NCT00691418

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

DHA Administration and Length of Gestation: a Feasibility Study

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Kaiser Permanente · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Premature Birth

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	docosahexaenoic acid (DHA)	600 mg per day of docosahexaenoic acid (DHA) starting at 22-24 weeks gestation until delivery.
DIETARY_SUPPLEMENT	placebo	placebo once per day starting at 22-24 weeks gestation until delivery.

Timeline

• Start date: 2008-07-01
• Primary completion: 2009-08-01
• Completion: 2009-08-01
• First posted: 2008-06-05
• Last updated: 2015-03-06