High Risk PregnancyPhase 2NCT02838030
Efficacy of Aspirin and L-arginine in High Risk Preeclamptic
A Phase 2 study testing L-arginine and acetylsalicylic acid in people with High Risk Pregnancy, run by University of Guadalajara at 1 site in Mexico.
Trial summary
Worldwide, the incidence of preeclampsia ranges from 2 to 10% of pregnancies. The World Health Organization (WHO) estimates that the incidence of preeclampsia is seven times higher in developing countries than in developed (2.8% and 0.4%). Read more about this study
- Who is it for?
- Ages 18 to 44 years, women only
- Conditions the study is for
- High Risk Pregnancy
- What is being tested?
- L-arginine and acetylsalicylic acid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- 1 siteMexico
- Study dates
- 1 Jul 2018to Aug 2021
- Phase
- Phase 2
- 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 44 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant before 12 weeks of gestation
- High risk of preeclampsia
- Signature of informed consent in writing
Who cannot join
- Noncompliance > 20% of drug intake
- Lack of tolerability L-arginine or acetylsalicylic acid
- Compliance with at least one non-inclusion criteria during the course of the study
- Serious adverse event
- Withdrawal of consent
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Antiguo Hospital Civil Fray Antonio Alcalde
Guadalajara, Jalisco, 44280
About this study
Official title: Efficacy of the Combination of Acetylsalicylic Acid and L-arginine to Prevent Preeclampsia in Pregnant High Risk
Worldwide, the incidence of preeclampsia ranges from 2 to 10% of pregnancies. The World Health Organization (WHO) estimates that the incidence of preeclampsia is seven times higher in developing countries than in developed (2.8% and 0.4%). In Mexico it is estimated that preeclampsia - eclampsia is a major cause of maternal and perinatal morbidity and mortality. Because it is an idiopathic heterogeneous syndrome associated with endothelial damage, so far there is no effective treatment to decrease the morbidity and mortality of this entity, so it is necessary to strengthen prevention; the use of aspirin alone is inconclusive, in addition to the information the investigators have reduced the effect of these strategies on arterial stiffness; Moreover, it has been observed that L-arginine lowers blood pressure in this population. It is for this that is of interest to know the efficacy and safety of the combination of L-arginine low dose, which is known as an important eNOS in NO production substrate, and aspirin for its qualities of antiinflammatory and anticoagulant in the prevention of preeclampsia and also determine their effect on arterial stiffness as a noninvasive method, as is the applanation tonometry.
Read the detailed description
It will conduct a clinical trial, double-blind, randomized and placebo control group female patients with 12 weeks of gestation have one or more risk factors for developing preeclampsia. 2 groups will be formed with 82 patients each, chance will determine the intervention (acetylsalicylic + L-arginine acetylsalicylic acid or acid + placebo). At the beginning and end of the intervention clinical and laboratory determinations, the end will be determined in both groups the incidence of preeclampsia, severity and number needed to treat is made. The data obtained were analyzed using SPSS statistical software version 22. It was considered statistically significant at p <0.05.
- Conditions
- High Risk Pregnancy
- Being tested
- L-arginine, Placebo (for L-arginine), acetylsalicylic acid
- Keywords
- Preeclampsia, L-arginine
- 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-arginineDrug
Also called arginine
3 gr per day
Placebo (for L-arginine)Drug
Also called Magnesia calcined
3 gr per day
acetylsalicylic acidDrug
Also called aspirin
3 gr per day
| Study group | Role | What they receive |
|---|---|---|
| acetylsalicylic acid and L-arginine | Experimental | acetylsalicylic acid 75 mg every 24 hours from the 12th week of pregnancy and L-arginine 3 gr every 8 hours from the 20th week of pregnancy to pregnancy termination Receives: Drug: L-arginine; Drug: acetylsalicylic acid |
| acetylsalicylic acid and placebo | Placebo comparator | acetylsalicylic acid 75 mg every 24 hours from the 12th week of pregnancy and placebo 3 gr every 8 hours from the 20th week of pregnancy to pregnancy termination Receives: Drug: Placebo (for L-arginine); Drug: acetylsalicylic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of preeclampsia
Measured: from 20 weeks gestation until 37 weeks
severity of preeclampsia
Measured: from 20 weeks gestation until 37 weeks
Secondary outcomes (16)
Pulmonary edema maternal
Measured: at week 37
Acute myocardial infarction maternal
Measured: at week 37
Stroke maternal
Measured: at week 37
Acute respiratory distress syndrome maternal
Measured: at week 37
Coagulopathy maternal
Measured: at week 37
Renal failure maternal
Measured: at week 37
Retinal damage maternal
Measured: at week 37
maternal mortality
Measured: at week 37
Birth weight
Measured: birth
Intrauterine growth restriction
Measured: birth
Fetal mortality
Measured: birth
systolic blood pressure maternal
Measured: from 12 weeks gestation until 37 weeks
diastolic blood pressure maternal
Measured: from 12 weeks gestation until 37 weeks
Mean blood pressure maternal
Measured: from 12 weeks gestation until 37 weeks
Pulse wave velocity maternal
Measured: from 12 weeks gestation until 37 weeks
Adverse effects maternal
Measured: from 12 weeks gestation until 37 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2016 (estimated)
- Study start1 Jul 2018
- Primary completionJul 2021 (estimated)
- Study completionAug 2021 (estimated)
Why it stopped: COVID-19 pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Risk PregnancyStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Guadalajara
- Sponsor type
- University, hospital or other
- Collaborators
- PhD Ernesto Javier Ramírez Lizardo, PhD Sylvia Elena Totsuka Sutto, PhD Fernando Grover Páez, MD Diego Hernández Molina
- Responsible party
- Principal investigator, Leonel Garcia Benavides, University of Guadalajara
- Investigators
- Leonel García Benavides, PhD, Principal investigator, University Guadalajara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02838030
- Sponsor's protocol ID
- ECAALA
- Status last verified
- Nov 2020
- First submitted
- 26 May 2016
- Last updated
- 27 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of the Combination of Acetylsalicylic Acid and L-arginine to Prevent Preeclampsia in Pregnant High Risk
- ClinicalTrials.gov ID
- NCT02838030
- Acronym / sponsor ID
- ECAALA
- Conditions
- High Risk Pregnancy
- Keywords
- Preeclampsia, L-arginine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: COVID-19 pandemic
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- University of GuadalajaraUniversity, hospital or other
- Collaborators
- PhD Ernesto Javier Ramírez Lizardo, PhD Sylvia Elena Totsuka Sutto, PhD Fernando Grover Páez, MD Diego Hernández Molina
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- Jul 2021 (estimated)
- Study completion
- Aug 2021 (estimated)
- First posted
- 20 Jul 2016 (estimated)
- 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.
