<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/NCT03825211</url>
  </required_header>
  <id_info>
    <org_study_id>Ujaen Sutura Lesiones</org_study_id>
    <nct_id>NCT03825211</nct_id>
  </id_info>
  <brief_title>Continuous Versus Discontinuous Suture in the Perineals Lesions</brief_title>
  <official_title>Continuous Versus Discontinuous Suture in the Perineals Lesions Produced During Delivery in Primiparous: Maternal Results: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Jaén</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Jaén</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 hypothesis: Women who have a continuous suture have better health outcomes Two types of&#xD;
      sutures were placed in the perineal lesion, using different techniques. Group A received&#xD;
      continuous sutures and Group B had interrupted sutures placed. The women were followed-up as&#xD;
      follows: Day of childbirth and in the postpartum period.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The hypothesis: Women who have a continuous suture have better health outcomes Two types of&#xD;
      sutures were placed in the perineal lesion, using different techniques. Group A received&#xD;
      continuous sutures and Group B had interrupted sutures placed. The women were allocated to a&#xD;
      treatment group using a computer-generated random numbers table. The sequence was placed in&#xD;
      individual opaque envelopes that were opened when a woman met the inclusion criteria.&#xD;
&#xD;
      The health personnel that carry out the sutures had taken a training course on continuous&#xD;
      suture technique and had at least one year experience in this technique. Additionally, this&#xD;
      person had a minimum of five years of experience in attending deliveries and therefore also&#xD;
      in the suturing of perineal lesions. The sutures were placed by ten trained midwives. Around&#xD;
      5% of the midwives in Torrecardenas, 10% in the Hospital Complex of Jaen, 12% in Granada, and&#xD;
      20% of the midwives in Ubeda and Linares participated.&#xD;
&#xD;
      Data collection Data was collected on sociodemographic variables, type of perineal trauma&#xD;
      (tear of second-degree or episiotomy), type of suture used, time spent placing suture, number&#xD;
      of suture packets used, complications, analogical scale of pain, type of pain, need for&#xD;
      analgesia, wound condition, care performed, urinary and/or fecal incontinence, start of&#xD;
      sexual relations, start of physical activity and type of newborn feeding. It was also&#xD;
      collected the start and type of delivery, medication during dilation, type of analgesia used,&#xD;
      gestational week, duration of dilation, second stage labor and delivery, and data on the&#xD;
      newborn.&#xD;
&#xD;
      Information was gathered by midwives which interviewed the women in the labor room, providing&#xD;
      them with an informed consent form, and hiding the suture technique that was going to be&#xD;
      used. The rest of the data were obtained from the clinical history, maternal record book and&#xD;
      phone calls made for the follow-up. The women did not know at any point which suture&#xD;
      technique had been used.&#xD;
&#xD;
      Follow-up&#xD;
&#xD;
      The women were followed-up as follows:&#xD;
&#xD;
      Day of childbirth: in the postpartum period, the midwife collected data on the type of&#xD;
      delivery, need for epidural analgesia, duration of dilation, stage two of labor, delivery,&#xD;
      type of perineal trauma, time used to place suture, number of suture packets, wound&#xD;
      complications, newborn weight and the Apgar score at one minute and at five minutes. After&#xD;
      the suture was placed, they assessed pain on the pain scale and assessed the wound.&#xD;
&#xD;
      Follow-up after delivery was done at two hours, 24 hours, 15 days and three months. Pain,&#xD;
      need for analgesia, wound condition, sphincter incontinence and the start of sexual relations&#xD;
      were assessed (15 days and three months).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2016</start_date>
  <completion_date type="Actual">December 31, 2018</completion_date>
  <primary_completion_date type="Actual">May 31, 2018</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>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Analogical scale of pain</measure>
    <time_frame>After delivery was done at two hours</time_frame>
    <description>It consists of a line horizontal 10 centimeters, at the ends of which are the extreme expressions of a symptom In the left is the absence or less intensity and in the right the greater intensity</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Numerical verbal scale for pain</measure>
    <time_frame>After delivery was done at 24 hours</time_frame>
    <description>Scale numbered 1-10, where 0 is the absence and 10 the highest intensity, the patient selects the number that best assesses the intensity of the symptom.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Numerical verbal scale for pain</measure>
    <time_frame>After delivery was done at 15 days</time_frame>
    <description>Scale numbered 1-10, where 0 is the absence and 10 the highest intensity, the patient selects the number that best assesses the intensity of the symptom.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Numerical verbal scale for pain</measure>
    <time_frame>After delivery was done at three months.</time_frame>
