<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/NCT03262961</url>
  </required_header>
  <id_info>
    <org_study_id>assiutu252</org_study_id>
    <nct_id>NCT03262961</nct_id>
  </id_info>
  <brief_title>Use of Sildenafil Citrate in Management of Mild Pre-eclampsia</brief_title>
  <official_title>Use of Sildenafil Citrate in Management of Mild Pre-eclampsia: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      -  Mild pre-eclampsia represents 75% of cases with pre-eclampsia, possible progression to&#xD;
           severe pre-eclampsia makes mild pre-eclampsia a serious problem that requires attention.&#xD;
&#xD;
        -  Previous studies have shown that expectant and conservative management of pre-eclampsia&#xD;
           in the context of extreme prematurity may improve perinatal outcomes. Indeed, it has&#xD;
           been estimated that for each additional day of pregnancy prolongation between 24 and 32&#xD;
           weeks of gestation, there is a nonlinear corresponding gain of 1% in fetal survival.&#xD;
&#xD;
        -  Sildenafil citrate has been used for increasing utero-placental perfusion in cases with&#xD;
           intrauterine growth restriction, which makes it a promising drug in management of mild&#xD;
           pre-eclampsia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      - Pre-eclampsia affects approximately 2-8% of all pregnancies worldwide. In Egypt, the&#xD;
      prevalence of pre-eclampsia is 10.7% in a community based study. While, in hospital based&#xD;
      studies it ranged from 9.1% to 12.5% of all deliveries. The incidence of pre-eclampsia has&#xD;
      risen in the developing countries and even in the developed countries as the USA since the&#xD;
      1990s. Among the hypertensive disorders that complicate pregnancy, pre-eclampsia and&#xD;
      eclampsia stand as major causes of maternal and perinatal morbidity and mortality worldwide.&#xD;
      Nearly one tenth of all maternal deaths in Africa and Asia and one quarter in Latin America&#xD;
      are associated with hypertensive diseases in pregnancy, a category that includes&#xD;
      pre-eclampsia and the complications that are related to it.&#xD;
&#xD;
      However, the pathogenesis of pre-eclampsia is only partially understood and it is related to&#xD;
      disturbances in placentation at the beginning of pregnancy, followed by generalized&#xD;
      inflammation and progressive endothelial damage. There are other uncertainties too: the&#xD;
      diagnosis, screening and management of pre-eclampsia remain controversial, as does the&#xD;
      classification and the degree of its severity.&#xD;
&#xD;
      However, it is generally accepted as published in the different journals and in the WHO&#xD;
      recommendations that the onset of a new episode of hypertension during pregnancy (with&#xD;
      persistent systolic blood pressure 140 mm Hg and diastolic blood pressure 90 mm Hg or more)&#xD;
      with the occurrence of substantial proteinuria (&gt;0.3 g/24 h or confirmation of proteinuria by&#xD;
      semiquantitative urine dipstick analysis with a result of at least 1+) can be used as&#xD;
      criteria for identifying pre-eclampsia.&#xD;
&#xD;
      Although pathophysiological changes (e.g. inadequate placentation) exist from very early&#xD;
      stages of the pregnancy, hypertension and proteinuria usually become apparent in the second&#xD;
      half of pregnancy.&#xD;
&#xD;
      Complications of pre-eclampsia can affect both the mother and the fetus. Acutely,&#xD;
      pre-eclampsia can be complicated by eclampsia , the development of HELLP Syndrome ,&#xD;
      hemorrhagic or ischemic stroke, liver damage and dysfunction, acute kidney injury and Acute&#xD;
      Respiratory Distress Syndrome (ARDS).&#xD;
&#xD;
      So early detection of pre-eclampsia and prevention of the occurrence of any of its&#xD;
      complications would save the lives of many women and prevent the possible devastating&#xD;
      maternal and neonatal outcome of pre-eclampsia, That's why we are concerned in our study with&#xD;
      pre-eclampsia, covering the gestational age from 28 - 36 weeks.&#xD;
&#xD;
      Mild pre-eclampsia represents 75% of cases with pre-eclampsia, possible progression to severe&#xD;
      pre-eclampsia makes mild pre-eclampsia a serious problem that requires attention.&#xD;
&#xD;
      Previous studies have shown that expectant and conservative management of pre-eclampsia in&#xD;
      the context of extreme prematurity may improve perinatal outcomes. Indeed, it has been&#xD;
      estimated that for each additional day of pregnancy prolongation between 24 and 32 weeks of&#xD;
      gestation, there is a nonlinear corresponding gain of 1% in fetal survival.&#xD;
&#xD;
      Sildenafil citrate has been used for increasing utero-placental perfusion in cases with&#xD;
      intrauterine growth restriction, which makes it a promising drug in management of mild&#xD;
      pre-eclampsia.&#xD;
&#xD;
