<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/NCT01665456</url>
  </required_header>
  <id_info>
    <org_study_id>P141/03/2012</org_study_id>
    <nct_id>NCT01665456</nct_id>
  </id_info>
  <brief_title>Assessing Childbirth-related Complications at the Community Level in Kenya</brief_title>
  <official_title>Assessing Childbirth-related Complications at the Community Level in Kenya: A Case Control Study Among Postpartum Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wilson Liambila</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Merck Sharp &amp; Dohme LLC</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Kenyatta National Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Kenya is one of the countries in sub-Saharan Africa that still experience high maternal&#xD;
      mortality. For instance, in 2008/09 maternal mortality ratio was estimated to be 488/100,000&#xD;
      live births. Direct obstetric complications such as puerperal sepsis, postpartum hemorrhage,&#xD;
      pre-eclampsia and eclampsia, obstructed labor and indirect causes including HIV, malaria and&#xD;
      anemia in pregnancy are responsible for the majority of these cases. Just under 44% of births&#xD;
      in Kenya are delivered under the supervision of a skilled birth attendant.&#xD;
&#xD;
      The overall objective of this study is to determine the effect of provider type in the&#xD;
      occurrence and management of serious childbirth related complications among postpartum women&#xD;
      at the community level in Bungoma and Lugari Districts of Western Province, Kenya.&#xD;
&#xD;
      The proposed study will employ a case control study design in which women with obstetric&#xD;
      complication(s)will be cases and women without obstetric complications will be controls.&#xD;
      Controls will be sampled concurrently with the cases. Each time a new case is diagnosed, a&#xD;
      control is selected from the population at risk in the neighborhood at that point in time.&#xD;
&#xD;
      The study population will consist of women aged 15-49 years with a delivery in the past 12&#xD;
      months. A woman who reports having experienced a birth-related complication will be recruited&#xD;
      as a case while woman who reports having experienced no complication during child-birth will&#xD;
      be recruited as a control.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Evidence from published literature is scanty on the effect of various categories of health&#xD;
      providers in averting serious child birth related complications at the community level. For&#xD;
      instance, no one knows what happens to pregnancy outcomes for both the mother and the baby in&#xD;
      a context where a significant proportion of women are delivered by neighbors, relatives or on&#xD;
      their own. Literature is also scanty regarding the outcomes of child birth related&#xD;
      complications in situations where Traditional Birth Attendants conduct a significant&#xD;
      proportion of deliveries.&#xD;
&#xD;
      A thorough understanding of factors that fuel disrespect and abuse as well as their effect on&#xD;
      utilization of delivery services will help providers and programme managers to explore ways&#xD;
      of addressing this issue. This study hypothesizes that since majority of deliveries take&#xD;
      place at the household level, most complications and even deaths are likely to occur at this&#xD;
      level.&#xD;
&#xD;
      The overall objective of this study is to determine the effect of provider type in the&#xD;
      occurrence and management of serious childbirth related complications among postpartum women&#xD;
      at the community level in Bungoma and Lugari Districts of Western Province, Kenya. Specific&#xD;
      objectives of the study are:&#xD;
&#xD;
      To determine the quality of obstetric care given by community midwives and TBAs to clients&#xD;
      seeking antenatal care, during delivery and post-partum care at the community level by&#xD;
      assessing providers' preparedness and the range of services offered.&#xD;
&#xD;
      To assess the nature of obstetric complications among those women who were delivered by&#xD;
      skilled health providers, versus those who were delivered by TBAs, neighbors, friends or on&#xD;
      their own To determine the role of socio-economic, demographic and health service related&#xD;
      factors in the occurrence of child birth related complications at the community level To&#xD;
      obtain views from key stakeholders on the extent and occurrence of child birth related&#xD;
      complications at the community level&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">March 2014</completion_date>
  <primary_completion_date type="Actual">November 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The odds ratio was the primary outcome measure of association between the the occurrence of complications and exposure to health providers in the past 12 months.</measure>
    <time_frame>One Year</time_frame>
    <description>The study sought to determine the association of provider type with the occurrence and management of serious childbirth related complications among postpartum women at the community level in Kenya in the past 12 months.The odds of exposure among cases were compared to the odds of exposure among controls to estimate the magnitude of association between exposure to health providers and other caregivers and the occurrence of complications.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of women receiving skilled attendance at birth in the community in the past 12 months.</measure>
