Table.
GRADE Evaluation of interventions for Recurrent miscarriage.
Important outcomes | Live birth rates, Miscarriage rates | ||||||||
Studies (Participants) | Outcome | Comparison | Type of evidence | Quality | Consistency | Directness | Effect size | GRADE | Comment |
What are the effects of treatments for unexplained recurrent miscarriage? | |||||||||
4 (180) | Miscarriage rates | Human chorionic gonadotrophin versus placebo | 4 | –3 | 0 | –1 | 0 | Very low | Quality points deducted for sparse data, uncertainty about randomisation, and for allocation and methodological weaknesses. Directness point deducted for inclusion of women with 2 or more consecutive miscarriages |
8 (303) | Live birth rates | Intravenous immunoglobulin versus placebo/no treatment | 4 | 0 | 0 | 0 | 0 | High | |
1 (54) | Live birth rates | Low-dose aspirin versus placebo | 4 | –2 | 0 | 0 | 0 | Low | Quality points deducted for sparse data and for methodological weaknesses |
12 (641) | Live birth rates | Paternal white cell immunisation versus placebo | 4 | 0 | 0 | 0 | 0 | High | |
4 (223) | Miscarriage rates | Progesterone versus placebo | 4 | –3 | 0 | 0 | 0 | Very low | Quality points deducted for sparse data, uncertainty about randomisation, allocation concealments, and methodological weaknesses |
1 (37) | Live birth rates | Trophoblastic membrane infusion versus placebo | 4 | –1 | 0 | 0 | 0 | Moderate | Quality point deducted for sparse data |
What are the effects of treatments for recurrent miscarriage caused by antiphospholipid syndrome? | |||||||||
3 (71) | Miscarriage rates | Low-dose aspirin versus placebo or usual care | 4 | –1 | 0 | 0 | 0 | Moderate | Quality point deducted for sparse data |
2 (140) | Miscarriage rates | Low-dose aspirin alone versus low-dose aspirin plus unfractionated heparin | 4 | –1 | 0 | 0 | 0 | Moderate | Quality point deducted for sparse data |
1 (72) | Live birth rates | Low-dose aspirin alone versus low-dose aspirin plus unfractionated heparin | 4 | –2 | 0 | 0 | 0 | Low | Quality points deducted for sparse data, and uncertainty about blinding and method of randomisation |
1 (98) | Miscarriage rates | Low-dose aspirin alone versus low-dose aspirin plus low molecular weight heparin | 4 | –2 | 0 | 0 | 0 | Low | Quality points deducted for sparse data and for enrolling women up to later gestation periods |
1 (88) | Miscarriage rates | Corticosteroids plus low-dose aspirin versus placebo | 4 | –1 | 0 | 0 | 0 | Moderate | Quality point deducted for sparse data |
1 (39) | Miscarriage rates | Corticosteroids plus low-dose aspirin versus low-dose aspirin alone | 4 | –3 | 0 | 0 | 0 | Very low | Quality points deducted for sparse data, incomplete reporting of results, and no intention-to-treat analysis |
We initially allocate 4 points to evidence from RCTs, and 2 points to evidence from observational studies. To attain the final GRADE score for a given comparison, points are deducted or added from this initial score based on preset criteria relating to the categories of quality, directness, consistency, and effect size. Quality: based on issues affecting methodological rigour (e.g., incomplete reporting of results, quasi-randomisation, sparse data [<200 people in the analysis]). Consistency: based on similarity of results across studies. Directness: based on generalisability of population or outcomes. Effect size: based on magnitude of effect as measured by statistics such as relative risk, odds ratio, or hazard ratio.