Efficacy of Aspirin and L-arginine in High Risk Preeclamptic | NCT02838030

Studies
Efficacy of Aspirin and L-arginine in High Risk Preeclamptic

NCT02838030

Sponsor

University of Guadalajara

Status

Suspended

Last Update Posted

Nov 27, 2020Actual

Enrollment

82Estimated

Phase

Phase 2

Conditions

High Risk Pregnancy

Interventions

L-arginine
Placebo (for L-arginine)
acetylsalicylic acid

Countries

Mexico

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2020

Overall Recruitment Status or Expanded Access Status

Suspended

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

COVID-19 pandemic

Expanded Access Info

Start Date

Jul 1, 2018Actual

Primary Completion Date

Jul 2021Estimated

Completion Date

Aug 2021Estimated

First Submitted Date

May 26, 2016

First Submission Date that Met QC Criteria

Jul 15, 2016

First Posted Date

Jul 20, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 25, 2020

Last Update Posted Date

Nov 27, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Leonel Garcia Benavides, PhD, University of GuadalajaraPrincipal Investigator

Lead Sponsor

University of GuadalajaraOTHER

Collaborators

Name	Class
PhD Ernesto Javier Ramírez Lizardo	UNKNOWN
PhD Sylvia Elena Totsuka Sutto	UNKNOWN
PhD Fernando Grover Páez	UNKNOWN
MD Diego Hernández Molina

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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%). 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

82Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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	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	Drug: Placebo (for L-arginine) Drug: acetylsalicylic acid

Interventions

Name	Type	Description	Arm Group Labels	Other Names
L-arginine	Drug	3 gr per day	acetylsalicylic acid and L-arginine	arginine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of preeclampsia		from 20 weeks gestation until 37 weeks
severity of preeclampsia		from 20 weeks gestation until 37 weeks

Secondary Outcomes

Measure	Description	Time Frame
Pulmonary edema maternal		at week 37
Acute myocardial infarction maternal		at week 37
Stroke maternal

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Pregnant before 12 weeks of gestation
High risk of preeclampsia
Signature of informed consent in writing

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

44 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Leonel García Benavides, PhD	University Guadalajara	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Antiguo Hospital Civil Fray Antonio Alcalde		Guadalajara	Jalisco	44280	Mexico

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D011225	Pre-Eclampsia

Ancestor Terms

ID	Term
D046110	Hypertension, Pregnancy-Induced
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001120	Arginine
D001241	Aspirin

Ancestor Terms

ID	Term
D024361	Amino Acids, Basic
D000596	Amino Acids
D000602	Amino Acids, Peptides, and Proteins
D000599	Amino Acids, Diamino

Browse Leaves

Not provided

Browse Branches

Not provided