Ismail 2016.
Methods | RCT: NCT01990690 | |
Participants | 140 women randomised Inclusion criteria: pregnant women with singleton pregnancy (30‐34 weeks' gestation) with an ultrasonographic diagnosis of oligohydramnios (amniotic fluid index ≤ 5 cm); women aged 20‐35 years with normal Doppler indices in uterine and umbilical arteries at the time of recruitment (the normal value of S/D ratio is from 2.5 to 3.5; RI is from 0.60 to 0.75; and PI is from 0.96 to 1.27) Exclusion criteria: women with evidence of IUGR, history of premature rupture of membranes, impaired liver or kidney function, PE or long‐term diabetes and any placental abnormalities; women with non‐reactive non‐stress test or women using NSAIDs or who had any congenital fetal malformation; and women who had abnormal Doppler indices at the time of recruitment Setting: Department of Obstetric and Gynecology, Woman's Health Hospital, Assiut University, Assiut, Egypt (conducted between 1 January 2015 and 1 August 2015) |
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Interventions |
SUPPLEMENTATION: EPA + DHA versus placebo Group 1: omega‐3 capsules: 1000 mg fish oil (containing 13% EPA and 9% DHA plus 100 mg wheat‐germ oil (LA 52% to 59%) as a natural source of vitamin E once daily for 4 weeks: n = 70 Group 2: placebo: once daily empty soft gelatin capsules of the same shape, size, colour and weight for the same duration: Total number randomised: n = 70 Timing of supplementation: from 30‐34 weeks' gestation for 4 weeks DHA + EPA dose/day: low: 90 mg DHA + 130 mg EPA |
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Outcomes | Women: improvement in amniotic fluid volume 4 weeks after start of treatment; Doppler blood flow changes in the uterine artery after 4 weeks of treatment; uterine artery Doppler indices | |
Notes | No outcomes could be used in this review. Funding: not reported Declarations of interest: none declared |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated random table |
Allocation concealment (selection bias) | Low risk | Allocation concealment was carried out using serially numbered closed opaque envelopes. Each envelope was labelled with a serial number and had a card noting the intervention type inside. Allocation was never changed after opening the envelopes. Preparation and sorting of the serially numbered envelopes was carried out by an investigator who did not participate in the evaluation of patients. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Placebo controlled |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Not specifically reported, but probably done. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | 14.3% (20/140) lost to follow‐up: 10/70 in omega‐3 group and 10/70 in the placebo group. |
Selective reporting (reporting bias) | Unclear risk | No perinatal health outcomes reported. |
Other bias | Low risk | Similar baseline characteristics |