<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/NCT04489901</url>
  </required_header>
  <id_info>
    <org_study_id>KırklareliAS</org_study_id>
    <nct_id>NCT04489901</nct_id>
  </id_info>
  <brief_title>Stria Gravidarum and Olive Oil for Pregnancy Women</brief_title>
  <official_title>The Effect of Olive Oil on Striae Gravidarum in Primiparous Women: A Randomized Controlled Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ayca Solt Kirca</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kırklareli University</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>
      The aim of this study was to investigate the clinical efficacy of olive oil on the severity&#xD;
      and progression of striae gravidarum. This randomized controlled clinical trial included 156&#xD;
      primipara women who were early third trimester. They were randomly allocated into two groups:&#xD;
      an experimental group and a control group. Women in the experimental group applied olive oil&#xD;
      to their abdomen twice a day in the morning and evening. The control group had no&#xD;
      intervention.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The development of striae is one of the most common skin changes in pregnancy. The aim of&#xD;
      this study was to investigate the clinical efficacy of olive oil on the severity and&#xD;
      progression of striae gravidarum.&#xD;
&#xD;
      This randomized controlled clinical trial included 156 primipara women who were early third&#xD;
      trimester. They were randomly allocated into two groups: an experimental group and a control&#xD;
      group. Women in the experimental group applied olive oil to their abdomen twice a day in the&#xD;
      morning and evening. The control group had no intervention.Data were collected using maternal&#xD;
      information form, Fitzpatrick Skin Type Scale and Davey's Severity Score.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 15, 2019</start_date>
  <completion_date type="Actual">February 29, 2020</completion_date>
  <primary_completion_date type="Actual">January 1, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Randomized controlled clinical trial</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Participant, Care Provider)</masking>
    <masking_description>This study was a randomized controlled clinical trial. To avoid bias, an impartial midwife who was working in the outpatient clinic on the day the data were collected and was not among the researchers asked each participant to select one of two closed envelopes that included the letters A (experimental group) or B (control group). The pregnant women were assigned to the experimental and control groups depending on the letter in the envelope they chose. Then, the researcher registered the participants in the experimental and control groups on a list. The obstetrician and pregnant women were informed about the procedure, but the obstetrician did not know which procedure would be applied to which pregnant woman. The pregnant women did not know why olive oil was being used. The participating women signed an informed consent form knowing that they could withdraw from the study at any time</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Prevent the severity and progression of SG</measure>
    <time_frame>All the participating women were followed-up from the 28th week of gestation to the 37th week of gestation.</time_frame>
    <description>The participants completed the Maternal Information Forms through face-to-face interviews with an unbiased midwife who was working in the outpatient clinic on the day the data were collected.The women in the experimental group were asked to apply 10 cc (4 tablespoons) of extra virgin olive oil to the entire abdomen by hand without massaging twice a day in the morning and evening. The control group did not undergo any intervention. The women were called via telephone by the researcher once a week and asked whether they were performing the application. Women who were not applying the olive oil or who were using other medicines or creams (at least three days a week) were excluded from the study. The women in the control group were asked whether they were performing any applications. Those who were applying any products were also excluded. The striae was evaluated all groups at 37 weeks of gestation based on the Fitzpatrick Skin Type Scale and Davey's Severity Score by obstetrician.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maternal information form</measure>
    <time_frame>All the participating women were followed-up from the 28th week of gestation to the 37th week of gestation.</time_frame>
    <description>The Maternal Information Form was used to select whether pregnant women met the study.This form, which was developed by the researchers in line with knowledge of the literature, included 30 items questioning the participants' sociodemographic ch criteria.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The Fitzpatrick Skin Type Scale</measure>
    <time_frame>All the participating women were followed-up from the 28th week of gestation to the 37th week of gestation.</time_frame>
