Informed Consent ~ From Childbirth Connection
Making Informed Decisions
When pregnant, giving birth and in the postpartum period, it is your responsibility to make informed decisions for yourself and on behalf of your baby. It is your legal right to give — or deny — permission for care. But how do you know what’s best for you both? Making informed decisions about maternity care means finding the best available information on your options and using that information to decide what’s right for you and your baby. It sometimes means having the courage and confidence to ask tough questions of potential or current care providers and birth setting staff to ensure the options you want are available to you.
Of course, there is only so much you can predict when it comes to giving birth. Being as informed as possible can help you deal wisely with any new decisions you have to make throughout the childbirth process. Now is the time to do your “homework”: Read up on risks and benefits, get answers to your questions, think about your preferences well before labor begins, and make those preferences known to your care providers and support system. You can make these known through discussion and by asking that your wishes be included in the health records that will be available at your place of birth.
You may feel uncertain or uneasy about becoming so actively involved in decision making. Information and advice from studies, news reports, online features, and friends and relatives can differ. It’s hard to know what or whom to believe, especially when facing decisions that can have lasting effects on you and your child. In the end, it is a good idea to make those decisions based on research and science that has measured the risks and benefits — combined, of course, with your own values and preferences.
Rights and Responsibilities
Maternity care providers are responsible for providing scientifically supported care and for meeting the legal standard of informed consent. Legally, more and more states are adopting a “patient viewpoint standard.” This means that providers must tell you about the possible benefits and harms that a reasonable person in your situation would want to know to make an informed decision. And studies have repeatedly shown that most women are interested in a detailed accounting of possible benefits and harms before accepting a specific course of action. (This is replacing a “clinician viewpoint standard,” or what a typical clinician feels you need to know.)
Informed Consent
Whenever a medical procedure, drug, test or other treatment is offered to you, your legal right to informed consent means that your health care provider is responsible for explaining:
- Why this type of care is being offered;
- What it would involve;
- The harms and benefits that are associated with this type of care; and
- Alternatives to this care, and the harms and benefits of those other options, including the possibility of doing nothing at the present time (“watchful waiting”).
Informed consent is not a form or a signature. It is a process between you and your care provider that helps you decide what will and will not be done to your body. In the case of maternity care, informed consent also gives you the authority to decide about the care that affects your baby.
The purpose of informed consent is to respect your right to self-determination. Your rights to autonomy, to the best available information and to protect your children and yourself from harm are very basic human rights.
You have a right to clear and full explanations about your care and answers to any questions you may have. You also have the right to request and receive a copy of your medical records and to get a second opinion. And there is a growing trend for people to have ready online access to their complete health records.
It can be hard to have these conversations in a busy health care setting with so much going on, but it’s important to set aside the time to discuss these issues with your care provider, both in advance and when it is time to make a decision. If at any point during pregnancy, these conversations raise concerns that your maternity care provider or your planned birth setting is not a good match for your values and preferences, you may want to explore other options.
Informed Refusal
If you disagree with your care provider and decide not to accept care, you have a right to this “informed refusal.” Even if you signed a form agreeing to a particular type of care, you have the right to change your mind.
Care Provider Rights
Your care provider has the right to agree or disagree to provide care that you may request. For example, if a woman requests a cesarean and has no medical need for this procedure, her care provider has the right to refuse to do the surgery. For many reasons, maternity care providers and hospitals may refuse to provide some types of care that would be a good and reasonable choice for many women, such as vaginal birth after cesarean (VBAC). This is another reason it is important to be aware of your options in advance and seek more responsive birth settings or care providers if you are not getting the answers you want.
Evidence-Based Maternity Care
“Evidence-based maternity care” means using results of the best research about the safety and effectiveness of specific tests, treatments and other interventions to help you make decisions about your maternity care.
Some basic principles of evidence-based health care are:
- Question common assumptions. Be skeptical! Many widely held beliefs about health care do not reflect the best available research. This may lead to poor care and poor health outcomes. Don’t hesitate to say, “Show me the evidence.”
- Consider the best studies. Some research studies are not designed or conducted well. These poorer quality studies should not be used to guide decisions. When a new study is reported, we should ask, “What is already known about this question on the basis of the best available research and what, if anything, does this study add?”
