Docosahexaenoic Acid (DHA) Administration and Length of Gestation: a Feasibility Study
|Premature Birth||Dietary Supplement: docosahexaenoic acid (DHA) Dietary Supplement: placebo|
|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|
- 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 ]
|Study Start Date:||July 2008|
|Study Completion Date:||August 2009|
|Primary Completion Date:||August 2009 (Final data collection date for primary outcome measure)|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00691418
|Principal Investigator:||Gabriel Escobar, MD||Kaiser Permanente|