Summary of findings 1. Laxative compared to placebo for preventing postpartum constipation.
| Laxative compared to placebo for preventing postpartum constipation | ||||||
| Patient or population: women in the postpartum period Setting: hospital setting in South Africa and the USA Intervention: laxative Comparison: placebo | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | № of participants (studies) | Certainty of the evidence (GRADE) | Comments | |
| Risk with placebo | Risk with laxative | |||||
| Pain or straining on defecation | ‐ | ‐ | ‐ | ‐ | ‐ | not reported |
| Incidence of postpartum constipation | ‐ | ‐ | ‐ | ‐ | ‐ | not reported |
| Quality of life | ‐ | ‐ | ‐ | ‐ | ‐ | not reported |
|
Time to first bowel movement (BM) (№ women with 1st BM less than 24 hours after delivery) |
Study population | RR 2.90 (2.24 to 3.75) | 471 (1 RCT) | ⊕⊕⊝⊝ LOWa |
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| 219 per 1000 | 634 per 1000 (490 to 820) | |||||
|
Time to first BM (№ women with 1st BM on day 1 after delivery) |
Study population | RR 0.94 (0.72 to 1.22) | 471 (1 RCT) | ⊕⊝⊝⊝ VERY LOWa,b,c | Two other studies measured this outcome but they were not pooled in a meta‐analysis. These studies investigated Danthron (a laxative that is no longer marketed due to carcinogenic properties), and bisoxatin acetate (a laxative that is not recommended for use when breastfeeding). | |
| 328 per 1000 | 308 per 1000 (236 to 400) | |||||
|
Time to first BM (№ women with 1st BM on day 2 after delivery) |
Study population | RR 0.23 (0.11 to 0.45) | 471 (1 RCT) | ⊕⊕⊝⊝ LOWa |
Two other studies measured this outcome but they were not pooled in a meta‐analysis. These studies investigated Danthron (a laxative that is no longer marketed due to carcinogenic properties), and bisoxatin acetate (a laxative that is not recommended for use when breastfeeding). | |
| 178 per 1000 | 41 per 1000 (20 to 80) | |||||
|
Time to first BM (№ women with 1st BM on day 3 after delivery) |
Study population | RR 0.05 (0.00 to 0.89) |
471 (1 RCT) | ⊕⊕⊝⊝ LOWa |
One other study measured this outcome but it was not included in a meta‐analysis because it investigated Danthron (a laxative that is no longer marketed due to carcinogenic properties). | |
| 40 per 1000 | 2 per 1000 (0 to 36) | |||||
|
Time to first BM (№ women with 1st BM on day 4 after delivery) |
Study population | RR 0.22 (0.03 to 1.87) | 471 (1 RCT) | ⊕⊝⊝⊝ VERY LOWa,b,c | One other study measured this outcome but it was not included in a meta‐analysis because it investigated Danthron (a laxative that is no longer marketed due to carcinogenic properties). | |
| 20 per 1000 | 4 per 1000 (1 to 38) | |||||
| Adverse effects on women: abdominal cramps | Study population | RR 4.23 (1.75 to 10.19) |
471 (1 RCT) | ⊕⊕⊝⊝ LOWa |
||
| 24 per 1000 | 103 per 1000 (43 to 248) |
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| Adverse effects on babies: loose stools | Study population | RR 0.62 (0.16 to 2.41) |
281 (1 RCT) |
⊕⊝⊝⊝ VERY LOWa,b,c | ||
| 39 per 1000 | 24 per 1000 (6 to 93) |
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| Adverse effects on babies: diarrhoea | Study population | RR 2.46 (0.23 to 26.82) |
281 (1 RCT) |
⊕⊝⊝⊝ VERY LOWa,b,c | ||
| 6 per 1000 | 16 per 1000 (1 to 173) |
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| *The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; RR: Risk ratio; | ||||||
| GRADE Working Group grades of evidence High certainty. We are very confident that the true effect lies close to that of the estimate of the effect Moderate certainty. We are moderately confident in the effect estimate; the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low certainty. Our confidence in the effect estimate is limited; the true effect may be substantially different from the estimate of the effect Very low certainty. We have very little confidence in the effect estimate; the true effect is likely to be substantially different from the estimate of effect | ||||||
aDowngraded by 2 levels due to very serious study limitations (high risk of attrition bias, selection bias (quasi‐randomised studies) or concern due to industry sponsorship and statistical analysis
bDowngraded by 1 level due to imprecision: wide confidence intervals that are consistent with possible benefit and possible harm
cDowngraded by 2 levels due to imprecision: few participants, few events and wide confidence intervals that are consistent with possible benefit and possible harm.
Note: We did not include in the analysis studies that assessed the effects of Danthron and Bisoxatin acetate, as the former has been shown to be carcinogenic in animals (National Toxicology Program 2016) and is no longer marketed, and the latter is no longer recommend in breastfeeding women (Omega Pharma 2016)