Effect of high volume saline enemas during labour

The primary outcomes were infections in newborns and /or puerperal women. During the analysis, neonatal and puerperal infections were described individually and then amalgamated into a new outcome. This outcome was the 'combined maternal-neonatal outcome'.

A neonatal outcome was positive when during follow-up, any of the following clinical conditions were diagnosed : ocular infection (defined as purulent drainage in the eye after the sixth day of delivery); umbilical infection (foul smell with periumbilical erythema); skin infection (cellulitis or impetigo); respiratory tract infection (clinical diagnosis of lower or upper respiratory tract infection); intestinal infection; meningitis, sepsis or if the child had been prescribed systemic antibiotics during the first month of life.

Positive puerperal outcomes were registered when the mother had any of the following conditions diagnosed by a health care provider: any suture dehiscence, purulent effusion from the episiorraphy, urinary tract infection, pelvic inflammatory disease or vulvovaginitis. While hospitalised, participating women and newborns were visited on a daily basis. Throughout the process data were gathered by trained research assistants using standardised questionnaires. Formats were also used to register data retrieved from telephone calls, during hospitalisation, at follow-up visits and when any communication was established with participants, their families or health care providers.

Not provided at time of registration