Sildenafil Citrate for the Management of Asymmetrical Intrauterine Growth Restriction

NCT02678221 | Unknown Phase 2

• 1 other identifier: SCIUGR
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Intrauterine Growth Restriction

Outcome Measures

Primary Outcomes (1)

• The fetal weight by grams

  1 year

Secondary Outcomes (3)

• Doppler indices changes in umbilical artery and middle cerebral artery.

  1 year

• Maternal blood pressure changes.

  1 year

• Number of babies admitted to Pediatric Care Unit.

  1 year

Study Arms (2)

Sildenafil citrate with Aspirin

ACTIVE COMPARATOR

will receive sildenafil citrate 20mg ̸ 8hours plus low dose aspirin 150mg/day

Drug: Sildenafil citrate; Drug: Aspirin

placebo with Aspirin

OTHER

will receive placebo plus low dose aspirin 150mg/day

Drug: Aspirin

Interventions

Sildenafil citrate DRUG

Sildenafil citrate with Aspirin

Aspirin DRUG

Sildenafil citrate with Aspirin; placebo with Aspirin

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant Women ≥ 28 wk
• Diagnosed as asymmetrical Intrauterine growth restriction

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Faculty of Medicine

Asyut, Asyut Governorate, Egypt

Location

MeSH Terms

Conditions

Fetal Growth Retardation

Interventions

Sildenafil Citrate; Aspirin

Condition Hierarchy (Ancestors)

Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: February 5, 2016
• First Posted: February 9, 2016
• Study Start: February 1, 2016
• Primary Completion: February 1, 2017
• Study Completion: April 1, 2017
• Last Updated: February 9, 2016

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)