L-arginine in Treatment of Intrauterine Growth Restriction

Ain Shams University

Status: Unknown

Conditions: Intrauterine Growth Restriction Asymmetrical

Treatments: Drug: L-arginine 1000 mg and Acetylesalicylic acid75mg; Drug: acetylsalicylic acid 75 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT03321292

Hayam Fathy Mohammad 2

Details and patient eligibility

About

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 .

Full 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:

1. Daily fetal movement counting
2. Day after day CTG
3. Doppler twice weekly
4. 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.

Enrollment: 260 estimated patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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260 participants in 2 patient groups

L-arginine and Acetylesalicylic acid

Experimental group

Description:

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

Treatment:

Drug: L-arginine 1000 mg and Acetylesalicylic acid75mg

Acetylesalicylic acid75mg

Active Comparator group

Description:

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

Treatment:

Drug: acetylsalicylic acid 75 mg