<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/NCT04451109</url>
  </required_header>
  <id_info>
    <org_study_id>Dilapan-S US E-registry</org_study_id>
    <nct_id>NCT04451109</nct_id>
  </id_info>
  <brief_title>Dilapan-S®: A Multicenter US E-registry</brief_title>
  <official_title>Dilapan-S®: A Multicenter US E-registry</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medicem Technology s.r.o.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The University of Texas Medical Branch, Galveston</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Medicem Technology s.r.o.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Objective of this registry is to collect a representative set of real world data on the use&#xD;
      of Dilapan-S® for pre-induction cervical ripening in daily clinical practice. Upon completion&#xD;
      of the registry, relevant collected data will be analyzed and published.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In the US, 23% of pregnant women undergo labor induction. A recent randomized controlled&#xD;
      trial showed that elective labor induction at term in low-risk nulliparous women is&#xD;
      associated with a lower risk of cesarean delivery and preeclampsia, with no increase in&#xD;
      adverse perinatal morbidities. Hence, one can assume that labor induction rates will&#xD;
      increase. The majority of women undergoing induction have unfavorable cervixes and require&#xD;
      cervical ripening agents. Dilapan-S®, a hygroscopic cervical dilator made from a patented&#xD;
      hydrogel (AQUACRYL), has been used in the past for cervical ripening for early gestation&#xD;
      uterine evacuation. Dilapan-S® was approved by the FDA for cervical ripening in the third&#xD;
      trimester in 2015.&#xD;
&#xD;
      The Dilapan-S® rods are inserted into the cervical canal, are contained within the vagina,&#xD;
      and do not require tension. Dilapan-S® works by absorbing fluid from cervical canal cells,&#xD;
      resulting in reversible cell membrane dehydration and softening. In addition, the increase in&#xD;
      the rod's volume creates a mechanical stretch and leads to the release of endogenous&#xD;
      prostaglandins, causing cervical ripening. Recently, a multicenter prospective cohort study&#xD;
      showed that Dilapan-S® is a safe and effective method for cervical ripening in term&#xD;
      gestations. Lastly, our group performed non-inferiority randomized clinical trial comparing&#xD;
      Dilapan-S® to Foley balloon for cervical ripening in term pregnancies and found that&#xD;
      Dilapan-S® is non-inferior to Foley balloon for pre-induction cervical ripening at term.&#xD;
&#xD;
      The Dilapan-S® rods are inserted into the cervical canal, are contained within the vagina,&#xD;
      and do not require tension. Dilapan-S® works by absorbing fluid from cervical canal cells,&#xD;
      resulting in reversible cell membrane dehydration and softening. In addition, the increase in&#xD;
      the rod's volume creates a mechanical stretch and leads to the release of endogenous&#xD;
      prostaglandins, causing cervical ripening. Advantages of Dilapan-S® over Foley include FDA&#xD;
      approval, safe profile, no protrusion from the introitus, no need to keep under tension and&#xD;
      better patient satisfaction.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Enrolling by invitation</overall_status>
  <start_date type="Actual">December 1, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2024</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of overall vaginal delivery</measure>
    <time_frame>right after child delivery</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of vaginal delivery within 24 hours</measure>
    <time_frame>24 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of vaginal delivery within 36 hours</measure>
    <time_frame>36 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to reach active stage of labor defined as ≥6 cm</measure>
    <time_frame>48 hours</time_frame>
    <description>minutes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Bishop score</measure>
    <time_frame>48 hours</time_frame>
    <description>scale 0-13 (positive gain in Bishop score is considered to be a positive consequence of the intervention)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of spontaneous vaginal delivery</measure>
    <time_frame>right after child delivery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of operative vaginal delivery</measure>
    <time_frame>right after child delivery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of caesarean sections</measure>
    <time_frame>right after child delivery</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">1200</enrollment>
  <condition>Post Term Pregnancy</condition>
  <condition>Premature Rupture of Membrane</condition>
  <condition>Fetal Growth Retardation</condition>
  <condition>Oligohydramnios</condition>
  <condition>Gestational Diabetes</condition>
  <condition>High Blood Pressure in Pregnancy</condition>
  <arm_group>
    <arm_group_label>Cases in which Dilapan-S was used for cervical ripening.</arm_group_label>
    <description>Every participating site will select 50 cases of pregnant women who underwent cervical ripening by Dilapan-S prior to induction of labor. These cases has to fulfill inclusion/exclusion criteria defined in the protocol.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Dilapan-S</intervention_name>
