Sildenafil in Sever Intrauterine Growth Retardation

Not Applicable

Completed

• Conditions: Intra-Uterine Growth Retardation
• Interventions: Other: treatment; Other: Placebo

• Registration Number: NCT03153215
• Lead Sponsor: Beni-Suef University

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.

Study Timeline

• Study First Submitted: 2017-05-05
• Study Start: 2017-05-06
• Study First Submitted QC: 2017-05-12
• Study First Posted: 2017-05-15
• Primary Completion: 2017-12-31
• Study Completion: 2017-12-31
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-06
• Last Update Posted: 2018-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 46

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	treatment	women with severe IUGR
Control group	Placebo	women with severe IUGR

Primary Outcome Measures

Name	Time	Method
Middle cerebral artery Pulsatility index	between 24 gestational weeks until 36 weeks	Change in middle cerebral artery pulsatility index after medication
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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Beni-Suef University; 🇪🇬 Cairo, Beni-Suef, Egypt