Friday, September 20, 2013

research

Picture this scene:
Part 1 - Plan A:
A woman having her first baby has laboured spontaneously through the day and the next night.  She has gone to the hospital, and spent a few hours in the water, staying upright and mobile.  At 08:00 hours her cervix has dilated to 4-5cm; her cervix is soft and baby's head is 'high'; and her contractions are less frequent than they were a few hours ago.  She is told that she needs her labour to be augmented: move to 'Plan B'.
[This is a major decision point for a labouring woman.  She can either continue working with her body's natural processes (hormonal, physical, and emotional), or give permission for medical processes to be commenced - all with the goal of a healthy woman giving birth to a healthy baby.]

Part 2 - decision to move to Plan B:
The woman agrees to augmentation of her labour, and after considering pain management options available, requests epidural anaesthesia. 
The hospital staff organise the intervention without delay: and IV line is sited, a pump with a second bag of IV fluids plus oxytocic is prepared, and the anaesthetics doctor introduces herself, asks questions about the woman's health, and explains what she is about to do.  The epidural is commenced, and after a couple of contractions the woman feels less pain and lies down quietly in the bed.  The electronic fetal monitor provides continuous information about the baby's condition, as well as charting the presence of uterine contractions.  After the doctor has checked the level of the anaesthetic block with ice, she goes out of the room.

Part 3 - invitation to participate in research
[and the reason for this post]
Soon after, a person comes into the room and introduces herself as a research midwife. She asks the woman if she would agree to being enlisted in a research trial.  She explains that the purpose of the trial is to reduce unnecessary caesareans.
She explains that, in this trial women who have already elected to have an epidural would be randomly allocated, if the question of whether or not to have a caesarean birth, to a particular test of the baby's blood (lactate), which would be accessed vaginally via a scratch on the baby's scalp.
[I won't tell you what the woman chose.  How would you respond?]


Comments on this research from a scientific, professional point of view:
  1. Research is an integral part of professional health care today.  I accept that.  
  2. The design of a particular trial - in this case to enlist women in labour after they have had an epidural, means that those who have spontaneous uncomplicated labours and births, or those who have elective surgical births, do not even think about the issues such as a decision to go to caesarean, or to continue in labour.
  3. This research seeks to look at those for whom the intervention (intrapartum fetal blood sampling for lactate measurement as an assessment of fetal wellbeing, in the presence of non-reassuring fetal heart rate trace) could be critical in making a decision about the way a baby will be born.
  4. The randomisation of all research subjects (labouring women who agree to being enlisted in the trial) into treatment or control groups seeks to prevent bias in decision-making. 
  5. Research on human subjects can only be approved if the researchers are able to demonstrate the value of the information to the relevant discipline(s), and strategies that prevent harm (to the mother and/or baby, in this case). 
     
    Comments on this research from a woman's point of view:
  6. If I agree to what you are asking, and my baby becomes distressed, do I have any say in what is done?  No - the decision is made according to the randomisation.
  7. I feel exhausted after a couple of nights without sleep, and now I am being asked to make a decision about something which I have never thought about before.  How can I know what's going to be best for me and my baby?  That's why the research is being done.  Noone knows what is the best way to proceed.  
  8. If I say no, I don't want to be in the research, and a decision needs to be made about whether or not to do a caesarean, how will that happen?   ...

I often argue that there is really only one real choice in childbirth: to do it yourself (Plan A), or to ask someone else to do it for you (Plan B). 

There are no guarantees in birth.  It's a journey, and decisions must be made as events unfold.

Midwives are bound, by definition, to promote normal birth.  A woman whose labour proceeds without complication is in the optimal position to give birth spontaneously, and with good outcomes for herself and her baby.   There will never be a safer or more appropriate way for these women to give birth, than to do it themselves.

Any intervention brings potential benefits and risks.  Augmentation of labour with oxytocic may, in many cases, bring about a more coordinated labour than what was being experienced before the augmentation, and a happy, healthy mother with a happy healthy baby in her arms a few hours later.  However, augmentation of labour can also lead to hyper-stimulation of the uterus, a distressed hypoxic baby, an emergency surgical birth, haemorrhage, ...

When a woman needs/chooses to move from Plan A to Plan B, the presence of a known and skilled midwife who can reassure her, and at times offer guidance, is essential.  Midwifery is not limited to promoting normal birth.  It's about being 'with woman' - a midwife with a woman, in a professional arrangement that enables sharing of information and support that is uniquely tailored to that woman and her baby.  The journey that leads to the birth is not predictable, but each woman's decision making is her own, without pressure or coercion.  This is, in my opinion, the pathway to safe birth through accessing appropriate interventions when indicated.

4 comments:

Joy Johnston said...

Comment from a reader (anonymous)
That would be an extremely difficult situation for the woman. To have to choose then and there on the spot, after the weariness of many hours of labour whether she would like to partake in the research.
It would have been a no from me considering that once the trial was conducted the woman would have no say in whether she ended up with a c section. I would have hated to be put in that position during that point of my labour.

Joy Johnston said...

For consent to be meaningful, you must feel free to say 'no'.

Katy Hood said...

I understand the need for continuing research to improve evidence based practice. However during labour is a completely inappropriate time to approach a woman about participating in a trial. I've had an emergency c-section and then a VBAC, and cant imagine wanting to think about someones research during labour. Maybe if i was approached well before with plenty of information and time to go through the pro's and cons, but not once labour had commenced.

Joy Johnston said...

Katy your response is what I have been hearing from other women who have laboured and given birth vaginally, and I agree.

I wonder if the consumer member of the hospital ethics committee that approved the research had any concerns about the woman being forced to make such a decision (to be enlisted in this trial, or not, and what the implications might be for her baby and her own body)?

A comment on a fb group:
"there is a lot of research around when is the ideal time to seek consent for cord blood collection - some even argue for staged consent such as in research done at the New York Blood Center (largest in world) - they say get consent in labour just for the collection and then post birth get consent for donation (which is far from ideal - take it first and question later.) Even those that support that type of consent model say consent should not be sought in labour if it can be avoided."
(and btw I would argue a resounding 'no' is a good response to the invitation to collect cord blood that should go to the baby.)