VBAC regulations at the Interested Party Meeting, by Madeleine Shernock

 Thank you Madeleine Shernock for allowing us to repost your blog report of the Interested Party meeting of the Medical Board of California from today December 15, 2014. We appreciate your work, and the time you spent putting this report together. 

Progress on Proposed Regulations for Licensed Midwifery Client Selection and Retention

Today was the second Interested Parties Meeting at the Medical Board of California (MBC) pertaining to some proposed midwifery regulations. These regulations regard the requirement of a physician referral for preexisting maternal diseases or conditions likely to affect a pregnancy, in addition to significant diseases arising from pregnancy that would necessitate physician referral.

The proposed regulations have caused quite a stir since a link surfaced in October. This link turned out to be a very early starting point in the regulations, compiled by Medical Board staff from regulations from other states in which midwifery is legal and licensure exists. Only days after the link surfaced, the first Interested Parties meeting allowed the MBC to hash out a few details, but the conversation became heated in regards to some topics, notably home birth after cesarean (or HBAC). Neither CAM nor ACOG had sufficient time to review the items before the meeting, and although it lasted several hours, very few decisions were made regarding the items on the list. For more information on that meeting, click here.

The attendees of the meeting today included members of California Association of Midwives (CAM), American Congress of Obstetricians and Gynecologists (ACOG), California Families for Access to Midwives (CFAM), many licensed midwives, and several parents. Jennifer Kamel of VbacFacts was also there again and gave valuable information about access to vaginal birth after multiple cesareans. Doctors Anne-Marie Adams and Stuart Fischbein, both home birth obstetricians, also provided input on several of the line items.

The format of the meeting today was interesting, in that it was in a separate room that allowed a round- (actually rectangular)-table discussion rather than a panel with an audience. This was more welcoming to public comment, and in my opinion facilitated more of an equal atmosphere in which all parties could feel heard.

HBAC

Kerrie Webb, the legal counsel from the MBC, facilitated the meeting and opened up the afternoon with a summary of her thoughts on the second set of criteria for client selection: "History of uterine surgery, including, but not limited to myomectomy, hysterotomy, or Cesarean section." She asked the representative from ACOG to elaborate on their reasoning for wanting cesarean section to remain in the regulations. Dr. John Wachtel, the chair for ACOG's District IX (California), mirrored Dr. Kelly McCue's statement from the previous IP meeting, saying that ACOG's policy is clear: a history of prior cesarean is a contraindication for home birth.

Webb then said that based on the research she was provided through public comment, complications from a VBAC are unlikely regardless of setting. If ACOG wants to take the position of prohibiting home birth after cesarean, the regulations need to have evidence behind them. Webb reiterated that without adequate support from research, a regulation that prohibits VBAC will not be reviewed.
Shannon Smith-Crowley, ACOG's lobbyist, clarified that in legal language, the phrase "likely" is supposed to mean over a 50% chance of occurring. In medical terms, the percentage is significantly lower and is related to various risk factors. She said that in using the word "likely" in AB1308, the legislative language of "likely" was meant to be more specific than "may." Webb asked again about the research on VBAC safety, and both Smith-Crowley and Wachtel very vaguely cited case studies of catastrophic outcomes from HBACs.

Curt Worden, the Chief of Licensing at the MBC eventually piped in. He said plainly that Licensed Midwives in California have done VBACs at home for a very long time, and their data (referring to the Licensed Midwives Annual Report) does not indicate a problem with safety. "I'm the one who decides. If you want to talk about regulating Vaginal Birth After Multiple Cesareans, we can do that. We collect data for the midwives and their outcomes are good. If you want to talk about the small percentage of outcomes that are bad, that 1-2% could be said for in-hospital births as well."

Wachtel then used an analogy of an airplane to illustrate the value of describing absolute risk to ensure patient safety. He said that if passengers were boarding an airplane and were told that there was a malfunction with the equipment that gives a 1% chance of crash, the passengers would be fools to stay on the plane. 99% safe is not good enough in some instances, and a 1% risk of complications is too much for most people, he argued.

Kamel then said that he was forgetting one crucial part: Most women in California don't have the option of getting on another plane when VBAC is banned in many California hospitals. Access to home birth midwives equals access to vaginal birth (and the health benefits of vaginal birth versus the health risks of repeat cesarean birth such as placenta accreta) in many cases. She later talked about the absolute risk of fetal demise from uterine rupture, which is somewhere between 1:3400-1:7000, far below 1%.