    <description>Application of Dilapan-S and all other procedures regarding cervical ripening and induction of labor will be carried out as per the hospital's standard practice.</description>
    <arm_group_label>Cases in which Dilapan-S was used for cervical ripening.</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Selected patients fulfilling eligibility criteria.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pregnant woman whose plan of care is induction of labor&#xD;
&#xD;
          -  Maternal age ≥ 18 years&#xD;
&#xD;
          -  Gestational age ≥ 37 +0/7 weeks&#xD;
&#xD;
          -  Dilapan-S® used for cervical ripening&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Data not available for extraction&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Antonio Saad, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The University of Texas Medical Branch, Galveston</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The University of Texas Medical Branch</name>
      <address>
        <city>Galveston</city>
        <state>Texas</state>
        <zip>77555</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Martin JA, Hamilton BE, Osterman MJ, Driscoll AK, Mathews TJ. Births: Final Data for 2015. Natl Vital Stat Rep. 2017 Jan;66(1):1.</citation>
    <PMID>28135188</PMID>
  </reference>
  <reference>
    <citation>Grobman WA, Rice MM, Reddy UM, Tita ATN, Silver RM, Mallett G, Hill K, Thom EA, El-Sayed YY, Perez-Delboy A, Rouse DJ, Saade GR, Boggess KA, Chauhan SP, Iams JD, Chien EK, Casey BM, Gibbs RS, Srinivas SK, Swamy GK, Simhan HN, Macones GA; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Labor Induction versus Expectant Management in Low-Risk Nulliparous Women. N Engl J Med. 2018 Aug 9;379(6):513-523. doi: 10.1056/NEJMoa1800566.</citation>
    <PMID>30089070</PMID>
  </reference>
  <reference>
    <citation>Rayburn WF. Preinduction cervical ripening: basis and methods of current practice. Obstet Gynecol Surv. 2002 Oct;57(10):683-92. doi: 10.1097/00006254-200210000-00022.</citation>
    <PMID>12368596</PMID>
  </reference>
  <reference>
    <citation>Gupta J, Chodankar R, Baev O, Bahlmann F, Brega E, Gala A, Hellmeyer L, Hruban L, Maier J, Mehta P, Murthy A, Ritter M, Saad A, Shmakov R, Suneja A, Zahumensky J, Gdovinova D. Synthetic osmotic dilators in the induction of labour-An international multicentre observational study. Eur J Obstet Gynecol Reprod Biol. 2018 Oct;229:70-75. doi: 10.1016/j.ejogrb.2018.08.004. Epub 2018 Aug 3.</citation>
    <PMID>30107363</PMID>
  </reference>
  <reference>
    <citation>Saad AF, Villarreal J, Eid J, Spencer N, Ellis V, Hankins GD, Saade GR. A randomized controlled trial of Dilapan-S vs Foley balloon for preinduction cervical ripening (DILAFOL trial). Am J Obstet Gynecol. 2019 Mar;220(3):275.e1-275.e9. doi: 10.1016/j.ajog.2019.01.008. Epub 2019 Feb 18.</citation>
    <PMID>30790569</PMID>
  </reference>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>June 17, 2020</study_first_submitted>
  <study_first_submitted_qc>June 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 30, 2020</study_first_posted>
  <last_update_submitted>November 22, 2022</last_update_submitted>
  <last_update_submitted_qc>November 22, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 23, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>induction of labour</keyword>
  <keyword>induction of labor</keyword>
  <keyword>labour induction</keyword>
  <keyword>labor induction</keyword>
  <keyword>Dilapan</keyword>
  <keyword>dilator</keyword>
  <keyword>cervical ripening</keyword>
  <keyword>cervical priming</keyword>
  <keyword>preinduction</keyword>
  <keyword>pre-induction</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes, Gestational</mesh_term>
    <mesh_term>Fetal Membranes, Premature Rupture</mesh_term>
    <mesh_term>Fetal Growth Retardation</mesh_term>
    <mesh_term>Oligohydramnios</mesh_term>
    <mesh_term>Pregnancy, Prolonged</mesh_term>
    <mesh_term>Hypertension</mesh_term>
    <mesh_term>Rupture</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04451109
org study id: Dilapan-S US E-registry
nct id: NCT04451109
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
Objective of this registry is to collect a representative set of real world data on the use
      of Dilapan-S® for pre-induction cervical ripening in daily clinical practice. Upon completion
      of the registry, relevant collected data will be analyzed and published.
In the US, 23% of pregnant women undergo labor induction. A recent randomized controlled
      trial showed that elective labor induction at term in low-risk nulliparous women is
      associated with a lower risk of cesarean delivery and preeclampsia, with no increase in
      adverse perinatal morbidities. Hence, one can assume that labor induction rates will
      increase. The majority of women undergoing induction have unfavorable cervixes and require
      cervical ripening agents. Dilapan-S®, a hygroscopic cervical dilator made from a patented
      hydrogel (AQUACRYL), has been used in the past for cervical ripening for early gestation
      uterine evacuation. Dilapan-S® was approved by the FDA for cervical ripening in the third
      trimester in 2015.

