Condition category
Pregnancy and Childbirth
Date applied
06/09/2008
Date assigned
29/09/2008
Last edited
29/09/2008
Prospective/Retrospective
Prospectively 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

Ms Jo Watson

ORCID ID

Contact details

98 Bessborough Drive
Toronto
M4G 3J1
Canada

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

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

Acronym

The FILL Trial

Study hypothesis

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

Ethics approval received from the Research Ethics Board of Sunnybrook Health Sciences Centre on the 21st August 2008 (ref: 237-2008)

Study design

Single site randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

Breastfed newborn weight loss in the first 48 hours.

Secondary outcome measures

Breastfeeding exclusivity, measured prior to discharge from the postpartum unit.

Overall trial start date

15/10/2008

Overall trial end date

15/10/2009

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

200

Participant 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

Recruitment start date

15/10/2008

Recruitment end date

15/10/2009

Locations

Countries of recruitment

Canada

Trial participating centre

98 Bessborough Drive
Toronto
M4G 3J1
Canada

Sponsor information

Organisation

Sunnybrook Health Sciences Centre (Canada)

Sponsor details

2075 Bayview Avenue
Toronto
M4N 3M5
Canada

Sponsor type

Hospital/treatment centre

Website

http://www.sunnybrook.ca/

Funders

Funder type

Research organisation

Funder name

Society of Obstetricians and Gynaecologists (Canada) - Strategic Training Initiative in Research in the Reproductive Health Sciences (STIRRHS) Fellowship

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Sunnybrook Health Sciences Centre (Canada)

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

Publication citations

Additional files

Editorial Notes