<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/NCT03840889</url>
  </required_header>
  <id_info>
    <org_study_id>CHU-423</org_study_id>
    <nct_id>NCT03840889</nct_id>
  </id_info>
  <brief_title>Secondary Postpartum Hemorrhage</brief_title>
  <acronym>SPPH</acronym>
  <official_title>Incidence and Risk Factors for Secondary Severe Postpartum Hemorrhage in the General Population</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Clermont-Ferrand</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>CRRF La Châtaigneraie</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>CH de Moulins</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>CH de Montluçon</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Jacques Lacarin Hospital Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>CH de Thiers</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>CH d'Issoire</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>CH d'Aurillac</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>CH du Puy-en-Velay</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>CH de Saint-Flour</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>AUDIPOG</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Université d'Auvergne</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Clermont-Ferrand</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Postpartum hemorrhage (PPH) remains one of the leading causes of maternal mortality and&#xD;
      morbidity worldwide, including in France, where it accounts for approximately 20% of maternal&#xD;
      mortality. Although numerous studies have examined immediate PPH, very few have explored&#xD;
      secondary (also called late) PPH. Moreover, there are no guidelines in France for the&#xD;
      management of secondary PPH. Its frequency appears to vary from 0.2% to 3.0% of deliveries.&#xD;
      It is, however, difficult to estimate because only severe secondary PPH will lead to&#xD;
      hospitalization and the rare publications concern single-center studies. The cause of these&#xD;
      secondary hemorrhages is often unknown, due to the lack of routine uterine aspiration.&#xD;
      Nonetheless, this aspiration is not always medically justified. The principal objective of&#xD;
      this study is thus to establish the incidence of severe late PPH in the general population.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. Justification of the non-interventional nature of the study:&#xD;
&#xD;
           Severe late PPH is a rare disorder that can be difficult to diagnose. It is a source of&#xD;
           severe maternal morbidity; its management is not well defined; and the lack of knowledge&#xD;
           of its risk factors means that groups of women at risk of this disorder cannot be&#xD;
           identified. Because of the lack of scientific data, it is impossible to set up&#xD;
           monitoring appropriate to each woman's risk or to provide women who have just given&#xD;
           birth with appropriate information.&#xD;
&#xD;
           The practices studied will be those usually used in the healthcare facilities in&#xD;
           Auvergne that manage PPH. The data useful for this study will be those collected&#xD;
           routinely in medical files, but will be collected prospectively for women who are&#xD;
           hospitalized after a severe late PPH. Investigators conducted this type of data&#xD;
           collection for the Hera study (national PHRC), which covered immediate postpartum&#xD;
           hemorrhages, for which management is well codified through the national good clinical&#xD;
           practice guidelines, updated in 2014 .The section on the management of secondary&#xD;
           hemorrhages shows the sparseness of the relevant scientific data on this subject. The&#xD;
           guidelines are thus based mainly on expert opinion. Accordingly, the value of this study&#xD;
           is that it will begin to develop an evidence base for the management of this disorder.&#xD;
           The guidelines specify that &quot;the management of late PPH depends on their cause and their&#xD;
           severity [antibiotic therapy (Grade A) and uterotonic agents (professional consensus)].&#xD;
           This treatment must follow the hospital's own protocols (professional consensus). Most&#xD;
           often, women are admitted for this management (professional consensus). In the case of&#xD;
           persistence of the PPH and retention of placental fragments, aspiration-curettage under&#xD;
           ultrasound control or operative hysteroscopy is recommended (professional consensus). In&#xD;
           cases of vascular abnormalities, selective embolization is the treatment of choice&#xD;
           (professional consensus).&quot; This study will not direct professionals to use any specific&#xD;
           rules or practices for the management of these late hemorrhages, other than the national&#xD;
           guidelines cited above. Because of the great autonomy it offers for this management, it&#xD;
           probably results in substantial heterogeneity in care, which this study will observe and&#xD;
           examine. At the end of the study, investigator hope to have highlighted the most&#xD;
           relevant management practices by cause of these severe late PPH.&#xD;
&#xD;
        2. Procedure for early withdrawal from the study: the woman's refusal to participate in the&#xD;
           study.&#xD;
&#xD;
        3. Methods of recruitment:&#xD;
&#xD;
           Women with a severe late PPH will be recruited prospectively after verification of the&#xD;
           inclusion criteria by a gynecologist-obstetrician or the investigating midwives, who&#xD;
           will provide the patients information about the study and include them unless they&#xD;
           object.&#xD;
&#xD;
        4. Steps taken to reduce and avoid bias:&#xD;
&#xD;
           Because the objective is to determine the incidence of severe late/secondary PPH,&#xD;
           investigator will have several investigators at each site to be able to optimize the&#xD;
