NCT00691418

Brief Summary

This is a feasibility study to determine if it will be possible to conduct a larger study of the effect of docosahexaenoic acid (DHA), an omega fatty acid, on increased length of gestation among women who have had a previous preterm delivery.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2008

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 3, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 5, 2008

Completed
26 days until next milestone

Study Start

First participant enrolled

July 1, 2008

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

March 6, 2015

Status Verified

March 1, 2015

Enrollment Period

1.1 years

First QC Date

June 3, 2008

Last Update Submit

March 4, 2015

Conditions

Premature Birth

Keywords

perinatalprematurepregnancygestation

Outcome Measures

Primary Outcomes (1)

  • Is daily intake of 600 mg per day of docosahexaenoic acid (DHA), a long-chain polyunsaturated fatty acid, beginning at 22-24 weeks gestation, associated with increased length of gestation among women who have had a previous preterm delivery?

    18 months

Study Arms (2)

1

ACTIVE COMPARATOR

600 mg per day of docosahexaenoic acid (DHA)

Dietary Supplement: docosahexaenoic acid (DHA)

2

PLACEBO COMPARATOR

Placebo

Dietary Supplement: placebo

Interventions

docosahexaenoic acid (DHA)DIETARY_SUPPLEMENT

600 mg per day of docosahexaenoic acid (DHA) starting at 22-24 weeks gestation until delivery.

Also known as: omega fatty acid
1
placeboDIETARY_SUPPLEMENT

placebo once per day starting at 22-24 weeks gestation until delivery.

2

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Previous preterm delivery (delivery prior to 37 completed weeks of gestation)

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Premature Birth

Interventions

Docosahexaenoic Acids

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3Dietary Fats, UnsaturatedDietary FatsFatsLipidsFatty Acids, UnsaturatedFatty AcidsFish OilsOils

Study Officials

  • Gabriel Escobar, MD

    Kaiser Permanente

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
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

June 3, 2008

First Posted

June 5, 2008

Study Start

July 1, 2008

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

March 6, 2015

Record last verified: 2015-03