<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/NCT03296969</url>
  </required_header>
  <id_info>
    <org_study_id>13</org_study_id>
    <nct_id>NCT03296969</nct_id>
  </id_info>
  <brief_title>Rectus Muscle Re-approximation at Cesarean Delivery</brief_title>
  <official_title>The Value of Rectus Muscle Re-approximation at Cesarean Delivery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      We include in our study 200 pregnant women, primigravidas, at term who underwent elective&#xD;
      lower segment Cesarean section for the first time among the age group of 20 - 35 years.&#xD;
&#xD;
      The patients are divided randomly into two groups as follows:&#xD;
&#xD;
        -  Group (A): undergoing rectus muscle re-approximation&#xD;
&#xD;
        -  Group (B): not undergoing rectus muscle re-approximation&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      We include in our study 200 pregnant women, primigravidas, at term who underwent elective&#xD;
      lower segment Cesarean section for the first time among the age group of 20 - 35 years.&#xD;
&#xD;
      The patients are divided randomly into two groups as follows:&#xD;
&#xD;
        -  Group (A): undergoing rectus muscle re-approximation&#xD;
&#xD;
        -  Group (B): not undergoing rectus muscle re-approximation&#xD;
&#xD;
        -  Examination for diastasis recti abdominis is done for all included patients before&#xD;
           delivery, at 6 weeks, and 6 months postpartum. The women are tested in a standardized&#xD;
           supine position with arms crossed over the chest. They are instructed to perform an&#xD;
           abdominal crunch till the shoulder blades are off the bench. Then we measure the&#xD;
           inter-recti distance. If there is no separation or separation ˂ 2 finger breadths so,&#xD;
           there is no diastasis recti abdominis. But if the separation is more than 2 finger&#xD;
           breadths or more than 4.5 cm so, this is considered diastasis recti abdominis.&#xD;
&#xD;
      The same surgical techniques are used for both groups. All women underwent Pfnannenstiel&#xD;
      incision under general or spinal anaesthesia, with a combination of sharp and blunt&#xD;
      dissection to open the abdomen. The rectus muscles are dissected off the fascia, and the&#xD;
      muscles are separated in the midline by pulling. Then the uterus is opened followed by fetal&#xD;
      and placental extraction. The transverse lower uterine segment incision is closed in two&#xD;
      layers of continuous Vicryl number 1 suture. The parietal peritoneum is closed using a&#xD;
      continuous absorbable suture. In group (A): rectus muscle re-approximation is done by 3&#xD;
      interrupted sutures, but muscle is not closed in the other group. The rectus sheath is&#xD;
      sutured using continuous absorbable sutures. Finally, skin is sutured with subcuticular&#xD;
      sutures with Vicryl Rapide.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">October 2017</start_date>
  <completion_date type="Anticipated">June 2018</completion_date>
  <primary_completion_date type="Anticipated">May 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>Post-operative pain</measure>
    <time_frame>4 hours after operation</time_frame>
    <description>• Post-operative pain is analyzed by using 4 point verbal rating scale (VRS) which consists of a list of adjectives describing different levels of pain intensity i.e (no pain =1, mild pain = 2, moderate pain = 3, severe pain = 4), patients are asked to read this list of adjectives and select the word that best describes their level of pain on the scale</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Post Cesarean Section Pain</condition>
  <arm_group>
