Sildenafil Citrate for the Management of Asymmetrical Intrauterine Growth Restriction

NCT ID: NCT02678221

Last Updated: 2016-02-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2017-04-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Sildenafil citrate with Aspirin

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

Group Type: ACTIVE_COMPARATOR

Sildenafil citrate

Intervention Type: DRUG

Aspirin

Intervention Type: DRUG

placebo with Aspirin

will receive placebo plus low dose aspirin 150mg/day

Group Type: OTHER

Aspirin

Intervention Type: DRUG

Interventions

Sildenafil citrate

Intervention Type: DRUG

Aspirin

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Omar Mamdouh Shaaban

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of Medicine

Asyut, Asyut Governorate, Egypt

Countries

Egypt

Other Identifiers

SCIUGR

Identifier Type: -

Identifier Source: org_study_id