A Randomized Trial of Docosahexaenoic Acid Supplementation During Pregnancy to Prevent Deep Placentation Disorders

Summary

This study evaluates the effectiveness of maternal supplementation with Docosahexaenoic acid (DHA) early in pregnancy to reduce the incidence of deep placentation disorders: preterm birth, preterm labor, preterm premature rupture of membranes, preeclampsia and fetal growth restriction. Half of the participants in early pregnancy will receive DHA 600 mg per day, while the other half will receive placebo. Investigators will study also the ability of DHA supplementation, early in pregnancy, to enhance invasion and transformation of spiral arteries by trophoblast, as deep placentation indicators.

Conditions

• Premature Birth
• Preeclampsia
• Fetal Growth Retardation
• Stillbirth

Interventions

DIETARY_SUPPLEMENT

Docosahexaenoic acid (DHA)

Docosahexaenoic acid (DHA), 600 mg per day. Each woman will take three DHA capsules per day (200 mg each), as early in gestation as possible and until the end of pregnancy.

DIETARY_SUPPLEMENT

Placebo (for Docosahexaenoic acid (DHA))

Each women allocated to the placebo group, will receive three placebo capsules per day. The placebo capsules will have same size, aspect and flavor than the DHA capsules.

Sponsors & Collaborators

• University of Chile

  collaborator OTHER

• Laboratorio Gynopharm - CFR

  collaborator UNKNOWN

• Pontificia Universidad Catolica de Chile

  lead OTHER

Principal Investigators

• Jorge Carvajal, PhD · Pontificia Universidad Catolica de Chile

• Claudio Vera, MSc · Pontificia Universidad Catolica de Chile

• Paulina Rojas, MD · Pontificia Universidad Catolica de Chile

• Paola Casanello, PhD · Pontificia Universidad Catolica de Chile

• Mauro Parra, MD · University of Chile

• Christian Figueroa, MD · Pontificia Universidad Catolica de Chile

• Sergio González, MD · Pontificia Universidad Catolica de Chile

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

45 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2015-05-31

Primary Completion

2018-03-31

Completion

2018-04-30

Countries

• Chile

Study Locations