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Use of Sildenafil Citrate in Management of Mild Pre-eclampsia

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ClinicalTrials.gov Identifier: NCT03262961
Recruitment Status : Unknown
Verified August 2017 by Fady Nasef Tous Abdallah, Assiut University.
Recruitment status was:  Recruiting
First Posted : August 28, 2017
Last Update Posted : August 28, 2017
Sponsor:
Information provided by (Responsible Party):
Fady Nasef Tous Abdallah, Assiut University

Study Description
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Brief Summary:
  • 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.

Condition or disease Intervention/treatment Phase
Pre-Eclampsia; Mild Drug: Sildenafil 20 MG Drug: Placebo Oral Tablet Phase 2 Phase 3

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Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: - Double blinded, randomized, placebo-controlled trial.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: - It's a double blinded, randomized, placebo-controlled trial.
Primary Purpose: Treatment
Official Title: Use of Sildenafil Citrate in Management of Mild Pre-eclampsia: A Randomized Controlled Trial
Actual Study Start Date : September 15, 2016
Estimated Primary Completion Date : December 15, 2017
Estimated Study Completion Date : January 15, 2018

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Intervention Group
• 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.
 Drug: Sildenafil 20 MG
Other Name: Sildenafil Citrate 20 mg ( Respatio® 20 mg)
Placebo Comparator: Control Group
- 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.
 Drug: Placebo Oral Tablet
Other Name: Placebo drug


Outcome Measures
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Primary Outcome Measures :
  1. Gestational age at time of termination and maternal outcome. [ Time Frame: up to 37 weeks of gestation ]
    Gestational age at time of termination and maternal outcome in terms of whether the disease would progress to severe pre-eclampsia or not.


Secondary Outcome Measures :
  1. Neonatal outcome. [ Time Frame: up to 37 weeks of gestation ]
    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).

  2. Control of maternal blood pressure. [ Time Frame: up to 37 weeks of gestation ]
    Control of maternal blood pressure.

  3. Method of termination of pregnancy. [ Time Frame: up to 37 weeks of gestation ]
    Method of termination of pregnancy.

  4. Identification of the side effects from the use of sildenafil citrate. [ Time Frame: up to 37 weeks of gestation ]
    Identification of possible maternal side effects from the use of sildenafil citrate i.e.; headache, flushing and dyspepsia.

  5. Evaluation of the effect of sildenafil citrate on the feto-maternal circulation through the Doppler ultrasound. [ Time Frame: up to 37 weeks of gestation ]
    Evaluation of the effect of sildenafil citrate on the feto-maternal circulation through the Doppler ultrasound.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Pregnant females
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Uncomplicated mild pre-eclampsia; No clinical or investigatory findings suggestive severe pre-eclamptic toxemia.
  2. Gestational age of 28 - 36 weeks by good dates according to ACOG's - committee on obstetric practice - Method for Estimating Due Date (2014) who will receive the study's drug for at least one week before termination.
  3. Singleton viable pregnancy.
  4. Age: 18-35 years.

Exclusion Criteria:

  1. Severe pre-eclamptic toxemia (according to the NICE guidelines (2010): Hypertension in pregnancy: diagnosis and management)
  2. Intrauterine growth retardation.
  3. Use of medication that could interact with sildenafil citrate such as nitrates erythromycin, ketoconazole, itraconazole, antiretroviral agents and others.
  4. Presence of maternal co-morbidity disease as: DM, chronic hypertension, congestive heart failure, chronic kidney disease and SLE.
  5. Placenta previa.
  6. The patient is using aspirin.

  7. The presence of a contraindication to the use of sildenafil citrate:

    • Hypersensitivity to sildenafil citrate or any of the tablet ingredients.
    • Patients with severe cardiovascular disease such as established cardiac failure and unstable angina pectoris.
    • Previous episode of non-arteritic anterior ischaemic optic neuropathy.
    • Severe hepatic impairment.
    • Hypotension (blood pressure <90/50 mmHg).
    • Hypertension (blood pressure >170/110 mmHg).
    • Recent history of stroke or myocardial infarction.
    • Known hereditary degenerative retinal disorders such as retinitis pigmentosa.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03262961


Contacts
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Contact: Fady Abdallah 00201002837042 fady.nasif@yahoo.com
Contact: Hisham Abou-Taleb 00201003332139 hishamaboutaleb1@yahoo.com

Locations
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Egypt
Assiut Univeristy Hospitals Recruiting
Assiut, Egypt, 71111
Contact: Abdallah Hamed    01002621430    obste.gyne_aun@yahoo.com   
Sponsors and Collaborators
Assiut University
Investigators
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Principal Investigator: Fady Abdallah Assiut University
Study Director: Hasan Kamel Assiut University
Study Director: Hisham Abou-Taleb Assiut University
  Study Documents (Full-Text)

Documents provided by Fady Nasef Tous Abdallah, Assiut University:
Study Protocol and Statistical Analysis Plan  [PDF] September 1, 2016

More Information
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Publications of Results:

Other Publications:
El-Moselhy, E; Khalifa, H; Amer, S (2011). "Risk Factors and Impacts of Pre-Eclampsia: An Epidemiological Study among Pregnant Mothers in Cairo, Egypt" J Am Sci 7(5): 311-323.
Matt H, Nigel J. (2016) "Renal disease in pregnancy" ;Obstet Gynaecol Reprod Med; 26:46-52

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Responsible Party: Fady Nasef Tous Abdallah, Resident of Obstetrics and Gynecology Department - Assiut University, Assiut University
ClinicalTrials.gov Identifier: NCT03262961     History of Changes
Other Study ID Numbers: assiutu252
First Posted: August 28, 2017    Key Record Dates
Last Update Posted: August 28, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Fady Nasef Tous Abdallah, Assiut University:
Mild pre-eclampsia Sildenafil Citrate
Additional relevant MeSH terms:
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Eclampsia
Pre-Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications
Sildenafil Citrate
Citric Acid
Sodium Citrate
Anticoagulants
Calcium Chelating Agents
 Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Urological Agents