<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/NCT03751553</url>
  </required_header>
  <id_info>
    <org_study_id>obstetrical gel</org_study_id>
    <nct_id>NCT03751553</nct_id>
  </id_info>
  <brief_title>Obstetrical Gel and Its Impact in Shortening the Duration of Labor in Women Undergoing a Vaginal Birth After Cesarean (VBAC)</brief_title>
  <official_title>Obstetrical Gel and Its Impact in Shortening the Duration of Labor in Women Undergoing a Vaginal Birth After Cesarean (VBAC):a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of our study is to investigate whether the use of obstetric gel shortens the&#xD;
      first and second stage of labor and exerts a protective effect on the lower genital tract in&#xD;
      women undergoing a Vaginal Birth After Cesarean (VBAC).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Recent literature shows that birth injury is associated with postpartum pelvic floor&#xD;
      dysfunction (pelvic organ prolapse and fecal and urinary incontinence). Prolonged labor,&#xD;
      namely during the 2nd stage, is one of the main obstetric risk factors responsible for anal&#xD;
      sphincter rupture and fecal incontinence. In addition, it is associated with increased&#xD;
      maternal and neonatal morbidities including increased risk of lower genital tract&#xD;
      lacerations. In an effort to shorten labor and decrease lower genital tract trauma many&#xD;
      techniques have been investigated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 30, 2018</start_date>
  <completion_date type="Actual">October 15, 2021</completion_date>
  <primary_completion_date type="Actual">September 15, 2021</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>Prevention</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>length of the second stage of labor</measure>
    <time_frame>1 hour</time_frame>
    <description>the length of the second stage of labor starting from full cervical dilatation till delivery of the fetus will be recorded.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">200</enrollment>
  <condition>Duration of Labor</condition>
  <arm_group>
    <arm_group_label>obstetric gel group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>they will have the standard care during labor and delivery with the vaginal application of the obstetrical gel.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>no intervention group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>they will receive the standard care during labor and delivery without the use of the obstetrical gel</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>obsteric gel(k-Y jelly)</intervention_name>
    <description>A sterile obstetric gel( K-Y Jelly 82GM; manufactured by Johnson&amp;amp; Johnson) will be used for this trial. The obstetric gel is a birth gel with no pharmacologic effects that have purely physical activity. Starting with the first vaginal examination the obstetric gel will be used. After each vaginal examination, 3-5 mL of obstetric gel will be introduced into the vaginal birth canal in the area in front of the child manually or using the sterile obstetric gel applicator without any manipulation or massage.</description>
    <arm_group_label>obstetric gel group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  • Age between 18 and 40 years&#xD;
&#xD;
               -  Women who have had only one prior cesarean birth with no previous vaginal&#xD;
                  delivery, are eligible for VBAC and plan to attempt a VBAC after counseling.&#xD;
&#xD;
               -  Singleton baby in vertex presentation&#xD;
&#xD;
               -  Low-risk pregnancy at term (37-41 weeks of gestation)&#xD;
&#xD;
               -  Estimated birth weight between 2000 g and 4500 g (clinically or by sonography)&#xD;
&#xD;
               -  Signed written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  • Contraindications for vaginal delivery (placenta previa, active herpes infection,&#xD;
             etc…)&#xD;
&#xD;
               -  Suspected amniotic infection (fever, foul-smelling discharge, fetal tachycardia,&#xD;
                  abdominal pain)&#xD;
&#xD;
               -  A non-reassuring fetal heart tracing&#xD;
&#xD;
               -  Prolonged rupture of the membranes (24 hours)&#xD;
&#xD;
               -  Suspected major fetal malformations&#xD;
&#xD;
               -  Suspected cephalopelvic disproportion&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>AHMED SAMY, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cairo University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ahmed Ashour</name>
      <address>
        <city>Giza</city>
        <zip>12944</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>November 16, 2018</study_first_submitted>
  <study_first_submitted_qc>November 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 23, 2018</study_first_posted>
  <last_update_submitted>December 29, 2021</last_update_submitted>
  <last_update_submitted_qc>December 29, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 14, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Ahmed Samy aly ashour</investigator_full_name>
    <investigator_title>lecturer in obstetrics and gynecology</investigator_title>
  </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/NCT03751553
org study id: obstetrical gel
nct id: NCT03751553
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The objective of our study is to investigate whether the use of obstetric gel shortens the
      first and second stage of labor and exerts a protective effect on the lower genital tract in
      women undergoing a Vaginal Birth After Cesarean (VBAC).
Recent literature shows that birth injury is associated with postpartum pelvic floor
      dysfunction (pelvic organ prolapse and fecal and urinary incontinence). Prolonged labor,
      namely during the 2nd stage, is one of the main obstetric risk factors responsible for anal
      sphincter rupture and fecal incontinence. In addition, it is associated with increased
      maternal and neonatal morbidities including increased risk of lower genital tract
      lacerations. In an effort to shorten labor and decrease lower genital tract trauma many
      techniques have been investigated.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: length of the second stage of labor
time frame: 1 hour
description: the length of the second stage of labor starting from full cervical dilatation till delivery of the fetus will be recorded.
arm group label: obstetric gel group
arm group type: Experimental
description: they will have the standard care during labor and delivery with the vaginal application of the obstetrical gel.
arm group label: no intervention group
arm group type: No Intervention
description: they will receive the standard care during labor and delivery without the use of the obstetrical gel
intervention type: Drug
intervention name: obsteric gel(k-Y jelly)
description: A sterile obstetric gel( K-Y Jelly 82GM; manufactured by Johnson&amp; Johnson) will be used for this trial. The obstetric gel is a birth gel with no pharmacologic effects that have purely physical activity. Starting with the first vaginal examination the obstetric gel will be used. After each vaginal examination, 3-5 mL of obstetric gel will be introduced into the vaginal birth canal in the area in front of the child manually or using the sterile obstetric gel applicator without any manipulation or massage.
arm group label: obstetric gel group
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: AHMED SAMY, MD
role: Principal Investigator
affiliation: Cairo University
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Ahmed Samy aly ashour
investigator title: lecturer in obstetrics and gynecology