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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This study has been withdrawn prior to enrollment.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)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00691418
First Posted: June 5, 2008
Last Update Posted: March 6, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
DSM Nutritional Products, Inc.
Information provided by (Responsible Party):
Kaiser Permanente
  Purpose
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: Quadruple (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
Placebo
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.

  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

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

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00691418


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

Responsible Party: Kaiser Permanente
ClinicalTrials.gov Identifier: NCT00691418     History of Changes
Other Study ID Numbers: KP-Martek01
First Submitted: June 3, 2008
First Posted: June 5, 2008
Last Update Posted: March 6, 2015
Last Verified: March 2015

Keywords provided by Kaiser Permanente:
perinatal
premature
pregnancy
gestation

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications