<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/NCT04464005</url>
  </required_header>
  <id_info>
    <org_study_id>112-19</org_study_id>
    <nct_id>NCT04464005</nct_id>
  </id_info>
  <brief_title>Comparison Between Pads With Cold Solution of Magnesium Sulfate or Cold Water Postpartum Perineal Pain and Healing</brief_title>
  <official_title>Comparison Between Pads With Cold Solution of Magnesium Sulfate or Cold Water to Treat Pain and Improve Healing of the Perineum After Vaginal Delivery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Baruch Padeh Medical Center, Poriya</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Baruch Padeh Medical Center, Poriya</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>
      Perineal pain after delivery is common and is caused by local bruising or episiotomy. The&#xD;
      pain may last for several days or months. Thus, several analgesic methods are offered.&#xD;
      Topical magnesium sulfate 33% solution is a common treatment for perineal pain, wound&#xD;
      treatment and alleviation of swelling. Yet, the efficacy of this treatment was not tested&#xD;
      sufficiently in a clinical trials.&#xD;
&#xD;
      In the present study we will compare the efficacy of topical magnesium sulfate versus cold&#xD;
      water for perineal pain and improved perineal healing after delivery.&#xD;
&#xD;
      Women after vaginal delivery (spontaneous or operative) with pain score of 3 in 0-10 numeric&#xD;
      rating scale (NRS) will randomly be allocated to receive either pad with cold magnesium&#xD;
      sulfate 33% solution or cold water. Pain score and healing parameters will be assessed at&#xD;
      baseline, after one day of treatment and after two days of treatment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">October 1, 2021</start_date>
  <completion_date type="Anticipated">December 1, 2023</completion_date>
  <primary_completion_date type="Anticipated">October 1, 2022</primary_completion_date>
  <phase>Phase 4</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of women with perineal pain score&lt; 3 NRS at the day after treatment initiation</measure>
    <time_frame>24 hours post enrollment</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Perineal pain intensity according to NRS scale at the day after treatment initiation</measure>
    <time_frame>24 hours post enrollment</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Degree of perineal healing using the REEDA scale</measure>
    <time_frame>2 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perineal pain intensity according to NRS scale two days after treatment initiation</measure>
    <time_frame>2 days (if still in hospital)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of women with improvement in hemorrhoids characteristics in women with hemorrhoids</measure>
    <time_frame>2 days</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">140</enrollment>
  <condition>Women After Delivery With Perineal Pain</condition>
  <arm_group>
    <arm_group_label>Pads with cold magnesium sulfate 33% solution</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Pads with cold water</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Magnesium sulfate 33% solution</intervention_name>
    <description>Topical pads with cold magnesium sulfate 33% solution will be given 5 times/day for 15 minutes</description>
    <arm_group_label>Pads with cold magnesium sulfate 33% solution</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Cold water</intervention_name>
    <description>Topical pads with cold water will be given 5 times/day for 15 minutes</description>
    <arm_group_label>Pads with cold water</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Woman after spontaneous or operative vaginal delivery&#xD;
&#xD;
          -  Perineal pain score of at least 2 NRS&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women after cesarean delivery&#xD;
&#xD;
          -  Refuse to participate&#xD;
&#xD;
          -  Under 18 years of age&#xD;
&#xD;
          -  Magnesium sulfate treatment not related to the study&#xD;
&#xD;
          -  Contraindication for magnesium sulfate treatment&#xD;
&#xD;
          -  Workers of the local obstetric department&#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_contact>
    <last_name>Enav Yefet, MD/PhD</last_name>
    <phone>972-46652306</phone>
    <email>enyefet@pmc.gov.il</email>
  </overall_contact>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 5, 2020</study_first_submitted>
  <study_first_submitted_qc>July 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 9, 2020</study_first_posted>
  <last_update_submitted>February 3, 2021</last_update_submitted>
  <last_update_submitted_qc>February 3, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 4, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Magnesium Sulfate</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04464005
org study id: 112-19
nct id: NCT04464005
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Perineal pain after delivery is common and is caused by local bruising or episiotomy. The
      pain may last for several days or months. Thus, several analgesic methods are offered.
      Topical magnesium sulfate 33% solution is a common treatment for perineal pain, wound
      treatment and alleviation of swelling. Yet, the efficacy of this treatment was not tested
      sufficiently in a clinical trials.

      In the present study we will compare the efficacy of topical magnesium sulfate versus cold
      water for perineal pain and improved perineal healing after delivery.

      Women after vaginal delivery (spontaneous or operative) with pain score of 3 in 0-10 numeric
      rating scale (NRS) will randomly be allocated to receive either pad with cold magnesium
      sulfate 33% solution or cold water. Pain score and healing parameters will be assessed at
      baseline, after one day of treatment and after two days of treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Rate of women with perineal pain score< 3 NRS at the day after treatment initiation
time frame: 24 hours post enrollment
measure: Perineal pain intensity according to NRS scale at the day after treatment initiation
time frame: 24 hours post enrollment
measure: Degree of perineal healing using the REEDA scale
time frame: 2 days
measure: Perineal pain intensity according to NRS scale two days after treatment initiation
time frame: 2 days (if still in hospital)
measure: Rate of women with improvement in hemorrhoids characteristics in women with hemorrhoids
time frame: 2 days
arm group label: Pads with cold magnesium sulfate 33% solution
arm group type: Experimental
arm group label: Pads with cold water
arm group type: Placebo Comparator
intervention type: Drug
intervention name: Magnesium sulfate 33% solution
description: Topical pads with cold magnesium sulfate 33% solution will be given 5 times/day for 15 minutes
arm group label: Pads with cold magnesium sulfate 33% solution
intervention type: Other
intervention name: Cold water
description: Topical pads with cold water will be given 5 times/day for 15 minutes
arm group label: Pads with cold water
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Enav Yefet, MD/PhD
phone: 972-46652306
email: enyefet@pmc.gov.il
responsible party type: Sponsor
mesh term: Magnesium Sulfate
sharing ipd: Undecided