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

Effect of vaginally administered docosahexaenoic acid (DHA) fatty acids on pregnancy outcome: a randomised controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN39268609
Enrollment
60
Registered
2009-08-04
Start date
2009-09-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low birth weight, preterm labour, hypertension in pregnancy, gestational diabetes Pregnancy and Childbirth Complications of pregnancy, childbirth and the puerperium

Interventions

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

Sponsors

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

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: All women with a viable foetus between 18+0 and 24+0 weeks of gestation

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
1. Hypertensive disorders 2. Diabetes Both endpoints will be measured at the end of the trial. No interim analysis will be performed.

Countries

Italy

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026