Sildenafil Citrate for the Management of Asymmetrical Intrauterine Growth Restriction

Intrauterine Growth Restriction Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02678221
• Other study ID #: SCIUGR
• Status: Not yet recruiting
• Phase: Phase 2
• First received: February 5, 2016
• Last updated: February 5, 2016
• Start date: February 2016
• Est. completion date: April 2017

Study information

• Verified date: February 2016
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Assiut Medical School Ethical Review Board
• Study type: Interventional

Clinical Trial Summary

Intrauterine growth restriction (IUGR) is defined as fetal abdominal circumference (AC) or estimated fetal weight (EFW) < 10th centile. In asymmetrical IUGR the parameter classically affected is the abdominal circumference (AC). Fetal growth restriction (FGR) complicates approximately 0.4% of pregnancies and severely increases the risk of perinatal morbidity and mortality. This is particularly due to premature delivery, both for fetal and for secondary maternal indications such as the development of pre-eclampsia.

Consequence of deficient uteroplacental blood flow, including IUGR, pre-eclampsia, and placental abruption have been implicated in more than 50% of iatrogenic premature births. For this reason, the problem of severe IUGR forms a substantial portion of the population that tertiary care centres care for.

The effect of early-onset IUGR is particularly significant: of those born alive, less than a third will survive their neonatal intensive care unit (NICU) stay without significant neurodevelopmental sequelae. Survival rates for severely growth-restricted fetuses very remote from term (<28 weeks' gestation) vary from 7% to 33%.

As these early-onset IUGR children are born very preterm, there are significant risks of neonatal mortality, major and minor morbidity, and long-term health sequelae.

The use of ultrasound Doppler waveform analysis in pregnancies complicated by IUGR suggests compromised uteroplacental circulation and placental hypoperfusion. Currently there are no specific evidence-based therapies for placental insufficiency and severe IUGR. Non-specific interventions include primarily lifestyle modifications, such as reducing or stopping work, stopping aerobic exercise, rest at home, and hospital admission for rest and surveillance. These interventions, which are not supported by evidence from randomized trials, are used in the belief that rest will enhance the uteroplacental circulation at the expense of that to the glutei and quadriceps muscles.

There is evidence from ex vivo and animal models of growth restriction that the phosphodiesterase 5 inhibitor sildenafil citrate increases average birth weight and improves uteroplacental blood flow (umbilical artery, uterine artery).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: April 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Pregnant Women = 28 wk

• Diagnosed as asymmetrical Intrauterine growth restriction

Exclusion Criteria:

• Severe preeclampsia

• Fetus with reversed umbilical artery end diastolic flow.

• Symmetrical Intrauterine growth restriction

• Diagnosed to have congenital anomalies.

• Diabetes mellitus with pregnancy.

• Patients with contraindication for the drugs given as gastric or duodenal ulcer,

• Twins pregnancy.

• Patients on antihypertensive or rheumatic heart disease

• Smokers.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fetal Growth Retardation
• Intrauterine Growth Restriction

Intervention

Drug:
• Sildenafil citrate

• Aspirin

Locations

Country	Name	City	State
Egypt	Faculty of Medicine	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The fetal weight by grams		1 year	Yes
Secondary	Doppler indices changes in umbilical artery and middle cerebral artery.		1 year	Yes
Secondary	Maternal blood pressure changes.		1 year	Yes
Secondary	Number of babies admitted to Pediatric Care Unit.		1 year	Yes