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ISRCTN
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ISRCTN43153145
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ClinicalTrials.gov identifier
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Public title
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Effect of high volume saline enemas during labour - randomised controlled trial
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Scientific title
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Acronym
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N/A
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Serial number at source
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N/A
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Study hypothesis
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The main objective of this trial was to determine if the use of high volume enemas during the first stage of labour modified neonatal and/or puerperal infectious rates. The null hypothesis stated that infectious morbidity was similar for intervention and control groups. A secondary objective was to establish if there is any effect on specific neonatal or puerperal infectious rates and other clinically relevant outcomes.
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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Colombia
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Disease/condition/study domain
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Puerperal and neonatal infections
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Participants - inclusion criteria
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1. Women attending labour ward at low risk for delivery
2. Greater than 36 week gestation
3. In labour
4. Cervix dilatation <8 cm
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Participants - exclusion criteria
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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.
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Anticipated start date
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01/02/1997
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Anticipated end date
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28/02/1998
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Status of trial
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Completed
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Patient information material
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Target number of participants
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443
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Interventions
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Enema versus no enema. Block randomisation allocation with sealed envelopes.
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Primary outcome measure(s)
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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.
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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1. International Clinical Epidemiology Network seed grant
2. Enemas donated by Baxter (without detailed knowledge of research protocol)
3. Own funds provided by Luis Gabriel Cuervo
4. Logistics by the School of Medicine at the Universidad Javeriana in Bogota
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Trial website
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Publications
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Results in http://www.ncbi.nlm.nih.gov/pubmed/16545140
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Contact name
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Dr
Luis Gabriel
Cuervo
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Address
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525 23rd St, NW
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City/town
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Washington
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Zip/Postcode
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DC 20037-2895
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Country
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United States of America
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Tel
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+ 1 202 974 3135
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Fax
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+1 202 974 3652
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Email
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lgcuervo@gmail.com
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Sponsor
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INCLEN Trust (USA)
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Address
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1420 Walnut Street, Suite 411
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City/town
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Philadelphia
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Zip/Postcode
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19102-4003
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Country
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United States of America
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Tel
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+1 215 222 7700
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Fax
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+1 215 222 7741
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Email
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inclen@inclen.org
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Sponsor website:
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http://www.inclentrust.org
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Date applied
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20/03/2002
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Last edited
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11/04/2008
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Date ISRCTN assigned
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20/03/2002
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