Intrauterine Growth Restriction Asymmetrical
Conditions
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: 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.
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.
DRUGacetylsalicylic acid 75 mg
acetylsalicylic acid 75 mg will be given orally once daily for group B starting of diagnosis till birth.
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
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
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 40 Years
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
* All pregnant woman diagnosed with IUGR before 28 weeks * Multiple pregnancy * Maternal systemic disease * Congenital fetal malformation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Birth weight | 15 min | neonatal birth weight will be measured immediately following delivery and compared with the estimated fetal weight measured by ultrasound |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Apgar score | 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 | 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 | 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. |
Countries
Egypt
Contacts
Primary ContactHayam FA Mohammad, MD
Backup ContactManar LO Kamal, MBBCH
Outcome results
None listed