Condition category
Pregnancy and Childbirth
Date applied
20/03/2002
Date assigned
20/03/2002
Last edited
11/04/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Luis Gabriel Cuervo

ORCID ID

Contact details

525 23rd St
NW
Washington
DC 20037-2895
United States of America
+ 1 202 974 3135
lgcuervo@gmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

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.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Puerperal and neonatal infections

Intervention

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

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

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 outcome measures

Not provided at time of registration

Overall trial start date

01/02/1997

Overall trial end date

28/02/1998

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

443

Participant 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.

Recruitment start date

01/02/1997

Recruitment end date

28/02/1998

Locations

Countries of recruitment

Colombia

Trial participating centre

525 23rd St, NW
Washington
DC 20037-2895
United States of America

Sponsor information

Organisation

INCLEN Trust (USA)

Sponsor details

1420 Walnut Street
Suite 411
Philadelphia
19102-4003
United States of America
+1 215 222 7700
inclen@inclen.org

Sponsor type

Research organisation

Website

http://www.inclentrust.org

Funders

Funder type

Research organisation

Funder name

International Clinical Epidemiology Network seed grant

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Enemas donated by Baxter (without detailed knowledge of research protocol)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Own funds provided by Luis Gabriel Cuervo

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Logistics by the School of Medicine at the Universidad Javeriana in Bogota

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Results in http://www.ncbi.nlm.nih.gov/pubmed/16545140

Publication citations

  1. Results

    Cuervo LG, Bernal Mdel P, Mendoza N, Effects of high volume saline enemas vs no enema during labour--The N-Ma Randomised Controlled Trial [ISRCTN43153145]., BMC Pregnancy Childbirth, 2006, 6, 8, doi: 10.1186/1471-2393-6-8.

Additional files

Editorial Notes