<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/NCT03001661</url>
  </required_header>
  <id_info>
    <org_study_id>Solve</org_study_id>
    <nct_id>NCT03001661</nct_id>
  </id_info>
  <brief_title>An RCT of a Synthetic Osmotic Cervical Dilator for Induction of Labour in Comparison to Dinoprostone Vaginal insErt</brief_title>
  <acronym>SOLVE</acronym>
  <official_title>A Randomised Controlled Trial of a Synthetic Osmotic Cervical Dilator for Induction of Labour in Comparison to Dinoprostone Vaginal insErt: the SOLVE Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Birmingham Women's NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Birmingham</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Medicem International CR s.r.o.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Birmingham Women's NHS Foundation Trust</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>
      Induction of labour (where labour is started artificially) is traditionally carried out with&#xD;
      a range of different drugs or by surgery (rupturing the membranes or 'waters'). Dilapan-S is&#xD;
      a mechanical device, known as an osmotic cervical dilator, which provides an alternative to&#xD;
      drugs or surgery. Thin rods of an absorbent material (no active drug present) are inserted&#xD;
      into the neck of the womb (cervix) and, as they absorb fluid, they swell and mimic the&#xD;
      natural process of 'ripening' (or preparing) the cervix. This initial process is important&#xD;
      before contractions begin. Unlike drugs, Dilapan-S does not cause premature contractions&#xD;
      that, when too frequent, may cause the baby to become distressed. The project will compare&#xD;
      cervical ripening using Dilapan-S with the standard use prostaglandin drug. Women with a&#xD;
      single pregnancy, who require induction of labour, and who are not considered high risk, will&#xD;
      be invited to participate. Investigators hope to recruit 860 women from UK maternity units&#xD;
      over 2 years. Participants will have an equal chance of being randomised to the drug, which&#xD;
      is standard practice, or the cervical dilator. The speed in which labour commences, the mode&#xD;
      of delivery and any side effects will be compared. Importantly, investigators shall also&#xD;
      assess patient satisfaction and anxiety during the induction process, by asking participants&#xD;
      to complete a short questionnaire about their experience before they go home after having&#xD;
      their baby. If osmotic dilators are effective investigators expect NICE to consider them an&#xD;
      option alongside other cervical ripening methods.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Prospective, Phase III, UK, Open, Multicentre, Superiority, Randomised Controlled Trial of a&#xD;
      CE marked medical device and an Investigational Medicinal Product (CTIMP).&#xD;
&#xD;
      Potentially eligible patients will be identified by their obstetrician or midwife, based on&#xD;
      the need for induction of labour. Once the decision to induce labour is made, women will be&#xD;
      approached to participate in the trial and will be given a patient information leaflet (PIL)&#xD;
      enclosed in the induction admission letter. Patients wishing to enter the trial will be&#xD;
      confirmed for eligibility by an obstetrician. Prior to patients undertaking any trial-related&#xD;
      procedures, informed consent will be obtained.&#xD;
&#xD;
      Participants will then be randomised in a 1:1 ratio to either 1) synthetic osmotic cervical&#xD;
      dilator or 2) a 10-mg controlled-release dinoprostone vaginal insert. Randomisation will be&#xD;
      provided by a computer generated programme. A research assistant discloses the nature of the&#xD;
      assignment only after enrolment. Investigators have calculated that 860 patients (430 in each&#xD;
      arm) will need to be recruited over a 2 year period. Given the nature of the intervention,&#xD;
      the SOLVE trial will not be a blinded trial.&#xD;
&#xD;
      Full data collection will be conducted for those patients giving informed consent, from&#xD;
      medical records. This will include baseline data, and details of mother and child at birth.&#xD;
      Patients will also be asked to complete a maternal satisfaction questionnaire before they are&#xD;
      discharged. There will be no further follow-up of patients post-discharge from care unless a&#xD;
      Serious Adverse Event requires this. If the patient withdraws her consent during the study,&#xD;
      data collection will be stopped. Only anonymised data will be entered into the Case Report&#xD;
      Forms (CRFs) by the study team. Details of all patients approached about the trial will be&#xD;
      recorded on the trial Screening Log, and fully anonymised copies returned to the trials&#xD;
      office for review.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 19, 2017</start_date>
  <completion_date type="Actual">February 6, 2021</completion_date>
  <primary_completion_date type="Actual">February 6, 2021</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Failure to achieve vaginal delivery</measure>
    <time_frame>1 year from study completion</time_frame>
