<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/NCT01665027</url>
  </required_header>
  <id_info>
    <org_study_id>SSU-389049</org_study_id>
    <nct_id>NCT01665027</nct_id>
  </id_info>
  <brief_title>Effect of Vacuum on Fetal and Maternal Complications During Difficult Caesarean Section</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Behnam Baghianimoghadam</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shahid Sadoughi University of Medical Sciences and Health Services</source>
  <brief_summary>
    <textblock>
      The Cesarean Section (C/S) rate from 1970 to 2007 in U.S is 31.8% and in Iran From 2000 to&#xD;
      2009 rose to 50-65%. This Surgical Procedure is not without risk. Difficult head Extraction&#xD;
      in C/S occur in 1-2% of all deliveries. This study was designed to compare the results of&#xD;
      delivery by vacuum in C/S with normal caesarean section.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2010</start_date>
  <completion_date type="Actual">January 2012</completion_date>
  <primary_completion_date type="Actual">August 2011</primary_completion_date>
  <phase>Phase 3</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>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean duration time between incision and fetal head delivery</measure>
    <time_frame>during surgery</time_frame>
    <description>In study was done by Arad et al in 1986, duration between incision and end of delivery was significantly lower in vacuum group that (PMID: 3735047). Also in study of Dimitrov et al was done prospectively on 19 caesarean with vacuum and 25 caesarean without it, similar results has been reported (PMID: 18756824).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>fetal complications</measure>
    <time_frame>after extraction of fetus and during cleaning of fetus under warmer</time_frame>
    <description>Mcquinery et al in 2009 in their study concluded that vacuum have less fetal complications (Mc Quivey RW, Laporte V. Vacuum- Assisted Cesarean Section. International Journal of OB/GYN. 2009; S413-S729.). Wen et al in their study concluded that forceps causes more injuries to head and face while cephal hematoma was higher in using vacuum(PMID: 11159152).</description>
  </secondary_outcome>
  <other_outcome>
    <measure>maternal complications</measure>
    <time_frame>during surgery and first hour after childbirth (after extraction of fetus when surgeon wanted to correct the lesions)</time_frame>
    <description>In wei study maternal complication like spreading of uterine incision and cervical rupture was lower in control group (PMID: 11159152). Pelosi et al also concluded that vacuum can lower maternal complications (PMID: 6716375). Mcquinvey et al in 2009 in their study found six patients with spreading incision and 1 case of cervical rupture in routine cesarean section but there was no case of these complications in vacuum group. Of course Bofill et al did not find any different between their groups in this context (PMID: 11110345).</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">108</enrollment>
  <condition>Complications; Cesarean Section</condition>
  <arm_group>
    <arm_group_label>vacuum</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Vacuum is an instrument that is using for helping delivery when there is no possibility of spontaneous delivery. First report of using vacuum was in 1962 by Solomon for delivery of fetal head. He suggested that using this instrument will lower pressure on fetal head and decrease delivery time (and then decrease fetal hypoxemia). Also it decreases spreading of incision and vascular injury (during manual maneuvers).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>routine manual maneuvers for fetal head extraction</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Procedure/Surgery:&#xD;
fetal head techniques like fundal pushing, pulling technique or reverse breech extraction</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>vacuum</intervention_name>
    <description>Vacuum is an instrument that is using for helping delivery when there is no possibility of spontaneous delivery. First report of using vacuum was in 1962 by Solomon for delivery of fetal head (12). He suggested that using this instrument will lower pressure on fetal head and decrease delivery time (and then decrease fetal hypoxemia). Also it decreases spreading of incision and vascular injury (during manual maneuvers). Some studies confirmed these results (13, 14) and some others disagreed it (15, 16).&#xD;
Considering with importance of fetal head delivery in a short time during C/S and to decrease maternal complications like lacerations and vascular injuries, this study was designed to compare the results of delivery by vacuum in C/S with routine methods for head extraction during difficult caesarean sections.</description>
    <arm_group_label>vacuum</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>routine manual maneuvers for fetal head extraction</intervention_name>
    <description>fetal head techniques like fundal pushing, pulling technique or reverse breech extraction</description>
    <arm_group_label>routine manual maneuvers for fetal head extraction</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  term pregnant women with cephalic presentation and singleton gestation that had&#xD;
             difficult labor and difficult head extraction during caesarean.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Elective cesarean&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Shahid sadoughi University of medical sciences</name>
