Effect of high volume saline enemas during labour
| ISRCTN | ISRCTN43153145 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN43153145 |
| Secondary identifying numbers | N/A |
- Submission date
- 20/03/2002
- Registration date
- 20/03/2002
- Last edited
- 04/10/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Dr Luis Gabriel Cuervo
Scientific
Scientific
525 23rd St, NW
Washington
DC 20037-2895
United States of America
| Phone | + 1 202 974 3135 |
|---|---|
| lgcuervo@gmail.com |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | Effect of high volume saline enemas during labour: a randomised controlled trial |
| 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(s) | Not provided at time of registration |
| Condition | Puerperal and neonatal infections |
| Intervention | Enema versus no enema. Block randomisation allocation with sealed envelopes. |
| Intervention type | Other |
| Primary outcome measure | 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 study start date | 01/02/1997 |
| Overall study end date | 28/02/1998 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 443 |
| 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 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
- United States of America
Study participating centre
525 23rd St, NW
Washington
DC 20037-2895
United States of America
DC 20037-2895
United States of America
Sponsor information
INCLEN Trust (USA)
Research organisation
Research organisation
1420 Walnut Street, Suite 411
Philadelphia
19102-4003
United States of America
| Phone | +1 215 222 7700 |
|---|---|
| inclen@inclen.org | |
| Website | http://www.inclentrust.org |
Funders
Funder type
Research organisation
International Clinical Epidemiology Network seed grant
No information available
Enemas donated by Baxter (without detailed knowledge of research protocol)
No information available
Own funds provided by Luis Gabriel Cuervo
No information available
Logistics by the School of Medicine at the Universidad Javeriana in Bogota
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 19/03/2006 | Yes | No |
Editorial Notes
04/10/2017: internal review.