      Its action is similar to the action of nitric oxide, which is a potent vasodilator,&#xD;
      especially for the venules, besides being an inhibitor of platelet aggregation. During&#xD;
      pregnancy, nitric oxide is synthesized in in utero-placental tissues and endothelial cells,&#xD;
      helping to maintain low vascular resistance in the utero- and fetoplacental circulations.&#xD;
      Phosphodiesterase metabolizes cyclic guanosine monophosphate; therefore, phosphodiesterase&#xD;
      type 5 inhibition leads to cyclic guanosine monophosphate increase with associated&#xD;
      vasodilation, independently of nitric oxide. Therefore, phosphodiesterase type 5 inhibitors&#xD;
      have the potential to achieve similar therapeutic goals when compared with nitric oxide.&#xD;
&#xD;
      A potential advantage of phosphodiesterase type 5 inhibitors is that they may overcome the&#xD;
      main limitation to nitric oxide use in pregnancy, which is tolerance and headaches. The most&#xD;
      studied phosphodiesterase type 5 inhibitor is sildenafil citrate, which has previously shown&#xD;
      promising outcomes both in vitro and in animal studies.&#xD;
&#xD;
      That is why we decided to study the role of Sildenafil Citrate in expectant and conservative&#xD;
      management of mild pre-eclampsia, as it has shown its ability to be beneficial to both the&#xD;
      mother and the fetus through increasing the maternofetal circulation perfusion and achieving&#xD;
      a maternal hemodynamic stability and compare it to the current NICE (National Institute for&#xD;
      Health and Care Excellence) guidelines that are currently used, that recommends conservative&#xD;
      management of mild pre-eclampsia through control of maternal blood pressure and frequent&#xD;
      screening of maternal laboratory investigations' abnormalities to detect possible progression&#xD;
      to severe pre-eclamptic toxemia.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 15, 2016</start_date>
  <completion_date type="Anticipated">January 15, 2018</completion_date>
  <primary_completion_date type="Anticipated">December 15, 2017</primary_completion_date>
  <phase>Phase 2/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>
    <intervention_model_description>- Double blinded, randomized, placebo-controlled trial.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>- It's a double blinded, randomized, placebo-controlled trial.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Gestational age at time of termination and maternal outcome.</measure>
    <time_frame>up to 37 weeks of gestation</time_frame>
    <description>Gestational age at time of termination and maternal outcome in terms of whether the disease would progress to severe pre-eclampsia or not.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Neonatal outcome.</measure>
    <time_frame>up to 37 weeks of gestation</time_frame>
    <description>Neonatal outcome in terms of survival and neonatal well-being ( by obtaining the birth weight and the apgar score at 1 and 5 minutes and direct postnatal need to NICU).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Control of maternal blood pressure.</measure>
    <time_frame>up to 37 weeks of gestation</time_frame>
    <description>Control of maternal blood pressure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Method of termination of pregnancy.</measure>
    <time_frame>up to 37 weeks of gestation</time_frame>
    <description>Method of termination of pregnancy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Identification of the side effects from the use of sildenafil citrate.</measure>
    <time_frame>up to 37 weeks of gestation</time_frame>
    <description>Identification of possible maternal side effects from the use of sildenafil citrate i.e.; headache, flushing and dyspepsia.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the effect of sildenafil citrate on the feto-maternal circulation through the Doppler ultrasound.</measure>
    <time_frame>up to 37 weeks of gestation</time_frame>
    <description>Evaluation of the effect of sildenafil citrate on the feto-maternal circulation through the Doppler ultrasound.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Pre-Eclampsia; Mild</condition>
  <arm_group>
    <arm_group_label>Intervention Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>• The intervention group will be supplied with Sildenafil Citrate (Respatio® 20mg tablets manufactured by Pharma Right Group , Egypt) according to the patient's weight by the rate of (1.5 mg/kg/day) divided into three doses per day ( every 8 hours) till termination of pregnancy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>- The control group will be supplied with a placebo drug that has the same shape, size and color but without the active ingredient and it would also be taken in a similar way. The placebo tablet will be manufactured at the faculty of pharmacy, Assiut University.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sildenafil 20 MG</intervention_name>
