I’m posting this letter with misgivings in case it gives “medwives” in other areas more ideas about how to assault women. Gloria
July 7, 2010
Ms. Audrey Levine, President
Midwives’ Association of Washington State
10002 Aurora Avenue N, #36
Seattle, WA 98133-9348
Re: Foley Catheter “Inductions” by Midwives in Washington State
Dear Ms. Levine:
The purpose of this letter is to follow up on a subject CSB brought to the attention of the Midwifery Advisory Committee on April 6, 2010 and June 15, 2010.
CSB is very concerned about a practice that is increasing in the Washington midwifery community. Midwifery clients are reporting that when they reach their due date at 40 weeks, midwives are routinely recommending that if they are not in labor by 41½ weeks, that they consider a foley catheter “induction” in order to avoid a postdates pregnancy and transfer to obstetrical care at 42 weeks. This procedure is taking place in the midwife’s office. The midwife inserts into the uterus either a “foley” catheter (approved for use in labor for urinary retention by the Legend drugs and devices law, WAC 246-834-250) or a “Cook” catheter, which is specifically designed for obstetrical use to ripen the cervix prior to the induction of labor. (The Cook catheter does not appear in the Legends drug and devices law.) She then fills this balloon with saline, tapes it to the woman’s leg and sends her home with instructions to release the fluid 12 hours later and remove the device. The purported purpose of this procedure is that it will cause the cervix to efface and dilate to where the woman will initiate labor on her own, thereby inducing labor.
Contrary to this stated purpose, a brief review of the literature (and certainly the marketing literature of the Cook catheter) by CSB shows that catheters are used as a “ripening balloon” or ripening procedure, not as an induction technique in and of themselves. The expectation in all of the studies CSB reviewed is that, after the removal of these catheters, the woman will be induced with other induction agents such as pitocin, and that she will have less of a failure rate of these other induction agents because the balloon procedure will have made her cervix favorable for the use of the induction agents. Of note, none of the literature CSB reviewed referenced the use of catheters (either foley or Cook), in and of themselves, as an independent agent of induction, which is how its use is being presented to midwifery clients.
Recently we were asked to bring the use of this procedure to the attention of appropriate authorities and organizations by a Seattle midwifery client. We present a short summary of her experience as an example of this issue.
At 40 weeks of pregnancy, this client’s midwives began a conversation with her regarding the potential for a postdates pregnancy. At 41 weeks, it was further discussed and it was recommended that if she was not in labor by 41½ weeks, a foley catheter would be inserted “to get labor started”. (Ultimately a Cook catheter was used for the procedure without the knowledge of the client.) The midwives recommended using this procedure to prevent her pregnancy from going postdates and thereby losing the opportunity to have the homebirth she wanted. She was told that labor would begin within 24 hours after the procedure was initiated. The midwives further told her that they would not care for her at home after 42 weeks. Given this information, the client felt that the use of the procedure was the only option available to insure her opportunity for a home birth. While waiting to see if labor began naturally was also an option, it did not seem like a good one considering the date and clear threat of a hospital birth. Of further note: (1) The midwives failed to inform this client that another midwife might be able to attend her at home past 42 weeks. (2) The client told us that she was not told that this procedure would most certainly require the use of pitocin as a second step. (3) No discussion was had about the possibility that using this procedure could create the need to transfer to the hospital for the induction, as midwives cannot legally use Pitocin in an out of hospital birth setting. (4) The client was never advised of the failure rate with the use of this device or method of “induction” necessitating cesarean; and, (5) The client also did not sign an informed consent document for this procedure.
Ultimately, she stalled in her labor, was transferred to the hospital and had a cesarean. Additionally of concern is that nowhere in the hospital records is there evidence that the staff at the hospital were ever apprised of the foley-Cook catheter “induction” that initiated her labor, thereby preventing the hospital staff from having a full appraisal of the patient’s condition and status upon her arrival at the hospital.
CSB felt that as the MAC is responsible for providing advice and recommendations to the Secretary of Health in regard to promoting and protecting public health and safety, that the first place to start would be to ask the MAC to investigate Washington midwives’ use of this procedure. We also felt it would be appropriate to ask the MAC to issue a position statement regarding the appropriateness for and/or legality of using this procedure. And lastly we suggested that the family ask for a review of their care by the Midwives’ Association of Washington State’s incident review process.
When we presented this information to the MAC, CSB also presented a Survey Monkey conducted via a 1,000 plus email list of past and current pregnant yoga clients. We found that women who had this “induction” procedure with a Licensed Midwife had a 100% subsequent c-section rate. (Please see the attached summary.) As well, a Seattle midwifery client was present to voice her concerns about her own individual case. We were quite surprised by the MAC’s response, however, particularly from the midwives on the committee. The MAC felt that the answer to this problem was for each individual client who was concerned by the actions of their midwife to make a complaint to the Department of Health and for each midwife to be investigated to see if there was any breach of the laws. They felt that MAWS would be the appropriate organization to bring about legislative changes to include foley or Cook catheter inductions in the scope of practice. (As the use of pitocin by Licensed Midwives as an induction agent has not been permitted by Legend Drugs and Devices, it is virtually impossible that such a legislative change would be permitted.)
