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

NCT02336243 | Unknown Phase 3 DMC

• 2 other identifiers: 13-2171141207
• Study Type: interventional
• Target: 2,400
• Locations: 1 country
• Sites: 5

Brief 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

Keywords

docosahexaenoic acid; premature birth; placentation disorders; preeclampsia; fetal growth

Outcome Measures

Primary Outcomes (1)

• Composite outcome: Preterm birth less than 34+0 gestational weeks or preeclampsia before 34+0 gestational weeks or severe fetal growth restrictions early than 34+0 gestational weeks.

  * Gestational age (first day of the last menstrual period (LMP) or estimated by ultrasound performed before 12+6 weeks of pregnancy). * Severe growth restriction defined as birth weight less than the 2nd percentile of population (according to the current national recommended standard). * Preeclampsia defined as blood pressure of 140 mm Hg systolic or higher or 90 mm Hg diastolic or higher that occurs after 20 weeks of pregnancy in a woman with previously normal blood pressure and proteinuria (urinary excretion of 0.3 g protein or higher in a 24-hour urine specimen). Or HELLP syndrome (Haemolysis, Elevated, Liver Enzymes, Low Platelets) or superimposed pre-eclampsia, defined as history of pre-existing hypertension (diagnosed pre-pregnancy or before 20+0 weeks' gestation) with new proteinuria. Or Eclampsia, defined as seizures that cannot be attributable to other causes, in a woman with preeclampsia.

  34 weeks of pregnancy

Secondary Outcomes (23)

• Stillbirth

  During pregnancy

• Intrauterine growth restriction

  At delivery

• Severe intrauterine growth restriction

  At birth

• Preterm birth

  At birth

• Perinatal death

  From the 20th gestational week to the 28th day of life

Study Arms (2)

Docosahexaenoic acid (DHA)

EXPERIMENTAL

Docosahexaenoic acid (DHA) 200 mg capsules, 3 capsules by mouth every day, from early gestation until the end of pregnancy

Dietary Supplement: Docosahexaenoic acid (DHA)

Placebo

PLACEBO COMPARATOR

Placebo 200 mg capsules, 3 capsules by mouth every day, from early gestation until the end of pregnancy

Dietary Supplement: Placebo (for Docosahexaenoic acid (DHA))

Interventions

Docosahexaenoic acid (DHA) DIETARY_SUPPLEMENT

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.

Docosahexaenoic acid (DHA)

Placebo (for Docosahexaenoic acid (DHA)) DIETARY_SUPPLEMENT

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.

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women 18 years old or older at time of consent
• Capability of the subject to comprehend and comply with study requirements
• Live embryo or fetus (documented with positive fetal heart rate prior randomisation)
• Gestational age before 16+0 weeks of pregnancy
• Planning to deliver at Hospital Dr. Sótero del Río, Hospital Padre Hurtado, or Hospital Clínico Universidad Católica de Chile.

You may not qualify if:

• Preexisting diabetes mellitus.
• Uterine anatomic malformation (bicornuate, septate uterus).
• Already taking a prenatal supplement with DHA.
• Bleeding disorder in which DHA was contraindicated.
• Anticoagulant therapy.
• Documented history of drug or alcohol abuse.
• Embryo or Fetus with a known mayor abnormality.
• Unable to give written informed consent.
• In the judgment of the investigator, will be unwilling or unable to comply with study protocol.
• Currently participating in another fatty acid trial

Sponsors & Collaborators

• Pontificia Universidad Catolica de Chile: lead
• University of Chile: collaborator
• Laboratorio Gynopharm - CFR: collaborator

Study Sites (5)

Centro de Salud Familiar ANCORA Juan Pablo II

Santiago, Chile

RECRUITING

Centro de Salud Familiar ANCORA Madre Teresa de Calcuta

Santiago, Chile

RECRUITING

Centro de Salud Familiar ANCORA San Alberto Hurtado

Santiago, Chile

RECRUITING

Centro Medico Lira 85

Santiago, Chile

RECRUITING

Centro Medico San Joaquin

Santiago, Chile

RECRUITING

MeSH Terms

Conditions

Premature Birth; Pre-Eclampsia; Fetal Growth Retardation; Stillbirth

Interventions

Docosahexaenoic Acids

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension, Pregnancy-Induced; Fetal Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Fetal Death; Death

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Study Officials

• Jorge Carvajal, PhD

  Pontificia Universidad Catolica de Chile

  PRINCIPAL INVESTIGATOR

• Claudio Vera, MSc

  Pontificia Universidad Catolica de Chile

  STUDY DIRECTOR

• Paulina Rojas, MD

  Pontificia Universidad Catolica de Chile

  STUDY DIRECTOR

• Paola Casanello, PhD

  Pontificia Universidad Catolica de Chile

  STUDY DIRECTOR

• Mauro Parra, MD

  University of Chile

  STUDY DIRECTOR

• Christian Figueroa, MD

  Pontificia Universidad Catolica de Chile

  STUDY DIRECTOR

• Sergio González, MD

  Pontificia Universidad Catolica de Chile

  STUDY DIRECTOR

Central Study Contacts

Jorge Carvajal, PhD

CONTACT

+56 223543409; jcarva@med.puc.cl

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2014
• First Posted: January 12, 2015
• Study Start: May 1, 2015
• Primary Completion: March 1, 2018
• Study Completion: April 1, 2018
• Last Updated: November 4, 2015

Record last verified: 2015-11

Locations

CL (5)