<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/NCT04413019</url>
  </required_header>
  <id_info>
    <org_study_id>PPROM</org_study_id>
    <nct_id>NCT04413019</nct_id>
  </id_info>
  <brief_title>Domiciliary Versus Hospital Management of PPROM</brief_title>
  <acronym>PPROM</acronym>
  <official_title>Planned Domiciliary Versus Hospital Care for Women With Preterm Prelabor Rupture of the Membranes (PPROM)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ahmed Mohammed Selim</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ain Shams Maternity Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is designed to compare efficacy &amp; safety of planned domiciliary versus hospital&#xD;
      care for women with preterm prelabor rupture of the membranes (PPROM) on fetal, neonatal and&#xD;
      maternal outcome.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: PPROM is encountered in 2.0% to 3.5% of pregnancies. Domiciliary care management&#xD;
      is developing more and more in obstetrics, with psychological benefits for patients as well&#xD;
      as other financial benefits. Reliable discharge criteria have been mentioned by few studies&#xD;
      for patients with PPROM. Studies had shown that domiciliary care management in a context of&#xD;
      PPROM did not modify perinatal morbidity and mortality, and allows a prolongation of the&#xD;
      latency period. However, eligibility criteria for domiciliary care management were&#xD;
      heterogeneous&#xD;
&#xD;
      Aim of The Work: The aim of this study is to compare efficacy &amp; safety of planned domiciliary&#xD;
      versus hospital care for women with preterm prelabor rupture of the membranes (PPROM) on&#xD;
      fetal, neonatal and maternal outcome.&#xD;
&#xD;
      Patients &amp; Methods: The current trial was conducted at Ain Shams University Maternity&#xD;
      Hospital. A total of 3662 pregnant women were recruited from the outpatient clinic &amp;&#xD;
      emergency room and included in the study. Then, they were randomized into two groups; group&#xD;
      (D) was counseled for home care management, while group (H) was hospitalized. Take-home baby&#xD;
      was assessed as a primary outcome and other maternal, fetal &amp; neonatal complications were&#xD;
      recorded &amp; moreover latency period, mode of delivery &amp; preference of care were assessed&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 15, 2019</start_date>
  <completion_date type="Actual">October 20, 2020</completion_date>
  <primary_completion_date type="Actual">October 1, 2020</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>2 Years</target_duration>
  <primary_outcome>
    <measure>Take-home baby</measure>
    <time_frame>2 years</time_frame>
    <description>this outcome is the best indicator of success of the management plan when the outcome is alive &amp; well baby</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">3662</enrollment>
  <condition>Preterm Premature Rupture of Membrane</condition>
  <arm_group>
    <arm_group_label>Group (D): Planned domiciliary care.</arm_group_label>
    <description>Patients within this group will be counseled for home care with self-monitoring for any symptoms suggestive of preterm labor, maternal or fetal distress.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group (H): Planned hospital care.</arm_group_label>
    <description>Patients within this group will be admitted at hospital for close monitoring of maternal &amp; fetal wellbeing &amp; finally the neonatal outcome</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Clinical follow up</intervention_name>
    <description>Patients recruited in this study commenced antibiotic treatment according to the recent guidelines :&#xD;
Erythromycin 250 mg 4 times daily for 10 days following the diagnosis of PPROM, or until the women is established labor (whichever sooner)&#xD;
Penicillin may be used in patients who can't tolerate erythromycin&#xD;
In cases of penicillin allergy: Cefazolin 1 g intravenously every 8 hours for 48 hours, followed by cephalexin 500 mg orally four times daily for five days. These drugs provide coverage for both GBS and Escherichia coli, the two major causes of neonatal infection.</description>
    <arm_group_label>Group (D): Planned domiciliary care.</arm_group_label>
    <arm_group_label>Group (H): Planned hospital care.</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study will include 3662 women with a history of preterm prelabor rupture of the&#xD;
        membranes&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria include women with PPROM ≥28 weeks &amp; &lt;37 weeks with no signs of&#xD;
        intra-amniotic infection &amp; membranes rupture is confirmed by a sterile speculum examination&#xD;
        and decrease amniotic fluid on ultrasound with singleton, viable, cephalic presenting&#xD;
        fetus, morphologically normal fetus by ultrasound &amp; reactive fetal heart rate tracing with&#xD;
        no evidence of meconium-stained liquor&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Query PPROM: A history of PPROM with no pooling of amniotic fluid from the cervix on a&#xD;
             sterile speculum examination&#xD;
&#xD;
          -  Maternal comorbidities (Diabetes mellitus, hypertension, etc.)&#xD;
&#xD;
          -  Patients with placenta previa&#xD;
&#xD;
          -  Amniotic fluid pocket on ultrasound &lt; 2x2 cm&#xD;
&#xD;
          -  Logistic problems interfering with follow-up&#xD;
&#xD;