    <time_frame>One Year</time_frame>
    <description>This secondary outcome measure was assessed by collecting information on the nature of obstetric complications among those women who were delivered by skilled health providers, versus those who were delivered by Traditional Birth attendants, neighbours, friends or delivered on their own.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Proportion of women with obstetric complications reporting to have been referred within 0-4 hours and 5-8 hours of admission or assessment to another level of care in the past 12 months.</measure>
    <time_frame>One Year</time_frame>
    <description>Prompt referral of women with obstetric complications is critical to their survival.Data was captured on the proportion of pregnant women in labour or in the postpartum period who were referred within 0-4hours and 5-8hours by health care providers or other care givers at the community level to the next level of care or the nearest health facilities after assessing or examining them.</description>
  </other_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">585</enrollment>
  <condition>Puerperal Sepsis</condition>
  <condition>Postpartum Hemorrhage</condition>
  <condition>Preeclampsia and Eclampsia</condition>
  <condition>Retained Placenta, Without Hemorrhage</condition>
  <condition>Obstructed Labor Due to Breech Presentation</condition>
  <arm_group>
    <arm_group_label>Cases (women with complications)</arm_group_label>
    <description>Cases are women aged 15-49 years who delivered within 12 months prior to data collection and had experienced obstetric complication(s) that either necessitated treatment or hospitalization in order to prevent the likelihood of death of the mother.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control (women who did not experience any complications)</arm_group_label>
    <description>Controls are women aged 15-49 years who delivered within 12 months prior to data collection. They did not have or develop any of the complications which cases experienced or suffered from.Although controls did not have complications, they were individually matched on the basis of age and location. The idea was to compare how many cases were exposed versus how many controls were exposed.</description>
  </arm_group>
  <biospec_retention>None Retained</biospec_retention>
  <biospec_descr>
    <textblock>
      This was a two-arm study (Cases and controls). Random identification of cases through&#xD;
      cross-sectional survey was done. Then, a random sample of controls was drawn from the source&#xD;
      population from which the cases were selected (i.e. from same study base except that they&#xD;
      were not cases) through matching variables i.e. age and location. Individual matching of&#xD;
      controls to the characteristics of the cases was done. A total of 585 clients (women) were&#xD;
      recruited (294cases and 291 controls).&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        The study population consisted of women aged 15-49 years with a delivery within 12 months&#xD;
        preceding data collection date. A woman who reported having experienced a birth-related&#xD;
        complication was recruited as a case. A woman aged 15-49 years with a delivery within 12&#xD;
        months preceding data collection who report having experienced no complication during&#xD;
        child-birth was recruited as a control.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Case Inclusion criteria:&#xD;
&#xD;
          -  Delivery in the past 12 months&#xD;
&#xD;
          -  Suffered from obstetric complications during child birth and within 42days&#xD;
&#xD;
          -  Provided oral or written informed consent to participate in the study&#xD;
&#xD;
          -  Age ranges 15-49 years&#xD;
&#xD;
        Control inclusion criteria&#xD;
&#xD;
          -  Delivered in the past 12 months&#xD;
&#xD;
          -  Did not suffer from obstetric complications during child birth and within 42 days&#xD;
             after delivery&#xD;
&#xD;
          -  Provided oral or written informed consent to participate in the study&#xD;
&#xD;
          -  Age ranges 15-49 years&#xD;
&#xD;
        Case and Control exclusion criteria:&#xD;
&#xD;
          -  Did not deliver in the past 12 months;&#xD;
&#xD;
          -  Refused to participate in the study;&#xD;
&#xD;
          -  Excluded as controls if experienced complications similar to cases&#xD;
&#xD;
          -  Excluded as cases if they didnot experience complications&#xD;
&#xD;
          -  If unable to give informed consent or follow an interview&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>49 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shiphrah N. Kuria, MB ChB, MMed (OBGYN)</last_name>
    <role>Principal Investigator</role>
    <affiliation>Division of Reproductive Health- Ministry of Public Health and Sanitation</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Wilson N. Liambila, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Population Council</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Lugari and Bungoma districts</name>
