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

NCT03111602 | Completed

• 1 other identifier: 18592013000005333
• Study Type: interventional
• Target: 75
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Pregnancy Complications

Keywords

polyphenols; pregnant; fetal ductal constriction; prostaglandin E2

Outcome Measures

Primary Outcomes (1)

• Plasma levels of prostaglandin E2 (PGE2)

  PGE2 was quantified by capture ELISA. The measurements were obtained through 4-parameter linear regression (Excel, Microsoft), and data were expressed in picograms of protein per milliliter (pg/mL).

  baseline and two weeks

Secondary Outcomes (1)

• Consumption of foods rich in Total Polyphenols (TP)

  baseline and two weeks

Other Outcomes (1)

• Diagnostic parameters of fetal ductus arteriosus constriction

  baseline and two weeks

Study Arms (2)

interventional group

EXPERIMENTAL

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

Other: restrict polyphenol-rich foods

control group

NO INTERVENTION

healthy group as comparator

Interventions

restrict polyphenol-rich foods OTHER

dietary orientation to restrict polyphenol-rich foods

interventional group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: pregnant: third-trimester mothers
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Instituto de Cardiologia do Rio Grande do Sul: lead

Related Publications (3)

• Vian I, Zielinsky P, Zilio AM, Mello A, Lazzeri B, Oliveira A, Lampert KV, Piccoli A, Nicoloso LH, Bubols GB, Garcia SC. Development and validation of a food frequency questionnaire for consumption of polyphenol-rich foods in pregnant women. Matern Child Nutr. 2015 Oct;11(4):511-24. doi: 10.1111/mcn.12025. Epub 2013 Jan 15.

  PMID: 23316751 BACKGROUND

• Momma K, Toyoshima K, Takeuchi D, Imamura S, Nakanishi T. In vivo constriction of the fetal and neonatal ductus arteriosus by a prostanoid EP4-receptor antagonist in rats. Pediatr Res. 2005 Nov;58(5):971-5. doi: 10.1203/01.pdr.0000182182.49476.24.

  PMID: 16257930 BACKGROUND

• Zielinsky P, Piccoli AL Jr, Manica JL, Nicoloso LH, Vian I, Bender L, Pizzato P, Pizzato M, Swarowsky F, Barbisan C, Mello A, Garcia SC. Reversal of fetal ductal constriction after maternal restriction of polyphenol-rich foods: an open clinical trial. J Perinatol. 2012 Aug;32(8):574-9. doi: 10.1038/jp.2011.153. Epub 2011 Nov 3.

  PMID: 22052330 BACKGROUND

MeSH Terms

Conditions

Pregnancy Complications

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Masking Details: Researchers were blinded to the allocation data of pregnant women in the groups
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator / Dietitian

Model Details: Clinical trial with a healthy group as comparator.

Study Record Dates

• First Submitted: March 29, 2017
• First Posted: April 13, 2017
• Study Start: May 1, 2011
• Primary Completion: June 1, 2015
• Study Completion: February 1, 2017
• Last Updated: April 13, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share