<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/NCT02220413</url>
  </required_header>
  <id_info>
    <org_study_id>00018603</org_study_id>
    <nct_id>NCT02220413</nct_id>
  </id_info>
  <brief_title>Predictors of Lactogenesis II</brief_title>
  <official_title>Predictors and Moderators of Delayed Lactogenesis II and Duration of Breastfeeding</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of South Florida</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of South Florida</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate what proportion of obese women will have a&#xD;
      self-reported delay in lactogenesis II (&quot;breastmilk coming in&quot;) compared to women with a&#xD;
      normal weight. We hypothesize that obese women will have an absolute 20% increase in delayed&#xD;
      lactogenesis II.&#xD;
&#xD;
      We will compare two group of women for delayed lactogenesis II, one group with obese women&#xD;
      (BMI&gt;30) and one group of women with a normal weight (BMI&lt;30).&#xD;
&#xD;
      The secondary objective is to assess what other factors influence the self-reported delayed&#xD;
      lactogenesis II.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Lactogenesis I occurs during pregnancy (midpregnancy and beyond), when the mammary glands&#xD;
      becomes sufficiently differentiated to secrete small quantities of specific milk components.&#xD;
      Lactogenesis II is defined as the onset of plentiful milk secretion and typically occurs&#xD;
      between 30-40 hours post delivery. It is typically described by women as a sense of fullness&#xD;
      and leakage of milk which is subjectively reported between 50-73 hours post delivery. The&#xD;
      incidence of delayed lactogenesis II ranges from 17-44%.&#xD;
&#xD;
      The risk of neonatal weight loss is up to 7 times greater for exclusively breastfed infants&#xD;
      of women who experience delayed lactogenesis II as compared to women who experience typical&#xD;
      onset lactogenesisII. In a qualitative study of 114 lactating women, increasing BMI was&#xD;
      significantly associated with maternal perceptions of delayed onset of lactogenesis II.&#xD;
&#xD;
      The United States Breastfeeding Committee supports exclusive breastfeeding for the first 6&#xD;
      months of life because it &quot;may exert a small but positive influence in reducing the risk of&#xD;
      obesity in childhood and later in life…&quot; Breastfeeding has also been associated with&#xD;
      decreased risk of maternal morbidities such as type 2 diabetes, subclinical cardiovascular&#xD;
      disease and less abdominal visceral adiposity. Given that prolonged breastfeeding improves&#xD;
      the overall health of the mother infant dyad, it is critical to obtain a better understanding&#xD;
      of those factors predictive of successful breastfeeding outcomes.&#xD;
&#xD;
      At University of South Florida our clinics serve an ethnically diverse population which would&#xD;
      benefit from directed efforts at improving breastfeeding. Before we can undertake such a plan&#xD;
      we need to assess the contemporary factors impacting lactogenesis.&#xD;
&#xD;
      We plan to prospectively enroll 186 pregnant women into a protocol to examine factors&#xD;
      associated with delayed lactogenesis. Ninety-three women will have a BMI of 30 or higher at&#xD;
      the time of delivery and the other 93 women will have a BMI ≤ 29 at the time of delivery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">January 1, 2017</completion_date>
  <primary_completion_date type="Actual">January 1, 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>Onset of lactogenesis II</measure>
    <time_frame>2-5 days post delivery</time_frame>
    <description>Women will be asked about the perception of the onset of their breastmilk coming such as breast engorgement.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Breastfeeding duration</measure>
    <time_frame>Six weeks post delivery</time_frame>
    <description>Women presenting for their 6 week postpartum exam will be asked to complete a short interview of 4 questions in regards to breastfeeding duration, &quot;Measurement of intensity of breastfeeding behavior&quot;. Exclusivity of breastfeeding will be based on Labbok's suggested levels of breastfeeding behaviors.Women will be asked &quot;How is your infant feeding? Why?&quot; Responses will be categorized into exclusive, almost exclusive, partial high, partial low, token or no breastfeeding. Women not currently breastfeeding will be asked when the infant last received any breast milk and what the reason is for stop breastfeeding. If we miss the patient at their postpartum visit, we will complete the questionnaire by telephone.</description>
  </secondary_outcome>
  <enrollment type="Actual">216</enrollment>
  <condition>Breastfeeding</condition>
  <eligibility>
    <study_pop>
      <textblock>
        We plan to prospectively enroll 186 pregnant women into a protocol to examine factors&#xD;
        associated with delayed lactogenesis. Ninety-three women will have a BMI of 30 or higher at&#xD;
        the time of delivery and the other 93 women will have a BMI ≤ 29 at the time of delivery.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  intend to attempt breastfeeding&#xD;
&#xD;
          -  Expecting a live-born infant&#xD;
&#xD;
          -  Singleton pregnancy&#xD;
&#xD;
          -  English or Spanish language fluency&#xD;
&#xD;
          -  Delivered at fullterm gestation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Multiple gestation delivery&#xD;
&#xD;
          -  Delivered pre-term (&lt;36weeks and 6 days of gestation)&#xD;
&#xD;
          -  Not admitted to Mother Baby Unit (MBU) (ie admitted to intensive or special care unit&#xD;
             or to Labor &amp; Delivery Unit for postpartum monitoring)&#xD;
&#xD;
          -  Mother did not initiate breastfeeding within 12 hours.&#xD;
&#xD;
          -  No telephone access&#xD;
&#xD;
          -  History of breast reduction or enlargement surgery&#xD;
&#xD;
          -  Planning to formula feed from birth (no intention to breastfeed or try breastfeeding).&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jessica Brumley, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>USF OB/GYN</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Tampa General Hospital</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>USF South Tampa Center</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TGH Health Park Genesis Clinic</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33610</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2016</verification_date>
  <study_first_submitted>August 15, 2014</study_first_submitted>
  <study_first_submitted_qc>August 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 19, 2014</study_first_posted>
  <last_update_submitted>September 20, 2018</last_update_submitted>
  <last_update_submitted_qc>September 20, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 21, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Breastmilk</keyword>
  <keyword>Lactogenesis</keyword>
  <keyword>Obesity</keyword>
  <!-- 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/NCT02220413
org study id: 00018603
nct id: NCT02220413
lead sponsor: 
has dmc: No
The purpose of this study is to investigate what proportion of obese women will have a
      self-reported delay in lactogenesis II ("breastmilk coming in") compared to women with a
      normal weight. We hypothesize that obese women will have an absolute 20% increase in delayed
      lactogenesis II.

