L-arginine in Treatment of Intrauterine Growth Restriction

Not Applicable

• Conditions: Intrauterine Growth Restriction Asymmetrical
• Interventions: Drug: L-arginine 1000 mg and Acetylesalicylic acid75mg; Drug: acetylsalicylic acid 75 mg

• Registration Number: NCT03321292
• Lead Sponsor: Ain Shams University

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:

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-09-28
• Study Start: 2017-10-15
• Study First Submitted QC: 2017-10-24
• Study First Posted: 2017-10-25
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-13
• Last Update Posted: 2018-08-14
• Primary Completion: 2018-12-01
• Study Completion: 2018-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 260

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

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Exclusion Criteria

• All pregnant woman diagnosed with IUGR before 28 weeks
• Multiple pregnancy
• Maternal systemic disease
• Congenital fetal malformation

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
L-arginine and Acetylesalicylic acid	L-arginine 1000 mg and Acetylesalicylic acid75mg	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
Acetylesalicylic acid75mg	acetylsalicylic acid 75 mg	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

Primary Outcome Measures

Name	Time	Method
Birth weight	15 min	neonatal birth weight will be measured immediately following delivery and compared with the estimated fetal weight measured by ultrasound

Secondary Outcome Measures

Name	Time	Method
Amniotic fluid index	evey one week from 28 weeks gestation till 40 weeks gestation	Amniotic fluid index (sum of the vertical diameter of the four pocket of amniotic fluid )
Umbilical artery Doppler	every from 28 weeks gestation till 40 weeks gestation	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.
Apgar score	at one and five minute after birth.	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).

Trial Locations

Locations (1)

Ain Shams University; 🇪🇬 Cairo, Egypt