      <address>
        <city>Kakamega</city>
        <state>Western Province</state>
        <country>Kenya</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Kenya</country>
  </location_countries>
  <link>
    <url>http://www.uonbi.ac.ke</url>
    <description>http://www.uonbi.ac.ke/activities/KNHUoN</description>
  </link>
  <link>
    <url>http://www.popcouncil.org</url>
    <description>http://www.popcouncil.org/pdfs/2012RH_APHIAII_CommunityMidwifery.pdf</description>
  </link>
  <reference>
    <citation>Brennan M. Training traditional birth attendants reduces maternal mortality and morbidity. Trop J Obstet Gynaecol. 1988;1(1):44-7.</citation>
    <PMID>12179276</PMID>
  </reference>
  <results_reference>
    <citation>Koblinsky MA, Tinker A, Daly P. Programming for safe motherhood: a guide to action. Health Policy Plan. 1994 Sep;9(3):252-66. doi: 10.1093/heapol/9.3.252.</citation>
    <PMID>10137741</PMID>
  </results_reference>
  <results_reference>
    <citation>Bisika T. The effectiveness of the TBA programme in reducing maternal mortality and morbidity in Malawi. East Afr J Public Health. 2008 Aug;5(2):103-10.</citation>
    <PMID>19024419</PMID>
  </results_reference>
  <results_reference>
    <citation>Magoma M, Requejo J, Campbell OM, Cousens S, Filippi V. High ANC coverage and low skilled attendance in a rural Tanzanian district: a case for implementing a birth plan intervention. BMC Pregnancy Childbirth. 2010 Mar 19;10:13. doi: 10.1186/1471-2393-10-13.</citation>
    <PMID>20302625</PMID>
  </results_reference>
  <results_reference>
    <citation>Knol MJ, Vandenbroucke JP, Scott P, Egger M. What do case-control studies estimate? Survey of methods and assumptions in published case-control research. Am J Epidemiol. 2008 Nov 1;168(9):1073-81. doi: 10.1093/aje/kwn217. Epub 2008 Sep 15.</citation>
    <PMID>18794220</PMID>
  </results_reference>
  <results_reference>
    <citation>Mushi D, Mpembeni R, Jahn A. Effectiveness of community based Safe Motherhood promoters in improving the utilization of obstetric care. The case of Mtwara Rural District in Tanzania. BMC Pregnancy Childbirth. 2010 Apr 1;10:14. doi: 10.1186/1471-2393-10-14.</citation>
    <PMID>20359341</PMID>
  </results_reference>
  <results_reference>
    <citation>Thatte N, Mullany LC, Khatry SK, Katz J, Tielsch JM, Darmstadt GL. Traditional birth attendants in rural Nepal: knowledge, attitudes and practices about maternal and newborn health. Glob Public Health. 2009;4(6):600-17. doi: 10.1080/17441690802472406.</citation>
    <PMID>19431006</PMID>
  </results_reference>
  <results_reference>
    <citation>Kwast BE. Reduction of maternal and perinatal mortality in rural and peri-urban settings: what works? Eur J Obstet Gynecol Reprod Biol. 1996 Oct;69(1):47-53. doi: 10.1016/0301-2115(95)02535-9.</citation>
    <PMID>8909956</PMID>
  </results_reference>
  <results_reference>
    <citation>Maine D, Akalin MZ, Chakraborty J, de Francisco A, Strong M. Why did maternal mortality decline in Matlab? Stud Fam Plann. 1996 Jul-Aug;27(4):179-87.</citation>
    <PMID>8875731</PMID>
  </results_reference>
  <results_reference>
    <citation>Rodrigues L, Kirkwood BR. Case-control designs in the study of common diseases: updates on the demise of the rare disease assumption and the choice of sampling scheme for controls. Int J Epidemiol. 1990 Mar;19(1):205-13. doi: 10.1093/ije/19.1.205.</citation>
    <PMID>2190942</PMID>
  </results_reference>
  <verification_date>April 2014</verification_date>
  <study_first_submitted>August 9, 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>April 25, 2014</last_update_submitted>
  <last_update_submitted_qc>April 25, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 28, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Kenyatta National Hospital</investigator_affiliation>
    <investigator_full_name>Wilson Liambila</investigator_full_name>
    <investigator_title>Senior Programme Officer</investigator_title>
  </responsible_party>
  <keyword>complications</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pre-Eclampsia</mesh_term>
    <mesh_term>Postpartum Hemorrhage</mesh_term>
    <mesh_term>Eclampsia</mesh_term>
    <mesh_term>Breech Presentation</mesh_term>
    <mesh_term>Placenta, Retained</mesh_term>
    <mesh_term>Dystocia</mesh_term>
    <mesh_term>Hemorrhage</mesh_term>
  </condition_browse>
  <pending_results>
    <submitted>October 3, 2014</submitted>
    <returned>October 6, 2014</returned>
    <submitted>October 8, 2014</submitted>
    <returned>October 15, 2014</returned>
  </pending_results>
  <!-- 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/NCT01665456
org study id: P141/03/2012
nct id: NCT01665456
lead sponsor: 
collaborator: 
has dmc: Yes
Kenya is one of the countries in sub-Saharan Africa that still experience high maternal
      mortality. For instance, in 2008/09 maternal mortality ratio was estimated to be 488/100,000
      live births. Direct obstetric complications such as puerperal sepsis, postpartum hemorrhage,
      pre-eclampsia and eclampsia, obstructed labor and indirect causes including HIV, malaria and
      anemia in pregnancy are responsible for the majority of these cases. Just under 44% of births
      in Kenya are delivered under the supervision of a skilled birth attendant.

