Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Cairo University | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Active Comparator | women with severe IUGR |
|
| Control group | Active Comparator | women with severe IUGR |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| treatment | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Umbilical artery Pulsatility index | Change in umbilical artery pulsatility index after medication | between 24 gestational weeks until 36 weeks |
| Middle cerebral artery Pulsatility index | Change in middle cerebral artery pulsatility index after medication | between 24 gestational weeks until 36 weeks |
| fetal abdominal circumference growth velocity | proportion of women in each group for whom fetal AC growth velocity will change post randomization. | between 24 gestational weeks until 36 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of drug side effects | Women in the Sildenafil-treated group will be also monitored for adverse side-effects, such as flushing, lightheadedness and visual disturbance | between 24 and 36 gestational weeks |
| Birth weight |
Not provided
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:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Nesreen A Shehata, MD | Beni-Suef University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beni-Suef University | Cairo | Beni Suweif Governorate | 12412 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17014813 | Background | Ananth CV, Vintzileos AM. Maternal-fetal conditions necessitating a medical intervention resulting in preterm birth. Am J Obstet Gynecol. 2006 Dec;195(6):1557-63. doi: 10.1016/j.ajog.2006.05.021. Epub 2006 Oct 2. | |
| 24007710 | Background | Lausman A, Kingdom J; MATERNAL FETAL MEDICINE COMMITTEE. Intrauterine growth restriction: screening, diagnosis, and management. J Obstet Gynaecol Can. 2013 Aug;35(8):741-748. doi: 10.1016/S1701-2163(15)30865-3. English, French. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D013812 | Therapeutics |
Not provided
Not provided
Not provided
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
Not provided
Not provided
Patients will randomly be allocated to two groups with 23 patients in each group
| Placebo | Other | Placebo tablets similar to Sildenafil will be given to control group in addition to fish oil and zinc supplementation. |
|
weight of neonate at birth in grams
| between 24 and 36 gestational weeks |
| 11594552 | Background | Lee MJ, Conner EL, Charafeddine L, Woods JR Jr, Del Priore G. A critical birth weight and other determinants of survival for infants with severe intrauterine growth restriction. Ann N Y Acad Sci. 2001 Sep;943:326-39. doi: 10.1111/j.1749-6632.2001.tb03813.x. |