    <description>The Fitzpatrick Skin Type Scale was developed by Fitzpatrick in 1975 to classify skin type.This scale uses genetic structure, eye color, reaction to sunlight to assign a skin type. According to the scale, the skin types vary from the extremely sensitive type, which always burns and does not tan, to the sun-resistant type, which is darkly pigmen and response to sunlight.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Davey's Severity Score</measure>
    <time_frame>All the participating women were followed-up from the 28th week of gestation to the 37th week of gestation.</time_frame>
    <description>Davey's Severity Score is a scoring method developed by Davey in 1972 to measure the severity of SG.It divides the abdomen into four equal quadrants. Each quadrant is rated as &quot;0&quot; for clean skin, &quot;1&quot; for moderate striae, and &quot;2&quot; for multiple striae. Accordingly, the total score ranges from 0 to 8.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">156</enrollment>
  <condition>Striae Gravidarum</condition>
  <condition>Pregnancy Related</condition>
  <arm_group>
    <arm_group_label>Extra Virgin Olivei oil group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The women in the experimental (olive oil) group were asked to apply 10 cc (4 tablespoons) of extra virgin olive oil to the entire abdomen by hand without massaging twice a day in the morning and evening.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The women in the control group did not undergo any intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Olive oil</intervention_name>
    <description>To apply 10 cc (4 tablespoons) of extra virgin olive oil to the entire abdomen by hand without massaging twice a day in the morning and evening.</description>
    <arm_group_label>Extra Virgin Olivei oil group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  being in the age group of 20-30 years, early third trimester (being at the 28th week&#xD;
             of gestation), having a singleton pregnancy, being primiparous, and volunteering to&#xD;
             participate in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  having a chronic disease (such as diabetes or hypertension), having striae (before&#xD;
             28th gestation week), having traces of scar tissue from adolescence, using cortisone&#xD;
             cream or another kind of topical cream, having polyhydramnios, having threatened&#xD;
             preterm labor or preterm delivery, having any disease of the skin, taking any&#xD;
             medication regularly, having a problem preventing communication, using pharmacological&#xD;
             or non-pharmacological methods (undergoing pharmacotherapy) to reduce nausea, and&#xD;
             undergoing psychiatric treatment (psychotherapy).&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Pregnancy</gender_description>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>30 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>AYCA S KIRCA, Phd</last_name>
    <role>Study Director</role>
    <affiliation>Kırklareli University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Medipol University</name>
      <address>
        <city>Istanbul</city>
        <zip>34180</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kırklareli University</name>
      <address>
        <city>Kırklareli</city>
        <zip>3900</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 15, 2020</study_first_submitted>
  <study_first_submitted_qc>July 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2020</study_first_posted>
  <last_update_submitted>July 27, 2020</last_update_submitted>
  <last_update_submitted_qc>July 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 28, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Kırklareli University</investigator_affiliation>
    <investigator_full_name>Ayca Solt Kirca</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Striae Gravidarum</keyword>
  <keyword>primipara women</keyword>
  <keyword>pregnancy</keyword>
  <keyword>Olive oil</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Striae Distensae</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The study will be accessible to everyone after publication in the journal</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>Data is available now</ipd_time_frame>
    <ipd_access_criteria>The study will be accessible to everyone after publication in the journal</ipd_access_criteria>
  </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/NCT04489901
org study id: KırklareliAS
nct id: NCT04489901
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study was to investigate the clinical efficacy of olive oil on the severity
      and progression of striae gravidarum. This randomized controlled clinical trial included 156
      primipara women who were early third trimester. They were randomly allocated into two groups:
      an experimental group and a control group. Women in the experimental group applied olive oil
      to their abdomen twice a day in the morning and evening. The control group had no
      intervention.
The development of striae is one of the most common skin changes in pregnancy. The aim of
      this study was to investigate the clinical efficacy of olive oil on the severity and
      progression of striae gravidarum.

