<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/NCT03268486</url>
  </required_header>
  <id_info>
    <org_study_id>ULisbon TAECG</org_study_id>
    <nct_id>NCT03268486</nct_id>
  </id_info>
  <brief_title>Evaluation of a Novel Signal Acquisition Technique for Intrapartum Cardiotocography</brief_title>
  <official_title>Evaluation of a Novel Signal Acquisition Technique for Intrapartum Cardiotocography</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Lisbon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Lisbon</source>
  <oversight_info>
    <has_dmc>No</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>
      Cardiotocography (CTG) is widely used during labour wards in industrialised countries and&#xD;
      consists of fetal heart rate and uterine contraction monitoring. The main aim is to identify&#xD;
      fetuses that are being poorly oxygenated during labour and require medical intervention to&#xD;
      revert the situation or expedite delivery.&#xD;
&#xD;
      The need for technical development of CTG is well-recognized, as some of the existing&#xD;
      techniques are prone to signal loss and contamination from the maternal heart rate, while&#xD;
      others are invasive and have established contra-indications. They also limit maternal&#xD;
      mobilisation, contributing to maternal dissatisfaction, and possibly to adverse maternal and&#xD;
      neonatal outcomes.&#xD;
&#xD;
      New techniques for CTG acquisition will shortly be made available by a leading technological&#xD;
      company, providing non-invasive monitoring and allowing full maternal mobilisation, and with&#xD;
      the potential to change the way labour is conducted in high-resource countries. There is a&#xD;
      need for a systematic evaluation of their clinical performance and benefit.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      First phase of the study will start in October 2017 in labor wards at Hospital de Santa&#xD;
      Maria, Lisbon where performing continuous cardiotocographic fetal monitoring with&#xD;
      conventional Doppler technology is the routine procedure. Through a collaboration with&#xD;
      Phillips (Boeblingen, Germany) we will have access to a transabdominal ECG/EHG recorder that&#xD;
      has high accuracy/reliability and Bluetooth technology providing mobility and and more&#xD;
      comfort for mothers. This new device works through five disposable electrodes that are&#xD;
      positioned on the maternal abdomen in a standardized manner: one electrode is placed near the&#xD;
      umbilicus, a second is placed above the symphysis pubis in a vertical line from the&#xD;
      umbilicus, a third and a fourth are placed on opposite sides of the abdomen horizontal to the&#xD;
      umbilicus; the ground is placed on the upper right side. Women will be informed of the study&#xD;
      by posters and leaflets distributed during the antenatal period and on arrival at labor&#xD;
      wards. The inclusion criteria are singleton term pregnancies, spontaneous or&#xD;
      induced/augmented labor, cephalic presentation, &gt; 18 years of age, able to provide written&#xD;
      informed consent, no contraindications to internal FHR monitoring and no known&#xD;
      contraindication to vaginal delivery. Patients with risk factors for intrapartum hypoxia will&#xD;
      also be included. After giving written informed consent, women will be simultaneously&#xD;
      monitored with scalp electrode, Doppler, trans-abdominal ECG, abdominal EHG and TOCO, as soon&#xD;
      as internal monitoring is possible. The maternal abdominal skin will be prepared for low&#xD;
      impedance by gentle excoriation of the surface skin cells. Monitoring will be maintained&#xD;
      until as close to delivery as possible, and the three FHR signals will be conveyed to a&#xD;
      computer acquisition storage system for offline analysis. We aim a sample size of 100&#xD;
      participants. EHG and TOCO will be compared for signal loss, contraction frequency, and&#xD;
      contraction area. Transabdominal ECG and Doppler will be compared in terms of signal loss,&#xD;
      and with internal ECG regarding signal accuracy. The signal quality will be analysed&#xD;
      separately for each monitoring method for the time during which the FHR recorded. As the two&#xD;
      FHR modalities do not share a common time clock, synchronisation should be achieved by cross&#xD;
      correlating the two heart rate files and locating the peak correlation. The clinical&#xD;
      management of labour will be uniquely on the basis of external Doppler ultrasound CTG&#xD;
      recordings. Both signals will also be compared for coincidences with MHR determined by&#xD;
      maternal ECG with FHR determined by internal ECG. The abdominal fECG monitor calculates the&#xD;
      MHR as well as the FHR simultaneously. It uses the height and the width of the QRS complex,&#xD;
      both of which are linked to the size of the heart, to differentiate between the fetal and&#xD;
      maternal heart signals. Women will be encouraged to perform a sequence of standardized&#xD;
      exercises, in the presence of the investigator, and the periods when the mother is lying&#xD;
      down, sitting, standing and walking will be recorded.&#xD;
&#xD;
      A subgroup analysis will be performed in the different stages of labour, particularly during&#xD;
      maternal pushing, as well as in women with different skin colour and body mass index&#xD;