    <description>To evaluate the efficacy of the use of the synthetic osmotic cervical dilator in cervical ripening, prior to induction of labour, in comparison to dinoprostone vaginal insert in the parameter of failure to achieve vaginal delivery</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Failure to achieve vaginal delivery within 24, 36 and 48 hours from randomisation</measure>
    <time_frame>24, 36 and 48 hours</time_frame>
    <description>Failure to achieve vaginal delivery within 24, 36 and 48 hours from randomisation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>caesarean section</measure>
    <time_frame>24 and 64 hours</time_frame>
    <description>caesarean section undertaken between randomisation and delivery of fetus. The maximum time period for use of trial induction methods is 64 hours for Propess and 24 for Dilapan-S, thus C-section should typically have taken place by these time periods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>instrumental delivery</measure>
    <time_frame>24 and 64 hours</time_frame>
    <description>instrumental delivery undertaken between randomisation and delivery of fetus. The maximum time period for use of trial induction methods is 64 hours for Propess and 24 for Dilapan-S, thus instrumental delivery should typically have taken place by these time periods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>spontaneous delivery</measure>
    <time_frame>0 - 64 hours</time_frame>
    <description>spontaneous delivery between randomisation and delivery of fetus. The maximum time period for use of intervention is 64 hours, so spontaneous labour should have taken place by this stage.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Bishop Score</measure>
    <time_frame>0 hours, 12 hours, 24 hours, 32 hours, 56 hours, 64 hours.</time_frame>
    <description>change in Bishop Score compared at initiation of cervical ripening (i.e. randomisation) and completion of cervical ripening (i.e. when treatment is completed at 12 or 24 hours with Dilapan-S, or at 24, 32, 56 or 64 hours with Propess; or once labour is initiated - whichever comes first)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total duration of intervention received</measure>
    <time_frame>0 hours, 12 hours, 24 hours, 32 hours, 56 hours, 64 hours.</time_frame>
    <description>Total duration of intervention received (i.e. randomisation) and completion of cervical ripening (i.e. when treatment is completed at 12 or 24 hours with Dilapan-S, or at 24, 32, 56 or 64 hours with Propess; or once labour is initiated - whichever comes first)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of Oxytocin</measure>
    <time_frame>0 hours, 12 hours, 24 hours, 32 hours, 56 hours, 64 hours.</time_frame>
    <description>Use of Oxytocin for induction and/or augmentation of labour from randomisation to completion of induction (i.e. when treatment is completed at 12 or 24 hours with Dilapan-S, or at 24, 32, 56 or 64 hours with Propess; or once labour is initiated - whichever comes first)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of Analgesia</measure>
    <time_frame>0 - 64 hours approx.</time_frame>
    <description>Use of Analgesia during induction and/or labour (from randomisation until delivery of fetus).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Amniotomy undertaken</measure>
    <time_frame>0 hours, 12 hours, 24 hours, 32 hours, 56 hours, 64 hours.</time_frame>
    <description>Amniotomy undertaken for induction and/or augmentation of labour from randomisation to completion of induction (i.e. when treatment is completed at 12 or 24 hours with Dilapan-S, or at 24, 32, 56 or 64 hours with Propess; or once labour is initiated - whichever comes first)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>maternal and neonatal safety: SAEs recorded from randomisation up to discharge, and resolution of SAE.</measure>
    <time_frame>0 hours up to discharge (typically 4 days for c-section) or resolution of SAE (approx 2 weeks).</time_frame>
    <description>maternal and neonatal safety: SAEs recorded from randomisation up to discharge, and resolution of SAE.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>maternal satisfaction with cervical ripening</measure>
    <time_frame>1hr to 4 days</time_frame>
    <description>maternal satisfaction with cervical ripening collected after delivery, prior to discharge.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>fetal status after delivery</measure>
    <time_frame>recorded on delivery of fetus</time_frame>
    <description>fetal status after delivery recorded on delivery of fetus</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">674</enrollment>
  <condition>Induction of Labor Affected Fetus / Newborn</condition>
  <arm_group>
    <arm_group_label>Propess</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Control intervention: Propess® (dinoprostone) Slow release vaginal drug delivery system (Prostaglandin E2).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dilapan-S</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Experimental intervention: DILAPAN-S® A synthetic osmotic cervical dilator for insertion into the cervical canal, using as many rods as necessary.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Dilapan-S</intervention_name>
