<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/NCT02967796</url>
  </required_header>
  <id_info>
    <org_study_id>PiL-Obs-ProtSC-014</org_study_id>
    <nct_id>NCT02967796</nct_id>
  </id_info>
  <brief_title>Strategy of Micronutrient Management in Parturient and Layered Women With a Dietary Supplement Rich in Porphyra HSP®</brief_title>
  <official_title>Descriptive Study About a Strategy of Micronutrient Management in Parturient and Layered Women With Proteochoc®, a Dietary Supplement Rich in Porphyra HSP®</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>PiLeJe</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>PiLeJe</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the study is to evaluate in primiparous patients the benefit of supplementation&#xD;
      with Proteochoc® to reduce perineal pain in the postpartum especially, in sitting posture.&#xD;
      The patient is followed from the delivery to 6 to 8 weeks after.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      For this study, 60 patients are going to be included. There will be 2 groups : a supplemented&#xD;
      one (proteochoc®) and a non supplemented one (control). The patients of these two groups will&#xD;
      have the same follow-up At the time of inclusion, an inclusion card is completed describing&#xD;
      the patient's socio-demographic characteristics, major medical, surgical and obstetric&#xD;
      history. After an uncomplicated delivery, women stay in maternity for a maximum of 3 days. In&#xD;
      accordance with standard medical practice, women will be seen daily from D0 to D + 3 by the&#xD;
      nursing staff. The investigating physician and his team will complete the follow-up sheets in&#xD;
      the aftermath (day1), day3 and 6-8 weeks after the usual visits.&#xD;
&#xD;
      The data collected are information on medication treatments, prescribed care, assessment of&#xD;
      the patient's overall condition and recovery, and monitoring of perineal lesions and&#xD;
      complications if applicable.&#xD;
&#xD;
      In the same time (day1, day3, day6, day14 and 6-8 weeks after, the patient will also complete&#xD;
      a patient follow-up sheet to collect her impressions.&#xD;
&#xD;
      The data collected are the medications taken, the care taken, the general pain felt, the&#xD;
      perineal pain felt if applicable, and the fatigue felt.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 4, 2015</start_date>
  <completion_date type="Actual">April 25, 2017</completion_date>
  <primary_completion_date type="Actual">April 25, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>perineal pain intensity in the sitting position</measure>
    <time_frame>day 6</time_frame>
    <description>The primary outcome will be the perineal pain intensity in the sitting position measured by a visual analogue scale (rated 0 to 10) at day 6 in women who chose to complement versus women who did not wish to take the supplementation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Doctor's evaluation</measure>
    <time_frame>Day 1 (day after the delivery)</time_frame>
    <description>Taking other medication Prescription of perineal care General condition of the patient Post-delivery recovery Type of perineal lesion and its evolution if applicable Complications and their evolutions if applicable Evolution of the scar(s) of the tear(s) or episiotomy if applicable Compliance with the Protéochoc® product</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Doctor's evaluation</measure>
    <time_frame>Day 3</time_frame>
    <description>Taking other medication Prescription of perineal care General condition of the patient Post-delivery recovery Type of perineal lesion and its evolution if applicable Complications and their evolutions if applicable Evolution of the scar(s) of the tear(s) or episiotomy if applicable Compliance with the Protéochoc® product</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Doctor's evaluation</measure>
    <time_frame>Day 56</time_frame>
    <description>Taking other medication Prescription of perineal care General condition of the patient Post-delivery recovery Type of perineal lesion and its evolution if applicable Complications and their evolutions if applicable Evolution of the scar(s) of the tear(s) or episiotomy if applicable Compliance with the Protéochoc® product</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient's evaluation</measure>
    <time_frame>Day 1 (day after the delivery)</time_frame>
    <description>Taking other medication Perineal care performed The level of pain in general, uterine pain and breast pain The level of perineal pain and its evolution The discomfort caused by perineal pain (rest, walking and urination) The state of fatigue (fatigue score, score 0 to 4) Compliance with the Protéochoc® product</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient's evaluation</measure>
    <time_frame>Day 3</time_frame>