           prospective identification of women meeting the inclusion criteria. Data entry will be&#xD;
           performed by a research midwife who will have access to all of the medical data sources&#xD;
           at each site (regional computerized pregnancy and delivery records, paper medical&#xD;
           records, local computerized file for surgical, laboratory, pathology and imaging&#xD;
           reports, hospital computerized discharge summary) to limit missing data. The aim is to&#xD;
           obtain an exhaustive list of severe late PPH in the general population, to be ensured by&#xD;
           the consultation of multiple data sources. Because these data sources are generated by&#xD;
           different institutions and agencies, the selection bias associated by collection from a&#xD;
           specific population (e.g., a single center) will be avoided.&#xD;
&#xD;
        5. Collection of data for women with a severe late PPH Patient inclusion and data&#xD;
           collection will take place continuously. Every case of severe late PPH among women who&#xD;
           give birth in the region of Auvergne will be included.&#xD;
&#xD;
           The women will be informed about the planned study and procedures by posters in the&#xD;
           maternity units (lounges and waiting rooms, the web site of the Auvergne perinatal&#xD;
           network) and by an information sheet.&#xD;
&#xD;
           At the time the case is identified, several data items will be collected immediately by&#xD;
           one of the local investigators (data about the late PPH episode); the other data, as&#xD;
           well as those concerning antenatal care during pregnancy will be collected by the&#xD;
           research midwife from the regional computerized records and other portions of the&#xD;
           woman's file, in each institution (laboratory, pathology, and surgery reports).&#xD;
&#xD;
           * Passive data collection: It will be based on the spontaneous reporting of cases by the&#xD;
           correspondents in each maternity unit. These lists of cases, on a specific form, will be&#xD;
           reported to the principal investigator monthly.&#xD;
&#xD;
           *Active data collection: A research midwife will complete the files already underway.&#xD;
           The investigator will visit the site to consult the woman's paper or computerized&#xD;
           records and complete the information then missing from the study file. Auvergne has a&#xD;
           regional computerized perinatal database. These site visits will be planned by the&#xD;
           investigator, who will telephone the local correspondent to make an appointment and&#xD;
           request from him or her a list of files to be made available.&#xD;
&#xD;
           The frequency of site visits will vary according to the number of patients reported by&#xD;
           each site.&#xD;
&#xD;
           The different modes of active data collection:&#xD;
&#xD;
             -  Data collection by telephone Will cover only the minimum data necessary to open the&#xD;
                file or the small quantities of missing data.&#xD;
&#xD;
             -  Data collection by mail The physician serving as the study director will contact&#xD;
                the study correspondents, if necessary, once a quarter to review the number of&#xD;
                women with late PPH at each facility. Investigators will check the data for each&#xD;
                case and open new files when applicable.&#xD;
&#xD;
             -  Collection from discharge database summaries (PMSI) Each year, the physician&#xD;
                serving as the study director will ask the Medical Information Department of each&#xD;
                healthcare facility to furnish a list of all women who were rehospitalized in the&#xD;
                42 days after giving birth or who had a surgical, or medical or interventional&#xD;
                radiology procedure during their postpartum stay. All of these records will be&#xD;
                studied manually by the investigator to check for cases of severe late PPH that&#xD;
                were not previously reported (quality control for case ascertainment).&#xD;
&#xD;
        6. Procedures to validate the cases of late PPH All reports of eligible women (that is, who&#xD;
           had a severe late PPH) will be checked at arrival by the investigator, who will verify&#xD;
           if this is the woman's first inclusion in the study. The investigator will verify the&#xD;
           woman's identity and date of birth during site visits, to avoid duplicate inclusions.&#xD;
&#xD;
           If it is a first inclusion, the investigator will validate the inclusion criteria before&#xD;
           submitting the file to one of the study directors, who will validate the etiological&#xD;
           diagnosis.&#xD;
&#xD;
           The investigator will verify the quality of the data collection and file completion: in&#xD;
           the case of missing data, he or she will take the steps required to have the data&#xD;
           completed at the reporting department.&#xD;
&#xD;
           The investigator will code the administrative items and drugs by using specific&#xD;
           thesauruses. The investigator will also enter the data for each record after coding,&#xD;
           using RedCap® software, available at the Clermont-Ferrand UHC.&#xD;
&#xD;
           A local index for each center, including the file number, if a file was opened, or&#xD;
           information about its status if it was not opened, the woman's first and last name, and&#xD;
           the reporting source will be maintained and kept up-to-date by the local investigator&#xD;
           for each late PPH diagnosis included.&#xD;
&#xD;
        7. Data analysis methods The α risk (of a type I error) will be set at 5%. The statistical&#xD;
           tests will be bilateral.&#xD;
&#xD;
           A descriptive analysis of the entire dataset will be performed. The incidence of severe&#xD;
           late PPH will be calculated with its 95% confidence interval.&#xD;
&#xD;
           A Cox model (with severe late PPH the variable to be explained) will be used to adjust&#xD;
