The Fluid In Low risk Labour Trial
| ISRCTN | ISRCTN06221064 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN06221064 |
| Secondary identifying numbers | N/A |
- Submission date
- 06/09/2008
- Registration date
- 29/09/2008
- Last edited
- 29/09/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Ms Jo Watson
Scientific
Scientific
98 Bessborough Drive
Toronto
M4G 3J1
Canada
Study information
| Study design | Single site randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | The effect of conservative versus routine intrapartum fluid management in women with epidural analgesia on breastfed newborn weight loss: a randomised controlled trial |
| Study acronym | The FILL Trial |
| Study objectives | For low risk women receiving epidural analgesia in labour, what is the effect of a conservative protocol for fluid management versus usual care on breastfed newborns weight loss in the first 48 hours of life? |
| Ethics approval(s) | Ethics approval received from the Research Ethics Board of Sunnybrook Health Sciences Centre on the 21st August 2008 (ref: 237-2008) |
| Health condition(s) or problem(s) studied | Fluid management in labour |
| Intervention | Total duration of treatment is from the time of admission to the labour unit until the time of delivery. Patients will be randomised to one of the following fluid management techniques: Usual Intrapartum Fluid Management: Usual intrapartum fluid management includes the initiation of intravenous therapy prior to epidural analgesia administration or when intravenous drugs need to be administered. Fluid preload for epidural analgesia initiation ranges from 500 cc to 1000 cc of Ringers Lactate and intravenous (IV) fluid is administered throughout labour for non-reassuring foetal heart rate tracings and maternal fever. Hourly infusion volumes vary from 125 to 250 ml per hour or greater. Calculations of fluid balance may not be routinely conducted intrapartum but summarised at the time of transfer of the woman to the postpartum floor. Intrapartum assessments do not routinely include hydration assessments or calculation of intrapartum fluid balance. Conservative Fluid Management: A conservative intrapartum fluid management protocol will be administered to the experimental group. This protocol assumes that care is individualised to the labouring woman and will be reflective of the events of her labour. Women will receive an epidural analgesia preload of 250 to 500 ml of Ringers Lactate and the intravenous infusion will continue at the hourly rate of 75 to 100 ml per hour. Hydration assessments and fluid balance calculations will be conducted and recorded every four hours. Reaching critical values for fluid infused greater than 2500 ml will require the nurse to review the fluid management plan with the physician responsible for the woman's care, maternal fever will be treated with acetaminophen. Decisions regarding bolus for abnormal foetal heart rate patterns will at the discretion of the caregivers. |
| Intervention type | Other |
| Primary outcome measure | Breastfed newborn weight loss in the first 48 hours. |
| Secondary outcome measures | Breastfeeding exclusivity, measured prior to discharge from the postpartum unit. |
| Overall study start date | 15/10/2008 |
| Completion date | 15/10/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 200 |
| Key inclusion criteria | 1. Women in early labour, 19 - 40 years of age 2. Experiencing a labour at no identified risk 3. Anticipating a vaginal birth 4. Planning to breastfeed 5. Requesting an epidural |
| Key exclusion criteria | 1. Planning discharge before 48 hours 2. Unable to read and write English 3. Previous breast surgery 4. Expected to deliver in the next 4 - 5 hours |
| Date of first enrolment | 15/10/2008 |
| Date of final enrolment | 15/10/2009 |
Locations
Countries of recruitment
- Canada
Study participating centre
98 Bessborough Drive
Toronto
M4G 3J1
Canada
M4G 3J1
Canada
Sponsor information
Sunnybrook Health Sciences Centre (Canada)
Hospital/treatment centre
Hospital/treatment centre
2075 Bayview Avenue
Toronto
M4N 3M5
Canada
| Website | http://www.sunnybrook.ca/ |
|---|---|
"ROR" |
https://ror.org/03wefcv03 |
Funders
Funder type
Research organisation
Society of Obstetricians and Gynaecologists (Canada) - Strategic Training Initiative in Research in the Reproductive Health Sciences (STIRRHS) Fellowship
No information available
Sunnybrook Health Sciences Centre (Canada)
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 |
