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Status unknownNCT03321292Updated Aug 14, 2018

L-arginine in Treatment of Intrauterine Growth Restriction

An interventional study of L-arginine 1000 mg and Acetylesalicylic acid75mg and acetylsalicylic acid 75 mg in Intrauterine Growth Restriction Asymmetrical, sponsored by Ain Shams University. Status unknown at 1 site in Egypt. Open to female participants aged 20 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-08-14.

Sponsored by Ain Shams University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2018), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
260
Allocation
Randomized
Ages
20 Years to 40 Years
Sex
Female
01

Study 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 .

Read the 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.

02

Conditions studied

  • Intrauterine Growth Restriction Asymmetrical
03

Who can participate

Ages eligible
20 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • All pregnant woman diagnosed with IUGR before 28 weeks
  • Multiple pregnancy
  • Maternal systemic disease
  • Congenital fetal malformation
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
260 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • DrugL-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.

    Also known as: L- arginine 1000mg capsule and Ezacard 75 mg tablet

  • Drugacetylsalicylic acid 75 mg

    acetylsalicylic acid 75 mg will be given orally once daily for group B starting of diagnosis till birth.

    Also known as: Ezacard 75mg

05

What researchers measure

Primary outcomes

  1. Birth weight

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

    Time frame: 15 min

Secondary outcomes

  1. 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).

    Time frame: at one and five minute after birth.

  2. Amniotic fluid index

    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

  3. 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.

    Time frame: every from 28 weeks gestation till 40 weeks gestation

06

Study locations

1 of 1 sites recruiting
07

Registry details

Key details

Study ID
NCT03321292
Lead sponsor
Ain Shams University
Responsible party
Hayam Fathy Mohammad (Assistant Professor of Obstetrics and Gynecology , Ain Shams University, Ain Shams University) — Principal investigator
First posted
Oct 25, 2017
Start date
Oct 15, 2017
Primary completion
Dec 1, 2018 (estimated)
Completion
Dec 30, 2018 (estimated)
Last update
Aug 14, 2018

Study contacts

Hayam FA Mohammad, MD
Contact
fatihy_9999@yahoo.com
002-01000069593
Manar LO Kamal, MBBCH
Contact
Manaryunis88@yahoo.com
002-01274252819
Hayam FA Mohammad, MD
principal investigator · Ain Shams University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.

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