           for the confounding factors or the clinically relevant prognostic factors for the onset&#xD;
           of severe late PPH. The point of origin will be the delivery. The model will make it&#xD;
           possible to calculate adjusted hazard ratios.&#xD;
&#xD;
        8. Patient information Patients will receive complete and fair information, expressed in&#xD;
           understandable terms, about the study objectives, the nature of the information&#xD;
           collected, and their right to object to at any point to the use of their data. The&#xD;
           investigator must also inform the patients of the Ethics Committee decision. Women will&#xD;
           be asked whether or not they object to participating in the study before their data are&#xD;
           collected.&#xD;
&#xD;
      All of this information will be included on an information sheet given to the woman to keep.&#xD;
      Her non-opposition will be collected and documented by the investigator.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">March 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</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of severe secondary PPH in the general population</measure>
    <time_frame>between Day 1 and Day 42</time_frame>
    <description>Severe secondary PPH is defined as a genital hemorrhage between Day 1 and Day 42 (6 weeks) after childbirth and requiring hospitalization</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Identification of the risk factors for severe late PPH.</measure>
    <time_frame>at day 1</time_frame>
    <description>The secondary outcome criteria will be to identify the medical risk factors for severe late PPH.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Identification of the management protocols most appropriate for women determined to be at risk of severe late PPH</measure>
    <time_frame>at day 1</time_frame>
    <description>Collection from the medical files of the procedures used for PPH management of the women included (medical, surgical, radiological, etc.).</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Postpartum Hemorrhage</condition>
  <condition>Maternal Morbidity</condition>
  <condition>Retained Placenta</condition>
  <condition>Postpartum Endometritis</condition>
  <condition>Delivery</condition>
  <arm_group>
    <arm_group_label>Women with a severe late PPH</arm_group_label>
    <description>Women with a severe late PPH will be recruited prospectively after verification of the inclusion criteria by a gynecologist-obstetrician or the investigating midwives, who will provide the patients information about the study and include them unless they object</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Data collection</intervention_name>
    <description>he different modes of active data collection:&#xD;
Data collection by telephone&#xD;
Data collection by mail&#xD;
Collection from discharge database summaries (PMSI)</description>
    <arm_group_label>Women with a severe late PPH</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All women presenting a severe secondary postpartum hemorrhage&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All women presenting a severe secondary postpartum hemorrhage, defined as a genital&#xD;
             hemorrhage (intra-abdominal or exteriorized vaginally) between 24 hours and 42 days (6&#xD;
             weeks) after childbirth and requiring either rehospitalization or a medical or&#xD;
             interventional procedure during the postpartum hospitalization (medication, vascular&#xD;
             embolization, and/or surgical procedures). Women with several episodes of severe&#xD;
             secondary postpartum hemorrhage during the 42 days postpartum will be included only&#xD;
             once.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  - All women with an immediate PPH, defined as a hemorrhage in the 24 hours after&#xD;
             delivery, unassociated with a secondary PPH.&#xD;
&#xD;
          -  All women who did not give birth in Auvergne.&#xD;
&#xD;
          -  All women who returned home after delivery without any medical or interventional&#xD;
             procedure during the postpartum hospitalization, with a hemorrhage in the 42 days&#xD;
             after delivery, but not rehospitalized, regardless of whether they sought care in an&#xD;
             emergency department.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Françoise VENDITELLI</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Clermont-Ferrand</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Lise LACLAUTRE</last_name>
    <phone>04 73 75 49 63</phone>
    <email>drci@chu-clermontferrand.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Ch Aurillac</name>
      <address>
        <city>Aurillac</city>
        <country>France</country>
      </address>
    </facility>
    <investigator>
      <last_name>Marianne JULIEN</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Marie-Laurence CHABANON</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Clinique La Chataigneraie</name>
      <address>
        <city>Beaumont</city>
        <country>France</country>
      </address>
    </facility>
    <investigator>
      <last_name>Marie-Agnès MESIOUX</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Isabelle VAZ</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Chu Clermont-Ferrand</name>
      <address>
        <city>Clermont-Ferrand</city>
        <zip>63003</zip>
        <country>France</country>
      </address>
    </facility>
    <contact>
      <last_name>Lise LACLAUTRE</last_name>
      <phone>04 73 75 49 63</phone>
      <email>drci@chu-clermontferrand.fr</email>
    </contact>
    <investigator>
      <last_name>Françoise VENDITELLI</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Chloé BARASINSKI</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Sandra CURINIER</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Bernadette BOUTET</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Julien PRANAL</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jean-Christophe JOURDY</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Ch Issoire</name>
