Clinical trial NCT03153215: Sildenafil in Sever Intrauterine Growth Retardation
Official title: Evaluation of Addition of Sildenafil Citrate for Treatment of Severe Intrauterine Growth Restriction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intra-Uterine Growth Retardation
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
Collaborators: name: Cairo University
First posted: 2017-05-15
Enrollment: 46
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Umbilical artery Pulsatility index
timeFrame: between 24 gestational weeks until 36 weeks
measure: Middle cerebral artery Pulsatility index
timeFrame: between 24 gestational weeks until 36 weeks
measure: fetal abdominal circumference growth velocity
timeFrame: between 24 gestational weeks until 36 weeks
Secondary outcomes:
measure: Rate of drug side effects
timeFrame: between 24 and 36 gestational weeks
measure: Birth weight
timeFrame: between 24 and 36 gestational weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Beni-Suef University
state: Beni-Suef
Study officials:
affiliation: Beni-Suef University
name: Nesreen A Shehata, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.