.5 mL aliquot of whole blood from the EDTA tube is reserved. The rest
      of the blood is processed and as many 0.5 mL aliquots of serum, EDTA plasma, and citrated
      plasma as possible are collected. In addition, a 1.5 mL aliquot of buffy coat is collected
      from one of the EDTA tubes.

      Urine Sample: A research or clinical staff member collects about 20 mL of clean catch urine
      from the participant and 2 urine aliquots (1.8 mL each).
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: George Saade, M.D.
role: Study Chair
affiliation: University of Texas Medical Branch at Galveston
last name: Brian M. Mercer, MD
role: Principal Investigator
affiliation: Case Western Reserve University
last name: Ronald Wapner, MD
role: Principal Investigator
affiliation: Columbia University
last name: David M. Haas, M.D., M.S.,
role: Principal Investigator
affiliation: Indiana University
last name: Hyagriv N. Simhan, MD, MSCR
role: Principal Investigator
affiliation: Magee Womens Hospital - University of Pittsburgh
last name: William Grobman, M.D., M.B.A.
role: Principal Investigator
affiliation: Northwestern University
last name: Judith Chung, M.D.
role: Principal Investigator
affiliation: University CA Irvine
last name: Samuel Parry, M.D.
role: Principal Investigator
affiliation: University of Pennsylvania
last name: Robert M. Silver, M.D.
role: Principal Investigator
affiliation: University of Utah
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country: United States
citation: Haas DM, Ehrenthal DB, Koch MA, Catov JM, Barnes SE, Facco F, Parker CB, Mercer BM, Bairey-Merz CN, Silver RM, Wapner RJ, Simhan HN, Hoffman MK, Grobman WA, Greenland P, Wing DA, Saade GR, Parry S, Zee PC, Reddy UM, Pemberton VL, Burwen DR; National Heart, Lung, and Blood Institute nuMoM2b Heart Health Study Network. Pregnancy as a Window to Future Cardiovascular Health: Design and Implementation of the nuMoM2b Heart Health Study. Am J Epidemiol. 2016 Mar 15;183(6):519-30. doi: 10.1093/aje/kwv309. Epub 2016 Jan 28.
PMID: 26825925
citation: Catov JM, Parker CB, Gibbs BB, Bann CM, Carper B, Silver RM, Simhan HN, Parry S, Chung JH, Haas DM, Wapner RJ, Saade GR, Mercer BM, Bairey-Merz CN, Greenland P, Ehrenthal DB, Barnes SE, Shanks AL, Reddy UM, Grobman WA; NICHD NuMoM2b and NHLBI NuMoM2b Heart Health Study Network. Patterns of leisure-time physical activity across pregnancy and adverse pregnancy outcomes. Int J Behav Nutr Phys Act. 2018 Jul 11;15(1):68. doi: 10.1186/s12966-018-0701-5.
PMID: 29996930
citation: Facco FL, Parker CB, Hunter S, Reid KJ, Zee PC, Silver RM, Haas DM, Chung JH, Pien GW, Nhan-Chang CL, Simhan HN, Parry S, Wapner RJ, Saade GR, Mercer BM, Torres C, Knight J, Reddy UM, Grobman WA; NICHD NuMoM2b and NHLBI NuMoM2b Heart Health Study Networks. Association of Adverse Pregnancy Outcomes With Self-Reported Measures of Sleep Duration and Timing in Women Who Are Nulliparous. J Clin Sleep Med. 2018 Dec 15;14(12):2047-2056. doi: 10.5664/jcsm.7534.
PMID: 30518449
responsible party type: Principal Investigator
investigator affiliation: RTI International
investigator full name: Becky McNeil
investigator title: Senior Research Statistician
mesh term: Respiratory Aspiration
mesh term: Sleep Wake Disorders
mesh term: Cardiovascular Diseases
sharing ipd: Yes
ipd description: De-identified data will be made available through an NIH data repository.