Intra-Uterine Growth Retardation
Conditions
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.
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.
Interventions
OTHERtreatment
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.
OTHERPlacebo
Placebo tablets similar to Sildenafil will be given to control group in addition to fish oil and zinc supplementation.
Sponsors
Cairo University
Beni-Suef University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Masking description
Patients will randomly be allocated to two groups with 23 patients in each group
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
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 40 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| fetal abdominal circumference growth velocity | between 24 gestational weeks until 36 weeks | proportion of women in each group for whom fetal AC growth velocity will change post randomization. |
| Umbilical artery Pulsatility index | between 24 gestational weeks until 36 weeks | Change in umbilical artery pulsatility index after medication |
| Middle cerebral artery Pulsatility index | between 24 gestational weeks until 36 weeks | Change in middle cerebral artery pulsatility index after medication |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of drug side effects | 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 | between 24 and 36 gestational weeks | weight of neonate at birth in grams |
Countries
Egypt
Outcome results
None listed