Pre-eclampsiaNCT07912866
Efficacy Of Supplemental L-Arginine in Preventing Preeclampsia in Pregnant Women
A study testing L-Arginine in people with Pre-eclampsia, run by Quaid-e-Azam Medical College at 1 site in Pakistan.
Trial summary
This study was designed to assess whether daily L-arginine supplementation could prevent preeclampsia in pregnant women at increased risk. Preeclampsia, a pregnancy complication involving high blood pressure and possible organ damage, was the condition of interest. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Pre-eclampsia
- What is being tested?
- L-Arginine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jul 2025to 30 Dec 2025
- 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 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women with age 18-40 years,
- Singleton pregnancy of 20 weeks on ultrasound
- High-risk pregnancy.
Who cannot join
- The identification of high blood pressure prior to the twentieth week of pregnancy.
- Individuals with history of diabetes mellitus (non-gestational).
- Individuals suffering from renal disease (assessed on history and medical record).
- Women with heart disease diagnosed on history and echocardiography.
- Patients with known major fetal anomalies (as defined by ultrasound studies.
- Patients on specific treatment protocols, including anti-oxidant therapy like selenium-rich diets or selenium supplements.
- Antiphospholipid Syndrome (APS) and Systemic Lupus Erythematosus (SLE) (assessed on history and medical record).
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Quaid-e-Azam Medical College Bahawalpur
Chak Eighty-seven -Twelve Left, Punjab Province, 63100
About this study
This study was designed to assess whether daily L-arginine supplementation could prevent preeclampsia in pregnant women at increased risk. Preeclampsia, a pregnancy complication involving high blood pressure and possible organ damage, was the condition of interest. The study hypothesis was that L-arginine supplementation would be more effective than placebo in preventing preeclampsia before delivery.
The study was designed as a randomized controlled trial at the Department of Gynaecology and Obstetrics, Bahawal Victoria Hospital, Bahawalpur, Pakistan. Eligible participants were women aged 18-40 years with a single-baby pregnancy at 20 weeks and an increased risk of preeclampsia based on their personal or family medical history. The protocol specified assignment by chance to either daily oral L-arginine supplementation or placebo until delivery.
Follow-up visits were scheduled every three weeks during pregnancy and two weeks after childbirth. Assessments included blood pressure, urine testing for protein, and monitoring for side effects. The main outcome was the proportion of women who remained free of preeclampsia until delivery. Other planned assessments included pregnancy complications, delivery outcomes, birth weight, newborn health, and admission to intensive care.
- Conditions
- Pre-eclampsia
- Being tested
- L-Arginine, placebo
- Keywords
- Arginine, Preeclampsia prevention, Pregnancy, High-Risk, Dietary Supplements, Oral supplementation
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-ArginineDietary supplement
L-arginine supplementation administered orally once daily after a meal until delivery.
placeboDrug
Oral placebo administered once daily until delivery.
| Study group | Role | What they receive |
|---|---|---|
| Group A-L-Arginine | Experimental | Received oral L-arginine supplementation once daily after a meal, dissolved in one cup of water, from enrollment at 20 weeks of pregnancy until delivery. Receives: Dietary Supplement: L-Arginine |
| Group B-Placebo | Placebo comparator | Received oral placebo once daily from enrollment at 20 weeks of pregnancy until delivery. Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Who Remained Free of Preeclampsia Until Delivery
Efficacy was measured as the percentage of participants in each study group who did not develop preeclampsia before delivery. According to the synopsis, preeclampsia was defined as new-onset systolic blood pressure >140 mmHg and diastolic blood pressure >90 mmHg, together with urinary protein excretion >300 mg over 24 hours, after 20 weeks of gestation in previously normotensive women.
