Premature BirthPhase 3NCT02336243
A Randomized Trial of Docosahexaenoic Acid Supplementation During Pregnancy to Prevent Deep Placentation Disorders
A Phase 3 study testing Docosahexaenoic acid (DHA) in people with Premature Birth and Preeclampsia, run by Pontificia Universidad Catolica de Chile at 5 sites in Chile.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Premature Birth, Preeclampsia, Fetal Growth Retardation
- What is being tested?
- Docosahexaenoic acid (DHA)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,400 participants
- Where
- 5 sitesChile
- Study dates
- May 2015to Apr 2018
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Chile5 sites, 5 recruiting
- Recruiting
Centro de Salud Familiar ANCORA Juan Pablo II
Santiago
Francisco Arancibia, Matron
+56 2 2482 2400
- Recruiting
Centro de Salud Familiar ANCORA Madre Teresa de Calcuta
Santiago
Patricia Alar, Enf Matrona
+56 2 2851 5211
- Recruiting
Centro de Salud Familiar ANCORA San Alberto Hurtado
Santiago
Ghislaine Bustamante, Matrona
+56 2 2587 9300
- Recruiting
Centro Medico Lira 85
Santiago
Cecilia Berrios, Enf Matrona
+56 2 2354 8077
- Recruiting
Centro Medico San Joaquin
Santiago
Veronica Nuñez, Enf Matrona
+56 2 2354 8540
About this study
Official title: Docosahexaenoic Acid (DHA) Supplementation During Pregnancy to Prevent Deep Placentation Disorders: A Randomized Clinical Trial and a Study of the Molecular Pathways of Abnormal Placentation Prevention
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.
Read the detailed description
Introduction: uteroplacental ischemia may cause preterm birth, either due to preterm labor, preterm premature rupture of membranes, or medical indication (in the presence of preeclampsia or fetal growth restriction). Uteroplacental ischemia is the product of defective deep placentation, that is a failure of invasion and transformation of the spiral arteries by the trophoblast. It has been reported that the failure of normal placentation generates a series of clinical abnormalities nowadays called "deep placentation disorders"; they include preeclampsia (PE), fetal growth restriction (FGR), preterm labor (PL), preterm premature rupture of membranes (PPROM), in utero fetal death and placental abruption. Strategies to prevent deep placentation disorders have been just partially effective. Docosahexaenoic acid (DHA) is an essential fatty acid of the family of long chain polyunsaturated fatty acids (LC-PUFAs) or omega-3 fatty acids. Early reports, suggested that a LC-PUFAs rich diet reduces the incidence of deep placentation disorders. Recent randomized controlled trials are inconsistent to show the benefit of DHA supplementation during pregnancy to prevent deep placentation disorders; but most of them showed that DHA supplementation was associated to lower risk of early preterm birth.
Hypothesis: investigators propose that Docosahexaenoic acid (DHA) supplementation, early in pregnancy, reduces the incidence of deep placentation disorders (preterm birth, preterm labor, preterm premature rupture of membranes, preeclampsia and fetal growth restriction), by improving deep placentation physiology: invasion and transformation of spiral arteries by trophoblast.
General Goals: in this proposal investigators aimed to
- Assess 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.
- Study the ability of DHA supplementation, early in pregnancy, to enhance invasion and transformation of spiral arteries by trophoblast, as deep placentation indicators. Methodology: investigators will conduct a randomized, placebo controlled, double blind, clinical trial of maternal supplementation with DHA (Docosahexaenoic acid) to prevent deep placentation disorders. Women will be recruited before 16 weeks of pregnancy from 5 ambulatory centers, 2.400 pregnant women will be assigned to 600 mg DHA per day or placebo. A composite outcome will be the primary outcome of the study. The components of the composite outcome will be: preterm birth < 34+0 weeks gestation; early preeclampsia (<34+0 weeks) and severe fetal growth restriction (lower than the 2 percentile and < 34+0 weeks). Each of the outcomes of the composite outcome and other clinically relevant maternal and fetal outcomes will be evaluated as the secondary outcomes of the study. Clinical samples will be obtained from pregnant women on both groups, including: plasma, trophoblast, placental bed and myometrium, to study changes of deep placentation or defective placentation markers. Trophoblast cell lines will be used to study the effect of DHA on trophoblast function in vitro.
Expected outcome: In the randomized clinical trial, a 50% reduction in the incidence of the composite outcome in the DHA group (4% placebo vs. 2% DHA) is expected. Investigators expect to decrease defective deep placentation (placental bed biopsies) and defective placentation markers in DHA supplemented women. Investigators expect also to demonstrate that DHA enhances trophoblast migration and invasion in vitro and decreases production of inflammatory cytokines and anti-vasculogenic mediators.
