Sildenafil Citrate for the Management of Asymmetrical Intrauterine Growth Restriction
Primary Purpose
Intrauterine Growth Restriction
Status
Unknown status
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Sildenafil citrate
Aspirin
Sponsored by
About this trial
This is an interventional treatment trial for Intrauterine Growth Restriction
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.
Sites / Locations
- Faculty of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Other
Arm Label
Sildenafil citrate with Aspirin
placebo with Aspirin
Arm Description
will receive sildenafil citrate 20mg ̸ 8hours plus low dose aspirin 150mg/day
will receive placebo plus low dose aspirin 150mg/day
Outcomes
Primary Outcome Measures
The fetal weight by grams
Secondary Outcome Measures
Doppler indices changes in umbilical artery and middle cerebral artery.
Maternal blood pressure changes.
Number of babies admitted to Pediatric Care Unit.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02678221
Brief Title
Sildenafil Citrate for the Management of Asymmetrical Intrauterine Growth Restriction
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Unknown status
Study Start Date
February 2016 (undefined)
Primary Completion Date
February 2017 (Anticipated)
Study Completion Date
April 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intrauterine Growth Restriction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sildenafil citrate with Aspirin
Arm Type
Active Comparator
Arm Description
will receive sildenafil citrate 20mg ̸ 8hours plus low dose aspirin 150mg/day
Arm Title
placebo with Aspirin
Arm Type
Other
Arm Description
will receive placebo plus low dose aspirin 150mg/day
Intervention Type
Drug
Intervention Name(s)
Sildenafil citrate
Intervention Type
Drug
Intervention Name(s)
Aspirin
Primary Outcome Measure Information:
Title
The fetal weight by grams
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Doppler indices changes in umbilical artery and middle cerebral artery.
Time Frame
1 year
Title
Maternal blood pressure changes.
Time Frame
1 year
Title
Number of babies admitted to Pediatric Care Unit.
Time Frame
1 year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Faculty of Medicine
City
Assiut
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Sildenafil Citrate for the Management of Asymmetrical Intrauterine Growth Restriction
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