      categories and in the different positions they adopt. Both umbilical cord arterial and venous&#xD;
      blood sampling will be performed for the diagnosis of newborn metabolic acidosis, as soon as&#xD;
      possible after birth. Data on basic demographic characteristics, pregnancy complications,&#xD;
      course of labor, and neonatal outcome will be obtained.&#xD;
&#xD;
      In the second phase of the study, we want to know if the different traces acquired from the&#xD;
      same fetus through transabdominal ECG and Doppler CTG may have different interpretations and&#xD;
      may lead to different obstetric attitudes. In order to do that we will retrospectively&#xD;
      analyze all the independent traces through a computer analysis (Omniview-SisPorto program).&#xD;
      This system emits visual and sound alerts when features associated with poor fetal&#xD;
      oxygenation are detected and has been shown to provide analysis that is in good agreement&#xD;
      with a consensus of experts. The main outcome will be the agreement of alerts displayed by&#xD;
      each signal acquisition technique regarding the same fetus.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">October 1, 2017</start_date>
  <completion_date type="Anticipated">May 31, 2019</completion_date>
  <primary_completion_date type="Anticipated">May 1, 2018</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>6 Months</target_duration>
  <primary_outcome>
    <measure>Signal quality</measure>
    <time_frame>The analysis will be made at the end of the recruiting phase (that will have 3 months of duration)</time_frame>
    <description>Transabdominal ECG and Doppler will be compared in terms of signal loss, and with internal ECG regarding signal accuracy. The signal quality will be analysed separately for each monitoring method for the time during which the FHR recorded.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Labor Fetal Anoxia</condition>
  <condition>Fetal Monitoring</condition>
  <arm_group>
    <arm_group_label>Triple monitoring</arm_group_label>
    <description>Pregnant women with singleton term pregnancies, spontaneous or induced/augmented labor, cephalic presentation, &gt; 18 years of age, able to provide written informed consent, no contraindications to internal FHR monitoring and no known contraindication to vaginal delivery. After giving written informed consent, women will be simultaneously monitored with scalp electrode, Doppler, trans-abdominal ECG, abdominal EHG and TOCO, as soon as internal monitoring is possible.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        All pregnant women in labour at Hospital de Santa Maria, Lisbon&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Singleton term pregnancies, spontaneous or induced/augmented labor, cephalic&#xD;
             presentation, &gt; 18 years of age, able to provide written informed consent, no&#xD;
             contraindications to internal FHR monitoring and no known contraindication to vaginal&#xD;
             delivery. Patients with risk factors for intrapartum hypoxia will also be included.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Do not give a written consent.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Only women (pregnant)</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Catarina Carvalho, Resident</last_name>
    <phone>+351919297913</phone>
    <email>catarinareiscarvalho@gmail.com</email>
  </overall_contact>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 29, 2017</study_first_submitted>
  <study_first_submitted_qc>August 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 31, 2017</study_first_posted>
  <last_update_submitted>August 30, 2017</last_update_submitted>
  <last_update_submitted_qc>August 30, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 31, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Lisbon</investigator_affiliation>
    <investigator_full_name>Ana Catarina Reis de Carvalho</investigator_full_name>
    <investigator_title>Resident</investigator_title>
  </responsible_party>
  <keyword>Fetal monitoring</keyword>
  <keyword>cardiotocography</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fetal Hypoxia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03268486
org study id: ULisbon TAECG
nct id: NCT03268486
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Cardiotocography (CTG) is widely used during labour wards in industrialised countries and
      consists of fetal heart rate and uterine contraction monitoring. The main aim is to identify
      fetuses that are being poorly oxygenated during labour and require medical intervention to
      revert the situation or expedite delivery.

      The need for technical development of CTG is well-recognized, as some of the existing
      techniques are prone to signal loss and contamination from the maternal heart rate, while
      others are invasive and have established contra-indications. They also limit maternal
      mobilisation, contributing to maternal dissatisfaction, and possibly to adverse maternal and
      neonatal outcomes.

      New techniques for CTG acquisition will shortly be made available by a leading technological
      company, providing non-invasive monitoring and allowing full maternal mobilisation, and with
      the potential to change the way labour is conducted in high-resource countries. There is a
      need for a systematic evaluation of their clinical performance and benefit.
