<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/NCT02243423</url>
  </required_header>
  <id_info>
    <org_study_id>AAAO1851</org_study_id>
    <nct_id>NCT02243423</nct_id>
  </id_info>
  <brief_title>Neonatal Acid-Base Status After C Section With Maternal Tilt vs. Supine</brief_title>
  <official_title>Neonatal Acid-base Status After Elective Cesarean Delivery Under Spinal Anesthesia - a Comparison of Maternal Supine Horizontal Position Versus Left Lateral Table Tilt</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Columbia University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Columbia University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to compare the neonatal acid-base status of women who remain supine&#xD;
      horizontal, with women who are tilted to the left side by 15° during elective cesarean&#xD;
      delivery at term under spinal anesthesia, with systolic BP maintained at baseline with a&#xD;
      phenylephrine (PE) infusion. The null hypothesis is that the position of the patient (supine&#xD;
      horizontal or tilted) during cesarean section will make no difference to neonatal wellbeing.&#xD;
      The primary outcome will be the neonatal umbilical arterial base deficit (BD) at birth. The&#xD;
      investigators will also examine the effects of maternal position during cesarean section&#xD;
      under spinal anesthesia on maternal cardiac output (CO) and whether these changes have a&#xD;
      correlation with the neonatal umbilical cord blood acid-base status. The secondary outcome&#xD;
      will be the total phenylephrine dose requirement at 15 minutes after spinal injection.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Methods: This will be a randomized trial structured as an equivalence trial. Subjects will be&#xD;
      American Society of Anesthesiologists (ASA) I and II women aged ≥18 years, non-laboring, at&#xD;
      term (&gt;37 weeks gestation) with singleton pregnancies in cephalic presentation, scheduled for&#xD;
      elective cesarean delivery under spinal anesthesia. Patients will receive spinal anesthesia&#xD;
      for cesarean section in the sitting position, after which they will lay either supine&#xD;
      horizontal or the surgical table will be tilted to the left by 15°, depending on the group to&#xD;
      which they were randomized (SUPINE or TILT). An IV phenylephrine infusion will be&#xD;
      administered to maintain systolic BP at baseline until delivery. A noninvasive hemodynamic&#xD;
      monitoring system (NICOM, Cheetah Medical Inc., Vancouver, WA, USA) will continuously monitor&#xD;
      CO and stroke volume. Neonatal umbilical vein and arterial blood gas results will be&#xD;
      recorded.The null hypothesis is that the position of the patient (supine horizontal or&#xD;
      tilted) during cesarean section will make no difference to neonatal wellbeing.&#xD;
&#xD;
      Statistical Design: The estimated sample size is the minimum number of study subjects&#xD;
      required for rejecting the alternative hypothesis (i.e., accepting the null hypothesis). A&#xD;
      significant difference between groups in the primary outcome, umbilical artery BD (which is a&#xD;
      measure of fetal well being at the time of delivery and an indirect indicator of the adequacy&#xD;
      of uteroplacental perfusion) would be of the order of magnitude of 2 mmol/L. Standard&#xD;
      deviation of BD tends to be of this magnitude also. It would therefore require 22 subjects&#xD;
      per group for 90% power to detect this magnitude of difference with alpha 0.05. Because BD is&#xD;
      often not normally distributed, it is appropriate to increase sample size by 10-20%, and&#xD;
      because the investigators have important secondary outcomes (PE usage, UA and UV pH, UV BD)&#xD;
      the investigators intend to recruit 50 subjects per group to allow sufficient power for&#xD;
      analysis of these secondary outcomes with appropriate correction for multiple comparisons,&#xD;
      and allowing for 10% dropout. PE usage in the investigators previous study tends to have a&#xD;
      standard deviation of about 30% of the mean, also roughly the magnitude of a clinically&#xD;
      significant difference.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">January 2016</completion_date>
