<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/NCT03774667</url>
  </required_header>
  <id_info>
    <org_study_id>MCHHFoshan-1901</org_study_id>
    <nct_id>NCT03774667</nct_id>
  </id_info>
  <brief_title>Characteristics, Complications and Perinatal Outcomes in Placenta Previa Women</brief_title>
  <official_title>Characteristics, Complications and Perinatal Outcomes in Placenta Previa Women: a Prospective, Matched Case-control Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Maternal and Child Health Hospital of Foshan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Maternal and Child Health Hospital of Foshan</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aim to investigate the characteristics, complications and perinatal outcomes in&#xD;
      pregnant women with placenta previa.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Placenta previa (PP) is defined as the placenta overlying the endocervical os and grades&#xD;
      according to the relationship and the distance between the lower placental edge and the&#xD;
      internal os of the uterine cervix: low-lying previa, marginal previa, partial previa, and&#xD;
      complete previa.&#xD;
&#xD;
      Cesarean delivery and assisted reproductive technology are associated with an increased risk&#xD;
      of placenta previa in subsequent pregnancies. Other risk factors for previa include previous&#xD;
      spontaneous, elective pregnancy terminations, previous uterine surgery, increasing maternal&#xD;
      age and maternal parity, multiple gestations, smoking, cocaine use, and prior previa.&#xD;
&#xD;
      It is associated with numerous adverse maternal and fetal-neonatal complications, such as&#xD;
      perinatal hemorrhage, preterm birth, blood transfusion, hysterectomy, maternal intensive care&#xD;
      unit admission, disseminated intravascular coagulation, septicemia, thrombophlebitis, and&#xD;
      even fetal-neonatal and maternal death.&#xD;
&#xD;
      This is a 1:2 prospective, matched and hospital-based case-control study to investigate the&#xD;
      characteristics, complications and perinatal outcomes in pregnant women with placenta previa.&#xD;
      For each placenta previa women, the investigators selected two none-placenta previa pregnant&#xD;
      women as control from the same department matched on the mode of delivery, using simple&#xD;
      random selection when excess matches are available. The date of their admission is limited to&#xD;
      two days.&#xD;
&#xD;
      This hospital is a tertiary university-affiliated medical center with a stable number of&#xD;
      approximately 12,000 deliveries per year. Placenta previa is diagnosed by experienced&#xD;
      ultrasonologists based on a transabdominal ultrasonic finding of placental tissue covering&#xD;
      the internal cervical os before delivery, and further confirmed by obstetricians at delivery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Anticipated">June 30, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2021</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>6 Months</target_duration>
  <primary_outcome>
    <measure>Number of Participants with postpartum hemorrhage</measure>
    <time_frame>24 hours after delivery</time_frame>
    <description>Blood loss &gt; 1000ml during cesarean section or &gt; 500 ml during vaginal delivery</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants with antepartum hemorrhage</measure>
    <time_frame>From the time of viability of pregnancy to the delivery of the baby, assessed up to 42 weeks</time_frame>
    <description>At least one episode of bleeding from the genital tract during the antenatal period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants with preterm birth</measure>
    <time_frame>From the time of viability of pregnancy to the delivery of the baby, assessed up to 37 weeks</time_frame>
    <description>Before 37 completed gestational weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants with very preterm birth</measure>
    <time_frame>From the time of viability of pregnancy to the delivery of the baby, assessed up to 32 weeks</time_frame>
    <description>Before 32 completed gestational weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participant needed for blood transfusion</measure>
    <time_frame>72 hours after delivery</time_frame>
    <description>Calculation of the number of participant needed for blood transfusion</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of urological injury</measure>
    <time_frame>72 hours after delivery</time_frame>
    <description>Calculation of the number of participant with bladder or ureteric injury</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of needed for extra surgical maneuvers</measure>
    <time_frame>72 hours after delivery</time_frame>
    <description>internal iliac ligation or hysterectomy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of need for caesarean hysterectomy</measure>
    <time_frame>72 hours after delivery</time_frame>
    <description>Yes or no</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of needed for neonatal ICU</measure>
    <time_frame>72 hours after delivery</time_frame>
    <description>Yes or no</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of needed for maternal ICU</measure>
    <time_frame>72 hours after delivery</time_frame>
    <description>Yes or no</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">1500</enrollment>
  <condition>Placenta Previa</condition>
  <arm_group>
    <arm_group_label>Placenta Previa</arm_group_label>
    <description>Pregnant women is diagnosed with placenta previa after delivery. Placenta previa is diagnosed by experienced ultrasonologists based on a transabdominal ultrasonic finding of placental tissue covering the internal cervical os before delivery, and further confirmed by obstetricians at delivery.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>None-Placenta Previa</arm_group_label>
    <description>Pregnant women is diagnosed without placenta previa after delivery. Placenta previa is diagnosed by experienced ultrasonologists based on a transabdominal ultrasonic finding of placental tissue covering the internal cervical os before delivery, and further confirmed by obstetricians at delivery.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Pregnant women is diagnosed with placenta previa after delivery and their matched pregnant&#xD;
        women.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Single Pregnancy&#xD;
&#xD;
          -  Informed consent&#xD;
&#xD;
          -  Fetal gestational age 28 to &lt; 42 weeks&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Multiple pregnancy&#xD;
&#xD;
          -  Refuses to consent&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
  </eligibility>
  <overall_contact>
    <last_name>Zhengping Liu, MD</last_name>
    <phone>86 757 82969772</phone>
    <email>liuzphlk81@outlook.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Dazhi Fan, MD</last_name>
    <phone>86 757 82969772</phone>
    <email>fandazhigw@163.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Maternal and Child Health Hospital of Foshan</name>
      <address>
        <city>Foshan</city>
        <state>Guangdong</state>
        <zip>528000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zhengping Liu, MD</last_name>
      <phone>86 757 82969772</phone>
      <email>liuzphlk81@outlook.com</email>
    </contact>
    <contact_backup>
      <last_name>Dazhi Fan, MD</last_name>
      <phone>86 757 82969772</phone>
      <email>fandazhigw@163.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>December 5, 2018</study_first_submitted>
  <study_first_submitted_qc>December 11, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 13, 2018</study_first_posted>
  <last_update_submitted>June 7, 2021</last_update_submitted>
  <last_update_submitted_qc>June 7, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Placenta Previa</keyword>
  <keyword>Risk Factors</keyword>
  <keyword>Perinatal Complications</keyword>
  <keyword>Perinatal Outcomes</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Placenta Previa</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>Six months after completion of the study</ipd_time_frame>
  </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/NCT03774667
org study id: MCHHFoshan-1901
nct id: NCT03774667
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study aim to investigate the characteristics, complications and perinatal outcomes in
      pregnant women with placenta previa.
Placenta previa (PP) is defined as the placenta overlying the endocervical os and grades
      according to the relationship and the distance between the lower placental edge and the
      internal os of the uterine cervix: low-lying previa, marginal previa, partial previa, and
      complete previa.