    <description>DILAPAN-S® is a non-pharmacological synthetic rod, which is inserted into the cervical canal and through the internal os, for cervical ripening prior to induction. Its mode of action consists in the hydrophilic properties of the device absorbing fluids from surrounding tissue structures, thus expanding the volume of DILAPAN-S® sticks, usually within a 12-hour period. Subsequently it exerts radial pressure on the surrounding structures (cervix) to dilate progressively. Endocervical pressure on the cervix results not only in its mechanical dilatation but the pressure on the endocervical structures also stimulates the production of endogenous PGs and promotes cervical ripening through its collagenolytic action.</description>
    <arm_group_label>Dilapan-S</arm_group_label>
    <other_name>Synthetic Osmotic Cervical Dilator</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dinoprostone</intervention_name>
    <description>Dinoprostone slow release 10mg vaginal insert is currently the standard method used for induction of labour in the NHS, particularly in nulliparous woman.</description>
    <arm_group_label>Propess</arm_group_label>
    <other_name>Propess</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria&#xD;
&#xD;
        Women must meet the following criteria prior to initiation of IoL:&#xD;
&#xD;
          1. ≥ 16 years of age&#xD;
&#xD;
          2. Able to provide informed consent&#xD;
&#xD;
          3. Singleton pregnancy&#xD;
&#xD;
          4. Indication for IoL&#xD;
&#xD;
          5. Pregnancy ≥ 37.0 weeks (assessed as an agreed gestational age by ultrasound dating&#xD;
             scan)&#xD;
&#xD;
          6. Living fetus with vertex presentation&#xD;
&#xD;
          7. Intact membranes&#xD;
&#xD;
        Exclusion criteria&#xD;
&#xD;
          1. Women already receiving oxytocin&#xD;
&#xD;
          2. Diagnosis of fulminant preeclampsia / eclampsia&#xD;
&#xD;
          3. Contraindication to DINOPROSTONE or DILAPAN&#xD;
&#xD;
          4. If DINOPROSTONE for IoL is non-compliant with local policy&#xD;
&#xD;
          5. Enrolled in other randomised controlled trials of an IMP or device for cervical&#xD;
             ripening or induction of labour&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Janesh Gupta, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Birmingham Women's and Children's Hospital NHS Foundation Trust</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Birmingham Women's and Children's NHS Trust</name>
      <address>
        <city>Birmingham</city>
        <state>West Midlands</state>
        <zip>B15 2TG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>November 11, 2016</study_first_submitted>
  <study_first_submitted_qc>December 20, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 23, 2016</study_first_posted>
  <last_update_submitted>July 14, 2021</last_update_submitted>
  <last_update_submitted_qc>July 14, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 15, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Birmingham Women's and Children's NHS Foundation Trust</investigator_affiliation>
    <investigator_full_name>Professor Janesh Gupta</investigator_full_name>
    <investigator_title>Professor of Obstetrics and Gynaecology</investigator_title>
  </responsible_party>
  <keyword>Propess</keyword>
  <keyword>Dilapan-S</keyword>
  <keyword>Dinoprostone</keyword>
  <keyword>Labour</keyword>
  <keyword>Induction</keyword>
  <keyword>Child birth</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dinoprostone</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Investigators will not be sharing individual patient data with other research studies</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>December 4, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/61/NCT03001661/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>February 10, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/61/NCT03001661/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03001661
org study id: Solve
nct id: NCT03001661
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Induction of labour (where labour is started artificially) is traditionally carried out with
      a range of different drugs or by surgery (rupturing the membranes or 'waters'). Dilapan-S is
      a mechanical device, known as an osmotic cervical dilator, which provides an alternative to
      drugs or surgery. Thin rods of an absorbent material (no active drug present) are inserted
      into the neck of the womb (cervix) and, as they absorb fluid, they swell and mimic the
      natural process of 'ripening' (or preparing) the cervix. This initial process is important
      before contractions begin. Unlike drugs, Dilapan-S does not cause premature contractions
      that, when too frequent, may cause the baby to become distressed. The project will compare
      cervical ripening using Dilapan-S with the standard use prostaglandin drug. Women with a
      single pregnancy, who require induction of labour, and who are not considered high risk, will
      be invited to participate. Investigators hope to recruit 860 women from UK maternity units
      over 2 years. Participants will have an equal chance of being randomised to the drug, which
      is standard practice, or the cervical dilator. The speed in which labour commences, the mode
      of delivery and any side effects will be compared. Importantly, investigators shall also
      assess patient satisfaction and anxiety during the induction process, by asking participants
      to complete a short questionnaire about their experience before they go home after having
      their baby. If osmotic dilators are effective investigators expect NICE to consider them an
      option alongside other cervical ripening methods.
