Increase of Prostaglandin E2 in Reversal of Ductal Constriction After Dietary Restriction of Polyphenols

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2017-02-28

Brief Summary

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INCREASE OF PROSTAGLANDIN E2 IN REVERSAL OF DUCTAL CONSTRICTION AFTER DIETARY RESTRICTION OF POLYPHENOLS.

Clinical trial with a healthy group as comparator. The interventional group was made up of third-trimester mothers whose single fetuses had ductal constriction, excluding those exposed to NSAID, and the control group only by third-trimester normal fetuses. The interventional group was submitted to dietary orientation to restrict polyphenol-rich foods and both groups answered a food frequency questionnaire after fetal Doppler-echocardiographic examination and blood draw for PGE2 levels analysis. After two weeks, the women were again submitted to fetal echocardiogram, dietary assessment and blood draw.

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Detailed Description

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INCREASE OF PROSTAGLANDIN E2 IN REVERSAL OF DUCTAL CONSTRICTION AFTER DIETARY RESTRICTION OF POLYPHENOLS.

Fetal ductal constriction is a clinical situation with high morbidity and potential mortality. Patency the fetal ductus arteriosus (DA) depends on circulating prostaglandin (PG), which is produced by the cyclooxygenase (COX) pathway during inflammatory response(1) and from the third trimester of pregnancy on, is physiologically released. COX-inhibiting substances, such as nonsteroidal anti-inflammatory drugs (NSAIDs), can interfere with PG metabolism and induce constriction of the DA. To treat or prevent DA constriction, it is therefore important to reduce fetal exposure to drugs that may interfere with prostaglandin biosynthesis, such as natural anti-inflammatory drugs and polyphenol-rich foods.

Polyphenols, the most abundant antioxidants present in the diet, are widely distributed in vegetable foods. One of the possible mechanisms to explain their activity is inhibition of synthesis and release of inflammatory mediators. However, clinical studies investigating the effect of polyphenols on inflammatory responses are inconclusive and, in most cases, only evaluate clinical outcomes. The role of polyphenols on the inflammatory response, and associated modifications of the plasma concentration of PGE2 in pregnant women, has not yet been studied.

Despite the potential benefits of a diet rich in polyphenols, a high consumption of these substances in the third trimester of pregnancy may reduce plasma levels of PGE2 and result in DA constriction,so that a restriction in their ingestion during this period is already recommended.This functional problem has high prevalence and may result in severe fetal and neonatal complications. These considerations raised the hypothesis that reversal of fetal ductal constriction after maternal restriction of polyphenol-rich foods is accompanied by increased in prostaglandin E2 levels. Demonstration of this effect would represent an advancement in knowledge and might result in changes in dietary guidance during pregnancy and prevention of perinatal complications, with potential impact in terms of public health.

The aim of this study was to test the hypothesis that reversal of fetal ductal constriction in the third trimester of pregnancy, after maternal restriction of polyphenol-rich foods, is accompanied by increased plasma levels of prostaglandin E2.

Conditions

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Pregnancy Complications

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Clinical trial with a healthy group as comparator.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Investigators

Researchers were blinded to the allocation data of pregnant women in the groups

Study Groups

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interventional group

The interventional group was submitted to dietary orientation to restrict polyphenol-rich foods

Group Type EXPERIMENTAL

restrict polyphenol-rich foods

Intervention Type OTHER

dietary orientation to restrict polyphenol-rich foods

control group

healthy group as comparator

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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restrict polyphenol-rich foods

dietary orientation to restrict polyphenol-rich foods

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Pregnancy with diagnosis of fetal ductal constriction
* Single fetus
* gestational age from 28 weeks

Exclusion Criteria

* cardiac malformations
* restricted intrauterine growth
* increased nuchal translucency
* present or suspected chromosomal disorders
* signs of any type of hydrops fetalis
* pregnancy
* hypertension
* diabetes mellitus
* structural or functional cardiac disorders
* current use of nonsteroidal anti-inflammatory drugs, steroids, antidepressants, illicit drugs, alcohol or smoking
* multiple pregnancy
* having received previous nutritional guidance in relation to restricted intake of polyphenol-rich foods

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes