An interventional study of docosahexaenoic acid (DHA) and placebo in Premature Birth, sponsored by Kaiser Permanente. Withdrawn. Open to female participants. Per ClinicalTrials.gov, last updated 2015-03-06.
Sponsored by Kaiser Permanente · Not applicable, Interventional, and Prevention
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.
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.
2,554 studies on the registry are indexed under Premature Birth; 498 are open to participants now.
Browse Premature Birth studies →Kaiser Permanente is the lead sponsor of 385 studies on the registry; 41 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 3 (50%) have results posted.
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Exclusion Criteria:
600 mg per day of docosahexaenoic acid (DHA)
Dietary Supplement: docosahexaenoic acid (DHA)
Placebo
Dietary Supplement: placebo
600 mg per day of docosahexaenoic acid (DHA) starting at 22-24 weeks gestation until delivery.
Also known as: omega fatty acid
placebo once per day starting at 22-24 weeks gestation until delivery.
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
No study locations are listed for this record.
This study is withdrawn, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.
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