      Cesarean delivery and assisted reproductive technology are associated with an increased risk
      of placenta previa in subsequent pregnancies. Other risk factors for previa include previous
      spontaneous, elective pregnancy terminations, previous uterine surgery, increasing maternal
      age and maternal parity, multiple gestations, smoking, cocaine use, and prior previa.

      It is associated with numerous adverse maternal and fetal-neonatal complications, such as
      perinatal hemorrhage, preterm birth, blood transfusion, hysterectomy, maternal intensive care
      unit admission, disseminated intravascular coagulation, septicemia, thrombophlebitis, and
      even fetal-neonatal and maternal death.

      This is a 1:2 prospective, matched and hospital-based case-control study to investigate the
      characteristics, complications and perinatal outcomes in pregnant women with placenta previa.
      For each placenta previa women, the investigators selected two none-placenta previa pregnant
      women as control from the same department matched on the mode of delivery, using simple
      random selection when excess matches are available. The date of their admission is limited to
      two days.

      This hospital is a tertiary university-affiliated medical center with a stable number of
      approximately 12,000 deliveries per year. Placenta previa is diagnosed by experienced
      ultrasonologists based on a transabdominal ultrasonic finding of placental tissue covering
      the internal cervical os before delivery, and further confirmed by obstetricians at delivery.
observational model: Case-Control
time perspective: Prospective
measure: Number of Participants with postpartum hemorrhage
time frame: 24 hours after delivery
description: Blood loss > 1000ml during cesarean section or > 500 ml during vaginal delivery
measure: Number of Participants with antepartum hemorrhage
time frame: From the time of viability of pregnancy to the delivery of the baby, assessed up to 42 weeks
description: At least one episode of bleeding from the genital tract during the antenatal period
measure: Number of Participants with preterm birth
time frame: From the time of viability of pregnancy to the delivery of the baby, assessed up to 37 weeks
description: Before 37 completed gestational weeks
measure: Number of Participants with very preterm birth
time frame: From the time of viability of pregnancy to the delivery of the baby, assessed up to 32 weeks
description: Before 32 completed gestational weeks
measure: Number of participant needed for blood transfusion
time frame: 72 hours after delivery
description: Calculation of the number of participant needed for blood transfusion
measure: Number of urological injury
time frame: 72 hours after delivery
description: Calculation of the number of participant with bladder or ureteric injury
measure: Number of needed for extra surgical maneuvers
time frame: 72 hours after delivery
description: internal iliac ligation or hysterectomy
measure: Number of need for caesarean hysterectomy
time frame: 72 hours after delivery
description: Yes or no
measure: Number of needed for neonatal ICU
time frame: 72 hours after delivery
description: Yes or no
measure: Number of needed for maternal ICU
time frame: 72 hours after delivery
description: Yes or no
arm group label: Placenta Previa
description: Pregnant women is diagnosed with placenta previa after delivery. Placenta previa is diagnosed by experienced ultrasonologists based on a transabdominal ultrasonic finding of placental tissue covering the internal cervical os before delivery, and further confirmed by obstetricians at delivery.
arm group label: None-Placenta Previa
description: Pregnant women is diagnosed without placenta previa after delivery. Placenta previa is diagnosed by experienced ultrasonologists based on a transabdominal ultrasonic finding of placental tissue covering the internal cervical os before delivery, and further confirmed by obstetricians at delivery.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 12 Years
maximum age: 60 Years
last name: Zhengping Liu, MD
phone: 86 757 82969772
email: liuzphlk81@outlook.com
last name: Dazhi Fan, MD
phone: 86 757 82969772
email: fandazhigw@163.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: China
responsible party type: Sponsor
mesh term: Placenta Previa
sharing ipd: Yes
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: Six months after completion of the study