Relevance: if the findings are positive, DHA supplementation, early in pregnancy, will become a safe and effective strategy for primary prevention of highly relevant pregnancy diseases, such as preterm birth, preeclampsia and fetal growth restriction.
- Conditions
- Premature Birth, Preeclampsia, Fetal Growth Retardation, Stillbirth
- Being tested
- Docosahexaenoic acid (DHA), Placebo (for Docosahexaenoic acid (DHA))
- Keywords
- docosahexaenoic acid, premature birth, placentation disorders, preeclampsia, fetal growth
- Medical subject headings
- Premature Birth, Pre-Eclampsia, Fetal Growth Retardation, Stillbirth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Docosahexaenoic acid (DHA) | Experimental | Docosahexaenoic acid (DHA) 200 mg capsules, 3 capsules by mouth every day, from early gestation until the end of pregnancy Receives: 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 Receives: Dietary Supplement: Placebo (for Docosahexaenoic acid (DHA)) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 34 weeks of pregnancy
Secondary outcomes (23)
Stillbirth
Defined as death of the fetus of at least 500 grams birth weight or, if birth weight is unavailable, a gestational age of at least 20+0 weeks of gestation.
Measured: During pregnancy
Intrauterine growth restriction
Birth weight less than the 10th percentile of the population standard for the gestational age.
Measured: At delivery
Severe intrauterine growth restriction
birth weight less than the 2nd percentile of population (according to the current national recommended standard).
Measured: At birth
Preterm birth
Birth < week 37th, < week 32th, < week 28th
Measured: At birth
Perinatal death
number of deaths (fetal deaths and neonatal deaths) of babies ≥500 grams, if birth weight is unavailable, a gestational age ≥20+0 weeks, up to 28 completed days after birth.
Measured: From the 20th gestational week to the 28th day of life
Neonatal
Death of a baby that occurred during the first 28 days of life
Measured: From birth to the 28th day of life
Respiratory Distress Syndrome (RDS)
Defined as requiring assisted ventilation via endotracheal tube or CPAP (Continuous positive airway pressure) or supplemental oxygen greater or equal to 40% all within the first 24 hours of life and for a duration of greater than or equal to 24 hours, and either an x-ray compatible with RDS or surfactant given between the first 2 and 24 hours of life.
Measured: Until the 28th day of life
Bronchopulmonary Dysplasia (BPD)
Defined as requiring oxygen supplementation at 28 days postnatal age
Measured: Until the 28th day of life
Intraventricular Hemorrhage (IVH)
Diagnosed by imaging, categorized by:
- Grade 1: blood in germinal matrix
- Grade 2: blood in germinal matrix and extending into ventricles
- Grade 3: ventricular enlargement
- Grade 4: intraparenchymal lesion
Measured: Until the 28th day of life
Proven Early onset Sepsis
Within first 48hr of life, confirmed by positive blood or cerebrospinal fluid cultures
Measured: Within the first 48 hours of life
Necrotizing Enterocolitis
Defined as Bell's stage II (definite case of necrotizing enterocolitis) or greater, or perforation of intestine identified by surgery, or at autopsy. (Neu J. Necrotizing enterocolitis: the search for a unifying pathogenic theory leading to prevention. Pediatr Clin North Am 1996; 43(2): 409-32.)
Measured: Until the 28th day of life
Low birth weight
Number of Infants with a birth weight < 1500 grams, number of Infants with a birth weight < 2500 grams
Measured: At birth
Admitted to Neonatal Intensive Care Unit (NICU)
Measured: Until the 28th day of life
Birth biometry
Measurement of ponderal index (birth weight/height^3×100), head circumference (cm), Birth weight (grams).
Measured: At birth
Cesarean section
Number of deliveries by cesarean section
Measured: At delivery
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, defined as urinary excretion of 0.3 g protein or higher in a 24-hour urine specimen. Or HELLP (Haemolysis, Elevated, Liver Enzymes, Low Platelets) syndrome 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.