      The Dilapan-S® rods are inserted into the cervical canal, are contained within the vagina,
      and do not require tension. Dilapan-S® works by absorbing fluid from cervical canal cells,
      resulting in reversible cell membrane dehydration and softening. In addition, the increase in
      the rod's volume creates a mechanical stretch and leads to the release of endogenous
      prostaglandins, causing cervical ripening. Recently, a multicenter prospective cohort study
      showed that Dilapan-S® is a safe and effective method for cervical ripening in term
      gestations. Lastly, our group performed non-inferiority randomized clinical trial comparing
      Dilapan-S® to Foley balloon for cervical ripening in term pregnancies and found that
      Dilapan-S® is non-inferior to Foley balloon for pre-induction cervical ripening at term.

      The Dilapan-S® rods are inserted into the cervical canal, are contained within the vagina,
      and do not require tension. Dilapan-S® works by absorbing fluid from cervical canal cells,
      resulting in reversible cell membrane dehydration and softening. In addition, the increase in
      the rod's volume creates a mechanical stretch and leads to the release of endogenous
      prostaglandins, causing cervical ripening. Advantages of Dilapan-S® over Foley include FDA
      approval, safe profile, no protrusion from the introitus, no need to keep under tension and
      better patient satisfaction.
observational model: Case-Only
time perspective: Retrospective
measure: Rate of overall vaginal delivery
time frame: right after child delivery
measure: Rate of vaginal delivery within 24 hours
time frame: 24 hours
measure: Rate of vaginal delivery within 36 hours
time frame: 36 hours
measure: Time to reach active stage of labor defined as ≥6 cm
time frame: 48 hours
description: minutes
measure: Change in Bishop score
time frame: 48 hours
description: scale 0-13 (positive gain in Bishop score is considered to be a positive consequence of the intervention)
measure: Rate of spontaneous vaginal delivery
time frame: right after child delivery
measure: Rate of operative vaginal delivery
time frame: right after child delivery
measure: Rate of caesarean sections
time frame: right after child delivery
arm group label: Cases in which Dilapan-S was used for cervical ripening.
description: Every participating site will select 50 cases of pregnant women who underwent cervical ripening by Dilapan-S prior to induction of labor. These cases has to fulfill inclusion/exclusion criteria defined in the protocol.
intervention type: Device
intervention name: Dilapan-S
description: Application of Dilapan-S and all other procedures regarding cervical ripening and induction of labor will be carried out as per the hospital's standard practice.
arm group label: Cases in which Dilapan-S was used for cervical ripening.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Antonio Saad, MD
role: Principal Investigator
affiliation: The University of Texas Medical Branch, Galveston
facility: 
country: United States
citation: Martin JA, Hamilton BE, Osterman MJ, Driscoll AK, Mathews TJ. Births: Final Data for 2015. Natl Vital Stat Rep. 2017 Jan;66(1):1.
PMID: 28135188
citation: Grobman WA, Rice MM, Reddy UM, Tita ATN, Silver RM, Mallett G, Hill K, Thom EA, El-Sayed YY, Perez-Delboy A, Rouse DJ, Saade GR, Boggess KA, Chauhan SP, Iams JD, Chien EK, Casey BM, Gibbs RS, Srinivas SK, Swamy GK, Simhan HN, Macones GA; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Labor Induction versus Expectant Management in Low-Risk Nulliparous Women. N Engl J Med. 2018 Aug 9;379(6):513-523. doi: 10.1056/NEJMoa1800566.
PMID: 30089070
citation: Rayburn WF. Preinduction cervical ripening: basis and methods of current practice. Obstet Gynecol Surv. 2002 Oct;57(10):683-92. doi: 10.1097/00006254-200210000-00022.
PMID: 12368596
citation: Gupta J, Chodankar R, Baev O, Bahlmann F, Brega E, Gala A, Hellmeyer L, Hruban L, Maier J, Mehta P, Murthy A, Ritter M, Saad A, Shmakov R, Suneja A, Zahumensky J, Gdovinova D. Synthetic osmotic dilators in the induction of labour-An international multicentre observational study. Eur J Obstet Gynecol Reprod Biol. 2018 Oct;229:70-75. doi: 10.1016/j.ejogrb.2018.08.004. Epub 2018 Aug 3.
PMID: 30107363
citation: Saad AF, Villarreal J, Eid J, Spencer N, Ellis V, Hankins GD, Saade GR. A randomized controlled trial of Dilapan-S vs Foley balloon for preinduction cervical ripening (DILAFOL trial). Am J Obstet Gynecol. 2019 Mar;220(3):275.e1-275.e9. doi: 10.1016/j.ajog.2019.01.008. Epub 2019 Feb 18.
PMID: 30790569
responsible party type: Sponsor
mesh term: Diabetes, Gestational
mesh term: Fetal Membranes, Premature Rupture
mesh term: Fetal Growth Retardation
mesh term: Oligohydramnios
mesh term: Pregnancy, Prolonged
mesh term: Hypertension
mesh term: Rupture
sharing ipd: No