    <arm_group_label>Intervention Group</arm_group_label>
    <other_name>Sildenafil Citrate 20 mg ( Respatio® 20 mg)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo Oral Tablet</intervention_name>
    <arm_group_label>Control Group</arm_group_label>
    <other_name>Placebo drug</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Uncomplicated mild pre-eclampsia; No clinical or investigatory findings suggestive&#xD;
             severe pre-eclamptic toxemia.&#xD;
&#xD;
          2. Gestational age of 28 - 36 weeks by good dates according to ACOG's - committee on&#xD;
             obstetric practice - Method for Estimating Due Date (2014) who will receive the&#xD;
             study's drug for at least one week before termination.&#xD;
&#xD;
          3. Singleton viable pregnancy.&#xD;
&#xD;
          4. Age: 18-35 years.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Severe pre-eclamptic toxemia (according to the NICE guidelines (2010): Hypertension in&#xD;
             pregnancy: diagnosis and management)&#xD;
&#xD;
          2. Intrauterine growth retardation.&#xD;
&#xD;
          3. Use of medication that could interact with sildenafil citrate such as nitrates&#xD;
             erythromycin, ketoconazole, itraconazole, antiretroviral agents and others.&#xD;
&#xD;
          4. Presence of maternal co-morbidity disease as: DM, chronic hypertension, congestive&#xD;
             heart failure, chronic kidney disease and SLE.&#xD;
&#xD;
          5. Placenta previa.&#xD;
&#xD;
          6. The patient is using aspirin.&#xD;
&#xD;
          7. The presence of a contraindication to the use of sildenafil citrate:&#xD;
&#xD;
               -  Hypersensitivity to sildenafil citrate or any of the tablet ingredients.&#xD;
&#xD;
               -  Patients with severe cardiovascular disease such as established cardiac failure&#xD;
                  and unstable angina pectoris.&#xD;
&#xD;
               -  Previous episode of non-arteritic anterior ischaemic optic neuropathy.&#xD;
&#xD;
               -  Severe hepatic impairment.&#xD;
&#xD;
               -  Hypotension (blood pressure &lt;90/50 mmHg).&#xD;
&#xD;
               -  Hypertension (blood pressure &gt;170/110 mmHg).&#xD;
&#xD;
               -  Recent history of stroke or myocardial infarction.&#xD;
&#xD;
               -  Known hereditary degenerative retinal disorders such as retinitis pigmentosa.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Pregnant females</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Fady Abdallah</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assiut University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Hasan Kamel</last_name>
    <role>Study Director</role>
    <affiliation>Assiut University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Hisham Abou-Taleb</last_name>
    <role>Study Director</role>
    <affiliation>Assiut University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Fady Abdallah</last_name>
    <phone>00201002837042</phone>
    <email>fady.nasif@yahoo.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Hisham Abou-Taleb</last_name>
    <phone>00201003332139</phone>
    <email>hishamaboutaleb1@yahoo.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Assiut Univeristy Hospitals</name>
      <address>
        <city>Assiut</city>
        <zip>71111</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Abdallah Hamed</last_name>
      <phone>01002621430</phone>
      <email>obste.gyne_aun@yahoo.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
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  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 19, 2017</study_first_submitted>
  <study_first_submitted_qc>August 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 28, 2017</study_first_posted>
  <last_update_submitted>August 24, 2017</last_update_submitted>
  <last_update_submitted_qc>August 24, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 28, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Fady Nasef Tous Abdallah</investigator_full_name>
    <investigator_title>Resident of Obstetrics and Gynecology Department - Assiut University</investigator_title>
  </responsible_party>
  <keyword>Mild pre-eclampsia Sildenafil Citrate</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Eclampsia</mesh_term>
    <mesh_term>Pre-Eclampsia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sildenafil Citrate</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</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>September 1, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/61/NCT03262961/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/NCT03262961
org study id: assiutu252
nct id: NCT03262961
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
-  Mild pre-eclampsia represents 75% of cases with pre-eclampsia, possible progression to
           severe pre-eclampsia makes mild pre-eclampsia a serious problem that requires attention.

