| Methods |
Randomised clinical trial. Block randomisations in blocks of 2 (20%), 4 (60%) and 6 (20%) using sealed envelopes when participants visited the obstetrics admission ward and filled inclusion criteria. |
| Participants |
Women attending a tertiary care hospital in Bogota, Colombia for delivery. Inclusion criteria included: living and staying in Bogota the month following delivery; gestational age of 36 or more weeks; willingness to participate. Exclusion criteria: medical emergency; use of antibiotics the week prior to admission; rupture of amniotic membranes; cervical dilatation over 7 cm. |
| Interventions |
High volume (1000 mL) saline solution enema or no enema. |
| Outcomes |
Participants and newborns were followed for 1 month after delivery. Visits were carried out at the puerperium and paediatrics ward and neonatal intensive care unit. Participants were evaluated through telephone interviews and/or physical examination carried out 1 and 4 weeks after delivery. 24‐hour pager service was offered to inform of any health problems. Telephone follow‐up was performed when patients failed to attend programmed visits. Infections were diagnosed on clinical grounds. Neonatal infections included: ocular, umbilical or skin infection; lower or upper respiratory tract infection; intestinal infection; meningitis or sepsis. Puerperal infections included: dehiscence of the episiorraphy suture; purulent effusion from episiorraphy; urinary tract infection; pelvic inflammatory disease or vulvovaginitis. |
| Notes |
Blinding was not possible although an effort was made to keep the hypothesis unknown to staff and participants. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Randomisation was done in blocks of 2 (20%), 4 (60%) and 6 (20%) using Ralloc® allocation software. |
| Allocation concealment (selection bias) |
Low risk |
Opaque envelope with sequential numbering and instructions was opened. |
| Blinding (performance bias and detection bias)
All outcomes |
High risk |
Not done. |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
There were 12 protocol violations; women who did not fulfil the inclusion criteria were identified and excluded from the final analysis (4 allocated to enema, 8 to no enema). The remaining women were analysed by intention‐to‐treat; losses to follow‐up were 35/217 (16%) in the enema group and 24/214 (11%) in the control group (P = 0.14). Losses to follow‐up among newborns were 18% in the enema group and 11% in the control group. |
| Selective reporting (reporting bias) |
Unclear risk |
Protocol of the study is not available. |
| Other bias |
Low risk |
Information was provided concerning baseline demographics. Declarations of interest are declared. |
