Methods |
Randomised clinical trial, with stratified allocation (primigravid vs multigravid). Randomisation method was not explained. |
Participants |
Women entering labour ward during the first stage of labour, for vaginal delivery, single pregnancy and 37 or more weeks of gestation. Exclusion criteria included diabetes, cardiac disease or pregnancy complicated by antepartum haemorrhage or severe pre‐eclampsia. 370 women were eligible and 222 (60%) agreed to participate. |
Interventions |
Low‐volume disposable phosphate enema in the study group vs no enema. Inclusion bias could have occurred when the clinic staff avoided the inclusion of women who had faecal deposition prior to admission. |
Outcomes |
Faecal contamination was evaluated with an arbitrary scale, not validated, previously described by Romney and Gordon (Romney 1981).
Infection evaluation is not clear. Follow‐up time is not clearly discussed, but there are no data suggesting that women were followed up after leaving the hospital. Infections were confirmed bacteriologically and association between the organism and soiling was established by a microbiologist and a research sister.
Duration of labour: it was stratified between primigravidae and multigravidae. Data were collected in 6 ordinal and arbitrary categories. No clear time of follow‐up. |
Notes |
Stratification would be better done by parity instead of gravidity. Randomisation method was not discussed in the article. |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Unclear risk |
Not reported. |
Allocation concealment (selection bias) |
Unclear risk |
Not reported. |
Blinding (performance bias and detection bias)
All outcomes |
High risk |
Not done. |
Incomplete outcome data (attrition bias)
All outcomes |
Unclear risk |
There are some missing data in outcomes' results. |
Selective reporting (reporting bias) |
Unclear risk |
Protocol of the study is not available. In the Drayton 1984 study the means to assess infection as well as the time of follow‐up was not reported by the authors. Infection rates were remarkably low in newborns and puerperal women as compared to the study from Colombia (Cuervo 2006). |
Other bias |
High risk |
Inclusion bias seemed to happen when clinic staff excluded women if they had faecal soiling prior to their evaluation (time span unspecified). The authors provide no demographic data that would be relevant to know the external validity of the study. |