L-arginine in Treatment of Intrauterine Growth Restriction

Intrauterine Growth Restriction Asymmetrical Clinical Trial

Official title:

Effect of L-Arginine on Intrauterine Growth Restriction Fetuses Measured by Birth Weight: Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03321292
• Other study ID #: Hayam Fathy Mohammad 2
• Status: Recruiting
• Phase: N/A
• Start date: October 15, 2017
• Est. completion date: December 30, 2018

Study information

• Verified date: August 2018
• Source: Ain Shams University
• Contact: Hayam FA Mohammad, MD
• Phone: 002-01000069593
• Email: fatihy_9999[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 260
• Est. completion date: December 30, 2018
• Est. primary completion date: December 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Fetal Growth Retardation
• Intrauterine Growth Restriction Asymmetrical

Intervention

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

Locations

Country	Name	City	State
Egypt	Ain Shams University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Birth weight	neonatal birth weight will be measured immediately following delivery and compared with the estimated fetal weight measured by ultrasound	15 min
Secondary	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).	at one and five minute after birth.
Secondary	Amniotic fluid index	Amniotic fluid index (sum of the vertical diameter of the four pocket of amniotic fluid )	evey one week from 28 weeks gestation till 40 weeks gestation
Secondary	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.	every from 28 weeks gestation till 40 weeks gestation