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

Premature Birth Clinical Trial

Official title:

DHA Administration and Length of Gestation: a Feasibility Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00691418
• Other study ID #: KP-Martek01
• Status: Withdrawn
• Phase: N/A
• First received: June 3, 2008
• Last updated: March 4, 2015
• Start date: July 2008
• Est. completion date: August 2009

Study information

• Verified date: March 2015
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Premature Birth

Intervention

Dietary Supplement:
• docosahexaenoic acid (DHA)
600 mg per day of docosahexaenoic acid (DHA) starting at 22-24 weeks gestation until delivery.
• placebo
placebo once per day starting at 22-24 weeks gestation until delivery.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Kaiser Permanente	DSM Nutritional Products, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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?		18 months	No