stirrhs (en) - Comments

Hi Jo, Thanks for the

Allaway — Fri, 22 Jan 2010 10:34:47 -0500

Hi Jo,

Thanks for the presentation. As a basic scientist I learned quite a bit. I still have a few questions for you.

1. Why is IV fluid required with an epidural? Can a woman request not to have an IV?

2. How long before the epidural do IV's typically get started in the UIF group/normal birth?

3. How long after delivery is the IV usually terminated in the UIF group?

4. In the CF group why was acetaminophen used for maternal fever before the epidural? What is put in the IV normally to combat the fever? Why didn't you use acetaminophen for maternal fever later in labor for the CF group to lower their fluid volume?

5. Why was 2500ml fluid infused used at the "magic number" for review over a patients care in the CF group? What were the options for treatment upon review? For the UIF group what is the total volume of fluid infused on average?

6. How do other types of analgesia compare to epidural in their association to birthweight loss?

7. Do you know if the regular treatment for low risk women in labor is the same across Canada or are there regional differences?

8. I am a bit worried about your knowledge transfer ideas. The ideas you have stated seem very limited to dissemination to Ontario. I think it is good to start with getting the information to the physicians in your own center but if this is information that can help the health care system as a whole big picture transfer needs to be thought of. There are many doctors around Canada who are unable to go to conferences. Many babies are born in small town facilities to family doctors. Why limit yourself to the clinical content for placements at the U of T? Do you think after your trial it would be of benefit to take what you have learned and get another trial started at a facility in a different province?

Heather

Hi Jo, Thanks for your

mcintyre — Tue, 19 Jan 2010 17:00:25 -0500

Hi Jo,

Thanks for your responses. I think web-based information is a great idea. Good luck with the study.

Alex.

Jo Watson RN, MScN,

jowatson — Mon, 18 Jan 2010 18:04:28 -0500

Jo Watson RN, MScN, ACNP
Director, Obstetrics and Gynaecology
Sunnybrook Health Sciences Centre

Hi Eric
I have described the intervention and usual care in my responses to Alex and Mingu. All women in the trial would have had intravenous therapy since they all had decided to have epidurals.

The model explaining greater weight loss in newborns whose mothers received higher volumes of fluid relates to the process of overloading the labouring woman and some of that IV fluid would also be shared with the fetus. The newborn is then born with an artificially elevated birth weight and diureses in the first 1-2 days after birth, losing more weight than a baby that didn't have addtional fluid to begin with. I have included the conceptual model for the trial below:

Conceptual Model for the FILL Trial

Usual IV fluid in labour Conservative Fluid

Unrestricted IV during labour Conservative IV
↓ ↓
Maternal intravascular Maternal intravascular
Compartment expanded compartment not expanded
↓ ↓
Fetal Intravascular Fetal intravascular
Compartment expands does not expand
↓ ↓
Fetal fluid overload No fetal fluid overload
↓ ↓
BNP levels rise BNP levels normal
↓ ↓
Naturiesis No excess fluid loss
↓ ↓
↑ newborn weight loss Normal newborn weight loss

I hope the explanations are helpful.
Jo

Jo Watson RN, MScN,

jowatson — Mon, 18 Jan 2010 17:55:37 -0500

Jo Watson RN, MScN, ACNP
Director, Obstetrics and Gynaecology
Sunnybrook Health Sciences Centre

Hi Mingju

Here is the description of the differences between the intervention (conservative care) and usual IV fluid management in labour:

Usual Intrapartum Fluid Management
Usual intrapartum fluid management included the initiation of intravenous therapy prior to epidural analgesia administration or when intravenous drugs need to be administered. Fluid preload for epidural analgesia initiation ranged from 500cc to 1000cc of Ringers Lactate and IV fluid is administered throughout labour for non-reassuring fetal heart rate tracings and maternal fever. Hourly infusion volumes were 125 ml per hour or greater.

