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L-arginine in Treatment of Intrauterine Growth Restriction

Primary Purpose

Intrauterine Growth Restriction Asymmetrical

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
L-arginine 1000 mg and Acetylesalicylic acid75mg
acetylsalicylic acid 75 mg
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intrauterine Growth Restriction Asymmetrical

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleAccepts 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

Sites / Locations

  • Ain Shams UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

L-arginine and Acetylesalicylic acid

Acetylesalicylic acid75mg

Arm 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

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

Outcomes

Primary Outcome Measures

Birth weight
neonatal birth weight will be measured immediately following delivery and compared with the estimated fetal weight measured by ultrasound

Secondary Outcome Measures

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).
Amniotic fluid index
Amniotic fluid index (sum of the vertical diameter of the four pocket of amniotic fluid )
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.

Full Information

First Posted
September 28, 2017
Last Updated
August 13, 2018
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT03321292
Brief Title
L-arginine in Treatment of Intrauterine Growth Restriction
Official Title
Effect of L-Arginine on Intrauterine Growth Restriction Fetuses Measured by Birth Weight: Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 15, 2017 (Actual)
Primary Completion Date
December 1, 2018 (Anticipated)
Study Completion Date
December 30, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: A) Fetal distress (non stress CTG) B) Mother starts labour C) Reversed umbilical artery Doppler.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intrauterine Growth Restriction Asymmetrical

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Participant
Allocation
Randomized
Enrollment
260 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
L-arginine and Acetylesalicylic acid
Arm Type
Experimental
Arm 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
Arm Title
Acetylesalicylic acid75mg
Arm Type
Active Comparator
Arm 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
Intervention Type
Drug
Intervention Name(s)
L-arginine 1000 mg and Acetylesalicylic acid75mg
Other Intervention Name(s)
L- arginine 1000mg capsule and Ezacard 75 mg tablet
Intervention Description
l-arginine 1000mg capsule will be given every 8 hours till delivery and acetylesalicylic acid75mg tablet once starting of diagnosis till birth.
Intervention Type
Drug
Intervention Name(s)
acetylsalicylic acid 75 mg
Other Intervention Name(s)
Ezacard 75mg
Intervention Description
acetylsalicylic acid 75 mg will be given orally once daily for group B starting of diagnosis till birth.
Primary Outcome Measure Information:
Title
Birth weight
Description
neonatal birth weight will be measured immediately following delivery and compared with the estimated fetal weight measured by ultrasound
Time Frame
15 min
Secondary Outcome Measure Information:
Title
Apgar score
Description
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).
Time Frame
at one and five minute after birth.
Title
Amniotic fluid index
Description
Amniotic fluid index (sum of the vertical diameter of the four pocket of amniotic fluid )
Time Frame
evey one week from 28 weeks gestation till 40 weeks gestation
Title
Umbilical artery Doppler
Description
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.
Time Frame
every from 28 weeks gestation till 40 weeks gestation

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hayam FA Mohammad, MD
Phone
002-01000069593
Email
fatihy_9999@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Manar LO Kamal, MBBCH
Phone
002-01274252819
Email
Manaryunis88@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hayam FA Mohammad, MD
Organizational Affiliation
Ain Shams University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ain Shams University
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hayam FA Mohammad, MD
Phone
002-01000069593
Email
fatihy_9999@yahoo.com
First Name & Middle Initial & Last Name & Degree
Manar LO Kamal, MBBCH
Phone
002-01274252819
Email
Manaryunis88@yahoo.com

12. IPD Sharing Statement

Learn more about this trial

L-arginine in Treatment of Intrauterine Growth Restriction

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