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
|Condition or disease||Intervention/treatment||Phase|
|Intra-Uterine Growth Retardation||Other: treatment Other: Placebo||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||46 participants|
|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|
|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|
Active Comparator: Intervention group
women with severe IUGR
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
Placebo tablets similar to Sildenafil will be given to control group in addition to fish oil and zinc supplementation.
- Umbilical artery Pulsatility index [ Time Frame: between 24 gestational weeks until 36 weeks ]Change in umbilical artery pulsatility index after medication
- Middle cerebral artery Pulsatility index [ Time Frame: between 24 gestational weeks until 36 weeks ]Change in middle cerebral artery pulsatility index after medication
- 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.
- 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
- Birth weight [ Time Frame: between 24 and 36 gestational weeks ]weight of neonate at birth in grams
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
|Cairo, Beni-Suef, Egypt, 12412|
|Principal Investigator:||Nesreen A Shehata, MD||Beni-Suef University|