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Sildenafil Citrate for the Management of Asymmetrical Intrauterine Growth Restriction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02678221
Recruitment Status : Unknown
Verified February 2016 by Omar Mamdouh Shaaban, Assiut University.
Recruitment status was:  Not yet recruiting
First Posted : February 9, 2016
Last Update Posted : February 9, 2016
Sponsor:
Information provided by (Responsible Party):
Omar Mamdouh Shaaban, Assiut University

Brief Summary:

Intrauterine growth restriction (IUGR) is defined as fetal abdominal circumference (AC) or estimated fetal weight (EFW) < 10th centile. In asymmetrical IUGR the parameter classically affected is the abdominal circumference (AC). Fetal growth restriction (FGR) complicates approximately 0.4% of pregnancies and severely increases the risk of perinatal morbidity and mortality. This is particularly due to premature delivery, both for fetal and for secondary maternal indications such as the development of pre-eclampsia.

Consequence of deficient uteroplacental blood flow, including IUGR, pre-eclampsia, and placental abruption have been implicated in more than 50% of iatrogenic premature births. For this reason, the problem of severe IUGR forms a substantial portion of the population that tertiary care centres care for.

The effect of early-onset IUGR is particularly significant: of those born alive, less than a third will survive their neonatal intensive care unit (NICU) stay without significant neurodevelopmental sequelae. Survival rates for severely growth-restricted fetuses very remote from term (<28 weeks' gestation) vary from 7% to 33%.

As these early-onset IUGR children are born very preterm, there are significant risks of neonatal mortality, major and minor morbidity, and long-term health sequelae.

The use of ultrasound Doppler waveform analysis in pregnancies complicated by IUGR suggests compromised uteroplacental circulation and placental hypoperfusion. Currently there are no specific evidence-based therapies for placental insufficiency and severe IUGR. Non-specific interventions include primarily lifestyle modifications, such as reducing or stopping work, stopping aerobic exercise, rest at home, and hospital admission for rest and surveillance. These interventions, which are not supported by evidence from randomized trials, are used in the belief that rest will enhance the uteroplacental circulation at the expense of that to the glutei and quadriceps muscles.

There is evidence from ex vivo and animal models of growth restriction that the phosphodiesterase 5 inhibitor sildenafil citrate increases average birth weight and improves uteroplacental blood flow (umbilical artery, uterine artery).


Condition or disease Intervention/treatment Phase
Intrauterine Growth Restriction Drug: Sildenafil citrate Drug: Aspirin Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Study Start Date : February 2016
Estimated Primary Completion Date : February 2017
Estimated Study Completion Date : April 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Sildenafil citrate with Aspirin
will receive sildenafil citrate 20mg ̸ 8hours plus low dose aspirin 150mg/day
Drug: Sildenafil citrate
Drug: Aspirin
placebo with Aspirin
will receive placebo plus low dose aspirin 150mg/day
Drug: Aspirin



Primary Outcome Measures :
  1. The fetal weight by grams [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Doppler indices changes in umbilical artery and middle cerebral artery. [ Time Frame: 1 year ]
  2. Maternal blood pressure changes. [ Time Frame: 1 year ]
  3. Number of babies admitted to Pediatric Care Unit. [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pregnant Women ≥ 28 wk
  • Diagnosed as asymmetrical Intrauterine growth restriction

Exclusion Criteria:

  • Severe preeclampsia
  • Fetus with reversed umbilical artery end diastolic flow.
  • Symmetrical Intrauterine growth restriction
  • Diagnosed to have congenital anomalies.
  • Diabetes mellitus with pregnancy.
  • Patients with contraindication for the drugs given as gastric or duodenal ulcer,
  • Twins pregnancy.
  • Patients on antihypertensive or rheumatic heart disease
  • Smokers.

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): NCT02678221


Locations
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Egypt
Faculty of Medicine
Assiut, Egypt
Sponsors and Collaborators
Assiut University
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Responsible Party: Omar Mamdouh Shaaban, Dr, Assiut University
ClinicalTrials.gov Identifier: NCT02678221    
Other Study ID Numbers: SCIUGR
First Posted: February 9, 2016    Key Record Dates
Last Update Posted: February 9, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Additional relevant MeSH terms:
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Fetal Growth Retardation
Fetal Diseases
Pregnancy Complications
Growth Disorders
Pathologic Processes
Aspirin
Sildenafil Citrate
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Urological Agents