Measured: From enrollment at 20 weeks of gestation until delivery,
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2026
- Study start1 Jul 2025
- Primary completion30 Dec 2025
- Study completion30 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-eclampsiaStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Quaid-e-Azam Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marium Khan Siraj, Quaid-e-Azam Medical College
- Investigators
- Marium Khan, Principal investigator, Quaid-e-Azam Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07912866
- Sponsor's protocol ID
- QAMC1
- Status last verified
- Oct 2026
- First submitted
- 28 Oct 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Of Supplemental L-Arginine in Preventing Preeclampsia in Pregnant Women
- ClinicalTrials.gov ID
- NCT07912866
- Acronym / sponsor ID
- QAMC1
- Conditions
- Pre-eclampsia
- Keywords
- Arginine, Preeclampsia prevention, Pregnancy, High-Risk, Dietary Supplements, Oral supplementation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Quaid-e-Azam Medical CollegeUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 30 Dec 2025 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 3 Nov 2026 (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.
This study was designed to assess whether daily L-arginine supplementation could prevent preeclampsia in pregnant women at increased risk. Preeclampsia, a pregnancy complication involving high blood pressure and possible organ damage, was the condition of interest. The study hypothesis was that L-arginine supplementation would be more effective than placebo in preventing preeclampsia before delivery.
The study was designed as a randomized controlled trial at the Department of Gynaecology and Obstetrics, Bahawal Victoria Hospital, Bahawalpur, Pakistan. Eligible participants were women aged 18-40 years with a single-baby pregnancy at 20 weeks and an increased risk of preeclampsia based on their personal or family medical history. The protocol specified assignment by chance to either daily oral L-arginine supplementation or placebo until delivery.
Follow-up visits were scheduled every three weeks during pregnancy and two weeks after childbirth. Assessments included blood pressure, urine testing for protein, and monitoring for side effects. The main outcome was the proportion of women who remained free of preeclampsia until delivery. Other planned assessments included pregnancy complications, delivery outcomes, birth weight, newborn health, and admission to intensive care.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A-L-Arginine | Experimental | Dietary Supplement: L-ArginineReceived oral L-arginine supplementation once daily after a meal, dissolved in one cup of water, from enrollment at 20 weeks of pregnancy until delivery. |
| Group B-Placebo | Placebo comparator | Drug: placeboReceived oral placebo once daily from enrollment at 20 weeks of pregnancy until delivery. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Women with age 18-40 years,
- Singleton pregnancy of 20 weeks on ultrasound
- High-risk pregnancy.
Key exclusion criteria (7 listed)
- The identification of high blood pressure prior to the twentieth week of pregnancy.
- Individuals with history of diabetes mellitus (non-gestational).
- Individuals suffering from renal disease (assessed on history and medical record).
- Women with heart disease diagnosed on history and echocardiography.
- Patients with known major fetal anomalies (as defined by ultrasound studies.
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-ArginineL-arginine supplementation administered orally once daily after a meal until delivery. | Dietary supplement | Group A-L-Arginine |
| placeboOral placebo administered once daily until delivery. | Drug | Group B-Placebo |
Primary outcome
Percentage of Participants Who Remained Free of Preeclampsia Until Delivery
Time frame: From enrollment at 20 weeks of gestation until delivery,
Efficacy was measured as the percentage of participants in each study group who did not develop preeclampsia before delivery. According to the synopsis, preeclampsia was defined as new-onset systolic blood pressure >140 mmHg and diastolic blood pressure >90 mmHg, together with urinary protein excretion >300 mg over 24 hours, after 20 weeks of gestation in previously normotensive women.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
Related trials for Pre-eclampsia
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Exercise to Improve Heart and Metabolic Health After Childbirth in Women at High Risk for Preeclampsia
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Preeclampsia
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The CoPenHagen PREeClampsia and cardIOvascUlar diSease Study
Pre-Eclampsia, Atherosclerosis
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Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
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Furosemide vs Placebo in Severe Preeclampsia Postpartum
Severe Preeclampsia
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.
Marium Khan principal investigator
Quaid-e-Azam Medical College
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 in people with Pre-eclampsia, run by Quaid-e-Azam Medical College at 1 site in Pakistan.
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 3 inclusion and 7 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: finished, as of the sponsor's last update on 3 Nov 2026. 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 Pakistan. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Who Remained Free of Preeclampsia Until Delivery (time frame: From enrollment at 20 weeks of gestation until delivery,). 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 3 Nov 2026.