    <arm_group_label>rectus muscle approximation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>All women underwent Pfnannenstiel incision under general or spinal anaesthesia, with a combination of sharp and blunt dissection to open the abdomen. The rectus muscles are dissected off the fascia, and the muscles are separated in the midline by pulling. Then the uterus is opened followed by fetal and placental extraction. The transverse lower uterine segment incision is closed in two layers of continuous Vicryl number 1 suture. The parietal peritoneum is closed using a continuous absorbable suture. In group (A): rectus muscle re-approximation is done by 3 interrupted sutures, but muscle is not closed in the other group. The rectus sheath is sutured using continuous absorbable sutures. Finally, skin is sutured with subcuticular sutures with Vicryl Rapide</description>
  </arm_group>
  <arm_group>
    <arm_group_label>rectus muscle non approximation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>All women underwent Pfnannenstiel incision under general or spinal anaesthesia, with a combination of sharp and blunt dissection to open the abdomen. The rectus muscles are dissected off the fascia, and the muscles are separated in the midline by pulling. Then the uterus is opened followed by fetal and placental extraction. The transverse lower uterine segment incision is closed in two layers of continuous Vicryl number 1 suture. The parietal peritoneum is closed using a continuous absorbable suture. In group (A): rectus muscle re-approximation is done by 3 interrupted sutures, but muscle is not closed in the other group. The rectus sheath is sutured using continuous absorbable sutures. Finally, skin is sutured with subcuticular sutures with Vicryl Rapide</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>cesarean section</intervention_name>
    <description>All women underwent Pfnannenstiel incision under general or spinal anaesthesia, with a combination of sharp and blunt dissection to open the abdomen. The rectus muscles are dissected off the fascia, and the muscles are separated in the midline by pulling. Then the uterus is opened followed by fetal and placental extraction. The transverse lower uterine segment incision is closed in two layers of continuous Vicryl number 1 suture. The parietal peritoneum is closed using a continuous absorbable suture. In group (A): rectus muscle re-approximation is done by 3 interrupted sutures, but muscle is not closed in the other group. The rectus sheath is sutured using continuous absorbable sutures. Finally, skin is sutured with subcuticular sutures with Vicryl Rapide</description>
    <arm_group_label>rectus muscle approximation</arm_group_label>
    <arm_group_label>rectus muscle non approximation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Rectus muscle approximation</intervention_name>
    <description>aprroximation of the lower parts of rectus abdomius muscles during cesarean section</description>
    <arm_group_label>rectus muscle approximation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  primigravida&#xD;
&#xD;
          -  undergoing elective Cesarean section&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with history of any pelvic or abdominal surgery those having any medical&#xD;
             disorder with pregnancy patients with BMI ≥ 40 chronic analgesia use multiple&#xD;
             pregnancies&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>39 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Ahmed Maged, MD</last_name>
    <phone>+20201005227404</phone>
    <email>dr_ahmedmaged08@kasralainy.edu.eg</email>
  </overall_contact>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 26, 2017</study_first_submitted>
  <study_first_submitted_qc>September 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 29, 2017</study_first_posted>
  <last_update_submitted>September 26, 2017</last_update_submitted>
  <last_update_submitted_qc>September 26, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 29, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Ahmed Maged</investigator_full_name>
    <investigator_title>professor</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/NCT03296969
org study id: 13
nct id: NCT03296969
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
We include in our study 200 pregnant women, primigravidas, at term who underwent elective
      lower segment Cesarean section for the first time among the age group of 20 - 35 years.

