Sildenafil in Sever Intrauterine Growth Retardation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-06

Study Completion Date

2017-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Intra-Uterine Growth Retardation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Patients will randomly be allocated to two groups with 23 patients in each group

Study Groups

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Intervention group

women with severe IUGR

Group Type ACTIVE_COMPARATOR

treatment

Intervention Type 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.

Control group

women with severe IUGR

Group Type ACTIVE_COMPARATOR

Placebo

Intervention Type OTHER

Placebo tablets similar to Sildenafil will be given to control group in addition to fish oil and zinc supplementation.

Interventions

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treatment

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.

Intervention Type OTHER

Placebo

Placebo tablets similar to Sildenafil will be given to control group in addition to fish oil and zinc supplementation.

Intervention Type OTHER

Eligibility Criteria

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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).