<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/NCT03814278</url>
  </required_header>
  <id_info>
    <org_study_id>RPM-PT_Estudo_Repouso</org_study_id>
    <nct_id>NCT03814278</nct_id>
  </id_info>
  <brief_title>Bed Rest After Preterm Premature Rupture of the Membranes</brief_title>
  <official_title>A Pilot Randomized Controlled Trial On Complete Bed Rest Versus Activity Restriction After Preterm Premature Rupture of the Membranes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centro Hospitalar Lisboa Norte</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centro Hospitalar Lisboa Norte</source>
  <oversight_info>
    <has_dmc>No</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>
      Antepartum bed rest is widely prescribed after preterm premature rupture of the membranes&#xD;
      (PPROM), although its effectiveness to prevent preterm birth has not been demonstrated. This&#xD;
      pilot randomized controled trial (RCT) aims to access the impact of bed rest in maternal and&#xD;
      neonatal outcomes in pregnancies complicated by premature rupture of the membranes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Aims - To access the impact of bed rest in latency time to delivery, chorioamnionitis&#xD;
      incidence and other maternal and neonatal outcomes in pregnancies complicated by PPROM, thus&#xD;
      enabling proper sample size calculation for future powered RCT.&#xD;
&#xD;
      Study population and Sample size - Eligible patients included those with single pregnancies&#xD;
      with PPROM at 24+0-33+6 weeks of gestation who were admitted to and delivering at our&#xD;
      tertiary center. PPROM was diagnosed on the basis of patient's history and sterile speculum&#xD;
      examination with visualization of amniotic fluid pooling in the vagina and/or leaking from&#xD;
      the cervical canal. Exclusion criteria included indication for immediate delivery on&#xD;
      admission (chorioamnionitis, placenta abruption, cord prolapse, signs of fetal&#xD;
      hypoxia/distress), fetal malformations, multiple gestation, and maternal immunosuppressive&#xD;
      disease. Considering future sample size calculation based upon assumed differences between&#xD;
      groups regarding latency and infection, we aimed a sample of 30 participants.&#xD;
&#xD;
      Randomization - A pilot unblinded randomized controlled trial (RCT) in a 1:1 allocation ratio&#xD;
      between two groups (complete bed rest versus activity restriction after PPROM). Simple random&#xD;
      allocation sequence was generated by the investigators and implemented by sequentially&#xD;
      numbered sealed envelopes. Participants were enrolled by physicians after hospital admission&#xD;
      and written informed consent was obtained before randomization. The trial was conducted in a&#xD;
      single tertiary center of the Portuguese national health system after approval by its ethical&#xD;
      committee.&#xD;
&#xD;
      Statistical analysis - An intention-to-treat analysis was performed with a significance level&#xD;
      of 5%.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2012</start_date>
  <completion_date type="Actual">January 2018</completion_date>
  <primary_completion_date type="Actual">December 2017</primary_completion_date>
  <phase>N/A</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Latency time</measure>
    <time_frame>From preterm premature rupture of the membranes until delivery, estimated average time of one week</time_frame>
    <description>Time between preterm premature rupture of the membranes and delivery, in days</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Chorioamnionitis</measure>
    <time_frame>From preterm premature rupture of the membranes until delivery, estimated average time of one week</time_frame>
    <description>Incidence of clinical chorioamnionitis (defined as maternal fever plus leukocytosis and CRP elevation, or as maternal fever plus any two of the following: fetal tachycardia; maternal tachycardia; uterine tenderness; purulent amniotic fluid)</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Preterm Premature Rupture of Membrane</condition>
  <arm_group>
    <arm_group_label>Complete bed rest</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants on complete bed rest group kept antepartum confinement to bed with toileting restricted to bedpan use. Participants in this group received prophylactic subcutaneous enoxaparin (40mg/day).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Activity restriction group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Activity restriction group had motion limited to bathroom privileges and walks to the ward canteen four times per day.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>complete bed rest</intervention_name>
    <description>Patients in this group received standard care for PPROM according to the institution protocol, including antepartum confinement to bed.</description>
    <arm_group_label>Complete bed rest</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>activity restriction</intervention_name>
    <description>Patients in this group received standard care for PPROM according to the institution protocol but to had bathroom privileges and walks to the ward canteen four times per day.</description>
    <arm_group_label>Activity restriction group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  single pregnancies AND&#xD;
&#xD;
          -  PPROM at 24+0-33+6 weeks of gestation AND&#xD;
&#xD;
          -  admitted to our tertiary center.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  indication for immediate delivery on admission (chorioamnionitis, placenta abruption,&#xD;
             cord prolapse, signs of fetal hypoxia/distress)&#xD;
&#xD;
          -  fetal malformations&#xD;
&#xD;
          -  multiple gestation&#xD;
&#xD;
          -  maternal immunosuppressive disease&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Patient eligibility is based on gender identity because we will include only pregnant women</gender_description>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>November 23, 2018</study_first_submitted>
  <study_first_submitted_qc>January 21, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 24, 2019</study_first_posted>
  <last_update_submitted>January 28, 2019</last_update_submitted>
  <last_update_submitted_qc>January 28, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 30, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Centro Hospitalar Lisboa Norte</investigator_affiliation>
    <investigator_full_name>Inês Martins</investigator_full_name>
    <investigator_title>Medical Doctor, Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Premature Birth</mesh_term>
    <mesh_term>Fetal Membranes, Premature Rupture</mesh_term>
    <mesh_term>Rupture</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>December 17, 2011</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/78/NCT03814278/Prot_SAP_000.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/NCT03814278
org study id: RPM-PT_Estudo_Repouso
nct id: NCT03814278
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Antepartum bed rest is widely prescribed after preterm premature rupture of the membranes
      (PPROM), although its effectiveness to prevent preterm birth has not been demonstrated. This
      pilot randomized controled trial (RCT) aims to access the impact of bed rest in maternal and
      neonatal outcomes in pregnancies complicated by premature rupture of the membranes.
Aims - To access the impact of bed rest in latency time to delivery, chorioamnionitis
      incidence and other maternal and neonatal outcomes in pregnancies complicated by PPROM, thus
      enabling proper sample size calculation for future powered RCT.

