L-arginine in Treatment of Intrauterine Growth Restriction

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

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 .

Study Overview

• Status: Unknown
• Conditions: Intrauterine Growth Restriction Asymmetrical
• Intervention / Treatment: Drug: L-arginine 1000 mg and Acetylesalicylic acid75mg; Drug: acetylsalicylic acid 75 mg

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.

• Study Type: Interventional
• Enrollment (Anticipated): 260
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hayam FA Mohammad, MD; Phone Number: 002-01000069593; Email: fatihy_9999@yahoo.com
• Study Contact Backup: Name: Manar LO Kamal, MBBCH; Phone Number: 002-01274252819; Email: Manaryunis88@yahoo.com

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Ain Shams University
    • Contact: Hayam FA Mohammad, MD; Phone Number: 002-01000069593; Email: fatihy_9999@yahoo.com
    • Contact: Manar LO Kamal, MBBCH; Phone Number: 002-01274252819; Email: Manaryunis88@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 38 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Drug: L-arginine 1000 mg and Acetylesalicylic acid75mg; l-arginine 1000mg capsule will be given every 8 hours till delivery and acetylesalicylic acid75mg tablet once starting of diagnosis till birth.; Other Names: L- arginine 1000mg capsule and Ezacard 75 mg tablet
Active Comparator: 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	Drug: acetylsalicylic acid 75 mg; acetylsalicylic acid 75 mg will be given orally once daily for group B starting of diagnosis till birth.; Other Names: Ezacard 75mg

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Principal Investigator: Hayam FA Mohammad, MD, Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2017
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): December 30, 2018

Study Registration Dates

• First Submitted: September 28, 2017
• First Submitted That Met QC Criteria: October 24, 2017
• First Posted (Actual): October 25, 2017

Study Record Updates

• Last Update Posted (Actual): August 14, 2018
• Last Update Submitted That Met QC Criteria: August 13, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Fetal Diseases; Pregnancy Complications; Growth Disorders; Fetal Growth Retardation; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Aspirin
• Other Study ID Numbers: Hayam Fathy Mohammad 2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No