Effect of high volume saline enemas during labour

Effect of high volume saline enemas during labour: a randomised controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN43153145

Enrollment

443

Registered

2002-03-20

Start date

1997-02-01

Completion date

Unknown

Last updated

2017-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Puerperal and neonatal infections Pregnancy and Childbirth Puerperal and neonatal infections

Interventions

Enema versus no enema. Block randomisation allocation with sealed envelopes.

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Women attending labour ward at low risk for delivery 2. Greater than 36 week gestation 3. In labour 4. Cervix dilatation <8 cm

Exclusion criteria

Exclusion criteria: Clinical diagnosis of any systemic or gynaecological bacterial infection, use of systemic antibiotics during the week prior to admission, rupture of amniotic membranes or doubt of their integrity, and a cervical dilatation greater than or equal to 7 cm.

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Secondary

Measure	Time frame
Not provided at time of registration	—

Countries

Colombia

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026