      <address>
        <city>Issoire</city>
        <country>France</country>
      </address>
    </facility>
    <investigator>
      <last_name>Carole BODA</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Françoise HEGAY</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CH PUY</name>
      <address>
        <city>Le Puy-en-Velay</city>
        <country>France</country>
      </address>
    </facility>
    <investigator>
      <last_name>Claire BONNEFOY</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Virginie ROUMEAU</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jonanna BONIAKOWSKI</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Sylvie ALU</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Ch Montlucon</name>
      <address>
        <city>Montluçon</city>
        <country>France</country>
      </address>
    </facility>
    <investigator>
      <last_name>Julie EPHREM-DURON</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Béatrice GAUTHIER</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Ch Moulins</name>
      <address>
        <city>Moulins</city>
        <country>France</country>
      </address>
    </facility>
    <investigator>
      <last_name>Jean-Baptiste MEEÜS</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Marilyn THEUWS</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CH Saint-Flour</name>
      <address>
        <city>Saint-Flour</city>
        <country>France</country>
      </address>
    </facility>
    <investigator>
      <last_name>Vladimir VLADIMIROV</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Mireille Bonnie DELEPINE</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Ch Thiers</name>
      <address>
        <city>Thiers</city>
        <country>France</country>
      </address>
    </facility>
    <investigator>
      <last_name>Erdogan NOHUZ</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Claire PAGANELLI</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CH VICHY</name>
      <address>
        <city>Vichy</city>
        <country>France</country>
      </address>
    </facility>
    <investigator>
      <last_name>Catherine LAMOINE</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Marion CHAPOULY</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <reference>
    <citation>Dewhurst CJ. Secondary post-partum haemorrhage. J Obstet Gynaecol Br Commonw. 1966 Feb;73(1):53-8. doi: 10.1111/j.1471-0528.1966.tb05120.x. No abstract available.</citation>
    <PMID>5295509</PMID>
  </reference>
  <reference>
    <citation>King PA, Duthie SJ, Dong ZG, Ma HK. Secondary postpartum haemorrhage. Aust N Z J Obstet Gynaecol. 1989 Nov;29(4):394-8. doi: 10.1111/j.1479-828x.1989.tb01776.x.</citation>
    <PMID>2631675</PMID>
  </reference>
  <reference>
    <citation>Hoveyda F, MacKenzie IZ. Secondary postpartum haemorrhage: incidence, morbidity and current management. BJOG. 2001 Sep;108(9):927-30. doi: 10.1111/j.1471-0528.2001.00230.x.</citation>
    <PMID>11563461</PMID>
  </reference>
  <reference>
    <citation>Dossou M, Debost-Legrand A, Dechelotte P, Lemery D, Vendittelli F. Severe secondary postpartum hemorrhage: a historical cohort. Birth. 2015 Jun;42(2):149-55. doi: 10.1111/birt.12164. Epub 2015 Apr 13.</citation>
    <PMID>25867033</PMID>
  </reference>
  <reference>
    <citation>Vendittelli F, Dossou M, Debost-Legrand A, Dechelotte P, Lemery D. Reply. Birth. 2016 Jun;43(2):185-6. doi: 10.1111/birt.12224. No abstract available.</citation>
    <PMID>27160377</PMID>
  </reference>
  <reference>
    <citation>Vendittelli F, Savary D, Storme B, Rieu V, Chabrot P, Charpy C, Lemery D, Jacquetin B. Ovarian thrombosis and uterine synechiae after arterial embolization for a late postpartum haemorrhage. Case Rep Womens Health. 2014 Nov 22;5:1-4. doi: 10.1016/j.crwh.2014.10.001. eCollection 2015 Jan.</citation>
    <PMID>29594009</PMID>
  </reference>
  <reference>
    <citation>Debost-Legrand A, Riviere O, Dossou M, Vendittelli F. Risk Factors for Severe Secondary Postpartum Hemorrhages: A Historical Cohort Study. Birth. 2015 Sep;42(3):235-41. doi: 10.1111/birt.12175. Epub 2015 May 29.</citation>
    <PMID>26032774</PMID>
  </reference>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>January 31, 2019</study_first_submitted>
  <study_first_submitted_qc>February 12, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <last_update_submitted>February 12, 2019</last_update_submitted>
  <last_update_submitted_qc>February 12, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Prospective cohort</keyword>
  <keyword>Population-based study</keyword>
  <keyword>Multicenter study</keyword>
  <keyword>Maternity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Postpartum Hemorrhage</mesh_term>
    <mesh_term>Endometritis</mesh_term>
    <mesh_term>Placenta, Retained</mesh_term>
    <mesh_term>Hemorrhage</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/NCT03840889
org study id: CHU-423
nct id: NCT03840889
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is fda regulated drug: No
is fda regulated device: No
Postpartum hemorrhage (PPH) remains one of the leading causes of maternal mortality and
      morbidity worldwide, including in France, where it accounts for approximately 20% of maternal
      mortality. Although numerous studies have examined immediate PPH, very few have explored
      secondary (also called late) PPH. Moreover, there are no guidelines in France for the
      management of secondary PPH. Its frequency appears to vary from 0.2% to 3.0% of deliveries.
      It is, however, difficult to estimate because only severe secondary PPH will lead to
      hospitalization and the rare publications concern single-center studies. The cause of these
      secondary hemorrhages is often unknown, due to the lack of routine uterine aspiration.
      Nonetheless, this aspiration is not always medically justified. The principal objective of
      this study is thus to establish the incidence of severe late PPH in the general population.
1. Justification of the non-interventional nature of the study:

