<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/NCT03274960</url>
  </required_header>
  <id_info>
    <org_study_id>127/16/JREC</org_study_id>
    <nct_id>NCT03274960</nct_id>
  </id_info>
  <brief_title>Screening and Treating Asymptomatic Bacteriuria Every Trimester and Preterm Birth</brief_title>
  <acronym>Pretermbirth</acronym>
  <official_title>The Effect of Screening and Treatment of Asymptomatic Bacteriuria Every Trimester During Pregnancy on Incidence of Preterm Birth in Harare, Zimbabwe</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Zimbabwe</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Zimbabwe</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>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is evaluating whether screening of a pregnant woman for asymptomatic bacteriuria&#xD;
      in each trimester for early detection and treatment of bacteriuria will reduce the incidence&#xD;
      of preterm birth in Harare.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Asymptomatic bacteriuria is common in pregnancy. If the disease is not detected early in&#xD;
      pregnancy and treated it often progresses to an acute symptomatic disease, pyelonephritis&#xD;
      which is associated with adverse pregnancy outcomes including preterm birth.&#xD;
&#xD;
      It is recommended that every woman be screened for asymptomatic bacteriuria by urine culture&#xD;
      test at initial antenatal care visit so that the disease is if identified is treated early to&#xD;
      prevent preventable complications of the disease in pregnancy. Culture test is expensive and&#xD;
      therefore unavailable at several primary care settings especially in low resource settings&#xD;
      where majority of pregnant women register and visit for antenatal care. In Zimbabwe antenatal&#xD;
      care at primary care clinics is not including screening for asymptomatic bacteriuria.&#xD;
      Majority who present with symptoms are empirically treated.&#xD;
&#xD;
      In this study the Griess nitrite test, an effective inexpensive screening test for&#xD;
      asymptomatic bacteriuria is used. the test detects nitrite in urine which is associated with&#xD;
      presence of nitrate reducing uropathogens, commonly the gram negative bacteria. All the&#xD;
      positive samples will then be further tested by culture for bacteria identification,&#xD;
      quantification and antibiotic sensitivity. A Randomized controlled trial research design is&#xD;
      being used. participants are randomly allocated to intervention group or control group. Urine&#xD;
      samples will be collected and tested 3 times for each recruited participant in the&#xD;
      intervention arm. treatment will be initiated for positive result according to sensitivity&#xD;
      test. Control group will only be subjected to routine existing antenatal care.&#xD;
&#xD;
      Participants will be recruited before 22 weeks gestation and followed on for second contact&#xD;
      by 28 weeks and third contact by 36 weeks. Follow up will be stopped on delivery for noting&#xD;
      gestation at delivery, whether preterm or term.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 23, 2017</start_date>
  <completion_date type="Actual">December 30, 2020</completion_date>
  <primary_completion_date type="Actual">January 30, 2020</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>
    <intervention_model_description>The control group shall be receiving the usual current antenatal services which do not include any screening at all for asymptomatic bacteriuria. Control group participants will however be treated as routinely being done when a woman presents with symptoms of a UTI. Control group will therefore continue to get the routine antenatal care service as currently being done at the clinics. Participants in the intervention group will each be screened for asymptomatic bacteriuria once in each trimester using the Griess test. A culture test will be done which will confirm diagnosis of bacteriuria. participants in intervention group who will present with symptoms and who will test positive for bacteriuria with the Griess and culture test will be treated with antibiotics as per usual treatment protocol. A comparison about number of preterm births for intervention group and control group will be done to reveal the effect of the study intervention.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
    <masking_description>The investigator will not be aware of study group at analysis stage of results. The assessors of outcome will be blinded to study arm as they analyse data to reduce risk of bias.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Preterm birth</measure>
    <time_frame>Preterm birth will be calculated as gestation at birth of baby using date of birth and the first date of last menstrual period.</time_frame>
    <description>Preterm birth will be delivery of a baby before 37 complete weeks of gestation from the first date of last menstrual period. It will be sub-categorized as extremely preterm (&lt;28 weeks), very preterm (28 to &lt;32 weeks) and moderate to late preterm (32 to &lt;37 weeks).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>symptomatic bacteriuria</measure>
    <time_frame>The symptoms will be noted at interviews at follow up after every 6 to 8 weeks from previous contact.</time_frame>
    <description>Noted from history of urinary tract symptoms which include pain on micturition, fever, blood in urine, increased urine frequency, foul smelling urine and cloudy urine.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Isolated uropathogen</measure>
    <time_frame>These will be available at recruitment by 22 weeks, between 22 and 28 weeks at second screening and at 28 to 36 weeks at the third screening.</time_frame>
    <description>All isolated bacterial species from urine sample identified from culture test. These are bacteria identified to be responsible for asymptomatic bacteriuria.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Antibiotic sensitivity</measure>
    <time_frame>These will be available at recruitment by 22 weeks, between 22 and 28 weeks at second screening and at 28 to 36 weeks at the third screening</time_frame>