          -  Inability to check temperature every six hours, with parameters for notifying their&#xD;
             clinician (temperature ≥38°C)&#xD;
&#xD;
          -  Non-Dependable transportation&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>pregnant women with rupture of the fetal membranes before 37 weeks of gestation</gender_description>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Faculty of medicine - Ain Shams university</name>
      <address>
        <city>Cairo</city>
        <zip>11517</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>May 29, 2020</study_first_submitted>
  <study_first_submitted_qc>June 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 2, 2020</study_first_posted>
  <last_update_submitted>January 4, 2021</last_update_submitted>
  <last_update_submitted_qc>January 4, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 6, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Ain Shams Maternity Hospital</investigator_affiliation>
    <investigator_full_name>Ahmed Mohammed Selim</investigator_full_name>
    <investigator_title>ASelim</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>Yes</sharing_ipd>
    <ipd_description>all statistical methods, results of the study ,discussion &amp; recommendations</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>onset of January, 2022 (6 months after publication)</ipd_time_frame>
    <ipd_access_criteria>sponsor e.mail &amp; the sponsor organisation</ipd_access_criteria>
    <ipd_url>http://www.asu.edu.eg/ar/</ipd_url>
  </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/NCT04413019
org study id: PPROM
nct id: NCT04413019
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study is designed to compare efficacy & safety of planned domiciliary versus hospital
      care for women with preterm prelabor rupture of the membranes (PPROM) on fetal, neonatal and
      maternal outcome.
Background: PPROM is encountered in 2.0% to 3.5% of pregnancies. Domiciliary care management
      is developing more and more in obstetrics, with psychological benefits for patients as well
      as other financial benefits. Reliable discharge criteria have been mentioned by few studies
      for patients with PPROM. Studies had shown that domiciliary care management in a context of
      PPROM did not modify perinatal morbidity and mortality, and allows a prolongation of the
      latency period. However, eligibility criteria for domiciliary care management were
      heterogeneous

      Aim of The Work: The aim of this study is to compare efficacy & safety of planned domiciliary
      versus hospital care for women with preterm prelabor rupture of the membranes (PPROM) on
      fetal, neonatal and maternal outcome.

      Patients & Methods: The current trial was conducted at Ain Shams University Maternity
      Hospital. A total of 3662 pregnant women were recruited from the outpatient clinic &
      emergency room and included in the study. Then, they were randomized into two groups; group
      (D) was counseled for home care management, while group (H) was hospitalized. Take-home baby
      was assessed as a primary outcome and other maternal, fetal & neonatal complications were
      recorded & moreover latency period, mode of delivery & preference of care were assessed
observational model: Cohort
time perspective: Prospective
measure: Take-home baby
time frame: 2 years
description: this outcome is the best indicator of success of the management plan when the outcome is alive & well baby
arm group label: Group (D): Planned domiciliary care.
description: Patients within this group will be counseled for home care with self-monitoring for any symptoms suggestive of preterm labor, maternal or fetal distress.
arm group label: Group (H): Planned hospital care.
description: Patients within this group will be admitted at hospital for close monitoring of maternal & fetal wellbeing & finally the neonatal outcome
intervention type: Other
intervention name: Clinical follow up
description: Patients recruited in this study commenced antibiotic treatment according to the recent guidelines :
Erythromycin 250 mg 4 times daily for 10 days following the diagnosis of PPROM, or until the women is established labor (whichever sooner)
Penicillin may be used in patients who can't tolerate erythromycin
In cases of penicillin allergy: Cefazolin 1 g intravenously every 8 hours for 48 hours, followed by cephalexin 500 mg orally four times daily for five days. These drugs provide coverage for both GBS and Escherichia coli, the two major causes of neonatal infection.
arm group label: Group (D): Planned domiciliary care.
arm group label: Group (H): Planned hospital care.
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
gender based: Yes
gender description: pregnant women with rupture of the fetal membranes before 37 weeks of gestation
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
country: Egypt
responsible party type: Sponsor-Investigator
investigator affiliation: Ain Shams Maternity Hospital
investigator full name: Ahmed Mohammed Selim
investigator title: ASelim
mesh term: Premature Birth
mesh term: Fetal Membranes, Premature Rupture
mesh term: Rupture
sharing ipd: Yes
ipd description: all statistical methods, results of the study ,discussion & recommendations
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: onset of January, 2022 (6 months after publication)
ipd access criteria: sponsor e.mail & the sponsor organisation
ipd url: http://www.asu.edu.eg/ar/