Intrauterine Growth Restriction AsymmetricalNCT03321292
L-arginine in Treatment of Intrauterine Growth Restriction
A study testing L-arginine 1000 mg and Acetylesalicylic acid75mg and acetylsalicylic acid 75 mg in people with Intrauterine Growth Restriction Asymmetrical, run by Ain Shams University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Intrauterine Growth Restriction Asymmetrical
- What is being tested?
- L-arginine 1000 mg and Acetylesalicylic acid75mg and acetylsalicylic acid 75 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Oct 2017to 30 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- All pregnant woman diagnosed with IUGR before 28 weeks
- Multiple pregnancy
- Maternal systemic disease
- Congenital fetal malformation
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams University
Cairo
Hayam FA Mohammad, MD, 002-01000069593, fatihy_9999@yahoo.com
Manar LO Kamal, MBBCH, 002-01274252819, Manaryunis88@yahoo.com
About this study
Official title: Effect of L-Arginine on Intrauterine Growth Restriction Fetuses Measured by Birth Weight: Randomized Controlled Trial
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:
- Daily fetal movement counting
- Day after day CTG
- Doppler twice weekly
- Pelvic u/s weekly for:
- 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:
- Fetal distress (non stress CTG) B) Mother starts labour C) Reversed umbilical artery Doppler.
- Being tested
- L-arginine 1000 mg and Acetylesalicylic acid75mg, acetylsalicylic acid 75 mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-arginine 1000 mg and Acetylesalicylic acid75mgDrug
Also called L- arginine 1000mg capsule and Ezacard 75 mg tablet
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 mgDrug
Also called Ezacard 75mg
acetylsalicylic acid 75 mg will be given orally once daily for group B starting of diagnosis till birth.
| Study group | Role | What they receive |
|---|---|---|
| L-arginine and Acetylesalicylic acid | Experimental | 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 Receives: Drug: L-arginine 1000 mg and Acetylesalicylic acid75mg |
| Acetylesalicylic acid75mg | Active comparator | 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 Receives: Drug: acetylsalicylic acid 75 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Birth weight
neonatal birth weight will be measured immediately following delivery and compared with the estimated fetal weight measured by ultrasound
Measured: 15 min
Secondary outcomes (3)
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).
Measured: at one and five minute after birth.
Amniotic fluid index
Amniotic fluid index (sum of the vertical diameter of the four pocket of amniotic fluid )
Measured: evey one week from 28 weeks gestation till 40 weeks gestation
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.
Measured: every from 28 weeks gestation till 40 weeks gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2017
- Study start15 Oct 2017
- Primary completion1 Dec 2018 (estimated)
- Study completion30 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intrauterine Growth Restriction AsymmetricalStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hayam Fathy Mohammad, Ain Shams University
- Investigators
- Hayam FA Mohammad, MD, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03321292
- Sponsor's protocol ID
- Hayam Fathy Mohammad 2
- Status last verified
- Aug 2018
- First submitted
- 28 Sep 2017
- Last updated
- 14 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of L-Arginine on Intrauterine Growth Restriction Fetuses Measured by Birth Weight: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03321292
- Acronym / sponsor ID
- Hayam Fathy Mohammad 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 15 Oct 2017 (actual)
- Primary completion
- 1 Dec 2018 (estimated)
- Study completion
- 30 Dec 2018 (estimated)
- First posted
- 25 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Daily fetal movement counting
- Day after day CTG
- Doppler twice weekly
- Pelvic u/s weekly for:
- 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:
- Fetal distress (non stress CTG) B) Mother starts labour C) Reversed umbilical artery Doppler.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| L-arginine and Acetylesalicylic acid | Experimental | Drug: L-arginine 1000 mg and Acetylesalicylic acid75mgL-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 |
| Acetylesalicylic acid75mg | Active comparator | Drug: acetylsalicylic acid 75 mgacetylsalicylic 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 |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- All pregnant woman diagnosed with IUGR before 28 weeks
- Multiple pregnancy
- Maternal systemic disease
- Congenital fetal malformation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| L-arginine 1000 mg and Acetylesalicylic acid75mgAlso: L- arginine 1000mg capsule and Ezacard 75 mg tabletl-arginine 1000mg capsule will be given every 8 hours till delivery and acetylesalicylic acid75mg tablet once starting of diagnosis till birth. | Drug | L-arginine and Acetylesalicylic acid |
| acetylsalicylic acid 75 mgAlso: Ezacard 75mgacetylsalicylic acid 75 mg will be given orally once daily for group B starting of diagnosis till birth. | Drug | Acetylesalicylic acid75mg |
Primary outcome
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
3 secondary outcomes
Apgar score
Time frame: at one and five minute after birth.
Amniotic fluid index
Time frame: evey one week from 28 weeks gestation till 40 weeks gestation
Umbilical artery Doppler
Time frame: every from 28 weeks gestation till 40 weeks gestation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2018.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hayam FA Mohammad, MD principal investigator
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing L-arginine 1000 mg and Acetylesalicylic acid75mg and acetylsalicylic acid 75 mg in people with Intrauterine Growth Restriction Asymmetrical, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hayam FA Mohammad, MD (002-01000069593, fatihy_9999@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Birth weight (time frame: 15 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2018.