L-arginine in Treatment of Intrauterine Growth Restriction

NCT ID: NCT03321292

Last Updated: 2018-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

260 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-15

Study Completion Date

2018-12-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Intrauterine Growth Restriction Asymmetrical

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

L-arginine 1000 mg and Acetylesalicylic acid75mg

Intervention Type DRUG

l-arginine 1000mg capsule will be given every 8 hours till delivery and acetylesalicylic acid75mg tablet once starting of diagnosis till birth.

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

Group Type ACTIVE_COMPARATOR

acetylsalicylic acid 75 mg

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DRUG

acetylsalicylic acid 75 mg

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

L- arginine 1000mg capsule and Ezacard 75 mg tablet Ezacard 75mg

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Hayam Fathy Mohammad

Assistant Professor of Obstetrics and Gynecology , Ain Shams University

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Hayam FA Mohammad, MD

Role: PRINCIPAL_INVESTIGATOR

Ain Shams University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Ain Shams University

Cairo, , Egypt

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Hayam FA Mohammad, MD

Role: CONTACT

002-01000069593

Manar LO Kamal, MBBCH

Role: CONTACT

002-01274252819

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Hayam FA Mohammad, MD

Role: primary

002-01000069593

Manar LO Kamal, MBBCH

Role: backup

002-01274252819

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Hayam Fathy Mohammad 2

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Oral L-Citrulline and ADMA in Pregnancy
NCT00743210 COMPLETED PHASE1
Nutraceutical Citrulline in Pregnancy
NCT02772887 TERMINATED NA