Measured: From pregnancy to discharge after delivery
Gestational Diabetes (GDM)
Screening during pregnancy
Measured: During pregnancy
Premature rupture of membranes
Rupture of the amniotic sac before the onset of labor
Measured: During pregnancy
Maternal Venous Thrombosis
Venous Thrombosis confirmed by imaging during pregnancy
Measured: During pregnancy
Bleeding during pregnancy
Genital bleeding diagnosed during pregnancy
Measured: During pregnancy
Placental Abruptio
Prematurely detachment of a normal positioned placenta for the wall of uterus
Measured: During pregnancy
Postpartum bleeding
Estimated bleeding more than 500 ml after vaginal birth or 1000 ml after cesarean section
Measured: Postpartum period
Postpartum depression
Postpartum Depression defined by the Edinburgh Postnatal Depression Scale (EPDS)
Measured: At the 6th postpartum week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2015 (estimated)
- Study startMay 2015
- Primary completionMar 2018 (estimated)
- Study completionApr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Premature BirthStudies of the same condition, open and under way.
- More trials run by Pontificia Universidad Catolica de ChileThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pontificia Universidad Catolica de Chile
- Sponsor type
- University, hospital or other
- Collaborators
- University of Chile, Laboratorio Gynopharm - CFR
- Responsible party
- Sponsor
- Investigators
- Jorge Carvajal, PhD, Principal investigator, Pontificia Universidad Catolica de ChileClaudio Vera, MSc, Study director, Pontificia Universidad Catolica de ChilePaulina Rojas, MD, Study director, Pontificia Universidad Catolica de ChilePaola Casanello, PhD, Study director, Pontificia Universidad Catolica de ChileMauro Parra, MD, Study director, University of ChileChristian Figueroa, MD, Study director, Pontificia Universidad Catolica de ChileSergio González, MD, Study director, Pontificia Universidad Catolica de Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02336243
- Sponsor's protocol ID
- 13-217
- Other IDs
- 1141207
- Status last verified
- Nov 2015
- First submitted
- 19 Oct 2014
- Last updated
- 4 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Carvajal JA, Carvajal SA, Araujo K, Rojas MP, Casanello PC, Vera CM. Early maternal DHA supplementation fails to modify clinical phenotypes associated with impaired placentation: A randomized, double-blind, placebo-controlled trial (DEEPER trial). Placenta. 2026 May 22;179:145-151. doi: 10.1016/j.placenta.2026.04.013. Epub 2026 Apr 16.
PubMed 42025271
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Docosahexaenoic Acid (DHA) Supplementation During Pregnancy to Prevent Deep Placentation Disorders: A Randomized Clinical Trial and a Study of the Molecular Pathways of Abnormal Placentation Prevention
- ClinicalTrials.gov ID
- NCT02336243
- Acronym / sponsor ID
- 13-217
- Conditions
- Premature Birth, Preeclampsia, Fetal Growth Retardation, Stillbirth
- Keywords
- docosahexaenoic acid, premature birth, placentation disorders, preeclampsia, fetal growth
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,400 participants (estimated)
- Lead sponsor
- Pontificia Universidad Catolica de ChileUniversity, hospital or other
- Collaborators
- University of Chile, Laboratorio Gynopharm - CFR
- Study start
- May 2015
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Apr 2018 (estimated)
- First posted
- 12 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Introduction: uteroplacental ischemia may cause preterm birth, either due to preterm labor, preterm premature rupture of membranes, or medical indication (in the presence of preeclampsia or fetal growth restriction). Uteroplacental ischemia is the product of defective deep placentation, that is a failure of invasion and transformation of the spiral arteries by the trophoblast. It has been reported that the failure of normal placentation generates a series of clinical abnormalities nowadays called "deep placentation disorders"; they include preeclampsia (PE), fetal growth restriction (FGR), preterm labor (PL), preterm premature rupture of membranes (PPROM), in utero fetal death and placental abruption. Strategies to prevent deep placentation disorders have been just partially effective. Docosahexaenoic acid (DHA) is an essential fatty acid of the family of long chain polyunsaturated fatty acids (LC-PUFAs) or omega-3 fatty acids. Early reports, suggested that a LC-PUFAs rich diet reduces the incidence of deep placentation disorders. Recent randomized controlled trials are inconsistent to show the benefit of DHA supplementation during pregnancy to prevent deep placentation disorders; but most of them showed that DHA supplementation was associated to lower risk of early preterm birth.
Hypothesis: investigators propose that Docosahexaenoic acid (DHA) supplementation, early in pregnancy, reduces the incidence of deep placentation disorders (preterm birth, preterm labor, preterm premature rupture of membranes, preeclampsia and fetal growth restriction), by improving deep placentation physiology: invasion and transformation of spiral arteries by trophoblast.
General Goals: in this proposal investigators aimed to
- Assess 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.