      Study population and Sample size - Eligible patients included those with single pregnancies
      with PPROM at 24+0-33+6 weeks of gestation who were admitted to and delivering at our
      tertiary center. PPROM was diagnosed on the basis of patient's history and sterile speculum
      examination with visualization of amniotic fluid pooling in the vagina and/or leaking from
      the cervical canal. Exclusion criteria included indication for immediate delivery on
      admission (chorioamnionitis, placenta abruption, cord prolapse, signs of fetal
      hypoxia/distress), fetal malformations, multiple gestation, and maternal immunosuppressive
      disease. Considering future sample size calculation based upon assumed differences between
      groups regarding latency and infection, we aimed a sample of 30 participants.

      Randomization - A pilot unblinded randomized controlled trial (RCT) in a 1:1 allocation ratio
      between two groups (complete bed rest versus activity restriction after PPROM). Simple random
      allocation sequence was generated by the investigators and implemented by sequentially
      numbered sealed envelopes. Participants were enrolled by physicians after hospital admission
      and written informed consent was obtained before randomization. The trial was conducted in a
      single tertiary center of the Portuguese national health system after approval by its ethical
      committee.

      Statistical analysis - An intention-to-treat analysis was performed with a significance level
      of 5%.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Latency time
time frame: From preterm premature rupture of the membranes until delivery, estimated average time of one week
description: Time between preterm premature rupture of the membranes and delivery, in days
measure: Chorioamnionitis
time frame: From preterm premature rupture of the membranes until delivery, estimated average time of one week
description: Incidence of clinical chorioamnionitis (defined as maternal fever plus leukocytosis and CRP elevation, or as maternal fever plus any two of the following: fetal tachycardia; maternal tachycardia; uterine tenderness; purulent amniotic fluid)
arm group label: Complete bed rest
arm group type: Experimental
description: Participants on complete bed rest group kept antepartum confinement to bed with toileting restricted to bedpan use. Participants in this group received prophylactic subcutaneous enoxaparin (40mg/day).
arm group label: Activity restriction group
arm group type: Experimental
description: Activity restriction group had motion limited to bathroom privileges and walks to the ward canteen four times per day.
intervention type: Behavioral
intervention name: complete bed rest
description: Patients in this group received standard care for PPROM according to the institution protocol, including antepartum confinement to bed.
arm group label: Complete bed rest
intervention type: Behavioral
intervention name: activity restriction
description: Patients in this group received standard care for PPROM according to the institution protocol but to had bathroom privileges and walks to the ward canteen four times per day.
arm group label: Activity restriction group
criteria: 
gender: Female
gender based: Yes
gender description: Patient eligibility is based on gender identity because we will include only pregnant women
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Centro Hospitalar Lisboa Norte
investigator full name: Inês Martins
investigator title: Medical Doctor, Principal Investigator
mesh term: Premature Birth
mesh term: Fetal Membranes, Premature Rupture
mesh term: Rupture
sharing ipd: Undecided
provided document: 