Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
IRS - 09 - 0001
Study information
Scientific title
Effect of vaginally administered docosahexaenoic acid (DHA) fatty acids on pregnancy outcome: a randomised controlled trial
Acronym
Study hypothesis
Until today supplementation in pregnancy is performed only with sources consumed per os. Moreover, trials for prevention of premature delivery or low weight baby uses docosahexaenoic acid (DHA) administered orally. The metabolism and absorption of lipids in the gastrointestinal tract is related to a complex pathway involving liver, pancreatic and gastric enzymes. This mechanism could lead to a loss of concentration in the blood that could causes in turn a low effective concentration. The purpose of our study is to assess the efficacy of DHA administered vaginally.
Ethics approval
Local Ethics Committee of the "Artemisia Medical Institute Network" (created according to the guidelines reported in the "Decreto Ministeriale (DM) 15/7/1997", Ministry of Health of Italy) on the 11th April 2009
Study design
Single centre double-blind randomised placebo controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Low birth weight, preterm labour, hypertension in pregnancy, gestational diabetes
Intervention
Iintervention group: vaginally 3 g fish oil (1 g DHA) daily for 20 weeks starting until delivery
Control group: vaginally 3 g placebo used as above
Intervention type
Drug
Phase
Phase III
Drug names
Docosahexaenoic acid (DHA) fatty acids
Primary outcome measures
1. Timing of pregnancy
2. Newborn weight
Both endpoints will be measured at the end of the trial. No interim analysis will be performed.
Secondary outcome measures
1. Hypertensive disorders
2. Diabetes
Both endpoints will be measured at the end of the trial. No interim analysis will be performed.
Overall trial start date
01/09/2009
Overall trial end date
31/05/2010
Reason abandoned
Eligibility
Participant inclusion criteria
All women with a viable foetus between 18+0 and 24+0 weeks of gestation
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
60
Participant exclusion criteria
1. History of placental abruption
2. Bleeding episode in the present pregnancy
3. Women using (or used) prostaglandin inhibitors
4. Multiple pregnancy
5. Allergy to fish
6. Regular intake of fish oil
Recruitment start date
01/09/2009
Recruitment end date
31/05/2010
Locations
Countries of recruitment
Italy
Trial participating centre
Viale Liegi, 45
Rome
00198
Italy
Sponsor information
Organisation
Italian Society of Prenatal Diagnosis and Fetal Maternal Medicine (S.I.Di.P.) (Italy)
Sponsor details
Viale Liegi
49
Rome
00198
Italy
Sponsor type
Research organisation
Website
Funders
Funder type
Industry
Funder name
Pharmarte Srl (Italy)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary