Summary of findings for the main comparison. Any anti‐adhesion therapy versus placebo or no treatment following operative hysteroscopy.
| Any anti‐adhesion therapy versus placebo or no treatment following operative hysteroscopy | ||||||
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Patient or population: women treated by operative hysteroscopy for uterine pathology associated with subfertility or adverse pregnancy outcome Settings: single centre, Hysteroscopy Unit or Department of Obstetrics and Gynaecology of a university or non‐university tertiary care hospital Intervention: any anti‐adhesion therapy Comparison: no treatment or placebo | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | No of participants (studies) | Quality of the evidence (GRADE) | Comments | |
| Assumed risk | Corresponding risk | |||||
| No treatment or placebo | Anti‐adhesion therapy | |||||
| Live birth a | No treatment or placebo | Device or hormonal treatment |
OR 0.94 (0.42 to 2.12) |
107 (2 RCTs) | ⊕⊝⊝⊝ Very low c,d,e | ‐ |
| Mean‐risk populationb | ||||||
| 407 per 1000 | 399 per 1000 (261 to 603) | |||||
|
Presence of intrauterine adhesions at second‐look hysteroscopy (second‐look hysteroscopy at 4‐12 weeks after operative hysteroscopy) |
No treatment or placebo | Device ± hormonal treatment or hormonal treatment or barrier gel | OR 0.35 g (0.21 to 0.60) | 560 (8 RCTs) |
⊕⊕⊝⊝ Low h,i | ‐ |
| Low‐risk populationf | ||||||
| 0 per 1000 | 0 per 1000 | |||||
| Medium‐risk population f | ||||||
| 545 per 1000 | 234 per 1000 (153 to 365) | |||||
| High‐risk population f | ||||||
| 875 per 1000 | 376 per 1000 (245 to 586) | |||||
| *The basis for the assumed risk is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; OR: odds ratio; RCT: randomised controlled trial. | ||||||
| GRADE Working Group grades of evidence. High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate. | ||||||
a The two included studies reported term delivery (Abu Rafea 2013) or ongoing pregnancy (Roy 2014), which we used as a surrogate outcome for live birth.
b The assumed risk for the mean‐risk population was the pooled risk of all live births in control groups of the two included studies.
c Downgraded one level for serious risk of bias: one study was at high risk of bias in several domains, including allocation concealment.
d Downgraded one level for serious imprecision; only 43 events in total.
e Downgraded one level for serious indirectness, because only 30% (35/118) of all randomised women in this analysis were subfertile.
f The assumed risk for low‐, medium‐ and high‐risk population based on presence of intrauterine adhesions following hysteroscopic removal of endometrial polyps/following removal of submucous fibroids and intrauterine adhesions (mean of both)/removal of uterine septum, respectively, based on findings of a prospective cohort study (Yang 2013).
G Two studies reported no events (Lin 2015a; Vercellini 1989).
h Downgraded one level for serious risk of bias: all eight studies had several limitations but none was at high risk for selection bias related to random sequence generation or allocation concealment.
i Downgraded one level for serious indirectness, because in four of eight studies less than 50% of participants were subfertile and in four of eight studies it was unclear whether subfertile women were included.