L-arginine in Treatment of Intrauterine Growth Restriction
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|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
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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||260 participants|
|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|
|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|
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
- 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
- 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).
- 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 )
- 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.
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
|Contact: Hayam FA Mohammad, MDfirstname.lastname@example.org|
|Contact: Manar LO Kamal, MBBCH||002-01274252819||Manaryunis88@yahoo.com|
|Principal Investigator:||Hayam FA Mohammad, MD||Ain Shams University|