  <primary_completion_date type="Actual">January 2016</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>Factorial Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Base deficit (umbilical artery) (mEq/L)</measure>
    <time_frame>Within 2 hours of birth</time_frame>
    <description>The primary outcome will be the neonatal umbilical arterial base deficit at birth.Neonatal umbilical vein and arterial blood gas results (these are routinely sent by the obstetric service at Columbia University Medical Center for all deliveries)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Total phenylephrine dose (mg)</measure>
    <time_frame>15 minutes after spinal injection</time_frame>
    <description>The secondary outcome will be the total phenylephrine dose requirement at 15 minutes after spinal injection. The phenylephrine (PE) infusion will be titrated to maintain the systolic arterial pressure (SBP) at baseline. If the SBP is at or above baseline, no PE will be administered. If SBP is 90-99% of baseline, PE infusion will be at 50 μg/min. If the SBP is 80-89% of baseline, PE will be 100 μg/min. If SBP is less than 80% of baseline, the infusion will be doubled to 200 μg/min. When SBP returns to more than 90% of baseline, the infusion will be returned to 50 μg/min. If the SBP remains &lt; 80% of baseline after 1 minute at 200 μg/min, additional boluses of IV phenylephrine 80 μg may be given. If this regimen is unsuccessful at restoring SBP to &gt;90% of baseline within 3 minutes, any other indicated maneuver may be used.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Aortocaval Compression</condition>
  <condition>Fetal Acidosis</condition>
  <arm_group>
    <arm_group_label>SUPINE group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The surgical table will remain horizontal after intrathecal (spinal) anesthesia injection for cesarean section. Choosing to position the patient supine is the intervention.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TILT group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The surgical table will be turned to 15° of left lateral tilt after patients are laid supine after spinal anesthesia injection. The tilted group is the control group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>SUPINE</intervention_name>
    <description>Patients in the SUPINE group will receive spinal anesthesia for cesarean section in the sitting position, after which they will lay supine horizontal on the surgical table.&#xD;
A phenylephrine intravenous infusion will be titrated according to a set protocol, to maintain the systolic blood pressure at baseline.</description>
    <arm_group_label>SUPINE group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>TILT</intervention_name>
    <description>Patients will receive spinal anesthesia for cesarean section in the sitting position, after which they will lay on the surgical table, which will be tilted to the left by 15°.&#xD;
A phenylephrine intravenous infusion will be titrated according to a set protocol to maintain the systolic blood pressure at baseline.</description>
    <arm_group_label>TILT group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ASA I and II women aged ≥18 years&#xD;
&#xD;
          -  Non-laboring&#xD;
&#xD;
          -  At term (&gt;37 weeks gestation) with singleton pregnancies in cephalic presentation&#xD;
&#xD;
          -  Scheduled for elective cesarean delivery under spinal anesthesia.&#xD;
&#xD;
          -  Maternal height will be between 150 - 180 cm and the body mass index (BMI)≤ 40 kg/m2.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Ruptured membranes&#xD;
&#xD;
          -  Severe polyhydramnios or oligohydramnios&#xD;
&#xD;
          -  Nonreassuring fetal heart rate&#xD;
&#xD;
          -  Intrauterine growth restriction&#xD;
&#xD;
          -  Abnormal lie - e.g. breech, transverse lie&#xD;
&#xD;
          -  Multiple gestation&#xD;
&#xD;
          -  Maternal comorbidities: hypertension, preeclampsia, other cardiovascular disease,&#xD;
             renal failure, diabetes mellitus&gt; 10 years, severe scoliosis or kyphosis, uterine&#xD;
             abnormalities (e.g. large fibroids, bicornuate uterus)&#xD;
&#xD;
          -  Medications - anti-hypertensive agents&#xD;
&#xD;
          -  Current smoking or illicit drug use&#xD;
&#xD;
          -  Failed spinal (sensory level &lt; T6 after 15 minutes), need to convert to general&#xD;
