L-arginine in Treatment of Intrauterine Growth Restriction

Study Overview
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Brief Summary
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Intrauterine growth restriction is an important problem in neonatal care. Intrauterine growth restriction (IUGR) is defined as a fetal weight below the 10th percentile for gestational age. One of the main causes of IUGR is placental insufficiency. Nitric oxide(NO) increases placental blood flow. So,it might be useful to improve IUGR pregnancy outcome .

Detailed Description
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The study population includes pregnant women attending Antenatal care clinic of Ain Shams University Maternity Hospital who first time diagnosed of IUGR at our antenatal care outpatient clinic either referred for this cause After confirm diagnosis of IUGR and distributing patient into two groups Patient in first group will receive oral L-arginine 3000mg/day till delivery and Acetylesalicylic acid 75mg once daily. Patients in second group will receive Acetylesalicylic acid 75mg once daily. then follow up of both group by: Daily fetal movement counting Day after day CTG Doppler twice weekly Pelvic u/s weekly for: A) Head circumference, Abdominal circumference, femur length B) Fetal weight C) Liquor amount: Amniotic Fluid Index Or MeanVertical Pocket Decision of delivery will be determined when: A) Fetal distress (non stress CTG) B) Mother starts labour C) Reversed umbilical artery Doppler.

Official Title
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Effect of L-Arginine on Intrauterine Growth Restriction Fetuses Measured by Birth Weight: Randomized Controlled Trial

Conditions
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Intrauterine Growth Restriction Asymmetrical

Intervention / Treatment
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* Drug: L-arginine 1000 mg and Acetylesalicylic acid75mg
* Drug: acetylsalicylic acid 75 mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All pregnant women diagnosed with IUGR from 28 weeks Singleton pregnancy No maternal systemic disease No congenital fetal malformation Estimated fetal weight below 10th percentile Exclusion Criteria: All pregnant woman diagnosed with IUGR before 28 weeks Multiple pregnancy Maternal systemic disease Congenital fetal malformation

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Group(A) 130 pregnant women diagnosed with IUGR will receive L-arginine and Acetylesalicylic acid 75mg Group(B) 130 pregnant women diagnosed with IUGR will receive Acetylesalicylic acid 75mg
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: L-arginine and Acetylesalicylic acid<br>L-arginine 1000mg capsules( manufactured by Putriant Pride,INC Holbrook,NY 11741 U.S.A.) every 8 hours Acetylesalicylic acid 75 mg tablet(manufactured by Multi_Apex Pharma , Egypt) once daily will be given for patients of group A starting from diagnosis till birth | Drug: L-arginine 1000 mg and Acetylesalicylic acid75mg<br>* l-arginine 1000mg capsule will be given every 8 hours till delivery and acetylesalicylic acid75mg tablet once starting of diagnosis till birth.<br>* Other names: L- arginine 1000mg capsule and Ezacard 75 mg tablet;|
| Active Comparator: Acetylesalicylic acid75mg<br>acetylsalicylic acid 75 mg tablet(manufactured by Multi_Apex Pharma , Egypt) orally once daily will be given for patients of group B starting from diagnosis till birth | Drug: acetylsalicylic acid 75 mg<br>* acetylsalicylic acid 75 mg will be given orally once daily for group B starting of diagnosis till birth.<br>* Other names: Ezacard 75mg;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Birth weight | neonatal birth weight will be measured immediately following delivery and compared with the estimated fetal weight measured by ultrasound | 15 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Apgar score | The Apgar scale is determined by evaluating the newborn baby on five simple criteria on a scale from zero to two, then summing up the five values thus obtained. The resulting Apgar score ranges from zero to 10. The five criteria are (Appearance, Pulse, Grimace, Activity, Respiration). | at one and five minute after birth. | 
| Amniotic fluid index | Amniotic fluid index (sum of the vertical diameter of the four pocket of amniotic fluid ) | evey one week from 28 weeks gestation till 40 weeks gestation | 
| Umbilical artery Doppler | umbilical artery Doppler will measured by two dimensional ultrasound power Doppler twice weekly for the presence of any abnormality as: marked decreased diastolic blood flow, absent or reversed diastolic blood flow. | every from 28 weeks gestation till 40 weeks gestation |