Effect of L-Arginine on Intrauterine Growth Restriction Fetuses Measured by Birth Weight: Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Ain Shams University
- Enrollment
- 260
- Locations
- 1
- Primary Endpoint
- Birth weight
Study Overview
Brief Summary
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
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:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 20 Years to 40 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
L-arginine and Acetylesalicylic acid
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
Intervention: L-arginine 1000 mg and Acetylesalicylic acid75mg (Drug)
Acetylesalicylic acid75mg
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
Intervention: acetylsalicylic acid 75 mg (Drug)
Outcomes
Primary Outcomes
Birth weight
Time Frame: 15 min
neonatal birth weight will be measured immediately following delivery and compared with the estimated fetal weight measured by ultrasound
Secondary Outcomes
- Umbilical artery Doppler(every from 28 weeks gestation till 40 weeks gestation)
- Apgar score(at one and five minute after birth.)
- Amniotic fluid index(evey one week from 28 weeks gestation till 40 weeks gestation)
Investigators
Hayam Fathy Mohammad
Assistant Professor of Obstetrics and Gynecology , Ain Shams University
Ain Shams University