Worldwide, the incidence of preeclampsia ranges from 2 to 10% of pregnancies. The World Health Organization (WHO) estimates that the incidence of preeclampsia is seven times higher in developing countries than in developed (2.8% and 0.4%). In Mexico it is estimated that preeclampsia - eclampsia is a major cause of maternal and perinatal morbidity and mortality. Because it is an idiopathic heterogeneous syndrome associated with endothelial damage, so far there is no effective treatment to decrease the morbidity and mortality of this entity, so it is necessary to strengthen prevention; the use of aspirin alone is inconclusive, in addition to the information the investigators have reduced the effect of these strategies on arterial stiffness; Moreover, it has been observed that L-arginine lowers blood pressure in this population. It is for this that is of interest to know the efficacy and safety of the combination of L-arginine low dose, which is known as an important eNOS in NO production substrate, and aspirin for its qualities of antiinflammatory and anticoagulant in the prevention of preeclampsia and also determine their effect on arterial stiffness as a noninvasive method, as is the applanation tonometry.
Detailed description
It will conduct a clinical trial, double-blind, randomized and placebo control group female patients with 12 weeks of gestation have one or more risk factors for developing preeclampsia. 2 groups will be formed with 82 patients each, chance will determine the intervention (acetylsalicylic + L-arginine acetylsalicylic acid or acid + placebo). At the beginning and end of the intervention clinical and laboratory determinations, the end will be determined in both groups the incidence of preeclampsia, severity and number needed to treat is made. The data obtained were analyzed using SPSS statistical software version 22. It was considered statistically significant at p <0.05.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| acetylsalicylic acid and L-arginine | Experimental | Drug: L-arginine, Drug: acetylsalicylic acidacetylsalicylic acid 75 mg every 24 hours from the 12th week of pregnancy and L-arginine 3 gr every 8 hours from the 20th week of pregnancy to pregnancy termination |
| acetylsalicylic acid and placebo | Placebo comparator | Drug: Placebo (for L-arginine), Drug: acetylsalicylic acidacetylsalicylic acid 75 mg every 24 hours from the 12th week of pregnancy and placebo 3 gr every 8 hours from the 20th week of pregnancy to pregnancy termination |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Pregnant before 12 weeks of gestation
- High risk of preeclampsia
- Signature of informed consent in writing
Key exclusion criteria (5 listed)
- Noncompliance > 20% of drug intake
- Lack of tolerability L-arginine or acetylsalicylic acid
- Compliance with at least one non-inclusion criteria during the course of the study
- Serious adverse event
- Withdrawal of consent
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-arginineAlso: arginine3 gr per day | Drug | acetylsalicylic acid and L-arginine |
| Placebo (for L-arginine)Also: Magnesia calcined3 gr per day | Drug | acetylsalicylic acid and placebo |
| acetylsalicylic acidAlso: aspirin3 gr per day | Drug | acetylsalicylic acid and L-arginine, acetylsalicylic acid and placebo |
Primary outcome
Incidence of preeclampsia
Time frame: from 20 weeks gestation until 37 weeks
severity of preeclampsia
Time frame: from 20 weeks gestation until 37 weeks
16 secondary outcomes
Pulmonary edema maternal
Time frame: at week 37
Acute myocardial infarction maternal
Time frame: at week 37
Stroke maternal
Time frame: at week 37
Acute respiratory distress syndrome maternal
Time frame: at week 37
Coagulopathy maternal
Time frame: at week 37
Renal failure maternal
Time frame: at week 37
Retinal damage maternal
Time frame: at week 37
maternal mortality
Time frame: at week 37
Birth weight
Time frame: birth
Intrauterine growth restriction
Time frame: birth
Fetal mortality
Time frame: birth
systolic blood pressure maternal
Time frame: from 12 weeks gestation until 37 weeks
diastolic blood pressure maternal
Time frame: from 12 weeks gestation until 37 weeks
Mean blood pressure maternal
Time frame: from 12 weeks gestation until 37 weeks
Pulse wave velocity maternal
Time frame: from 12 weeks gestation until 37 weeks
Adverse effects maternal
Time frame: from 12 weeks gestation until 37 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2020.
- Individual participant dataSharing planned: No
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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.
Leonel García Benavides, PhD principal investigator
University Guadalajara
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing L-arginine and acetylsalicylic acid in people with High Risk Pregnancy, run by University of Guadalajara at 1 site in Mexico.
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 5 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: paused, as of the sponsor's last update on 27 Nov 2020. 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 Mexico. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
Incidence of preeclampsia (time frame: from 20 weeks gestation until 37 weeks). The study lists 2 primary outcomes in all. 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 27 Nov 2020.