Prospective, Phase III, UK, Open, Multicentre, Superiority, Randomised Controlled Trial of a
      CE marked medical device and an Investigational Medicinal Product (CTIMP).

      Potentially eligible patients will be identified by their obstetrician or midwife, based on
      the need for induction of labour. Once the decision to induce labour is made, women will be
      approached to participate in the trial and will be given a patient information leaflet (PIL)
      enclosed in the induction admission letter. Patients wishing to enter the trial will be
      confirmed for eligibility by an obstetrician. Prior to patients undertaking any trial-related
      procedures, informed consent will be obtained.

      Participants will then be randomised in a 1:1 ratio to either 1) synthetic osmotic cervical
      dilator or 2) a 10-mg controlled-release dinoprostone vaginal insert. Randomisation will be
      provided by a computer generated programme. A research assistant discloses the nature of the
      assignment only after enrolment. Investigators have calculated that 860 patients (430 in each
      arm) will need to be recruited over a 2 year period. Given the nature of the intervention,
      the SOLVE trial will not be a blinded trial.

      Full data collection will be conducted for those patients giving informed consent, from
      medical records. This will include baseline data, and details of mother and child at birth.
      Patients will also be asked to complete a maternal satisfaction questionnaire before they are
      discharged. There will be no further follow-up of patients post-discharge from care unless a
      Serious Adverse Event requires this. If the patient withdraws her consent during the study,
      data collection will be stopped. Only anonymised data will be entered into the Case Report
      Forms (CRFs) by the study team. Details of all patients approached about the trial will be
      recorded on the trial Screening Log, and fully anonymised copies returned to the trials
      office for review.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Failure to achieve vaginal delivery
time frame: 1 year from study completion
description: To evaluate the efficacy of the use of the synthetic osmotic cervical dilator in cervical ripening, prior to induction of labour, in comparison to dinoprostone vaginal insert in the parameter of failure to achieve vaginal delivery
measure: Failure to achieve vaginal delivery within 24, 36 and 48 hours from randomisation
time frame: 24, 36 and 48 hours
description: Failure to achieve vaginal delivery within 24, 36 and 48 hours from randomisation
measure: caesarean section
time frame: 24 and 64 hours
description: caesarean section undertaken between randomisation and delivery of fetus. The maximum time period for use of trial induction methods is 64 hours for Propess and 24 for Dilapan-S, thus C-section should typically have taken place by these time periods.
measure: instrumental delivery
time frame: 24 and 64 hours
description: instrumental delivery undertaken between randomisation and delivery of fetus. The maximum time period for use of trial induction methods is 64 hours for Propess and 24 for Dilapan-S, thus instrumental delivery should typically have taken place by these time periods.
measure: spontaneous delivery
time frame: 0 - 64 hours
description: spontaneous delivery between randomisation and delivery of fetus. The maximum time period for use of intervention is 64 hours, so spontaneous labour should have taken place by this stage.
measure: Change in Bishop Score
time frame: 0 hours, 12 hours, 24 hours, 32 hours, 56 hours, 64 hours.
