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Sildenafil in Sever Intrauterine Growth Retardation (IUGR)

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ClinicalTrials.gov Identifier: NCT03153215
Recruitment Status : Completed
First Posted : May 15, 2017
Last Update Posted : July 10, 2018
Sponsor:
Collaborator:
Cairo University
Information provided by (Responsible Party):
Nesreen Abdel Fattah Abdullah Shehata, Beni-Suef University

Brief Summary:
Severe fetal growth restriction (FGR) complicates approximately 0.4% of pregnancies and severely increases the risk of perinatal morbidity and mortality.Sildenafil citrate may offer a potential therapeutic strategy to improve uteroplacental blood flow in IUGR pregnancies.

Condition or disease Intervention/treatment Phase
Intra-Uterine Growth Retardation Other: treatment Other: Placebo Not Applicable

Detailed Description:

The aim of our study is to evaluate the effect of sildenafil citrate therapy on severe early and late onset intrauterine growth retardation.A total of 46 patients with severe early onset intrauterine growth retardation will be enrolled in a prospective case control study .

Patients will randomly be allocated to two groups with 23 patients in each group.Sildenafil citrate therapy may increase the likelihood of increased growth velocity [measured by abdominal circumference (AC) (ultrasound)] for fetuses of pregnancies complicated by severe early-onset IUGR .Sildenafil is a potent and selective inhibitor of cGMP-specific phosphodiesterase type 5 (PDE5), which is responsible for degradation of cGMP which results in increased levels of cGMP, leading to smooth muscle relaxation. Placental disease, consequent on deficient uteroplacental blood flow, includes FGR, pre-eclampsia, and placental abruption and has been implicated in more than 50% of iatrogenic premature births .For this reason, the problem of severe FGR forms a substantial portion of the population that tertiary care centres care.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

A total of 46 patients with severe early onset intrauterine growth retardation will be enrolled in a randomized placebo control controlled study .

Patients will randomly be allocated to two groups with 23 patients in each group

Masking: Double (Participant, Investigator)
Masking Description: Patients will randomly be allocated to two groups with 23 patients in each group
Primary Purpose: Other
Official Title: Evaluation of Addition of Sildenafil Citrate for Treatment of Severe Intrauterine Growth Restriction
Actual Study Start Date : May 6, 2017
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : December 31, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Intervention group
women with severe IUGR
Other: treatment
We will offer Sildenafil citrate (20 mg per os three times daily until delivery) as innovative therapy to 23 women with severe IUGR ('Sildenafil-treated') in addition to fish oil and zinc supplementation.

Active Comparator: Control group
women with severe IUGR
Other: Placebo
Placebo tablets similar to Sildenafil will be given to control group in addition to fish oil and zinc supplementation.




Primary Outcome Measures :
  1. Umbilical artery Pulsatility index [ Time Frame: between 24 gestational weeks until 36 weeks ]
    Change in umbilical artery pulsatility index after medication

  2. Middle cerebral artery Pulsatility index [ Time Frame: between 24 gestational weeks until 36 weeks ]
    Change in middle cerebral artery pulsatility index after medication

  3. fetal abdominal circumference growth velocity [ Time Frame: between 24 gestational weeks until 36 weeks ]
    proportion of women in each group for whom fetal AC growth velocity will change post randomization.


Secondary Outcome Measures :
  1. Rate of drug side effects [ Time Frame: between 24 and 36 gestational weeks ]
    Women in the Sildenafil-treated group will be also monitored for adverse side-effects, such as flushing, lightheadedness and visual disturbance

  2. Birth weight [ Time Frame: between 24 and 36 gestational weeks ]
    weight of neonate at birth in grams



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Ages Eligible for Study:   25 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

• pregnancy complicated by severe IUGR [abdominal circumference (AC)< 5th percentile] the gestational age <25 weeks or an estimate of the fetal weight was <600 gm (excluding known fetal anomaly/syndrome and/or planned termination) ( von Dadelszen.et al;2011).

Exclusion Criteria:

  • known aneuploid anomaly, syndrome congenital infection.
  • If there is a plan to terminate the pregnancy.

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): NCT03153215


Locations
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Egypt
Beni-Suef University
Cairo, Beni-Suef, Egypt, 12412
Sponsors and Collaborators
Beni-Suef University
Cairo University
Investigators
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Principal Investigator: Nesreen A Shehata, MD Beni-Suef University

Publications:
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Responsible Party: Nesreen Abdel Fattah Abdullah Shehata, Assistant Professor of Obstetrics and Gynecology, Beni-Suef University
ClinicalTrials.gov Identifier: NCT03153215     History of Changes
Other Study ID Numbers: Beni-Suef 12
First Posted: May 15, 2017    Key Record Dates
Last Update Posted: July 10, 2018
Last Verified: July 2018
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
Additional relevant MeSH terms:
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Fetal Growth Retardation
Fetal Diseases
Pregnancy Complications
Growth Disorders
Pathologic Processes
Sildenafil Citrate
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents