Condition category
Pregnancy and Childbirth
Date applied
27/05/2009
Date assigned
04/08/2009
Last edited
04/08/2009
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Claudio Giorlandino

ORCID ID

Contact details

Viale Liegi
45
Rome
00198
Italy

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

http://www.ilfeto.it/

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

Publication citations

Additional files

Editorial Notes