             anesthesia before delivery (exclusion from data analysis&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Richard Smiley, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Columbia University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>New York Presbyterian, Allen Hospital</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10034</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Lee SW, Khaw KS, Ngan Kee WD, Leung TY, Critchley LA. Haemodynamic effects from aortocaval compression at different angles of lateral tilt in non-labouring term pregnant women. Br J Anaesth. 2012 Dec;109(6):950-6. doi: 10.1093/bja/aes349. Epub 2012 Oct 11.</citation>
    <PMID>23059960</PMID>
  </reference>
  <reference>
    <citation>Crawford JS, Burton M, Davies P. Time and lateral tilt at Caesarean section. Br J Anaesth. 1972 May;44(5):477-84. doi: 10.1093/bja/44.5.477. No abstract available.</citation>
    <PMID>5044078</PMID>
  </reference>
  <reference>
    <citation>Cluver C, Novikova N, Hofmeyr GJ, Hall DR. Maternal position during caesarean section for preventing maternal and neonatal complications. Cochrane Database Syst Rev. 2013 Mar 28;(3):CD007623. doi: 10.1002/14651858.CD007623.pub3.</citation>
    <PMID>23543552</PMID>
  </reference>
  <verification_date>January 2016</verification_date>
  <study_first_submitted>September 6, 2014</study_first_submitted>
  <study_first_submitted_qc>September 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 18, 2014</study_first_posted>
  <last_update_submitted>January 22, 2016</last_update_submitted>
  <last_update_submitted_qc>January 22, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 26, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Columbia University</investigator_affiliation>
    <investigator_full_name>Richard M. Smiley</investigator_full_name>
    <investigator_title>Virginia Apgar Professor of Anesthesiology at Columbia University Medical Center</investigator_title>
  </responsible_party>
  <keyword>Aortocaval compression</keyword>
  <keyword>Cesarean Section</keyword>
  <keyword>Spinal Anesthesia</keyword>
  <keyword>Phenylephrine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acidosis</mesh_term>
  </condition_browse>
  <!-- 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/NCT02243423
org study id: AAAO1851
nct id: NCT02243423
lead sponsor: 
has dmc: Yes
This study aims to compare the neonatal acid-base status of women who remain supine
      horizontal, with women who are tilted to the left side by 15° during elective cesarean
      delivery at term under spinal anesthesia, with systolic BP maintained at baseline with a
      phenylephrine (PE) infusion. The null hypothesis is that the position of the patient (supine
      horizontal or tilted) during cesarean section will make no difference to neonatal wellbeing.
      The primary outcome will be the neonatal umbilical arterial base deficit (BD) at birth. The
      investigators will also examine the effects of maternal position during cesarean section
      under spinal anesthesia on maternal cardiac output (CO) and whether these changes have a
      correlation with the neonatal umbilical cord blood acid-base status. The secondary outcome
      will be the total phenylephrine dose requirement at 15 minutes after spinal injection.
Methods: This will be a randomized trial structured as an equivalence trial. Subjects will be
      American Society of Anesthesiologists (ASA) I and II women aged ≥18 years, non-laboring, at
      term (>37 weeks gestation) with singleton pregnancies in cephalic presentation, scheduled for
      elective cesarean delivery under spinal anesthesia. Patients will receive spinal anesthesia
      for cesarean section in the sitting position, after which they will lay either supine
      horizontal or the surgical table will be tilted to the left by 15°, depending on the group to
      which they were randomized (SUPINE or TILT). An IV phenylephrine infusion will be
      administered to maintain systolic BP at baseline until delivery. A noninvasive hemodynamic
      monitoring system (NICOM, Cheetah Medical Inc., Vancouver, WA, USA) will continuously monitor
      CO and stroke volume. Neonatal umbilical vein and arterial blood gas results will be
      recorded.The null hypothesis is that the position of the patient (supine horizontal or
      tilted) during cesarean section will make no difference to neonatal wellbeing.