      The overall objective of this study is to determine the effect of provider type in the
      occurrence and management of serious childbirth related complications among postpartum women
      at the community level in Bungoma and Lugari Districts of Western Province, Kenya.

      The proposed study will employ a case control study design in which women with obstetric
      complication(s)will be cases and women without obstetric complications will be controls.
      Controls will be sampled concurrently with the cases. Each time a new case is diagnosed, a
      control is selected from the population at risk in the neighborhood at that point in time.

      The study population will consist of women aged 15-49 years with a delivery in the past 12
      months. A woman who reports having experienced a birth-related complication will be recruited
      as a case while woman who reports having experienced no complication during child-birth will
      be recruited as a control.
Evidence from published literature is scanty on the effect of various categories of health
      providers in averting serious child birth related complications at the community level. For
      instance, no one knows what happens to pregnancy outcomes for both the mother and the baby in
      a context where a significant proportion of women are delivered by neighbors, relatives or on
      their own. Literature is also scanty regarding the outcomes of child birth related
      complications in situations where Traditional Birth Attendants conduct a significant
      proportion of deliveries.

      A thorough understanding of factors that fuel disrespect and abuse as well as their effect on
      utilization of delivery services will help providers and programme managers to explore ways
      of addressing this issue. This study hypothesizes that since majority of deliveries take
      place at the household level, most complications and even deaths are likely to occur at this
      level.

      The overall objective of this study is to determine the effect of provider type in the
      occurrence and management of serious childbirth related complications among postpartum women
      at the community level in Bungoma and Lugari Districts of Western Province, Kenya. Specific
      objectives of the study are:

      To determine the quality of obstetric care given by community midwives and TBAs to clients
      seeking antenatal care, during delivery and post-partum care at the community level by
      assessing providers' preparedness and the range of services offered.

      To assess the nature of obstetric complications among those women who were delivered by
      skilled health providers, versus those who were delivered by TBAs, neighbors, friends or on
      their own To determine the role of socio-economic, demographic and health service related
      factors in the occurrence of child birth related complications at the community level To
      obtain views from key stakeholders on the extent and occurrence of child birth related
      complications at the community level
observational model: Case-Control
time perspective: Retrospective
measure: The odds ratio was the primary outcome measure of association between the the occurrence of complications and exposure to health providers in the past 12 months.
time frame: One Year
description: The study sought to determine the association of provider type with the occurrence and management of serious childbirth related complications among postpartum women at the community level in Kenya in the past 12 months.The odds of exposure among cases were compared to the odds of exposure among controls to estimate the magnitude of association between exposure to health providers and other caregivers and the occurrence of complications.
measure: Proportion of women receiving skilled attendance at birth in the community in the past 12 months.
time frame: One Year
description: This secondary outcome measure was assessed by collecting information on the nature of obstetric complications among those women who were delivered by skilled health providers, versus those who were delivered by Traditional Birth attendants, neighbours, friends or delivered on their own.
measure: Proportion of women with obstetric complications reporting to have been referred within 0-4 hours and 5-8 hours of admission or assessment to another level of care in the past 12 months.
time frame: One Year
description: Prompt referral of women with obstetric complications is critical to their survival.Data was captured on the proportion of pregnant women in labour or in the postpartum period who were referred within 0-4hours and 5-8hours by health care providers or other care givers at the community level to the next level of care or the nearest health facilities after assessing or examining them.
arm group label: Cases (women with complications)
description: Cases are women aged 15-49 years who delivered within 12 months prior to data collection and had experienced obstetric complication(s) that either necessitated treatment or hospitalization in order to prevent the likelihood of death of the mother.
arm group label: Control (women who did not experience any complications)
description: Controls are women aged 15-49 years who delivered within 12 months prior to data collection. They did not have or develop any of the complications which cases experienced or suffered from.Although controls did not have complications, they were individually matched on the basis of age and location. The idea was to compare how many cases were exposed versus how many controls were exposed.