    <description>Taking other medication Perineal care performed The level of pain in general, uterine pain and breast pain The level of perineal pain and its evolution The discomfort caused by perineal pain (rest, walking and urination) The state of fatigue (fatigue score, score 0 to 4) Compliance with the Protéochoc® product</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient's evaluation</measure>
    <time_frame>Day 6</time_frame>
    <description>Taking other medication Perineal care performed The level of pain in general, uterine pain and breast pain The level of perineal pain and its evolution The discomfort caused by perineal pain (rest, walking and urination) The state of fatigue (fatigue score, score 0 to 4) Compliance with the Protéochoc® product</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient's evaluation</measure>
    <time_frame>Day 14</time_frame>
    <description>Taking other medication Perineal care performed The level of pain in general, uterine pain and breast pain The level of perineal pain and its evolution The discomfort caused by perineal pain (rest, walking and urination) The state of fatigue (fatigue score, score 0 to 4) Compliance with the Protéochoc® product</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient's evaluation</measure>
    <time_frame>Day 56</time_frame>
    <description>Taking other medication Perineal care performed The level of pain in general, uterine pain and breast pain The level of perineal pain and its evolution The discomfort caused by perineal pain (rest, walking and urination) The state of fatigue (fatigue score, score 0 to 4) Compliance with the Protéochoc® product</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">60</enrollment>
  <condition>Postpartum Perineal Pain</condition>
  <arm_group>
    <arm_group_label>Supplemented group</arm_group_label>
    <description>6 capsule of Proteochoc during 4 day, from day 0 (day of delivery) to day 4</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <description>no supplementation, just the same follow-up as supplemented group</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Proteochoc</intervention_name>
    <arm_group_label>Supplemented group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Women running their first pregnancy&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female aged over 18&#xD;
&#xD;
          -  First pregnancy&#xD;
&#xD;
          -  Having given birth, at a term greater than or equal to 37 SA, by low route, of a&#xD;
             single child born alive and not hospitalized in the aftermath of immediate layers&#xD;
&#xD;
          -  For whom the investigator has freely decided to propose a complementation by&#xD;
             Protéochoc® on the day of delivery and its sequences of layers&#xD;
&#xD;
          -  Having freely decided to buy Protéochoc® and follow the advice of consumption proposed&#xD;
             by its gynecologist-obstetrician&#xD;
&#xD;
          -  Having agreed to sign a consent to participate in the investigation after receiving&#xD;
             informed information from the investigator&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Serious pathology running&#xD;
&#xD;
          -  Suffering before the pregnancy of any of the following conditions:&#xD;
&#xD;
          -  Chronic pelvic pain syndrome&#xD;
&#xD;
          -  Ilio-inguinal, ilio-hypogastric and genito-femoral pudendal neuralgia&#xD;
&#xD;
          -  Pains with osteo-ligamentary component: the syndrome of the dorsolumbar hinge and the&#xD;
             coccygodynia&#xD;
&#xD;
          -  Myofacial Syndrome&#xD;
&#xD;
          -  Pain of muscular origin: the syndrome of the pyriform muscle, syndrome of the&#xD;
             obturator muscle&#xD;
&#xD;
          -  Pains of venous origin: pelvic varices&#xD;
&#xD;
          -  Allergy to any of the components of Proteochoc®&#xD;
&#xD;
          -  Patient refusing to participate or unable to participate in the survey due to major&#xD;
             language problems or major neuropsychiatric disorders&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Centre hospitalier d'Auch</name>
      <address>
        <city>Auch</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>November 16, 2016</study_first_submitted>
  <study_first_submitted_qc>November 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 18, 2016</study_first_posted>
  <last_update_submitted>July 13, 2018</last_update_submitted>
  <last_update_submitted_qc>July 13, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 17, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT02967796
org study id: PiL-Obs-ProtSC-014
nct id: NCT02967796
lead sponsor: 
has dmc: No
The aim of the study is to evaluate in primiparous patients the benefit of supplementation
      with Proteochoc® to reduce perineal pain in the postpartum especially, in sitting posture.
      The patient is followed from the delivery to 6 to 8 weeks after.
