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Docosahexaenoic Acid (DHA) Administration and Length of Gestation: a Feasibility Study

This study has been withdrawn prior to enrollment.
(decision made not to proceed -- no subjects were ever enrolled)
DSM Nutritional Products, Inc.
Information provided by (Responsible Party):
Kaiser Permanente Identifier:
First received: June 3, 2008
Last updated: March 4, 2015
Last verified: March 2015
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.

Condition Intervention
Premature Birth
Dietary Supplement: docosahexaenoic acid (DHA)
Dietary Supplement: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: DHA Administration and Length of Gestation: a Feasibility Study

Resource links provided by NLM:

Further study details as provided by Kaiser Permanente:

Primary Outcome Measures:
  • 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? [ Time Frame: 18 months ]

Enrollment: 0
Study Start Date: July 2008
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
600 mg per day of docosahexaenoic acid (DHA)
Dietary Supplement: docosahexaenoic acid (DHA)
600 mg per day of docosahexaenoic acid (DHA) starting at 22-24 weeks gestation until delivery.
Other Name: omega fatty acid
Placebo Comparator: 2
Dietary Supplement: placebo
placebo once per day starting at 22-24 weeks gestation until delivery.

Detailed Description:

We propose to conduct an 18-month feasibility study to determine (a) how many women we could approach during a 4-month period, (b) how many of these women would be eligible for a future RCT, (c) how many would consent to participate in the RCT, and (d) how many would be subsequently rendered ineligible due to poor compliance. Women enrolled during the 4-month recruitment period would be followed until 1 month after delivery using telephone contact (for assessing compliance) and scanning of KPMCP electronic databases (for quantifying outcomes). We hope to enroll 50 to 75 women during our fixed time (4 months) recruitment period. Half of these 50-75 women would receive DHA; half would receive placebo.

We will identify potential subjects based on their response to the Preterm Birth Prevention Program questionnaire (a screening instrument administered by the Regional Perinatal Service Center [RPSC] to all women in the KPMCP entering prenatal care). Eligible women are those pregnant women entering prenatal care who, based on their response to the abovementioned RPSC questionnaire, are identified as having had a previous preterm delivery (delivery prior to 37 completed weeks of gestation).

Results of this study will (a) permit us to determine whether an RCT is feasible at a reasonable cost, and (b) assuming the answer to (a) is positive, it would then be possible for us to design an RCT that could address our primary study question.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  Contacts and Locations
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Please refer to this study by its identifier: NCT00691418

Sponsors and Collaborators
Kaiser Permanente
DSM Nutritional Products, Inc.
Principal Investigator: Gabriel Escobar, MD Kaiser Permanente
  More Information

Responsible Party: Kaiser Permanente Identifier: NCT00691418     History of Changes
Other Study ID Numbers: KP-Martek01
Study First Received: June 3, 2008
Last Updated: March 4, 2015

Keywords provided by Kaiser Permanente:

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications processed this record on May 25, 2017