      The patients are divided randomly into two groups as follows:

        -  Group (A): undergoing rectus muscle re-approximation

        -  Group (B): not undergoing rectus muscle re-approximation
We include in our study 200 pregnant women, primigravidas, at term who underwent elective
      lower segment Cesarean section for the first time among the age group of 20 - 35 years.

      The patients are divided randomly into two groups as follows:

        -  Group (A): undergoing rectus muscle re-approximation

        -  Group (B): not undergoing rectus muscle re-approximation

        -  Examination for diastasis recti abdominis is done for all included patients before
           delivery, at 6 weeks, and 6 months postpartum. The women are tested in a standardized
           supine position with arms crossed over the chest. They are instructed to perform an
           abdominal crunch till the shoulder blades are off the bench. Then we measure the
           inter-recti distance. If there is no separation or separation ˂ 2 finger breadths so,
           there is no diastasis recti abdominis. But if the separation is more than 2 finger
           breadths or more than 4.5 cm so, this is considered diastasis recti abdominis.

      The same surgical techniques are used for both groups. All women underwent Pfnannenstiel
      incision under general or spinal anaesthesia, with a combination of sharp and blunt
      dissection to open the abdomen. The rectus muscles are dissected off the fascia, and the
      muscles are separated in the midline by pulling. Then the uterus is opened followed by fetal
      and placental extraction. The transverse lower uterine segment incision is closed in two
      layers of continuous Vicryl number 1 suture. The parietal peritoneum is closed using a
      continuous absorbable suture. In group (A): rectus muscle re-approximation is done by 3
      interrupted sutures, but muscle is not closed in the other group. The rectus sheath is
      sutured using continuous absorbable sutures. Finally, skin is sutured with subcuticular
      sutures with Vicryl Rapide.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Participant)
measure: Post-operative pain
time frame: 4 hours after operation
description: • Post-operative pain is analyzed by using 4 point verbal rating scale (VRS) which consists of a list of adjectives describing different levels of pain intensity i.e (no pain =1, mild pain = 2, moderate pain = 3, severe pain = 4), patients are asked to read this list of adjectives and select the word that best describes their level of pain on the scale
arm group label: rectus muscle approximation
arm group type: Active Comparator
description: All women underwent Pfnannenstiel incision under general or spinal anaesthesia, with a combination of sharp and blunt dissection to open the abdomen. The rectus muscles are dissected off the fascia, and the muscles are separated in the midline by pulling. Then the uterus is opened followed by fetal and placental extraction. The transverse lower uterine segment incision is closed in two layers of continuous Vicryl number 1 suture. The parietal peritoneum is closed using a continuous absorbable suture. In group (A): rectus muscle re-approximation is done by 3 interrupted sutures, but muscle is not closed in the other group. The rectus sheath is sutured using continuous absorbable sutures. Finally, skin is sutured with subcuticular sutures with Vicryl Rapide
arm group label: rectus muscle non approximation
arm group type: Active Comparator
description: All women underwent Pfnannenstiel incision under general or spinal anaesthesia, with a combination of sharp and blunt dissection to open the abdomen. The rectus muscles are dissected off the fascia, and the muscles are separated in the midline by pulling. Then the uterus is opened followed by fetal and placental extraction. The transverse lower uterine segment incision is closed in two layers of continuous Vicryl number 1 suture. The parietal peritoneum is closed using a continuous absorbable suture. In group (A): rectus muscle re-approximation is done by 3 interrupted sutures, but muscle is not closed in the other group. The rectus sheath is sutured using continuous absorbable sutures. Finally, skin is sutured with subcuticular sutures with Vicryl Rapide
intervention type: Procedure
intervention name: cesarean section
description: All women underwent Pfnannenstiel incision under general or spinal anaesthesia, with a combination of sharp and blunt dissection to open the abdomen. The rectus muscles are dissected off the fascia, and the muscles are separated in the midline by pulling. Then the uterus is opened followed by fetal and placental extraction. The transverse lower uterine segment incision is closed in two layers of continuous Vicryl number 1 suture. The parietal peritoneum is closed using a continuous absorbable suture. In group (A): rectus muscle re-approximation is done by 3 interrupted sutures, but muscle is not closed in the other group. The rectus sheath is sutured using continuous absorbable sutures. Finally, skin is sutured with subcuticular sutures with Vicryl Rapide
arm group label: rectus muscle approximation
arm group label: rectus muscle non approximation
intervention type: Procedure
intervention name: Rectus muscle approximation
description: aprroximation of the lower parts of rectus abdomius muscles during cesarean section
arm group label: rectus muscle approximation
criteria: 
gender: Female
gender based: Yes
minimum age: 18 Years
maximum age: 39 Years
healthy volunteers: No
last name: Ahmed Maged, MD
phone: +20201005227404
email: dr_ahmedmaged08@kasralainy.edu.eg
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Ahmed Maged
investigator title: professor