For this study, 60 patients are going to be included. There will be 2 groups : a supplemented
      one (proteochoc®) and a non supplemented one (control). The patients of these two groups will
      have the same follow-up At the time of inclusion, an inclusion card is completed describing
      the patient's socio-demographic characteristics, major medical, surgical and obstetric
      history. After an uncomplicated delivery, women stay in maternity for a maximum of 3 days. In
      accordance with standard medical practice, women will be seen daily from D0 to D + 3 by the
      nursing staff. The investigating physician and his team will complete the follow-up sheets in
      the aftermath (day1), day3 and 6-8 weeks after the usual visits.

      The data collected are information on medication treatments, prescribed care, assessment of
      the patient's overall condition and recovery, and monitoring of perineal lesions and
      complications if applicable.

      In the same time (day1, day3, day6, day14 and 6-8 weeks after, the patient will also complete
      a patient follow-up sheet to collect her impressions.

      The data collected are the medications taken, the care taken, the general pain felt, the
      perineal pain felt if applicable, and the fatigue felt.
observational model: Case-Control
time perspective: Prospective
measure: perineal pain intensity in the sitting position
time frame: day 6
description: The primary outcome will be the perineal pain intensity in the sitting position measured by a visual analogue scale (rated 0 to 10) at day 6 in women who chose to complement versus women who did not wish to take the supplementation
measure: Doctor's evaluation
time frame: Day 1 (day after the delivery)
description: Taking other medication Prescription of perineal care General condition of the patient Post-delivery recovery Type of perineal lesion and its evolution if applicable Complications and their evolutions if applicable Evolution of the scar(s) of the tear(s) or episiotomy if applicable Compliance with the Protéochoc® product
measure: Doctor's evaluation
time frame: Day 3
description: Taking other medication Prescription of perineal care General condition of the patient Post-delivery recovery Type of perineal lesion and its evolution if applicable Complications and their evolutions if applicable Evolution of the scar(s) of the tear(s) or episiotomy if applicable Compliance with the Protéochoc® product
measure: Doctor's evaluation
time frame: Day 56
description: Taking other medication Prescription of perineal care General condition of the patient Post-delivery recovery Type of perineal lesion and its evolution if applicable Complications and their evolutions if applicable Evolution of the scar(s) of the tear(s) or episiotomy if applicable Compliance with the Protéochoc® product
measure: Patient's evaluation
time frame: Day 1 (day after the delivery)
description: Taking other medication Perineal care performed The level of pain in general, uterine pain and breast pain The level of perineal pain and its evolution The discomfort caused by perineal pain (rest, walking and urination) The state of fatigue (fatigue score, score 0 to 4) Compliance with the Protéochoc® product
measure: Patient's evaluation
time frame: Day 3
description: Taking other medication Perineal care performed The level of pain in general, uterine pain and breast pain The level of perineal pain and its evolution The discomfort caused by perineal pain (rest, walking and urination) The state of fatigue (fatigue score, score 0 to 4) Compliance with the Protéochoc® product
measure: Patient's evaluation
time frame: Day 6
description: Taking other medication Perineal care performed The level of pain in general, uterine pain and breast pain The level of perineal pain and its evolution The discomfort caused by perineal pain (rest, walking and urination) The state of fatigue (fatigue score, score 0 to 4) Compliance with the Protéochoc® product
measure: Patient's evaluation
time frame: Day 14
description: Taking other medication Perineal care performed The level of pain in general, uterine pain and breast pain The level of perineal pain and its evolution The discomfort caused by perineal pain (rest, walking and urination) The state of fatigue (fatigue score, score 0 to 4) Compliance with the Protéochoc® product
measure: Patient's evaluation
time frame: Day 56
description: Taking other medication Perineal care performed The level of pain in general, uterine pain and breast pain The level of perineal pain and its evolution The discomfort caused by perineal pain (rest, walking and urination) The state of fatigue (fatigue score, score 0 to 4) Compliance with the Protéochoc® product
arm group label: Supplemented group
description: 6 capsule of Proteochoc during 4 day, from day 0 (day of delivery) to day 4
arm group label: Control group
description: no supplementation, just the same follow-up as supplemented group
intervention type: Dietary Supplement
intervention name: Proteochoc
arm group label: Supplemented group
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor