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L-arginine in Treatment of Intrauterine Growth Restriction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03321292
Recruitment Status : Unknown
Verified August 2018 by Hayam Fathy Mohammad, Ain Shams University.
Recruitment status was:  Recruiting
First Posted : October 25, 2017
Last Update Posted : August 14, 2018
Sponsor:
Information provided by (Responsible Party):
Hayam Fathy Mohammad, 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 .


Condition or disease Intervention/treatment Phase
Intrauterine Growth Restriction Asymmetrical Drug: L-arginine 1000 mg and Acetylesalicylic acid75mg Drug: acetylsalicylic acid 75 mg Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant)
Primary Purpose: Treatment
Official Title: Effect of L-Arginine on Intrauterine Growth Restriction Fetuses Measured by Birth Weight: Randomized Controlled Trial
Actual Study Start Date : October 15, 2017
Estimated Primary Completion Date : December 1, 2018
Estimated Study Completion Date : December 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Weight

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 Name: 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 Name: Ezacard 75mg




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Apgar score [ Time Frame: 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).

  2. Amniotic fluid index [ Time Frame: 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 )

  3. Umbilical artery Doppler [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03321292


Contacts
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Contact: Hayam FA Mohammad, MD 002-01000069593 fatihy_9999@yahoo.com
Contact: Manar LO Kamal, MBBCH 002-01274252819 Manaryunis88@yahoo.com

Locations
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Egypt
Ain Shams University Recruiting
Cairo, Egypt
Contact: Hayam FA Mohammad, MD    002-01000069593    fatihy_9999@yahoo.com   
Contact: Manar LO Kamal, MBBCH    002-01274252819    Manaryunis88@yahoo.com   
Sponsors and Collaborators
Ain Shams University
Investigators
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Principal Investigator: Hayam FA Mohammad, MD Ain Shams University
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Responsible Party: Hayam Fathy Mohammad, Assistant Professor of Obstetrics and Gynecology , Ain Shams University, Ain Shams University
ClinicalTrials.gov Identifier: NCT03321292    
Other Study ID Numbers: Hayam Fathy Mohammad 2
First Posted: October 25, 2017    Key Record Dates
Last Update Posted: August 14, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fetal Growth Retardation
Fetal Diseases
Pregnancy Complications
Growth Disorders
Pathologic Processes
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics