L-arginine in Treatment of Intrauterine Growth Restriction
Effect of L-Arginine on Intrauterine Growth Restriction Fetuses Measured by Birth Weight: Randomized Controlled Trial
1 other identifier
interventional
260
1 country
1
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 .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 28, 2017
CompletedStudy Start
First participant enrolled
October 15, 2017
CompletedFirst Posted
Study publicly available on registry
October 25, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2018
CompletedAugust 14, 2018
August 1, 2018
1.1 years
September 28, 2017
August 13, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Birth weight
neonatal birth weight will be measured immediately following delivery and compared with the estimated fetal weight measured by ultrasound
15 min
Secondary Outcomes (3)
Apgar score
at one and five minute after birth.
Amniotic fluid index
evey one week from 28 weeks gestation till 40 weeks gestation
Umbilical artery Doppler
every from 28 weeks gestation till 40 weeks gestation
Study Arms (2)
L-arginine and Acetylesalicylic acid
EXPERIMENTALL-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
ACTIVE COMPARATORacetylsalicylic 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
Interventions
l-arginine 1000mg capsule will be given every 8 hours till delivery and acetylesalicylic acid75mg tablet once starting of diagnosis till birth.
acetylsalicylic acid 75 mg will be given orally once daily for group B starting of diagnosis till birth.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- All pregnant woman diagnosed with IUGR before 28 weeks
- Multiple pregnancy
- Maternal systemic disease
- Congenital fetal malformation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ain Shams University
Cairo, Egypt
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hayam FA Mohammad, MD
Ain Shams University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Obstetrics and Gynecology , Ain Shams University
Study Record Dates
First Submitted
September 28, 2017
First Posted
October 25, 2017
Study Start
October 15, 2017
Primary Completion
December 1, 2018
Study Completion
December 30, 2018
Last Updated
August 14, 2018
Record last verified: 2018-08