        -  Previous studies have shown that expectant and conservative management of pre-eclampsia
           in the context of extreme prematurity may improve perinatal outcomes. Indeed, it has
           been estimated that for each additional day of pregnancy prolongation between 24 and 32
           weeks of gestation, there is a nonlinear corresponding gain of 1% in fetal survival.

        -  Sildenafil citrate has been used for increasing utero-placental perfusion in cases with
           intrauterine growth restriction, which makes it a promising drug in management of mild
           pre-eclampsia.
- Pre-eclampsia affects approximately 2-8% of all pregnancies worldwide. In Egypt, the
      prevalence of pre-eclampsia is 10.7% in a community based study. While, in hospital based
      studies it ranged from 9.1% to 12.5% of all deliveries. The incidence of pre-eclampsia has
      risen in the developing countries and even in the developed countries as the USA since the
      1990s. Among the hypertensive disorders that complicate pregnancy, pre-eclampsia and
      eclampsia stand as major causes of maternal and perinatal morbidity and mortality worldwide.
      Nearly one tenth of all maternal deaths in Africa and Asia and one quarter in Latin America
      are associated with hypertensive diseases in pregnancy, a category that includes
      pre-eclampsia and the complications that are related to it.

      However, the pathogenesis of pre-eclampsia is only partially understood and it is related to
      disturbances in placentation at the beginning of pregnancy, followed by generalized
      inflammation and progressive endothelial damage. There are other uncertainties too: the
      diagnosis, screening and management of pre-eclampsia remain controversial, as does the
      classification and the degree of its severity.

      However, it is generally accepted as published in the different journals and in the WHO
      recommendations that the onset of a new episode of hypertension during pregnancy (with
      persistent systolic blood pressure 140 mm Hg and diastolic blood pressure 90 mm Hg or more)
      with the occurrence of substantial proteinuria (>0.3 g/24 h or confirmation of proteinuria by
      semiquantitative urine dipstick analysis with a result of at least 1+) can be used as
      criteria for identifying pre-eclampsia.

      Although pathophysiological changes (e.g. inadequate placentation) exist from very early
      stages of the pregnancy, hypertension and proteinuria usually become apparent in the second
      half of pregnancy.

      Complications of pre-eclampsia can affect both the mother and the fetus. Acutely,
      pre-eclampsia can be complicated by eclampsia , the development of HELLP Syndrome ,
      hemorrhagic or ischemic stroke, liver damage and dysfunction, acute kidney injury and Acute
      Respiratory Distress Syndrome (ARDS).

      So early detection of pre-eclampsia and prevention of the occurrence of any of its
      complications would save the lives of many women and prevent the possible devastating
      maternal and neonatal outcome of pre-eclampsia, That's why we are concerned in our study with
      pre-eclampsia, covering the gestational age from 28 - 36 weeks.

      Mild pre-eclampsia represents 75% of cases with pre-eclampsia, possible progression to severe
      pre-eclampsia makes mild pre-eclampsia a serious problem that requires attention.

      Previous studies have shown that expectant and conservative management of pre-eclampsia in
      the context of extreme prematurity may improve perinatal outcomes. Indeed, it has been
      estimated that for each additional day of pregnancy prolongation between 24 and 32 weeks of
      gestation, there is a nonlinear corresponding gain of 1% in fetal survival.

      Sildenafil citrate has been used for increasing utero-placental perfusion in cases with
      intrauterine growth restriction, which makes it a promising drug in management of mild
      pre-eclampsia.

      Its action is similar to the action of nitric oxide, which is a potent vasodilator,
      especially for the venules, besides being an inhibitor of platelet aggregation. During
      pregnancy, nitric oxide is synthesized in in utero-placental tissues and endothelial cells,
      helping to maintain low vascular resistance in the utero- and fetoplacental circulations.
      Phosphodiesterase metabolizes cyclic guanosine monophosphate; therefore, phosphodiesterase
      type 5 inhibition leads to cyclic guanosine monophosphate increase with associated
      vasodilation, independently of nitric oxide. Therefore, phosphodiesterase type 5 inhibitors
      have the potential to achieve similar therapeutic goals when compared with nitric oxide.