      This randomized controlled clinical trial included 156 primipara women who were early third
      trimester. They were randomly allocated into two groups: an experimental group and a control
      group. Women in the experimental group applied olive oil to their abdomen twice a day in the
      morning and evening. The control group had no intervention.Data were collected using maternal
      information form, Fitzpatrick Skin Type Scale and Davey's Severity Score.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized controlled clinical trial
primary purpose: Prevention
masking: Double (Participant, Care Provider)
masking description: This study was a randomized controlled clinical trial. To avoid bias, an impartial midwife who was working in the outpatient clinic on the day the data were collected and was not among the researchers asked each participant to select one of two closed envelopes that included the letters A (experimental group) or B (control group). The pregnant women were assigned to the experimental and control groups depending on the letter in the envelope they chose. Then, the researcher registered the participants in the experimental and control groups on a list. The obstetrician and pregnant women were informed about the procedure, but the obstetrician did not know which procedure would be applied to which pregnant woman. The pregnant women did not know why olive oil was being used. The participating women signed an informed consent form knowing that they could withdraw from the study at any time
measure: Prevent the severity and progression of SG
time frame: All the participating women were followed-up from the 28th week of gestation to the 37th week of gestation.
description: The participants completed the Maternal Information Forms through face-to-face interviews with an unbiased midwife who was working in the outpatient clinic on the day the data were collected.The women in the experimental group were asked to apply 10 cc (4 tablespoons) of extra virgin olive oil to the entire abdomen by hand without massaging twice a day in the morning and evening. The control group did not undergo any intervention. The women were called via telephone by the researcher once a week and asked whether they were performing the application. Women who were not applying the olive oil or who were using other medicines or creams (at least three days a week) were excluded from the study. The women in the control group were asked whether they were performing any applications. Those who were applying any products were also excluded. The striae was evaluated all groups at 37 weeks of gestation based on the Fitzpatrick Skin Type Scale and Davey's Severity Score by obstetrician.
measure: Maternal information form
time frame: All the participating women were followed-up from the 28th week of gestation to the 37th week of gestation.
description: The Maternal Information Form was used to select whether pregnant women met the study.This form, which was developed by the researchers in line with knowledge of the literature, included 30 items questioning the participants' sociodemographic ch criteria.
measure: The Fitzpatrick Skin Type Scale
time frame: All the participating women were followed-up from the 28th week of gestation to the 37th week of gestation.
description: The Fitzpatrick Skin Type Scale was developed by Fitzpatrick in 1975 to classify skin type.This scale uses genetic structure, eye color, reaction to sunlight to assign a skin type. According to the scale, the skin types vary from the extremely sensitive type, which always burns and does not tan, to the sun-resistant type, which is darkly pigmen and response to sunlight.
measure: Davey's Severity Score
time frame: All the participating women were followed-up from the 28th week of gestation to the 37th week of gestation.
description: Davey's Severity Score is a scoring method developed by Davey in 1972 to measure the severity of SG.It divides the abdomen into four equal quadrants. Each quadrant is rated as "0" for clean skin, "1" for moderate striae, and "2" for multiple striae. Accordingly, the total score ranges from 0 to 8.
arm group label: Extra Virgin Olivei oil group
arm group type: Experimental
description: The women in the experimental (olive oil) group were asked to apply 10 cc (4 tablespoons) of extra virgin olive oil to the entire abdomen by hand without massaging twice a day in the morning and evening.
arm group label: Control group
arm group type: No Intervention
description: The women in the control group did not undergo any intervention.
intervention type: Other
intervention name: Olive oil
description: To apply 10 cc (4 tablespoons) of extra virgin olive oil to the entire abdomen by hand without massaging twice a day in the morning and evening.
arm group label: Extra Virgin Olivei oil group
criteria: 
gender: Female
gender based: Yes
gender description: Pregnancy
minimum age: 20 Years
maximum age: 30 Years
healthy volunteers: Accepts Healthy Volunteers
last name: AYCA S KIRCA, Phd
role: Study Director
affiliation: Kırklareli University
facility: 
facility: 
country: Turkey
responsible party type: Sponsor-Investigator
investigator affiliation: Kırklareli University
investigator full name: Ayca Solt Kirca
investigator title: Assistant Professor
mesh term: Striae Distensae
sharing ipd: Yes
ipd description: The study will be accessible to everyone after publication in the journal
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: Data is available now
ipd access criteria: The study will be accessible to everyone after publication in the journal