Conservative Fluid Management
A conservative intrapartum fluid management protocol was administered to the Conservative Care group. This protocol assumed that care would be individualized to the labouring woman and would be reflective of the events of her labour. Women received an epidural analgesia preload of 250 to 500 ml of Ringers Lactate and the intravenous infusion continued at the hourly rate of 75 to100 ml per hour. Fluid balance calculations were conducted and recorded every four hours. Reaching critical values for fluid infused > 2500 ml prompted the nurse to review the fluid management plan with the physician responsible for the woman’s care. Maternal fever was initially treated with acetaminophen rather than fluid bolus. Decisions regarding bolus for abnormal fetal heart rate patterns were at the discretion of the caregivers.

What is low risk?
Low risk was defined as women who had a healthy pregnancy at “no predictable risk”, according to the Ontario Medical Association Risk Scoring Tool (Ontario Medical Association, 2007
https://www.oma.org/Forms/OntarioAntenatalRecord2005.pdf. The Ontario Antenatal record has a scoring tool used to determine levels of risk.

What is NT-proBNP?

One approach to quantifying the extent of fluid overload is through the use of serum measures. Serum Brain Natriuretic Peptide (BNP) and Atrial Natriuretic Peptide (ANP) are two such serum markers that can be measured in cord blood. ANP and BNP are hormones released from the cardiac myocytes that counteract the effects of fluid overload through their action on the adrenals, kidneys and blood vessels. Datta et al., (1991) suggested that fetal neuropeptide levels may be able to provide important information about fetal well-being. This trial will attempt to determine if NT-proBNP levels are elevated in cord blood samples of newborns whose mothers receive routine fluid management intrapartum. Cord serum levels could be useful in determining whether a conservative fluid protocol maintains normal fetal NT-proBNP levels, avoiding a fluid overload response.

Jo Watson RN, MScN,

jowatson — Mon, 18 Jan 2010 17:50:42 -0500

Jo Watson RN, MScN, ACNP
Director, Obstetrics and Gynaecology
Sunnybrook Health Sciences Centre

Hi Alex
Thanks for your thoughtful questions.
Here are my responses:

1. There is no interim analysis planned and I am not monitoring results as I go. There is a safety monitoring mechanism to ensure that the intervention is safe and other than that step-reviewing any cases of adverse outcomes, there is no peeking before the recruitment is completed. Knowing interim results could bias future recruitment and data collection.

2. Regarding the difference between Usual and Conservative care

3. There are many ways to disseminate the findings and I am interested in being as creative as possible in my plans. Your ideas are good ones for dissemination, I would include web based information as well. I would like more ideas from other STIRRHS fellows through the course of this discussion.

4. Regarding patient perceptions, there were several women who declined to participate in the trial because they, or their partner felt the intervention less fluid would be unsafe.

Hi Jo, Thank you for your

boucher — Mon, 18 Jan 2010 14:42:08 -0500

Hi Jo,

Thank you for your presentation. I've found it to be very original and interesting, especially since it could have direct impacts on patient care/mdedical practice. Here's a few question that came to mind reading your presentation.

1) Could you please describe in more detail the treatment recieved by your two groups (conservative protocol and routine care)? Do both groups recieve IV therapy (in which case what constiture the difference: volume, type of fluid, etc.)?

2) What could be the nature of a greater loss in BW (or of a greater proportion of higher BW loss) in babies that recieved IV intrapartum? Is it related to higher difficulties in breastfeeding for their mothers (volume, quality, etc.) or is it related to physiological impacts of the intrapartum IV therapy on the babies (independant of putative effects on the mothers)?

Thanks

Eric

Hi Jo, Thanks for your

cao — Mon, 18 Jan 2010 14:05:31 -0500

Hi Jo,

Thanks for your presentation. I am a basic scientist, don`t know some terms in your study. Can you please provide me more information about 1) what is the conservative intrapartum fluid management, what is the routine intrapartum fluid management? 2) How do you define the low risk women in labour? 3) what does NT-proBNP stand for? What can the NT-proBNP levels tell us? Many thanks!

Best Wishes for your publications,

Mingju

Hi Jo, Very interesting and

mcintyre — Mon, 18 Jan 2010 13:29:35 -0500

Hi Jo,

Very interesting and involved study. It's too bad there are no results available yet as I am curious to know the outcome.

In terms of thoughts about your study, a few things come to mind:

1) Are you monitoring your results as you go and will you discontinue the trial if you find one group is doing significantly better than the other group?

2) What is the difference between the conservative protocol and TAU. Are they quite different?