- Look for the “Gold Standard.” When available, well-conducted systematic reviews of research should inform care decisions. A systematic review uses careful processes to limit bias and assess the weight of the best available research about the possible harms and benefits of specific care practices. If systematic reviews are not available, individual studies with randomized controlled trial designs can provide a good alternative (read more about both of these in the next section). It may be important to consider other types of studies as well.
This focus on high-quality evidence helps support your informed decision-making.
While health care systems and providers should strive to ensure that the care that is provided reflects the best available research, they are busy and it is hard to keep up with and understand the large and ever-growing body of research on any given maternity topic. Even when they understand lessons from the best available research, it can be hard to change established beliefs and routines. That’s why it’s important for you to take time to understand the quality of evidence and what has been shown to be beneficial or harmful. Policymakers, insurers, administrators, health professions educators and journalists also play an important role in ensuring women have access to and understand high-quality health care.
High-Quality Evidence
There are many different types of research studies and the ways the findings are reported also differ. In this section, we describe two types of studies that are considered the highest quality: systematic reviews and randomized controlled trials.
Systematic Reviews
A systematic review involves a thorough search for the best available studies (randomized controlled trials, when possible) on a specific topic. Only relevant and better-quality studies are included in the review. When possible, researchers reach a conclusion about the topic (for example, effects of cesarean birth) by combining data from the studies that are both relevant and of better quality, using statistical techniques called “meta-analysis.” These techniques help limit bias and error and allow us to draw accurate and confident conclusions. A rigorous systematic review of original studies gives the best possible answers to questions about the benefits and harms of specific health practices.
Randomized Controlled Trials
Randomized controlled trials (RCTs) are a type of individual study that may be included in a systematic review. In an RCT, participants are randomly assigned to receive one or another form of care. This means that a study participant has an equal chance of being in each study group. Those receiving the standard care (or placebo treatment, such as a sugar pill) are in the “control group.” Those receiving the type of care that is being studied (for example, a new medication) are in the “treatment” or “experimental group.” Random assignment helps ensure that the groups are truly similar so that we know that any changes we see in the treatment group (like the lessening of symptoms) are because of the treatment being studied and not some other difference between the groups (like age or income). This type of research can also compare the effects of different treatments (for example, drug A versus drug B or one dose versus another).
RCTs do not do a good job of measuring possible differences for rare but important outcomes (such as maternal mortality) and outcomes that may occur far into the future (for example, effects of cesarean surgeries on mothers and babies in future pregnancies). They are not ethical in some situations (for example, we would avoid assigning babies at random to a “no breastfeeding” group because it would not be ethical to intentionally withhold the benefits of breastfeeding from a group of babies). We need to rely on other types of studies in such cases.
Fortunately, many thousands of RCTs and systematic reviews are available to help guide maternity care decisions. New studies and new or updated systematic reviews are frequently published in this field. In the Research and Evidence sections of the Giving Birth pages on this website, you will find recent findings from systematic reviews to help you understand the risks and benefits of various types of maternity care.
Shared Decision-Making: Working with Your Maternity Care Provider
Now that you have obtained information from high-quality sources on maternity care options, risks and benefits, you may be wondering how to have a productive conversation about all you’ve learned with your care provider. Ideally, you and your provider will engage in a process called “shared decision-making.” This process involves working together to consider the best available scientific evidence and your values and preferences.
If a high-quality “decision aid” tool is available for a decision that you face, it can prepare you to have a fruitful discussion with your care provider. Key elements of decision aids include clarifying that there is a decision to make, identifying the options, presenting pros and cons of the options and helping you think about how the options might align with your values and preferences.
Having a strong working relationship with your care provider based on open communication, mutual respect and similar points of view can support this shared decision-making process. You may also want to make a list of questions before each visit and jot down answers during your visits. To get the information you need, you may need to say:
- I don’t understand.
- Please explain this to me.
- What could happen to me or my baby if I do that? What if I don’t?
- What are my other options? What if I take no action (“watchful waiting”)?
- Please show me the research to support what you’re recommending.
- Where can I get more information?
- I have some information I’d like to share with you.
- I’m uncomfortable with what you are recommending.
- I’m not ready to make a decision yet.
- I’m thinking about getting a second opinion.
Be sure to take care to choose a doctor or midwife who respects your needs, values and goals. If you find out over time that you disagree with your care provider or the policies at your planned birth setting, you can explore other options.