           Severe late PPH is a rare disorder that can be difficult to diagnose. It is a source of
           severe maternal morbidity; its management is not well defined; and the lack of knowledge
           of its risk factors means that groups of women at risk of this disorder cannot be
           identified. Because of the lack of scientific data, it is impossible to set up
           monitoring appropriate to each woman's risk or to provide women who have just given
           birth with appropriate information.

           The practices studied will be those usually used in the healthcare facilities in
           Auvergne that manage PPH. The data useful for this study will be those collected
           routinely in medical files, but will be collected prospectively for women who are
           hospitalized after a severe late PPH. Investigators conducted this type of data
           collection for the Hera study (national PHRC), which covered immediate postpartum
           hemorrhages, for which management is well codified through the national good clinical
           practice guidelines, updated in 2014 .The section on the management of secondary
           hemorrhages shows the sparseness of the relevant scientific data on this subject. The
           guidelines are thus based mainly on expert opinion. Accordingly, the value of this study
           is that it will begin to develop an evidence base for the management of this disorder.
           The guidelines specify that "the management of late PPH depends on their cause and their
           severity [antibiotic therapy (Grade A) and uterotonic agents (professional consensus)].
           This treatment must follow the hospital's own protocols (professional consensus). Most
           often, women are admitted for this management (professional consensus). In the case of
           persistence of the PPH and retention of placental fragments, aspiration-curettage under
           ultrasound control or operative hysteroscopy is recommended (professional consensus). In
           cases of vascular abnormalities, selective embolization is the treatment of choice
           (professional consensus)." This study will not direct professionals to use any specific
           rules or practices for the management of these late hemorrhages, other than the national
           guidelines cited above. Because of the great autonomy it offers for this management, it
           probably results in substantial heterogeneity in care, which this study will observe and
           examine. At the end of the study, investigator hope to have highlighted the most
           relevant management practices by cause of these severe late PPH.

