Skip to main content
OpenTrials
Completed

NCT Number: NCT03153215

Sildenafil in Sever Intrauterine Growth Retardation

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

25 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Beni-Suef University

Cairo, Beni Suweif Governorate, 12412, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Placebo

Other

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

Primary outcomes

  1. Umbilical artery Pulsatility index

    Time frame: between 24 gestational weeks until 36 weeks

    Change in umbilical artery pulsatility index after medication

  2. Middle cerebral artery Pulsatility index

    Time frame: between 24 gestational weeks until 36 weeks

    Change in middle cerebral artery pulsatility index after medication

  3. fetal abdominal circumference growth velocity

    Time frame: between 24 gestational weeks until 36 weeks

    proportion of women in each group for whom fetal AC growth velocity will change post randomization.

Secondary outcomes

  1. Rate of drug side effects

    Time frame: 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

  2. Birth weight

    Time frame: between 24 and 36 gestational weeks

    weight of neonate at birth in grams

Sponsors and collaborators

Lead sponsor

Beni-Suef University

Other

Collaborators

  • Cairo University

Registry information

Official study title

Evaluation of Addition of Sildenafil Citrate for Treatment of Severe Intrauterine Growth Restriction

Acronym: IUGR

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
May 15, 2017
Registry last updated
Jul 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.