    <description>Scale numbered 1-10, where 0 is the absence and 10 the highest intensity, the patient selects the number that best assesses the intensity of the symptom.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Questionnaire</measure>
    <time_frame>After delivery was done 15 days</time_frame>
    <description>The woman was asked if she had involuntary urine losses.The possible answer is &quot;yes&quot; (she has incontinence) or &quot;no&quot; (she has no incontinence)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Questionnaire</measure>
    <time_frame>After delivery was done three months.</time_frame>
    <description>The woman was asked if she had involuntary urine losses. The possible answer is &quot;yes&quot; (she has incontinence) or &quot;no&quot; (she has no incontinence)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Questionnaire on Women Sexual Function (WSF)</measure>
    <time_frame>After delivery was done at three months.</time_frame>
    <description>This questionnaire has been validated in Spain. The instrument is composed of two types of domains: the evaluators of sexual activity, which are answered by a Likert scale of five values; and the descriptive ones, which have no quantitative value and help to know issues such as the frequency of sexual activity or the existence of sexual dysfunction in the respondent. It consists of 14 items, an alternative item and a question to open the questionnaire. To diagnose sexual dysfunction, only 6 questions are counted: Desire, Excitement, Lubrication, Orgasm, Problems with vaginal penetration, Anticipatory anxiety. Diagnostic results are categorized into: severe, moderate and no-disorder disorder. It does not establish degrees of dysfunctionality of sexual function, it is not shown in validation study if there is a cutoff point. The maximum score of this questionnaire is 100, which is interpreted as &quot;without sexual dysfunction&quot;.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">134</enrollment>
  <condition>Perineal Tear</condition>
  <condition>Episiotomy Wound</condition>
  <arm_group>
    <arm_group_label>Continuous suture</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All parts of the perineal lesion (vaginal mucosa , perineal muscle and skin) be sutured with the same suture thread. A single suture for perineal lesion</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Discontinuous suture</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Interrupted suture technique: vaginal mucosa, perineal muscle and skin are sutured with separate and different threads, that is, the vaginal mucosa is sutured with a thread, then independently the perineal muscle is sutured with another type of thread and finally the skin is also sutured independently with another different thread. Three independent sutures for each of the parts that form a single perineal lesion</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Continuous suture in the perineals lesions</intervention_name>
    <description>A continuous suture of the vagina, muscle and skin is performed continuously, without knotting or cutting the suture thread.</description>
    <arm_group_label>Continuous suture</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Discontinuous suture in the perineals lesions</intervention_name>
    <description>Suture the muscle independently of the vagina and independently of the skin</description>
    <arm_group_label>Discontinuous suture</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt;18 years&#xD;
&#xD;
          -  Primiparous&#xD;
&#xD;
          -  Singleton and eutocic delivery&#xD;
&#xD;
          -  Second-degree perineal tear or an episiotomy as part of labor&#xD;
&#xD;
          -  Newborn weight between 2500 g and 4000 g&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Language barrier (to no speak spanish)&#xD;
&#xD;
          -  Problems related to the pelvic floor prior to labor (prolapse, incontinence, vulva&#xD;
             varices)&#xD;
&#xD;
          -  Dyspareunia or sexual dysfunction&#xD;
&#xD;
          -  Hemorrhoids perceived as uncomfortable or painful&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 25, 2019</study_first_submitted>
  <study_first_submitted_qc>January 30, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 31, 2019</study_first_posted>
  <last_update_submitted>January 30, 2019</last_update_submitted>
  <last_update_submitted_qc>January 30, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 31, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Jaén</investigator_affiliation>
    <investigator_full_name>Juan Miguel Martinez-Galiano</investigator_full_name>
    <investigator_title>Principal Investigator</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/NCT03825211
org study id: Ujaen Sutura Lesiones
nct id: NCT03825211
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The hypothesis: Women who have a continuous suture have better health outcomes Two types of
      sutures were placed in the perineal lesion, using different techniques. Group A received
      continuous sutures and Group B had interrupted sutures placed. The women were followed-up as
      follows: Day of childbirth and in the postpartum period.
The hypothesis: Women who have a continuous suture have better health outcomes Two types of
      sutures were placed in the perineal lesion, using different techniques. Group A received
      continuous sutures and Group B had interrupted sutures placed. The women were allocated to a
      treatment group using a computer-generated random numbers table. The sequence was placed in
      individual opaque envelopes that were opened when a woman met the inclusion criteria.