        2. Procedure for early withdrawal from the study: the woman's refusal to participate in the
           study.

        3. Methods of recruitment:

           Women with a severe late PPH will be recruited prospectively after verification of the
           inclusion criteria by a gynecologist-obstetrician or the investigating midwives, who
           will provide the patients information about the study and include them unless they
           object.

        4. Steps taken to reduce and avoid bias:

           Because the objective is to determine the incidence of severe late/secondary PPH,
           investigator will have several investigators at each site to be able to optimize the
           prospective identification of women meeting the inclusion criteria. Data entry will be
           performed by a research midwife who will have access to all of the medical data sources
           at each site (regional computerized pregnancy and delivery records, paper medical
           records, local computerized file for surgical, laboratory, pathology and imaging
           reports, hospital computerized discharge summary) to limit missing data. The aim is to
           obtain an exhaustive list of severe late PPH in the general population, to be ensured by
           the consultation of multiple data sources. Because these data sources are generated by
           different institutions and agencies, the selection bias associated by collection from a
           specific population (e.g., a single center) will be avoided.

        5. Collection of data for women with a severe late PPH Patient inclusion and data
           collection will take place continuously. Every case of severe late PPH among women who
           give birth in the region of Auvergne will be included.

           The women will be informed about the planned study and procedures by posters in the
           maternity units (lounges and waiting rooms, the web site of the Auvergne perinatal
           network) and by an information sheet.

           At the time the case is identified, several data items will be collected immediately by
           one of the local investigators (data about the late PPH episode); the other data, as
           well as those concerning antenatal care during pregnancy will be collected by the
           research midwife from the regional computerized records and other portions of the
           woman's file, in each institution (laboratory, pathology, and surgery reports).

           * Passive data collection: It will be based on the spontaneous reporting of cases by the
           correspondents in each maternity unit. These lists of cases, on a specific form, will be
           reported to the principal investigator monthly.

           *Active data collection: A research midwife will complete the files already underway.
           The investigator will visit the site to consult the woman's paper or computerized
           records and complete the information then missing from the study file. Auvergne has a
           regional computerized perinatal database. These site visits will be planned by the
           investigator, who will telephone the local correspondent to make an appointment and
           request from him or her a list of files to be made available.

           The frequency of site visits will vary according to the number of patients reported by
           each site.

           The different modes of active data collection:

             -  Data collection by telephone Will cover only the minimum data necessary to open the
                file or the small quantities of missing data.

             -  Data collection by mail The physician serving as the study director will contact
                the study correspondents, if necessary, once a quarter to review the number of
                women with late PPH at each facility. Investigators will check the data for each
                case and open new files when applicable.

             -  Collection from discharge database summaries (PMSI) Each year, the physician
                serving as the study director will ask the Medical Information Department of each
                healthcare facility to furnish a list of all women who were rehospitalized in the
                42 days after giving birth or who had a surgical, or medical or interventional
                radiology procedure during their postpartum stay. All of these records will be
                studied manually by the investigator to check for cases of severe late PPH that
                were not previously reported (quality control for case ascertainment).

        6. Procedures to validate the cases of late PPH All reports of eligible women (that is, who
           had a severe late PPH) will be checked at arrival by the investigator, who will verify
           if this is the woman's first inclusion in the study. The investigator will verify the
           woman's identity and date of birth during site visits, to avoid duplicate inclusions.

           If it is a first inclusion, the investigator will validate the inclusion criteria before
           submitting the file to one of the study directors, who will validate the etiological
           diagnosis.

           The investigator will verify the quality of the data collection and file completion: in
           the case of missing data, he or she will take the steps required to have the data
           completed at the reporting department.

           The investigator will code the administrative items and drugs by using specific
           thesauruses. The investigator will also enter the data for each record after coding,
           using RedCap® software, available at the Clermont-Ferrand UHC.

           A local index for each center, including the file number, if a file was opened, or
           information about its status if it was not opened, the woman's first and last name, and
           the reporting source will be maintained and kept up-to-date by the local investigator
           for each late PPH diagnosis included.

        7. Data analysis methods The α risk (of a type I error) will be set at 5%. The statistical
           tests will be bilateral.

           A descriptive analysis of the entire dataset will be performed. The incidence of severe
           late PPH will be calculated with its 95% confidence interval.