description: change in Bishop Score compared at initiation of cervical ripening (i.e. randomisation) and completion of cervical ripening (i.e. when treatment is completed at 12 or 24 hours with Dilapan-S, or at 24, 32, 56 or 64 hours with Propess; or once labour is initiated - whichever comes first)
measure: Total duration of intervention received
time frame: 0 hours, 12 hours, 24 hours, 32 hours, 56 hours, 64 hours.
description: Total duration of intervention received (i.e. randomisation) and completion of cervical ripening (i.e. when treatment is completed at 12 or 24 hours with Dilapan-S, or at 24, 32, 56 or 64 hours with Propess; or once labour is initiated - whichever comes first)
measure: Use of Oxytocin
time frame: 0 hours, 12 hours, 24 hours, 32 hours, 56 hours, 64 hours.
description: Use of Oxytocin for induction and/or augmentation of labour from randomisation to completion of induction (i.e. when treatment is completed at 12 or 24 hours with Dilapan-S, or at 24, 32, 56 or 64 hours with Propess; or once labour is initiated - whichever comes first)
measure: Use of Analgesia
time frame: 0 - 64 hours approx.
description: Use of Analgesia during induction and/or labour (from randomisation until delivery of fetus).
measure: Amniotomy undertaken
time frame: 0 hours, 12 hours, 24 hours, 32 hours, 56 hours, 64 hours.
description: Amniotomy undertaken for induction and/or augmentation of labour from randomisation to completion of induction (i.e. when treatment is completed at 12 or 24 hours with Dilapan-S, or at 24, 32, 56 or 64 hours with Propess; or once labour is initiated - whichever comes first)
measure: maternal and neonatal safety: SAEs recorded from randomisation up to discharge, and resolution of SAE.
time frame: 0 hours up to discharge (typically 4 days for c-section) or resolution of SAE (approx 2 weeks).
description: maternal and neonatal safety: SAEs recorded from randomisation up to discharge, and resolution of SAE.
measure: maternal satisfaction with cervical ripening
time frame: 1hr to 4 days
description: maternal satisfaction with cervical ripening collected after delivery, prior to discharge.
measure: fetal status after delivery
time frame: recorded on delivery of fetus
description: fetal status after delivery recorded on delivery of fetus
arm group label: Propess
arm group type: Active Comparator
description: Control intervention: Propess® (dinoprostone) Slow release vaginal drug delivery system (Prostaglandin E2).
arm group label: Dilapan-S
arm group type: Experimental
description: Experimental intervention: DILAPAN-S® A synthetic osmotic cervical dilator for insertion into the cervical canal, using as many rods as necessary.
intervention type: Device
intervention name: Dilapan-S
description: DILAPAN-S® is a non-pharmacological synthetic rod, which is inserted into the cervical canal and through the internal os, for cervical ripening prior to induction. Its mode of action consists in the hydrophilic properties of the device absorbing fluids from surrounding tissue structures, thus expanding the volume of DILAPAN-S® sticks, usually within a 12-hour period. Subsequently it exerts radial pressure on the surrounding structures (cervix) to dilate progressively. Endocervical pressure on the cervix results not only in its mechanical dilatation but the pressure on the endocervical structures also stimulates the production of endogenous PGs and promotes cervical ripening through its collagenolytic action.
arm group label: Dilapan-S
other name: Synthetic Osmotic Cervical Dilator
intervention type: Drug
intervention name: Dinoprostone
description: Dinoprostone slow release 10mg vaginal insert is currently the standard method used for induction of labour in the NHS, particularly in nulliparous woman.
arm group label: Propess
other name: Propess
criteria: 
gender: Female
minimum age: 16 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Janesh Gupta, MD
role: Principal Investigator
affiliation: Birmingham Women's and Children's Hospital NHS Foundation Trust
facility: 
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: Birmingham Women's and Children's NHS Foundation Trust
investigator full name: Professor Janesh Gupta
investigator title: Professor of Obstetrics and Gynaecology
mesh term: Dinoprostone
sharing ipd: No
ipd description: Investigators will not be sharing individual patient data with other research studies
provided document: 
provided document: 