This was a two-arm study (Cases and controls). Random identification of cases through
      cross-sectional survey was done. Then, a random sample of controls was drawn from the source
      population from which the cases were selected (i.e. from same study base except that they
      were not cases) through matching variables i.e. age and location. Individual matching of
      controls to the characteristics of the cases was done. A total of 585 clients (women) were
      recruited (294cases and 291 controls).
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 15 Years
maximum age: 49 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Shiphrah N. Kuria, MB ChB, MMed (OBGYN)
role: Principal Investigator
affiliation: Division of Reproductive Health- Ministry of Public Health and Sanitation
last name: Wilson N. Liambila, MSc
role: Principal Investigator
affiliation: Population Council
facility: 
country: Kenya
url: http://www.uonbi.ac.ke
description: http://www.uonbi.ac.ke/activities/KNHUoN
url: http://www.popcouncil.org
description: http://www.popcouncil.org/pdfs/2012RH_APHIAII_CommunityMidwifery.pdf
citation: Brennan M. Training traditional birth attendants reduces maternal mortality and morbidity. Trop J Obstet Gynaecol. 1988;1(1):44-7.
PMID: 12179276
citation: Koblinsky MA, Tinker A, Daly P. Programming for safe motherhood: a guide to action. Health Policy Plan. 1994 Sep;9(3):252-66. doi: 10.1093/heapol/9.3.252.
PMID: 10137741
citation: Bisika T. The effectiveness of the TBA programme in reducing maternal mortality and morbidity in Malawi. East Afr J Public Health. 2008 Aug;5(2):103-10.
PMID: 19024419
citation: Magoma M, Requejo J, Campbell OM, Cousens S, Filippi V. High ANC coverage and low skilled attendance in a rural Tanzanian district: a case for implementing a birth plan intervention. BMC Pregnancy Childbirth. 2010 Mar 19;10:13. doi: 10.1186/1471-2393-10-13.
PMID: 20302625
citation: Knol MJ, Vandenbroucke JP, Scott P, Egger M. What do case-control studies estimate? Survey of methods and assumptions in published case-control research. Am J Epidemiol. 2008 Nov 1;168(9):1073-81. doi: 10.1093/aje/kwn217. Epub 2008 Sep 15.
PMID: 18794220
citation: Mushi D, Mpembeni R, Jahn A. Effectiveness of community based Safe Motherhood promoters in improving the utilization of obstetric care. The case of Mtwara Rural District in Tanzania. BMC Pregnancy Childbirth. 2010 Apr 1;10:14. doi: 10.1186/1471-2393-10-14.
PMID: 20359341
citation: Thatte N, Mullany LC, Khatry SK, Katz J, Tielsch JM, Darmstadt GL. Traditional birth attendants in rural Nepal: knowledge, attitudes and practices about maternal and newborn health. Glob Public Health. 2009;4(6):600-17. doi: 10.1080/17441690802472406.
PMID: 19431006
citation: Kwast BE. Reduction of maternal and perinatal mortality in rural and peri-urban settings: what works? Eur J Obstet Gynecol Reprod Biol. 1996 Oct;69(1):47-53. doi: 10.1016/0301-2115(95)02535-9.
PMID: 8909956
citation: Maine D, Akalin MZ, Chakraborty J, de Francisco A, Strong M. Why did maternal mortality decline in Matlab? Stud Fam Plann. 1996 Jul-Aug;27(4):179-87.
PMID: 8875731
citation: Rodrigues L, Kirkwood BR. Case-control designs in the study of common diseases: updates on the demise of the rare disease assumption and the choice of sampling scheme for controls. Int J Epidemiol. 1990 Mar;19(1):205-13. doi: 10.1093/ije/19.1.205.
PMID: 2190942
responsible party type: Sponsor-Investigator
investigator affiliation: Kenyatta National Hospital
investigator full name: Wilson Liambila
investigator title: Senior Programme Officer
mesh term: Pre-Eclampsia
mesh term: Postpartum Hemorrhage
mesh term: Eclampsia
mesh term: Breech Presentation
mesh term: Placenta, Retained
mesh term: Dystocia
mesh term: Hemorrhage
submitted: October 3, 2014
returned: October 6, 2014
submitted: October 8, 2014
returned: October 15, 2014