           A Cox model (with severe late PPH the variable to be explained) will be used to adjust
           for the confounding factors or the clinically relevant prognostic factors for the onset
           of severe late PPH. The point of origin will be the delivery. The model will make it
           possible to calculate adjusted hazard ratios.

        8. Patient information Patients will receive complete and fair information, expressed in
           understandable terms, about the study objectives, the nature of the information
           collected, and their right to object to at any point to the use of their data. The
           investigator must also inform the patients of the Ethics Committee decision. Women will
           be asked whether or not they object to participating in the study before their data are
           collected.

      All of this information will be included on an information sheet given to the woman to keep.
      Her non-opposition will be collected and documented by the investigator.
observational model: Cohort
time perspective: Prospective
measure: Incidence of severe secondary PPH in the general population
time frame: between Day 1 and Day 42
description: Severe secondary PPH is defined as a genital hemorrhage between Day 1 and Day 42 (6 weeks) after childbirth and requiring hospitalization
measure: Identification of the risk factors for severe late PPH.
time frame: at day 1
description: The secondary outcome criteria will be to identify the medical risk factors for severe late PPH.
measure: Identification of the management protocols most appropriate for women determined to be at risk of severe late PPH
time frame: at day 1
description: Collection from the medical files of the procedures used for PPH management of the women included (medical, surgical, radiological, etc.).
arm group label: Women with a severe late PPH
description: Women with a severe late PPH will be recruited prospectively after verification of the inclusion criteria by a gynecologist-obstetrician or the investigating midwives, who will provide the patients information about the study and include them unless they object
intervention type: Other
intervention name: Data collection
description: he different modes of active data collection:
Data collection by telephone
Data collection by mail
Collection from discharge database summaries (PMSI)
arm group label: Women with a severe late PPH
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 12 Years
maximum age: 55 Years
healthy volunteers: No
last name: Françoise VENDITELLI
role: Principal Investigator
affiliation: University Hospital, Clermont-Ferrand
last name: Lise LACLAUTRE
phone: 04 73 75 49 63
email: drci@chu-clermontferrand.fr
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country: France
citation: Dewhurst CJ. Secondary post-partum haemorrhage. J Obstet Gynaecol Br Commonw. 1966 Feb;73(1):53-8. doi: 10.1111/j.1471-0528.1966.tb05120.x. No abstract available.
PMID: 5295509
citation: King PA, Duthie SJ, Dong ZG, Ma HK. Secondary postpartum haemorrhage. Aust N Z J Obstet Gynaecol. 1989 Nov;29(4):394-8. doi: 10.1111/j.1479-828x.1989.tb01776.x.
PMID: 2631675
citation: Hoveyda F, MacKenzie IZ. Secondary postpartum haemorrhage: incidence, morbidity and current management. BJOG. 2001 Sep;108(9):927-30. doi: 10.1111/j.1471-0528.2001.00230.x.
PMID: 11563461
citation: Dossou M, Debost-Legrand A, Dechelotte P, Lemery D, Vendittelli F. Severe secondary postpartum hemorrhage: a historical cohort. Birth. 2015 Jun;42(2):149-55. doi: 10.1111/birt.12164. Epub 2015 Apr 13.
PMID: 25867033
citation: Vendittelli F, Dossou M, Debost-Legrand A, Dechelotte P, Lemery D. Reply. Birth. 2016 Jun;43(2):185-6. doi: 10.1111/birt.12224. No abstract available.
PMID: 27160377
citation: Vendittelli F, Savary D, Storme B, Rieu V, Chabrot P, Charpy C, Lemery D, Jacquetin B. Ovarian thrombosis and uterine synechiae after arterial embolization for a late postpartum haemorrhage. Case Rep Womens Health. 2014 Nov 22;5:1-4. doi: 10.1016/j.crwh.2014.10.001. eCollection 2015 Jan.
PMID: 29594009
citation: Debost-Legrand A, Riviere O, Dossou M, Vendittelli F. Risk Factors for Severe Secondary Postpartum Hemorrhages: A Historical Cohort Study. Birth. 2015 Sep;42(3):235-41. doi: 10.1111/birt.12175. Epub 2015 May 29.
PMID: 26032774
responsible party type: Sponsor
mesh term: Postpartum Hemorrhage
mesh term: Endometritis
mesh term: Placenta, Retained
mesh term: Hemorrhage