      A potential advantage of phosphodiesterase type 5 inhibitors is that they may overcome the
      main limitation to nitric oxide use in pregnancy, which is tolerance and headaches. The most
      studied phosphodiesterase type 5 inhibitor is sildenafil citrate, which has previously shown
      promising outcomes both in vitro and in animal studies.

      That is why we decided to study the role of Sildenafil Citrate in expectant and conservative
      management of mild pre-eclampsia, as it has shown its ability to be beneficial to both the
      mother and the fetus through increasing the maternofetal circulation perfusion and achieving
      a maternal hemodynamic stability and compare it to the current NICE (National Institute for
      Health and Care Excellence) guidelines that are currently used, that recommends conservative
      management of mild pre-eclampsia through control of maternal blood pressure and frequent
      screening of maternal laboratory investigations' abnormalities to detect possible progression
      to severe pre-eclamptic toxemia.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: - Double blinded, randomized, placebo-controlled trial.
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: - It's a double blinded, randomized, placebo-controlled trial.
measure: Gestational age at time of termination and maternal outcome.
time frame: up to 37 weeks of gestation
description: Gestational age at time of termination and maternal outcome in terms of whether the disease would progress to severe pre-eclampsia or not.
measure: Neonatal outcome.
time frame: up to 37 weeks of gestation
description: Neonatal outcome in terms of survival and neonatal well-being ( by obtaining the birth weight and the apgar score at 1 and 5 minutes and direct postnatal need to NICU).
measure: Control of maternal blood pressure.
time frame: up to 37 weeks of gestation
description: Control of maternal blood pressure.
measure: Method of termination of pregnancy.
time frame: up to 37 weeks of gestation
description: Method of termination of pregnancy.
measure: Identification of the side effects from the use of sildenafil citrate.
time frame: up to 37 weeks of gestation
description: Identification of possible maternal side effects from the use of sildenafil citrate i.e.; headache, flushing and dyspepsia.
measure: Evaluation of the effect of sildenafil citrate on the feto-maternal circulation through the Doppler ultrasound.
time frame: up to 37 weeks of gestation
description: Evaluation of the effect of sildenafil citrate on the feto-maternal circulation through the Doppler ultrasound.
arm group label: Intervention Group
arm group type: Active Comparator
description: • The intervention group will be supplied with Sildenafil Citrate (Respatio® 20mg tablets manufactured by Pharma Right Group , Egypt) according to the patient's weight by the rate of (1.5 mg/kg/day) divided into three doses per day ( every 8 hours) till termination of pregnancy.
arm group label: Control Group
arm group type: Placebo Comparator
description: - The control group will be supplied with a placebo drug that has the same shape, size and color but without the active ingredient and it would also be taken in a similar way. The placebo tablet will be manufactured at the faculty of pharmacy, Assiut University.
intervention type: Drug
intervention name: Sildenafil 20 MG
arm group label: Intervention Group
other name: Sildenafil Citrate 20 mg ( Respatio® 20 mg)
intervention type: Drug
intervention name: Placebo Oral Tablet
arm group label: Control Group
other name: Placebo drug
criteria: 
gender: Female
gender based: Yes
gender description: Pregnant females
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: No
last name: Fady Abdallah
role: Principal Investigator
affiliation: Assiut University
last name: Hasan Kamel
role: Study Director
affiliation: Assiut University
last name: Hisham Abou-Taleb
role: Study Director
affiliation: Assiut University
last name: Fady Abdallah
phone: 00201002837042
email: fady.nasif@yahoo.com
last name: Hisham Abou-Taleb
phone: 00201003332139
email: hishamaboutaleb1@yahoo.com
facility: 
status: Recruiting
contact: 
country: Egypt
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responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Fady Nasef Tous Abdallah
investigator title: Resident of Obstetrics and Gynecology Department - Assiut University
mesh term: Eclampsia
mesh term: Pre-Eclampsia
mesh term: Sildenafil Citrate
sharing ipd: No
provided document: 