Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06565728
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-07-14
Brief Title:
Vitamin D Versus Sildenafil Citrate in Fetal Growth Restriction
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Comparative Study of the Role of Vitamin D Supplementation Versus Sildenafil Citrate in Patients Diagnosed With Fetal Growth Restriction Randomized Control Trial
Status:
COMPLETED
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Fetal growth restriction also named Intrauterine growth restriction is a prevalent disease in pregnancy it is a descriptive term for a pathological process and can be described as the process where a fetus who has a certain growth potential based on genetic criteria is limited in its growth because of a pathological environmental influence
Detailed Description:
Fetal or Intrauterine growth restriction describes a pathological condition in which the fetus fails to grow to its biological potential because of poor placental function both American society of obstetrics and gynecology of and Royal college of obstetrics and gynecology have adopted the definition of Intrauterine growth restriction as estimated fetal weight is less than 10th percentile
It is a multifaceted problem that increases the risk of hypoxemia acidemia preterm deaths and maternal distress and disposes the infant to a number of metabolic disorders polycythemia lung problems intraventricular hemorrhage cognitive dysfunction and cerebral palsy which occur in both term and preterm infants
Vitamin D deficiency is highly prevalent among pregnant women not only vitamin D deficiency during pregnancy causes maternal and fetal side effects it also increases the risk of preeclampsia gestational diabetes preterm birth and birth of a child younger than small for gestational age inadequate fetal immune system wheezing and eczema and risk of respiratory infections in the infants
Vitamin D is a transcriptional regulator of endothelial NO synthase effectively increasing the production of NO the most potent vasodilator within the vasculature previous Studies showed that the vitamin-D receptors play a critical role in maintaining vascular health and this assumption was supported by data Showing reduced NO production
It was suggested that vitamin D improves vascular function via reducing the production of NO-scavenging oxygen radicals and subsequently improving NO bioavailability and maintain vascular health
Vitamin D level during the pregnancy in women with low-birth-weight infants was significantly lower than its level in other women It was eventually found that vitamin D level in pregnancy was effective in bone metabolism and growth process of the fetus
Vitamin D deficiency during pregnancy causes potentially harmful implications in the mother and the fetus Several studies have referred to the relationship between vitamin D deficiency and the incidence of intrauterine growth retardation
Some studies have shown that increasing the amount of 25-hydroxy vitamin D in the bloodstream before and during pregnancy contributes to nesting and causes stability in pregnancy as well as increased calcium uptake required for fetal growth and development
Studies have also indicated that the decreased expression of vitamin D receptors results in functional impairment and limitation in the beneficial effects of vitamin D in regulating the fetus-placental growth
Maternal vitamin D deficiency was observed in all pathological pregnancies with a decrease in the staining levels of placental vitamin D receptor in intrauterine growth retardation And severe vitamin D deficiency may play an important role in placental inflammation which in turn may lead to a higher risk of intrauterine growth retardation and other neonatal side effects
Vitamin D supplementation doses should be 1500-2000 IUday necessary for maintaining 25OHD serum level above 30 ngmL currently available studies seem to recommend starting prophylaxis with vitamin D at the beginning of the pregnancy to be continued throughout the entire pregnancy and during lactation
The standard options for management of intrauterine growth retardation are expectant management till pregnancy termination This involves modification of maternal lifestyle together with fetal surveillance since impaired placental circulation is a major cause vasodilators may have their role
Sildenafil citrate trade name Revatio Viagra Respatio etc was emerged as a drug helping vasodilation which may represent an effective intervention for intrauterine growth retardation pregnancies with dose of 20 mg once daily Studies showed that mean birth weight at delivery was increased significantly with sildenafil usage Of course this had its value in decreasing admission to the newborn nursery unit
Sildenafil citrate treatment may present a new hope towards better perinatal outcomes for pregnancies complicated by intrauterine growth retardation that may help to decrease neonatal admission to newborn nursery
Sildenafil citrate induces vasodilation through inhibition of type 5 phosphodiesterase PDE5 which is responsible for the degradation of cGMP to guanosine monophosphate Therefore inhibiting PDE5 delays the breakdown of cGMP and increases vasodilation
It is a multifaceted problem that increases the risk of hypoxemia acidemia preterm deaths and maternal distress and disposes the infant to a number of metabolic disorders polycythemia lung problems intraventricular hemorrhage cognitive dysfunction and cerebral palsy which occur in both term and preterm infants
Vitamin D deficiency is highly prevalent among pregnant women not only vitamin D deficiency during pregnancy causes maternal and fetal side effects it also increases the risk of preeclampsia gestational diabetes preterm birth and birth of a child younger than small for gestational age inadequate fetal immune system wheezing and eczema and risk of respiratory infections in the infants
Vitamin D is a transcriptional regulator of endothelial NO synthase effectively increasing the production of NO the most potent vasodilator within the vasculature previous Studies showed that the vitamin-D receptors play a critical role in maintaining vascular health and this assumption was supported by data Showing reduced NO production
It was suggested that vitamin D improves vascular function via reducing the production of NO-scavenging oxygen radicals and subsequently improving NO bioavailability and maintain vascular health
Vitamin D level during the pregnancy in women with low-birth-weight infants was significantly lower than its level in other women It was eventually found that vitamin D level in pregnancy was effective in bone metabolism and growth process of the fetus
Vitamin D deficiency during pregnancy causes potentially harmful implications in the mother and the fetus Several studies have referred to the relationship between vitamin D deficiency and the incidence of intrauterine growth retardation
Some studies have shown that increasing the amount of 25-hydroxy vitamin D in the bloodstream before and during pregnancy contributes to nesting and causes stability in pregnancy as well as increased calcium uptake required for fetal growth and development
Studies have also indicated that the decreased expression of vitamin D receptors results in functional impairment and limitation in the beneficial effects of vitamin D in regulating the fetus-placental growth
Maternal vitamin D deficiency was observed in all pathological pregnancies with a decrease in the staining levels of placental vitamin D receptor in intrauterine growth retardation And severe vitamin D deficiency may play an important role in placental inflammation which in turn may lead to a higher risk of intrauterine growth retardation and other neonatal side effects
Vitamin D supplementation doses should be 1500-2000 IUday necessary for maintaining 25OHD serum level above 30 ngmL currently available studies seem to recommend starting prophylaxis with vitamin D at the beginning of the pregnancy to be continued throughout the entire pregnancy and during lactation
The standard options for management of intrauterine growth retardation are expectant management till pregnancy termination This involves modification of maternal lifestyle together with fetal surveillance since impaired placental circulation is a major cause vasodilators may have their role
Sildenafil citrate trade name Revatio Viagra Respatio etc was emerged as a drug helping vasodilation which may represent an effective intervention for intrauterine growth retardation pregnancies with dose of 20 mg once daily Studies showed that mean birth weight at delivery was increased significantly with sildenafil usage Of course this had its value in decreasing admission to the newborn nursery unit
Sildenafil citrate treatment may present a new hope towards better perinatal outcomes for pregnancies complicated by intrauterine growth retardation that may help to decrease neonatal admission to newborn nursery
Sildenafil citrate induces vasodilation through inhibition of type 5 phosphodiesterase PDE5 which is responsible for the degradation of cGMP to guanosine monophosphate Therefore inhibiting PDE5 delays the breakdown of cGMP and increases vasodilation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None