3) I think your topic is really cool and patients would probably be very interested in your study. Is there any way to dissemnate your results to them? Perhaps via pamphlets or posters in the waiting room, or in parenting or prenatal materials/magazines.

4) In terms of other outcome measures, this is not my area of expertise but one thing that came to mind was patient perceptions of different fluid regimens. It may not be overly relevant in this area, but I wonder if women on different regimens feel differently and if this has an impact on breastfeeding, etc.

I'm curious to hear your thoughts on this.
Alex.

Hi Eric, I do have access

simonet — Thu, 10 Dec 2009 17:58:42 -0500

Hi Eric, I do have access to maternal age and parity, and both of them are taken into account in the analysis.My analysis does not account for sex-specific outcomes, but that’s a good point.You are absolutely right about the possible impact of pollutants on birth outcomes, but unfortunately I do not have access to this kind of data. Thank you very much for your comments. Fabienne

Hi Fabienne, Thank you for

boucher — Wed, 09 Dec 2009 16:58:17 -0500

Hi Fabienne,

Thank you for your presentation, it is as far as it can be from my domain of study, and was very refreshing to read.

Do you have access to the age of the mother and the number of prior pregnancies? Both of these are important biological factors for birth outcome. It also seems to me that those factors might also be looked at as community-level characteristics. Does your analysis account for possible sex-specific outcomes? For example, males generally have a poorer outcome when it comes to premature births. Males are also more susceptible to certain environmental pollutants (ex.: BPA). This could also contribute to difference amongst communities concerning birth-outcome. Some pollutants tend to accumulate at higher levels in northern regions. Also differences in diet (rural vs urban ; hunthing vs fishing vs non-traditional) amongst communities could make some difference. I doubt your data base includes data concerning the levels of specific pollutants in the communities that you have studied, but it might wield interesting results.

Good luck,

Eric

Thanks for that Fabienne and

mcintyre — Wed, 09 Dec 2009 16:44:56 -0500

Thanks for that Fabienne and for your thoughtful response: interaction with participants.

Hi Alex, My research

simonet — Tue, 08 Dec 2009 17:23:38 -0500

Hi Alex, My research project is indeed being conducted within the context of a larger CIHR-funded project “community characteristics and birth outcomes among Canadian aboriginal women”.I don’t have contacts with Inuit women I am studying since it is a retrospective database-based analysis. It is not really a problem in this type of study, especially because we have an Inuit advisory board member who helped in refining the study protocol, to make it more useful and relevant for Inuit communities. But on the other hand, I would say that it is important to see the global daily reality of people enrolled in a study, to reduce this “distance” between the researcher and the researched! Some preliminary results have already been published; I have enclosed a paper comparing the two birthing attendant types. Thank you for your interest. Fabienne

Thank you Jo and Heather for

simonet — Tue, 08 Dec 2009 17:20:04 -0500

Thank you Jo and Heather for your relevant inputs.

Unfortunately, considering the nature of the database that we have, it is not possible to account for the characteristics you mentioned.

Fabienne

Very interesting research

mcintyre — Tue, 08 Dec 2009 16:05:47 -0500

Very interesting research project. I guess I am wondering about the general context of your study. Is it part of a larger project? Do you have any contact with Innuit women that you are studying? If yes or no, what do you see as the advantages/disadvantages of having this contact or not as a researcher? I was also wondering if you have any preliminary results since it sounds so interesting.

Good luck with the research,
Alex.

Hi Fabienne, I have to agree

Allaway — Mon, 07 Dec 2009 12:57:42 -0500

Hi Fabienne,

I have to agree with Jo. The definition of community should primarily be defined by your participants. What they as inuit and we as non-indigenous define community as are probably very different. You could give both types of definitions. It is possible you will see a significant difference in one of your outcomes with one definition and not the other. I think a neighbourhood can be considered a community depending on the nature of the interaction of the individuals residing there.

One of the community characteristics you may be interested in including would be time till presence of primary birth attendent. I live in rural Saskatchewan on a farm and it takes 20 minutes for us to get to town to the hospital and it may be longer before the doctor is there depending on if he is working or is on call and out of the hospital. It may be an interesting community factor to look at.

Thanks for you presentation,

Heather