First phase of the study will start in October 2017 in labor wards at Hospital de Santa
      Maria, Lisbon where performing continuous cardiotocographic fetal monitoring with
      conventional Doppler technology is the routine procedure. Through a collaboration with
      Phillips (Boeblingen, Germany) we will have access to a transabdominal ECG/EHG recorder that
      has high accuracy/reliability and Bluetooth technology providing mobility and and more
      comfort for mothers. This new device works through five disposable electrodes that are
      positioned on the maternal abdomen in a standardized manner: one electrode is placed near the
      umbilicus, a second is placed above the symphysis pubis in a vertical line from the
      umbilicus, a third and a fourth are placed on opposite sides of the abdomen horizontal to the
      umbilicus; the ground is placed on the upper right side. Women will be informed of the study
      by posters and leaflets distributed during the antenatal period and on arrival at labor
      wards. The inclusion criteria are singleton term pregnancies, spontaneous or
      induced/augmented labor, cephalic presentation, > 18 years of age, able to provide written
      informed consent, no contraindications to internal FHR monitoring and no known
      contraindication to vaginal delivery. Patients with risk factors for intrapartum hypoxia will
      also be included. After giving written informed consent, women will be simultaneously
      monitored with scalp electrode, Doppler, trans-abdominal ECG, abdominal EHG and TOCO, as soon
      as internal monitoring is possible. The maternal abdominal skin will be prepared for low
      impedance by gentle excoriation of the surface skin cells. Monitoring will be maintained
      until as close to delivery as possible, and the three FHR signals will be conveyed to a
      computer acquisition storage system for offline analysis. We aim a sample size of 100
      participants. EHG and TOCO will be compared for signal loss, contraction frequency, and
      contraction area. Transabdominal ECG and Doppler will be compared in terms of signal loss,
      and with internal ECG regarding signal accuracy. The signal quality will be analysed
      separately for each monitoring method for the time during which the FHR recorded. As the two
      FHR modalities do not share a common time clock, synchronisation should be achieved by cross
      correlating the two heart rate files and locating the peak correlation. The clinical
      management of labour will be uniquely on the basis of external Doppler ultrasound CTG
      recordings. Both signals will also be compared for coincidences with MHR determined by
      maternal ECG with FHR determined by internal ECG. The abdominal fECG monitor calculates the
      MHR as well as the FHR simultaneously. It uses the height and the width of the QRS complex,
      both of which are linked to the size of the heart, to differentiate between the fetal and
      maternal heart signals. Women will be encouraged to perform a sequence of standardized
      exercises, in the presence of the investigator, and the periods when the mother is lying
      down, sitting, standing and walking will be recorded.

      A subgroup analysis will be performed in the different stages of labour, particularly during
      maternal pushing, as well as in women with different skin colour and body mass index
      categories and in the different positions they adopt. Both umbilical cord arterial and venous
      blood sampling will be performed for the diagnosis of newborn metabolic acidosis, as soon as
      possible after birth. Data on basic demographic characteristics, pregnancy complications,
      course of labor, and neonatal outcome will be obtained.

      In the second phase of the study, we want to know if the different traces acquired from the
      same fetus through transabdominal ECG and Doppler CTG may have different interpretations and
      may lead to different obstetric attitudes. In order to do that we will retrospectively
      analyze all the independent traces through a computer analysis (Omniview-SisPorto program).
      This system emits visual and sound alerts when features associated with poor fetal
      oxygenation are detected and has been shown to provide analysis that is in good agreement
      with a consensus of experts. The main outcome will be the agreement of alerts displayed by
      each signal acquisition technique regarding the same fetus.
observational model: Case-Only
time perspective: Prospective
measure: Signal quality
time frame: The analysis will be made at the end of the recruiting phase (that will have 3 months of duration)
description: Transabdominal ECG and Doppler will be compared in terms of signal loss, and with internal ECG regarding signal accuracy. The signal quality will be analysed separately for each monitoring method for the time during which the FHR recorded.
arm group label: Triple monitoring
description: Pregnant women with singleton term pregnancies, spontaneous or induced/augmented labor, cephalic presentation, > 18 years of age, able to provide written informed consent, no contraindications to internal FHR monitoring and no known contraindication to vaginal delivery. After giving written informed consent, women will be simultaneously monitored with scalp electrode, Doppler, trans-abdominal ECG, abdominal EHG and TOCO, as soon as internal monitoring is possible.
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
gender based: Yes
gender description: Only women (pregnant)
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Catarina Carvalho, Resident
phone: +351919297913
email: catarinareiscarvalho@gmail.com
responsible party type: Principal Investigator
investigator affiliation: University of Lisbon
investigator full name: Ana Catarina Reis de Carvalho
investigator title: Resident
mesh term: Fetal Hypoxia
sharing ipd: No