      The health personnel that carry out the sutures had taken a training course on continuous
      suture technique and had at least one year experience in this technique. Additionally, this
      person had a minimum of five years of experience in attending deliveries and therefore also
      in the suturing of perineal lesions. The sutures were placed by ten trained midwives. Around
      5% of the midwives in Torrecardenas, 10% in the Hospital Complex of Jaen, 12% in Granada, and
      20% of the midwives in Ubeda and Linares participated.

      Data collection Data was collected on sociodemographic variables, type of perineal trauma
      (tear of second-degree or episiotomy), type of suture used, time spent placing suture, number
      of suture packets used, complications, analogical scale of pain, type of pain, need for
      analgesia, wound condition, care performed, urinary and/or fecal incontinence, start of
      sexual relations, start of physical activity and type of newborn feeding. It was also
      collected the start and type of delivery, medication during dilation, type of analgesia used,
      gestational week, duration of dilation, second stage labor and delivery, and data on the
      newborn.

      Information was gathered by midwives which interviewed the women in the labor room, providing
      them with an informed consent form, and hiding the suture technique that was going to be
      used. The rest of the data were obtained from the clinical history, maternal record book and
      phone calls made for the follow-up. The women did not know at any point which suture
      technique had been used.

      Follow-up

      The women were followed-up as follows:

      Day of childbirth: in the postpartum period, the midwife collected data on the type of
      delivery, need for epidural analgesia, duration of dilation, stage two of labor, delivery,
      type of perineal trauma, time used to place suture, number of suture packets, wound
      complications, newborn weight and the Apgar score at one minute and at five minutes. After
      the suture was placed, they assessed pain on the pain scale and assessed the wound.

      Follow-up after delivery was done at two hours, 24 hours, 15 days and three months. Pain,
      need for analgesia, wound condition, sphincter incontinence and the start of sexual relations
      were assessed (15 days and three months).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Participant)
measure: Analogical scale of pain
time frame: After delivery was done at two hours
description: It consists of a line horizontal 10 centimeters, at the ends of which are the extreme expressions of a symptom In the left is the absence or less intensity and in the right the greater intensity
measure: Numerical verbal scale for pain
time frame: After delivery was done at 24 hours
description: Scale numbered 1-10, where 0 is the absence and 10 the highest intensity, the patient selects the number that best assesses the intensity of the symptom.
measure: Numerical verbal scale for pain
time frame: After delivery was done at 15 days
description: Scale numbered 1-10, where 0 is the absence and 10 the highest intensity, the patient selects the number that best assesses the intensity of the symptom.
measure: Numerical verbal scale for pain
time frame: After delivery was done at three months.
description: Scale numbered 1-10, where 0 is the absence and 10 the highest intensity, the patient selects the number that best assesses the intensity of the symptom.
measure: Questionnaire
time frame: After delivery was done 15 days
description: The woman was asked if she had involuntary urine losses.The possible answer is "yes" (she has incontinence) or "no" (she has no incontinence)
measure: Questionnaire
time frame: After delivery was done three months.
description: The woman was asked if she had involuntary urine losses. The possible answer is "yes" (she has incontinence) or "no" (she has no incontinence)
measure: Questionnaire on Women Sexual Function (WSF)
time frame: After delivery was done at three months.
description: This questionnaire has been validated in Spain. The instrument is composed of two types of domains: the evaluators of sexual activity, which are answered by a Likert scale of five values; and the descriptive ones, which have no quantitative value and help to know issues such as the frequency of sexual activity or the existence of sexual dysfunction in the respondent. It consists of 14 items, an alternative item and a question to open the questionnaire. To diagnose sexual dysfunction, only 6 questions are counted: Desire, Excitement, Lubrication, Orgasm, Problems with vaginal penetration, Anticipatory anxiety. Diagnostic results are categorized into: severe, moderate and no-disorder disorder. It does not establish degrees of dysfunctionality of sexual function, it is not shown in validation study if there is a cutoff point. The maximum score of this questionnaire is 100, which is interpreted as "without sexual dysfunction".
arm group label: Continuous suture
arm group type: Experimental
description: All parts of the perineal lesion (vaginal mucosa , perineal muscle and skin) be sutured with the same suture thread. A single suture for perineal lesion
arm group label: Discontinuous suture
arm group type: Active Comparator
description: Interrupted suture technique: vaginal mucosa, perineal muscle and skin are sutured with separate and different threads, that is, the vaginal mucosa is sutured with a thread, then independently the perineal muscle is sutured with another type of thread and finally the skin is also sutured independently with another different thread. Three independent sutures for each of the parts that form a single perineal lesion
intervention type: Procedure
intervention name: Continuous suture in the perineals lesions
description: A continuous suture of the vagina, muscle and skin is performed continuously, without knotting or cutting the suture thread.
arm group label: Continuous suture
intervention type: Procedure
intervention name: Discontinuous suture in the perineals lesions
description: Suture the muscle independently of the vagina and independently of the skin
arm group label: Discontinuous suture
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: University of Jaén
investigator full name: Juan Miguel Martinez-Galiano
investigator title: Principal Investigator