    <description>from urine culture results identified antibiotics sensitive for treatment of isolated bacteria will be noted.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gestation at birth</measure>
    <time_frame>Gestation will be calculated at delivery of baby.</time_frame>
    <description>Gestation is the calculated total number of weeks from first date of last menstrual period to the date of delivery.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">480</enrollment>
  <condition>Preterm Birth</condition>
  <condition>Asymptomatic Bacteriuria in Pregnancy</condition>
  <arm_group>
    <arm_group_label>Griess, Culture and antibiotic</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Griess reagents, sulfanilamide and NED added in urine sample for 20 minutes, urine culture using blood agar for 24 hours and treatment with antibiotic every trimester for up to 7 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No Griess, culture, treatment</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No Griess reagents added in urine sample, no culture test with blood agar and no treatment with antibiotic for every positive results every trimester</description>
  </arm_group>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>Griess,</intervention_name>
    <description>Experimental: Griess, Culture and antibiotic Griess reagents, sulfanilamide and NED added in urine sample for 20 minutes, urine culture using blood agar for 24 hours and treatment with antibiotic every trimester for up to 7 days.</description>
    <arm_group_label>Griess, Culture and antibiotic</arm_group_label>
    <other_name>Culture</other_name>
    <other_name>Treatment</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pregnant women registering at study site.&#xD;
&#xD;
          -  Woman is able to identify her date of last menstrual period.&#xD;
&#xD;
          -  Gestation of pregnancy is between 6 and 22 weeks.&#xD;
&#xD;
          -  Woman is asymptomatic for bacteriuria&#xD;
&#xD;
          -  Woman voluntarily signs the consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant woman ill and unwell&#xD;
&#xD;
          -  Pregnant woman unwilling to sign consent form&#xD;
&#xD;
          -  Woman who had antibiotic treatment 2 weeks before recruitment&#xD;
&#xD;
          -  Woman on long term antibiotic treatment&#xD;
&#xD;
          -  Woman who fails to identify date of last menstrual period&#xD;
&#xD;
          -  Woman symptomatic for urinary tract infection&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Muchabaiwa F Gidiri, MD</last_name>
    <role>Study Director</role>
    <affiliation>Senior Lecturer, Chairperson Obstetrics and Gynecology Department, University of Zimbabwe</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Pasipanodya Nziramasamga, PHD</last_name>
    <role>Study Director</role>
    <affiliation>Senior Lecturer, Medical Microbiology Department, University of Zimbabwe</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Babil Stray- Pedersen, Professor</last_name>
    <role>Study Director</role>
    <affiliation>Doctor, Medisin Department, Oslo University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Clara Haruzivishe, PHD</last_name>
    <role>Study Chair</role>
    <affiliation>Senior lecturer, Department of Nursing Science, University of Zimbabwe</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Zimbabwe</name>
      <address>
        <city>Harare</city>
        <state>Metropolitan</state>
        <zip>+263</zip>
        <country>Zimbabwe</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Zimbabwe</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>August 25, 2017</study_first_submitted>
  <study_first_submitted_qc>September 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 7, 2017</study_first_posted>
  <last_update_submitted>May 9, 2023</last_update_submitted>
  <last_update_submitted_qc>May 9, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 11, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Zimbabwe</investigator_affiliation>
    <investigator_full_name>Judith Rukweza, DPhil Student</investigator_full_name>
    <investigator_title>Mrs</investigator_title>
  </responsible_party>
  <keyword>asymptomati bacteriuria, Griess nitrite test, preterm birth</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bacteriuria</mesh_term>
    <mesh_term>Premature Birth</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>plan to share individual participant information will include sharing culture test results on antibiotic sensitivity for those with positive urine culture results. the in formation shared is intended to assist with effective decision making on selection of the best antibiotic to use to treat asymptomatic bacteriuria.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>for the period of study for the protocol As soon as culture results are out</ipd_time_frame>
    <ipd_access_criteria>Soft copy Hard copy</ipd_access_criteria>
  </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/NCT03274960
org study id: 127/16/JREC
nct id: NCT03274960
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: Yes
This study is evaluating whether screening of a pregnant woman for asymptomatic bacteriuria
      in each trimester for early detection and treatment of bacteriuria will reduce the incidence
      of preterm birth in Harare.
Asymptomatic bacteriuria is common in pregnancy. If the disease is not detected early in
      pregnancy and treated it often progresses to an acute symptomatic disease, pyelonephritis
      which is associated with adverse pregnancy outcomes including preterm birth.

      It is recommended that every woman be screened for asymptomatic bacteriuria by urine culture
      test at initial antenatal care visit so that the disease is if identified is treated early to
      prevent preventable complications of the disease in pregnancy. Culture test is expensive and
      therefore unavailable at several primary care settings especially in low resource settings
      where majority of pregnant women register and visit for antenatal care. In Zimbabwe antenatal
      care at primary care clinics is not including screening for asymptomatic bacteriuria.
      Majority who present with symptoms are empirically treated.

