Giorlandino 2013.

Methods	RCT: ISRCTN39268609
Participants	43 women randomised Inclusion criteria: women at high risk of preterm birth (history of previous IUGR, fetal demise or PE) with 1 or more previous preterm birth and/or ultrasonographic findings of cervical incompetence Exclusion criteria: a non‐viable fetus (before or after randomisation), a history of placental abruption, bleeding episode in the present pregnancy, use of (or used) PG inhibitors, multiple pregnancy, allergy to fish, regular intake of fish oil, a positive cervical swab for chlamydia, mycoplasma/ureaplasma and bacterial vaginosis infections, major fetal abnormalities. Setting: Artemisia Medical Centre, Rome, Italy
Interventions	VAGINAL APPLICATION: DHA versus placebo Group 1: DHA (1 g/day) vaginally: n = 22 Group 2: placebo vaginally: n = 21 Timing: from 21 weeks to 37 weeks 0 days DHA + EPA dose/day: high: 1 g DHA
Outcomes	Women/birth: GA at birth Babies/infants/children: birthweight
Notes	Funding: Pharmarte Srl (Italy) and sponsors Italian Society of Prenatal Diagnosis and Fetal Maternal Medicine (S.I.Di.P.) (Italy) and the Artemisia Foundation in Fetal‐Maternal Medical Research. The authors report that the funders had no role in data collection, data analysis, data interpretation or writing of the report. Declarations of interest: not reported
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "customised randomisation programme that generated a random number for each participant, with equal ratio of selection"
Allocation concealment (selection bias)	Unclear risk	Not reported
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Physicians and women were blinded to treatment.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Not reported, but probably done.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	1 woman in the omega‐3 group was lost to follow‐up (1/22); and women whose condition worsened were taken off treatment (1/22 in the omega‐3 group and 7/21 in the placebo group).
Selective reporting (reporting bias)	Unclear risk	Birthweight was only reported for women who gave birth at 37 weeks' gestation or later (and was therefore not included in the meta‐analysis).
Other bias	Low risk	No apparent risk of other bias.