Ignite Creation Date:
2025-12-24 @ 3:56 PM
Ignite Modification Date:
2026-02-23 @ 6:27 AM
Study NCT ID:
NCT03321292
Status:
UNKNOWN
Last Update Posted:
2018-08-14
First Post:
2017-09-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
L-arginine in Treatment of Intrauterine Growth Restriction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001120', 'term': 'Arginine'}, {'id': 'D013607', 'term': 'Tablets'}, {'id': 'D001241', 'term': 'Aspirin'}], 'ancestors': [{'id': 'D024361', 'term': 'Amino Acids, Basic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000599', 'term': 'Amino Acids, Diamino'}, {'id': 'D000601', 'term': 'Amino Acids, Essential'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D012459', 'term': 'Salicylates'}, {'id': 'D062385', 'term': 'Hydroxybenzoates'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 260}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2018-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-08-13', 'studyFirstSubmitDate': '2017-09-28', 'studyFirstSubmitQcDate': '2017-10-24', 'lastUpdatePostDateStruct': {'date': '2018-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Birth weight', 'timeFrame': '15 min', 'description': 'neonatal birth weight will be measured immediately following delivery and compared with the estimated fetal weight measured by ultrasound'}], 'secondaryOutcomes': [{'measure': 'Apgar score', 'timeFrame': 'at one and five minute after birth.', 'description': '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).'}, {'measure': 'Amniotic fluid index', 'timeFrame': 'evey one week from 28 weeks gestation till 40 weeks gestation', 'description': 'Amniotic fluid index (sum of the vertical diameter of the four pocket of amniotic fluid )'}, {'measure': 'Umbilical artery Doppler', 'timeFrame': 'every from 28 weeks gestation till 40 weeks gestation', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Intrauterine Growth Restriction Asymmetrical']}, 'descriptionModule': {'briefSummary': '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.\n\nNitric oxide(NO) increases placental blood flow. So,it might be useful to improve IUGR pregnancy outcome .', 'detailedDescription': '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.\n\nPatients in second group will receive Acetylesalicylic acid 75mg once daily. then follow up of both group by:\n\n1. Daily fetal movement counting\n2. Day after day CTG\n3. Doppler twice weekly\n4. Pelvic u/s weekly for:\n\nA) Head circumference, Abdominal circumference, femur length B) Fetal weight C) Liquor amount: Amniotic Fluid Index Or MeanVertical Pocket\n\nDecision of delivery will be determined when:\n\nA) Fetal distress (non stress CTG) B) Mother starts labour C) Reversed umbilical artery Doppler.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All pregnant women diagnosed with IUGR from 28 weeks\n* Singleton pregnancy\n* No maternal systemic disease\n* No congenital fetal malformation\n* Estimated fetal weight below 10th percentile\n\nExclusion Criteria:\n\n* All pregnant woman diagnosed with IUGR before 28 weeks\n* Multiple pregnancy\n* Maternal systemic disease\n* Congenital fetal malformation'}, 'identificationModule': {'nctId': 'NCT03321292', 'briefTitle': 'L-arginine in Treatment of Intrauterine Growth Restriction', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Effect of L-Arginine on Intrauterine Growth Restriction Fetuses Measured by Birth Weight: Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'Hayam Fathy Mohammad 2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'L-arginine and Acetylesalicylic acid', 'description': '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', 'interventionNames': ['Drug: L-arginine 1000 mg and Acetylesalicylic acid75mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Acetylesalicylic acid75mg', 'description': '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', 'interventionNames': ['Drug: acetylsalicylic acid 75 mg']}], 'interventions': [{'name': 'L-arginine 1000 mg and Acetylesalicylic acid75mg', 'type': 'DRUG', 'otherNames': ['L- arginine 1000mg capsule and Ezacard 75 mg tablet'], 'description': 'l-arginine 1000mg capsule will be given every 8 hours till delivery and acetylesalicylic acid75mg tablet once starting of diagnosis till birth.', 'armGroupLabels': ['L-arginine and Acetylesalicylic acid']}, {'name': 'acetylsalicylic acid 75 mg', 'type': 'DRUG', 'otherNames': ['Ezacard 75mg'], 'description': 'acetylsalicylic acid 75 mg will be given orally once daily for group B starting of diagnosis till birth.', 'armGroupLabels': ['Acetylesalicylic acid75mg']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Hayam FA Mohammad, MD', 'role': 'CONTACT', 'email': 'fatihy_9999@yahoo.com', 'phone': '002-01000069593'}, {'name': 'Manar LO Kamal, MBBCH', 'role': 'CONTACT', 'email': 'Manaryunis88@yahoo.com', 'phone': '002-01274252819'}], 'facility': 'Ain Shams University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Hayam FA Mohammad, MD', 'role': 'CONTACT', 'email': 'fatihy_9999@yahoo.com', 'phone': '002-01000069593'}, {'name': 'Manar LO Kamal, MBBCH', 'role': 'CONTACT', 'email': 'Manaryunis88@yahoo.com', 'phone': '002-01274252819'}], 'overallOfficials': [{'name': 'Hayam FA Mohammad, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ain Shams University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Obstetrics and Gynecology , Ain Shams University', 'investigatorFullName': 'Hayam Fathy Mohammad', 'investigatorAffiliation': 'Ain Shams University'}}}}