CSB is not in support of legislative changes; however, we are bringing this to the attention of MAWS as we believe the continued use of this procedure is detrimental to the health of mothers and babies of Washington as well as to the profession of midwifery in the state. Certainly, given the 100% cesarean rate for Licensed Midwifery clients who had this procedure, the Survey Monkey results present a very real and concerning health issue. Furthermore, considering the history and the current state of the MAC’s budget deficit, supposedly fueled by investigations of midwives, and not to mention the individual cost of investigation to the midwife, we believe that the continued use of this procedure could create a real issue for midwifery, even though this is secondary as a concern for CSB.
We ask that MAWS consider the following:
First and foremost, there is the concern of health and safety to mothers and babies. IF we believe that morbidity and mortality is increased with the use of cesarean, then we must be concerned for midwifery clients in Washington State.
Second, we believe that there are questions under the law.
CSB believes that this practice should be investigated as it may violate RCW 18.130.180(12), Unprofessional conduct. Use of this practice likely constitutes unprofessional conduct because use of catheters to induce labor is by definition: “practice beyond the scope of practice as defined by law or rule.” Furthermore, WAC 246-834-250, Legend drugs and devices, specifically states which drugs and devices licensed midwives may purchase and use. While it does list urinary catheters, it does not list Cook catheters. It is our belief that at the time of writing of this document, it was intended that urinary catheters would be used for the purposes of urinary drainage only. Use of a foley or Cook catheter for the purposes of induction is practice outside of the law – as a result, midwives who use this practice would be engaging in unprofessional conduct. Furthermore, use of this practice is outside the scope of practice of midwifery, entering the realm of the practice of medicine, as defined by RCW 18.71.011.
Third, we are aware that even though the Department of Health does not operate in accordance with documents of the Midwives’ Association of Washington State, we do believe that the standard of care expected of reasonably prudent midwives is outlined by The Standards for the Practice of Midwifery, (2002). We believe that these standards are being violated by midwives who are using this procedure, creating an unreasonable risk that a patient will be harmed.
Specifically these standards were likely violated because:
(1) The midwives may not have followed the law (as outlined above.)
(2) The MAWS (or ACNM) practice mechanism for introducing expanded clinical procedures into midwifery practice was likely not followed. This document is very thorough in its description of considerations that should be evaluated to make any new clinical procedure a safe practice within both the standard of practice as well as scope of practice of midwifery. We at CSB are not aware as to whether or not this practice mechanism was followed in this case; however, we believe it is unlikely. As the practice mechanism states: “any expanded practice should fall within scope of practice limitations as outlined in law” and as noted above, it does not appear that the law has been followed, CSB believes it is therefore unlikely that this practitioner followed the mechanism for introducing this procedure into her practice.
(3) As shown by the Survey Monkey results, in virtually every case, thorough informed consent was not provided, in accordance with RCW 7.70.060 Consent form, which requires a risk/benefit analysis of options for care and upholding the client’s right to information and resources. In the example noted above, this client both does not feel she received informed consent, nor does she believe she was given the resources needed to evaluate any other option than to continue with her current midwives and abide by their recommendations to use this practice if she wanted to continue her midwifery care. On reflection, she feels her midwives would have abandoned her care had she refused use of this procedure.
Lastly, we feel that it is important that MAWS be aware that it appears that this client’s midwives may not have followed the planned out of hospital birth transport guideline (the Maternal Referral from Out-of-Hospital Birth to Hospital) that was prepared by MAWS in April 2008 to aid in hospital transfers. When this client requested complete medical records from the transferring hospital there was no Maternal Transport form. In addition, there was no mention in the patient’s hospital records of her “Cook catheter” induction which would have been certainly included in information required to complete this form giving the attending physicians valuable information for their care of this client. In fact there was a notation of spontaneous labor as her admitting diagnosis. We feel this is a great opportunity to remind the membership of the importance of the use of this process in the best interest of the health of mothers and babies.
While our efforts to work with the DOH and MAC on this issue will continue, we find use of this procedure by Licensed Midwives to be unacceptable. To protect both midwives and their clients, we feel MAWS should issue a position statement regarding the practice of foley and Cook catheter “inductions” by Licensed Midwives. CSB feels this practice should be stopped immediately.
With continued concern for the safety of maternity care in Washington State, we thank you in advance for your consideration of this matter.
President, Citizens for Safe Birth
cc: Mary Selecky, Secretary of Health
Kendra Pitzler, Program Manager, Midwifery Advisory Committee
Jessica Laing, Chair, Midwifery Advisory Committee via Kendra Pitzler