      Statistical Design: The estimated sample size is the minimum number of study subjects
      required for rejecting the alternative hypothesis (i.e., accepting the null hypothesis). A
      significant difference between groups in the primary outcome, umbilical artery BD (which is a
      measure of fetal well being at the time of delivery and an indirect indicator of the adequacy
      of uteroplacental perfusion) would be of the order of magnitude of 2 mmol/L. Standard
      deviation of BD tends to be of this magnitude also. It would therefore require 22 subjects
      per group for 90% power to detect this magnitude of difference with alpha 0.05. Because BD is
      often not normally distributed, it is appropriate to increase sample size by 10-20%, and
      because the investigators have important secondary outcomes (PE usage, UA and UV pH, UV BD)
      the investigators intend to recruit 50 subjects per group to allow sufficient power for
      analysis of these secondary outcomes with appropriate correction for multiple comparisons,
      and allowing for 10% dropout. PE usage in the investigators previous study tends to have a
      standard deviation of about 30% of the mean, also roughly the magnitude of a clinically
      significant difference.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Base deficit (umbilical artery) (mEq/L)
time frame: Within 2 hours of birth
description: The primary outcome will be the neonatal umbilical arterial base deficit at birth.Neonatal umbilical vein and arterial blood gas results (these are routinely sent by the obstetric service at Columbia University Medical Center for all deliveries)
measure: Total phenylephrine dose (mg)
time frame: 15 minutes after spinal injection
description: The secondary outcome will be the total phenylephrine dose requirement at 15 minutes after spinal injection. The phenylephrine (PE) infusion will be titrated to maintain the systolic arterial pressure (SBP) at baseline. If the SBP is at or above baseline, no PE will be administered. If SBP is 90-99% of baseline, PE infusion will be at 50 μg/min. If the SBP is 80-89% of baseline, PE will be 100 μg/min. If SBP is less than 80% of baseline, the infusion will be doubled to 200 μg/min. When SBP returns to more than 90% of baseline, the infusion will be returned to 50 μg/min. If the SBP remains < 80% of baseline after 1 minute at 200 μg/min, additional boluses of IV phenylephrine 80 μg may be given. If this regimen is unsuccessful at restoring SBP to >90% of baseline within 3 minutes, any other indicated maneuver may be used.
arm group label: SUPINE group
arm group type: Experimental
description: The surgical table will remain horizontal after intrathecal (spinal) anesthesia injection for cesarean section. Choosing to position the patient supine is the intervention.
arm group label: TILT group
arm group type: Active Comparator
description: The surgical table will be turned to 15° of left lateral tilt after patients are laid supine after spinal anesthesia injection. The tilted group is the control group.
intervention type: Procedure
intervention name: SUPINE
description: Patients in the SUPINE group will receive spinal anesthesia for cesarean section in the sitting position, after which they will lay supine horizontal on the surgical table.
A phenylephrine intravenous infusion will be titrated according to a set protocol, to maintain the systolic blood pressure at baseline.
arm group label: SUPINE group
intervention type: Procedure
intervention name: TILT
description: Patients will receive spinal anesthesia for cesarean section in the sitting position, after which they will lay on the surgical table, which will be tilted to the left by 15°.
A phenylephrine intravenous infusion will be titrated according to a set protocol to maintain the systolic blood pressure at baseline.
arm group label: TILT group
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Richard Smiley, MD, PhD
role: Principal Investigator
affiliation: Columbia University
facility: 
country: United States
citation: Lee SW, Khaw KS, Ngan Kee WD, Leung TY, Critchley LA. Haemodynamic effects from aortocaval compression at different angles of lateral tilt in non-labouring term pregnant women. Br J Anaesth. 2012 Dec;109(6):950-6. doi: 10.1093/bja/aes349. Epub 2012 Oct 11.
PMID: 23059960
citation: Crawford JS, Burton M, Davies P. Time and lateral tilt at Caesarean section. Br J Anaesth. 1972 May;44(5):477-84. doi: 10.1093/bja/44.5.477. No abstract available.
PMID: 5044078
citation: Cluver C, Novikova N, Hofmeyr GJ, Hall DR. Maternal position during caesarean section for preventing maternal and neonatal complications. Cochrane Database Syst Rev. 2013 Mar 28;(3):CD007623. doi: 10.1002/14651858.CD007623.pub3.
PMID: 23543552
responsible party type: Principal Investigator
investigator affiliation: Columbia University
investigator full name: Richard M. Smiley
investigator title: Virginia Apgar Professor of Anesthesiology at Columbia University Medical Center
mesh term: Acidosis