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

Kaiser Permanente

Status: Withdrawn

Conditions: Premature Birth

Treatments: Dietary Supplement: placebo; Dietary Supplement: docosahexaenoic acid (DHA)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00691418

KP-Martek01

Details and patient eligibility

About

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.

Full 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.

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• None

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Description:

600 mg per day of docosahexaenoic acid (DHA)

Treatment:

Dietary Supplement: docosahexaenoic acid (DHA)

2

Placebo Comparator group

Description:

Placebo

Treatment:

Dietary Supplement: placebo