- Study the ability of DHA supplementation, early in pregnancy, to enhance invasion and transformation of spiral arteries by trophoblast, as deep placentation indicators. Methodology: investigators will conduct a randomized, placebo controlled, double blind, clinical trial of maternal supplementation with DHA (Docosahexaenoic acid) to prevent deep placentation disorders. Women will be recruited before 16 weeks of pregnancy from 5 ambulatory centers, 2.400 pregnant women will be assigned to 600 mg DHA per day or placebo. A composite outcome will be the primary outcome of the study. The components of the composite outcome will be: preterm birth < 34+0 weeks gestation; early preeclampsia (<34+0 weeks) and severe fetal growth restriction (lower than the 2 percentile and < 34+0 weeks). Each of the outcomes of the composite outcome and other clinically relevant maternal and fetal outcomes will be evaluated as the secondary outcomes of the study. Clinical samples will be obtained from pregnant women on both groups, including: plasma, trophoblast, placental bed and myometrium, to study changes of deep placentation or defective placentation markers. Trophoblast cell lines will be used to study the effect of DHA on trophoblast function in vitro.
Expected outcome: In the randomized clinical trial, a 50% reduction in the incidence of the composite outcome in the DHA group (4% placebo vs. 2% DHA) is expected. Investigators expect to decrease defective deep placentation (placental bed biopsies) and defective placentation markers in DHA supplemented women. Investigators expect also to demonstrate that DHA enhances trophoblast migration and invasion in vitro and decreases production of inflammatory cytokines and anti-vasculogenic mediators.
Relevance: if the findings are positive, DHA supplementation, early in pregnancy, will become a safe and effective strategy for primary prevention of highly relevant pregnancy diseases, such as preterm birth, preeclampsia and fetal growth restriction.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Docosahexaenoic acid (DHA) | Experimental | Dietary Supplement: Docosahexaenoic acid (DHA)Docosahexaenoic acid (DHA) 200 mg capsules, 3 capsules by mouth every day, from early gestation until the end of pregnancy |
| Placebo | Placebo comparator | Dietary Supplement: Placebo (for Docosahexaenoic acid (DHA))Placebo 200 mg capsules, 3 capsules by mouth every day, from early gestation until the end of pregnancy |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Docosahexaenoic acid (DHA) |
| 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. | Dietary supplement | Placebo |
Primary outcome
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.
Time frame: 34 weeks of pregnancy
* 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.
23 secondary outcomes
Stillbirth
Time frame: During pregnancy
Intrauterine growth restriction
Time frame: At delivery
Severe intrauterine growth restriction
Time frame: At birth
Preterm birth
Time frame: At birth
Perinatal death
Time frame: From the 20th gestational week to the 28th day of life
Neonatal
Time frame: From birth to the 28th day of life
Respiratory Distress Syndrome (RDS)
Time frame: Until the 28th day of life
Bronchopulmonary Dysplasia (BPD)
Time frame: Until the 28th day of life
Intraventricular Hemorrhage (IVH)
Time frame: Until the 28th day of life
Proven Early onset Sepsis
Time frame: Within the first 48 hours of life
Necrotizing Enterocolitis
Time frame: Until the 28th day of life
Low birth weight
Time frame: At birth
Admitted to Neonatal Intensive Care Unit (NICU)
Time frame: Until the 28th day of life
Birth biometry
Time frame: At birth
Cesarean section
Time frame: At delivery
Preeclampsia
Time frame: From pregnancy to discharge after delivery
Gestational Diabetes (GDM)
Time frame: During pregnancy
Premature rupture of membranes
Time frame: During pregnancy
Maternal Venous Thrombosis
Time frame: During pregnancy
Bleeding during pregnancy
Time frame: During pregnancy
Placental Abruptio
Time frame: During pregnancy
Postpartum bleeding
Time frame: Postpartum period
Postpartum depression
Time frame: At the 6th postpartum week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2015.
- Derived from this study: PubMed 42025271Carvajal JA, Carvajal SA, Araujo K, Rojas MP, Casanello PC, Vera CM. Early maternal DHA supplementation fails to modify clinical phenotypes associated with impaired placentation: A randomized, double-blind, placebo-controlled trial (DEEPER trial). Placenta. 2026 May 22;179:145-151. doi: 10.1016/j.placenta.2026.04.013. Epub 2026 Apr 16.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jorge Carvajal, PhD principal investigator
Pontificia Universidad Catolica de Chile
Claudio Vera, MSc study director
Pontificia Universidad Catolica de Chile
Paulina Rojas, MD study director
Pontificia Universidad Catolica de Chile
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Docosahexaenoic acid (DHA) in people with Premature Birth and Preeclampsia, run by Pontificia Universidad Catolica de Chile at 5 sites in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jorge Carvajal, PhD (+56 223543409, jcarva@med.puc.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 34 weeks of pregnancy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02336243, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2015.