Alexandra Rounds from CFAM reiterated the issue of access to a VBAC provider, saying that the need for a physician consult for a planned VBAC places an unnecessary burden on families especially in rural areas, and increases the cost of healthcare without improving patient safety.

Webb then said that ACOG will need to make a compromise regarding VBAC at home, which may involve proposing the placement of some limitations (involving the number of cesareans, incision type, or both). She said that if ACOG cannot justify the limitations proposed, the MBC will not let them through. She said that Licensed Midwives can assume VBAC will continue to be allowed without a physician consulting with the patient.

Moving away from HBAC, the meeting was extremely productive with only a couple of points of contention remaining in the regulations. Many of the regulations were struck during the meeting due to redundancy, superfluous language, or general consensus that a consult with a physician would not likely alter the outcome of a client's pregnancy. Compare this list to the one from after the previous meeting, and you will see a lot of improvement.

Updated Proposed Regulations (following the Interested Parties Meeting on December 15, 2014)

(a) For purposes of Section 2507(b)(1)(A)(i) of the code, "Any preexisting maternal disease or condition likely to affect the pregnancy" includes, but is not limited to clinically significant evidence of conditions such as the following:

• Significant pelvic or uterine abnormalities, including tumors or malformations;

• History of uterine surgery, including, but not limited to myomectomy, hysterotomy, or Cesarean Section (the MBC said that VBA1C was definitely protected and a matter of clarifying this language; it will be up to ACOG to provide research to support any further restrictions)

• Current or significant history of cardiovascular disease, renal disease, hepatic disorders, neurological disorders, severe gastrointestinal disease.

• Current or significant history of endocrine disorders (excluding controlled hypothyroidism)

• Current or significant history of pulmonary disease, active tuberculosis, or severe asthma if symptomatic on medication

• Current or history of pulmonary embolus or DVT

• Current or history of epilepsy

• Collagen-vascular diseases

• Significant hematological disorder or coagulopathies

• Current or significant history of cancer

• Isoimmunization

• History of cervical cerclage if client is beyond 32 weeks' gestation at entry to care

• Essential hypertension (blood pressure greater than 140/90 on two or more occasions, six hours apart)

• Medication-dependent diabetes mellitus

• Serious congenital abnormalities affecting childbirth

• History of pre-term birth (this was one of the ones ACOG wants to keep, as they argue it would change the client's course of care if she were offered IM progesterone early in pregnancy. They did not seem confident in an LM's ability to give the client information on this therapy prior to consult)

• Current alcohol or drug abuse

• Positive HIV status or AIDS

• Current significant psychiatric illness

• Other known significant conditions likely to affect pregnancy

• (b) For purposes of Section 2507(b)(a)(A)(ii) of the code, "Significant disease arising from the pregnancy" includes, but is not limited to, clinically significant evidence of conditions such as:

• Threatened or spontaneous miscarriage after 14 weeks

• Significant vaginal bleeding

• Persistent vomiting with dehydration

• Symptoms of malnutrition or anorexia

• Gestational diabetes, uncontrolled by diet

• Severe anemia, not responsive to treatment

• Severe, persistent headache

• Evidence of pregnancy-induced hypertension (PIH) or pre-eclampsia (blood pressure reading greater than 140/90, 6 hours apart)

• Deep vein thrombosis

• Urinary tract infection (UTI), unresponsive to treatment

• Pyelonephritis

• Significant systemic disease

• Significant signs or symptoms of infection

• Isoimmunization, positive Rh antibody titer for Rh-negative mother, or any other positive antibody titer which may have a detrimental effect on mother or fetus

• Significant placental anomaly or previa

• Anterior low-lying placenta in women with history of previous cesarean

• Fetal growth restriction

• Significant fetal abnormality

• Suspected fetal demise

• Oligohydramnios

• Polyhydramnios

• Cervical insufficiency

• Premature rupture of membranes (before 37-0/7 completed weeks of pregnancy)

• Pregnancy with non-reactive stress test and/or abnormal biophysical profile

• Other known diseases arising from the pregnancy

Thank you again Madeleine Shernock!

 To read more from Madeleine please check out her blog 

http://shernock.blogspot.com/2014/12/progress-on-proposed-regulations-for.html

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