      We will compare two group of women for delayed lactogenesis II, one group with obese women
      (BMI>30) and one group of women with a normal weight (BMI<30).

      The secondary objective is to assess what other factors influence the self-reported delayed
      lactogenesis II.
Lactogenesis I occurs during pregnancy (midpregnancy and beyond), when the mammary glands
      becomes sufficiently differentiated to secrete small quantities of specific milk components.
      Lactogenesis II is defined as the onset of plentiful milk secretion and typically occurs
      between 30-40 hours post delivery. It is typically described by women as a sense of fullness
      and leakage of milk which is subjectively reported between 50-73 hours post delivery. The
      incidence of delayed lactogenesis II ranges from 17-44%.

      The risk of neonatal weight loss is up to 7 times greater for exclusively breastfed infants
      of women who experience delayed lactogenesis II as compared to women who experience typical
      onset lactogenesisII. In a qualitative study of 114 lactating women, increasing BMI was
      significantly associated with maternal perceptions of delayed onset of lactogenesis II.

      The United States Breastfeeding Committee supports exclusive breastfeeding for the first 6
      months of life because it "may exert a small but positive influence in reducing the risk of
      obesity in childhood and later in life…" Breastfeeding has also been associated with
      decreased risk of maternal morbidities such as type 2 diabetes, subclinical cardiovascular
      disease and less abdominal visceral adiposity. Given that prolonged breastfeeding improves
      the overall health of the mother infant dyad, it is critical to obtain a better understanding
      of those factors predictive of successful breastfeeding outcomes.

      At University of South Florida our clinics serve an ethnically diverse population which would
      benefit from directed efforts at improving breastfeeding. Before we can undertake such a plan
      we need to assess the contemporary factors impacting lactogenesis.

      We plan to prospectively enroll 186 pregnant women into a protocol to examine factors
      associated with delayed lactogenesis. Ninety-three women will have a BMI of 30 or higher at
      the time of delivery and the other 93 women will have a BMI ≤ 29 at the time of delivery.
observational model: Cohort
time perspective: Prospective
measure: Onset of lactogenesis II
time frame: 2-5 days post delivery
description: Women will be asked about the perception of the onset of their breastmilk coming such as breast engorgement.
measure: Breastfeeding duration
time frame: Six weeks post delivery
description: Women presenting for their 6 week postpartum exam will be asked to complete a short interview of 4 questions in regards to breastfeeding duration, "Measurement of intensity of breastfeeding behavior". Exclusivity of breastfeeding will be based on Labbok's suggested levels of breastfeeding behaviors.Women will be asked "How is your infant feeding? Why?" Responses will be categorized into exclusive, almost exclusive, partial high, partial low, token or no breastfeeding. Women not currently breastfeeding will be asked when the infant last received any breast milk and what the reason is for stop breastfeeding. If we miss the patient at their postpartum visit, we will complete the questionnaire by telephone.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
last name: Jessica Brumley, PhD
role: Principal Investigator
affiliation: USF OB/GYN
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor