Sildenafil Citrate for the Management of Asymmetrical Intrauterine Growth Restriction
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|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
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Study Start Date :||February 2016|
|Estimated Primary Completion Date :||February 2017|
|Estimated Study Completion Date :||April 2017|
Active Comparator: Sildenafil citrate with Aspirin
will receive sildenafil citrate 20mg ̸ 8hours plus low dose aspirin 150mg/day
Drug: Sildenafil citrate
placebo with Aspirin
will receive placebo plus low dose aspirin 150mg/day
- The fetal weight by grams [ Time Frame: 1 year ]
- Doppler indices changes in umbilical artery and middle cerebral artery. [ Time Frame: 1 year ]
- Maternal blood pressure changes. [ Time Frame: 1 year ]
- Number of babies admitted to Pediatric Care Unit. [ Time Frame: 1 year ]
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
|Faculty of Medicine|