      <address>
        <city>Yazd</city>
        <zip>8916863411</zip>
        <country>Iran, Islamic Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Iran, Islamic Republic of</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 1, 2012</study_first_submitted>
  <study_first_submitted_qc>August 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2012</study_first_posted>
  <last_update_submitted>August 14, 2012</last_update_submitted>
  <last_update_submitted_qc>August 14, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 15, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Shahid Sadoughi University of Medical Sciences and Health Services</investigator_affiliation>
    <investigator_full_name>Behnam Baghianimoghadam</investigator_full_name>
    <investigator_title>shahid sadoughi university of medical sciences and health services, Yazd, Iran</investigator_title>
  </responsible_party>
  <keyword>caesarean section,</keyword>
  <keyword>vacuum,</keyword>
  <keyword>fetal head extraction,</keyword>
  <keyword>maternal complication,</keyword>
  <keyword>fetal complication</keyword>
  <!-- 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/NCT01665027
org study id: SSU-389049
nct id: NCT01665027
lead sponsor: 
The Cesarean Section (C/S) rate from 1970 to 2007 in U.S is 31.8% and in Iran From 2000 to
      2009 rose to 50-65%. This Surgical Procedure is not without risk. Difficult head Extraction
      in C/S occur in 1-2% of all deliveries. This study was designed to compare the results of
      delivery by vacuum in C/S with normal caesarean section.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Mean duration time between incision and fetal head delivery
time frame: during surgery
description: In study was done by Arad et al in 1986, duration between incision and end of delivery was significantly lower in vacuum group that (PMID: 3735047). Also in study of Dimitrov et al was done prospectively on 19 caesarean with vacuum and 25 caesarean without it, similar results has been reported (PMID: 18756824).
measure: fetal complications
time frame: after extraction of fetus and during cleaning of fetus under warmer
description: Mcquinery et al in 2009 in their study concluded that vacuum have less fetal complications (Mc Quivey RW, Laporte V. Vacuum- Assisted Cesarean Section. International Journal of OB/GYN. 2009; S413-S729.). Wen et al in their study concluded that forceps causes more injuries to head and face while cephal hematoma was higher in using vacuum(PMID: 11159152).
measure: maternal complications
time frame: during surgery and first hour after childbirth (after extraction of fetus when surgeon wanted to correct the lesions)
description: In wei study maternal complication like spreading of uterine incision and cervical rupture was lower in control group (PMID: 11159152). Pelosi et al also concluded that vacuum can lower maternal complications (PMID: 6716375). Mcquinvey et al in 2009 in their study found six patients with spreading incision and 1 case of cervical rupture in routine cesarean section but there was no case of these complications in vacuum group. Of course Bofill et al did not find any different between their groups in this context (PMID: 11110345).
arm group label: vacuum
arm group type: Experimental
description: Vacuum is an instrument that is using for helping delivery when there is no possibility of spontaneous delivery. First report of using vacuum was in 1962 by Solomon for delivery of fetal head. He suggested that using this instrument will lower pressure on fetal head and decrease delivery time (and then decrease fetal hypoxemia). Also it decreases spreading of incision and vascular injury (during manual maneuvers).
arm group label: routine manual maneuvers for fetal head extraction
arm group type: Experimental
description: Procedure/Surgery:
fetal head techniques like fundal pushing, pulling technique or reverse breech extraction
intervention type: Procedure
intervention name: vacuum
description: Vacuum is an instrument that is using for helping delivery when there is no possibility of spontaneous delivery. First report of using vacuum was in 1962 by Solomon for delivery of fetal head (12). He suggested that using this instrument will lower pressure on fetal head and decrease delivery time (and then decrease fetal hypoxemia). Also it decreases spreading of incision and vascular injury (during manual maneuvers). Some studies confirmed these results (13, 14) and some others disagreed it (15, 16).
Considering with importance of fetal head delivery in a short time during C/S and to decrease maternal complications like lacerations and vascular injuries, this study was designed to compare the results of delivery by vacuum in C/S with routine methods for head extraction during difficult caesarean sections.
arm group label: vacuum
intervention type: Procedure
intervention name: routine manual maneuvers for fetal head extraction
description: fetal head techniques like fundal pushing, pulling technique or reverse breech extraction
arm group label: routine manual maneuvers for fetal head extraction
criteria: 
gender: Female
minimum age: 15 Years
maximum age: 45 Years
healthy volunteers: No
facility: 
country: Iran, Islamic Republic of
responsible party type: Sponsor-Investigator
investigator affiliation: Shahid Sadoughi University of Medical Sciences and Health Services
investigator full name: Behnam Baghianimoghadam
investigator title: shahid sadoughi university of medical sciences and health services, Yazd, Iran