      In this study the Griess nitrite test, an effective inexpensive screening test for
      asymptomatic bacteriuria is used. the test detects nitrite in urine which is associated with
      presence of nitrate reducing uropathogens, commonly the gram negative bacteria. All the
      positive samples will then be further tested by culture for bacteria identification,
      quantification and antibiotic sensitivity. A Randomized controlled trial research design is
      being used. participants are randomly allocated to intervention group or control group. Urine
      samples will be collected and tested 3 times for each recruited participant in the
      intervention arm. treatment will be initiated for positive result according to sensitivity
      test. Control group will only be subjected to routine existing antenatal care.

      Participants will be recruited before 22 weeks gestation and followed on for second contact
      by 28 weeks and third contact by 36 weeks. Follow up will be stopped on delivery for noting
      gestation at delivery, whether preterm or term.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: The control group shall be receiving the usual current antenatal services which do not include any screening at all for asymptomatic bacteriuria. Control group participants will however be treated as routinely being done when a woman presents with symptoms of a UTI. Control group will therefore continue to get the routine antenatal care service as currently being done at the clinics. Participants in the intervention group will each be screened for asymptomatic bacteriuria once in each trimester using the Griess test. A culture test will be done which will confirm diagnosis of bacteriuria. participants in intervention group who will present with symptoms and who will test positive for bacteriuria with the Griess and culture test will be treated with antibiotics as per usual treatment protocol. A comparison about number of preterm births for intervention group and control group will be done to reveal the effect of the study intervention.
primary purpose: Prevention
masking: Double (Investigator, Outcomes Assessor)
masking description: The investigator will not be aware of study group at analysis stage of results. The assessors of outcome will be blinded to study arm as they analyse data to reduce risk of bias.
measure: Preterm birth
time frame: Preterm birth will be calculated as gestation at birth of baby using date of birth and the first date of last menstrual period.
description: Preterm birth will be delivery of a baby before 37 complete weeks of gestation from the first date of last menstrual period. It will be sub-categorized as extremely preterm (<28 weeks), very preterm (28 to <32 weeks) and moderate to late preterm (32 to <37 weeks).
measure: symptomatic bacteriuria
time frame: The symptoms will be noted at interviews at follow up after every 6 to 8 weeks from previous contact.
description: Noted from history of urinary tract symptoms which include pain on micturition, fever, blood in urine, increased urine frequency, foul smelling urine and cloudy urine.
measure: Isolated uropathogen
time frame: These will be available at recruitment by 22 weeks, between 22 and 28 weeks at second screening and at 28 to 36 weeks at the third screening.
description: All isolated bacterial species from urine sample identified from culture test. These are bacteria identified to be responsible for asymptomatic bacteriuria.
measure: Antibiotic sensitivity
time frame: These will be available at recruitment by 22 weeks, between 22 and 28 weeks at second screening and at 28 to 36 weeks at the third screening
description: from urine culture results identified antibiotics sensitive for treatment of isolated bacteria will be noted.
measure: Gestation at birth
time frame: Gestation will be calculated at delivery of baby.
description: Gestation is the calculated total number of weeks from first date of last menstrual period to the date of delivery.
arm group label: Griess, Culture and antibiotic
arm group type: Experimental
description: Griess reagents, sulfanilamide and NED added in urine sample for 20 minutes, urine culture using blood agar for 24 hours and treatment with antibiotic every trimester for up to 7 days.
arm group label: No Griess, culture, treatment
arm group type: No Intervention
description: No Griess reagents added in urine sample, no culture test with blood agar and no treatment with antibiotic for every positive results every trimester
intervention type: Combination Product
intervention name: Griess,
description: Experimental: Griess, Culture and antibiotic Griess reagents, sulfanilamide and NED added in urine sample for 20 minutes, urine culture using blood agar for 24 hours and treatment with antibiotic every trimester for up to 7 days.
arm group label: Griess, Culture and antibiotic
other name: Culture
other name: Treatment
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Muchabaiwa F Gidiri, MD
role: Study Director
affiliation: Senior Lecturer, Chairperson Obstetrics and Gynecology Department, University of Zimbabwe
last name: Pasipanodya Nziramasamga, PHD
role: Study Director
affiliation: Senior Lecturer, Medical Microbiology Department, University of Zimbabwe
last name: Babil Stray- Pedersen, Professor
role: Study Director
affiliation: Doctor, Medisin Department, Oslo University
last name: Clara Haruzivishe, PHD
role: Study Chair
affiliation: Senior lecturer, Department of Nursing Science, University of Zimbabwe
facility: 
country: Zimbabwe
responsible party type: Principal Investigator
investigator affiliation: University of Zimbabwe
investigator full name: Judith Rukweza, DPhil Student
investigator title: Mrs
mesh term: Bacteriuria
mesh term: Premature Birth
sharing ipd: Yes
ipd description: plan to share individual participant information will include sharing culture test results on antibiotic sensitivity for those with positive urine culture results. the in formation shared is intended to assist with effective decision making on selection of the best antibiotic to use to treat asymptomatic bacteriuria.
ipd info type: Study Protocol
ipd info type: Clinical Study Report (CSR)
ipd time frame: for the period of study for the protocol As soon as culture results are out
ipd access criteria: Soft copy Hard copy