Effect of vaginally administered docosahexaenoic acid (DHA) fatty acids on pregnancy outcome

ISRCTN	ISRCTN39268609
DOI	https://doi.org/10.1186/ISRCTN39268609
Secondary identifying numbers	IRS - 09 - 0001

Submission date: 27/05/2009
Registration date: 04/08/2009
Last edited: 04/08/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Claudio Giorlandino
Scientific

Viale Liegi, 45
Rome
00198
Italy

Study information

Study design	Single centre double-blind randomised placebo controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Effect of vaginally administered docosahexaenoic acid (DHA) fatty acids on pregnancy outcome: a randomised controlled trial
Study objectives	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(s)	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
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Phase III
Drug / device / biological / vaccine name(s)	Docosahexaenoic acid (DHA) fatty acids
Primary outcome measure	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 study start date	01/09/2009
Completion date	31/05/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target number of participants	60
Key inclusion criteria	All women with a viable foetus between 18+0 and 24+0 weeks of gestation
Key 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
Date of first enrolment	01/09/2009
Date of final enrolment	31/05/2010

Locations

Countries of recruitment

Italy

Study participating centre

Viale Liegi, 45

Rome
00198
Italy

Sponsor information

Italian Society of Prenatal Diagnosis and Fetal Maternal Medicine (S.I.Di.P.) (Italy)
Research organisation

Viale Liegi, 49
Rome
00198
Italy

Website	http://www.ilfeto.it/

Funders

Funder type

Industry

Pharmarte Srl (Italy)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan