AJOG — anti-phb paper ~ section on Patient Safety

by faithgibson on January 5, 2013

Patient safety

Discussion of patient safety is best based on evidence about obstetric outcomes.12, 13, 14, 15 ACOG in its statement accepts the finding of Wax et al16 that there is a 2-fold to 3-fold risk of neonatal death from planned home vs hospital birth.11 ACOG takes the view that pregnant women should be informed about this risk.11

The RCOG and RCM Joint Statement goes further and claims that planned home birth is a “safe option for many women.”10 This claim does not withstand close scrutiny for planned home birth without immediate access to hospital-based care. Such settings are unavoidably at risk for transport to the hospital. It is not surprising that the perinatal mortality rate was reported to be more than 8 times higher when transport from home to an obstetric unit was used.17 As clinicians we have all experienced that unavoidable delay involved in even the best transport systems from home to hospital and even from labor and delivery to the operating room results in increased risks of mortality and morbidity for pregnant, fetal, and neonatal patients.18, 19

Maternal and fetal necessity for transport during labor is often impossible to predict and indications include failure for labor to progress, unbearable labor pain, fetal malpresentation, increasing maternal temperature, suspicious fetal heart-rate tracings, abrupt deterioration of fetal heart rate, uterine rupture, acute bleeding, placental abruption, vasa previa, acute sepsis, and cord prolapse. For unpredictable, extremely sudden complications, even rapid transport may not prevent the fetus or pregnant woman from death or severe harm, such as sudden cardiopulmonary arrest, shoulder dystocia, or maternal exsaguination.20

Postnatal reasons for transport include lacerations of the vagina or cervix, sphincter rupture, uterine atony, and placenta accreta, increta, or percreta. In patients with severe hemorrhage and placental problems the pregnant woman may already be in shock when arriving at a hospital. Even though operative and shock treatment can be immediately instituted, death may nevertheless sometimes occur.

Neonatal reasons for transport are myriad and include unexpected very low or very high birthweight, neonatal depression, signs of respiratory distress, unexpected malformations, and acute sepsis. In the general population, the incidence of common problems, such as major malformations (3%), prematurity (≥6%), and severe fetal growth restriction (3%) is not inconsequential.21 Moreover, the best screening procedures, even when optimally performed, sometimes fail to detect these high-risk conditions. Given the severity and frequency of reasons for transport, even a very low rate of emergency transport should prompt considerable concern. This has been proven by a review of perinatal deaths in planned home births in Southern Australia where inappropriate inclusion of women with risk factors resulted in inadequate fetal surveillance during labor.17

The recent Birthplace in England prospective cohort study reported transport rates from nonobstetric units to the hospital of 36 to 45% for nulliparous women and 9 to 13% for multiparous women.22 For the primary outcome measure of perinatal mortality and specific morbidities, there was an adjusted odds ratio [OR] of 1.59 (95% confidence interval [CI], 1.01−2.52) for women “without any complicating factor at the start of care in labour” for planned home vs planned obstetric unit births. The adjusted OR was 1.75 (95% CI, 1.07–2.86) for the primary outcome for planned home vs planned obstetric unit births for nulliparous women, which increased to 2.8 when restricted to nulliparous women with no complications at the start of labor. The 59 to 75% increase in a poor primary outcome is frequently attributable to the delay in access to hospital care from transport time. Only in the online appendix were so called “events” elucidated. In the primary outcome population, intrapartum stillbirths and early neonatal deaths accounted for 13%, neonatal encephalopathy for 46%, meconium aspiration syndrome for 30%, brachial plexus injury for 8%, and fractured humerus or clavicle for 4% of “events.” It is concluded that these “results support a policy of offering healthy nulliparous and multiparous women with low risk pregnancies a choice of birth setting.”22 We contend that this view is irrational and cannot be supported in light of the reported adverse outcomes for birth outside of an obstetric service.

In the Netherlands, there is a long tradition of optimally organized home birth, with well-trained midwifes and a transport system with short distances to hospitals. Nonetheless, 49% of primiparous and 17% of multiparous women are transported during labor.23 The most frequent indications are the need for pain relief (which is subjective and possibly influenced by anxieties to continue with the delivery at home) and prolonged labor. Women who are transferred to a hospital have a significantly higher rate of operative vaginal delivery and secondary cesarean delivery (relative risk [RR], 1.42 and 1.2) and a higher rate of peridural anesthesia (RR, 1.45). Of all primiparous women transported in the Netherlands to a hospital because of prolonged labor, two-thirds need pain treatment.24

De Neef et al25 analyzed the intention to deliver either at home (45%), under guidance of a midwife within a hospital (44%) or under guidance of an obstetrician in a hospital (11%) in Dutch primiparous women in the first trimester. The reality was that only 17% of these women delivered at home, 10% delivered under the guidance of a midwife in an obstetric unit, but 73% delivered in a hospital under the care of an obstetrician. The authors logically conclude that patients have to be informed about these numbers and the high transport rates. Such information is essential for pregnant women to make good decisions about the site of delivery.25 In Germany, midwives are obligated to inform their patients about the distance from the freestanding midwifery unit (or home) to the nearest hospital obstetric unit and the approximate average time of transport. Midwives are also obligated to document this information in the informed consent form and in the patient’s record. Nevertheless, many pregnant women are not aware of what this might mean in an emergency.

Some authors from the Netherlands acknowledge and discount the clinical significance of an increased risk of adverse outcomes of planned home vs hospital birth. Van de Kooy et al,26, 27 for example, state: “With about 50,000 women annually starting delivery under supervision of a midwife at home, a 5% risk (of adverse outcome) may be nontrivial. On an individual level, such a difference leaves room for individual choice where other aspects may matter.” The authors had investigated the perinatal outcome of 679,952 low-risk women obtained from the Netherlands Perinatal Registry (2000-2007) representing women who had a choice between home and hospital birth. After case mix adjustment, there was a trend, but nonsignificant, toward increased mortality risk within the group of intended home birth (OR, 1.05; 95% CI, 0.91−1.21). In subgroups, additional mortality arose at home if risk conditions emerged during birth (up to a 20% increase).26

A study from South Australia reported that home births between 1991 and 2006 accounted for only 0.38% of 300,011 births despite an average long distance from home to a perinatal center. The perinatal mortality rate of nonhospital deliveries was similar to that for planned hospital births (7.9 vs 8.2 per 1000 births). However, there was a 7-fold higher risk of intrapartum death (95% CI, 1.53−35.87) and a 27-fold increased risk of death from intrapartum asphyxia (95% CI, 8.02−88.83).17 This shows that the perinatal mortality rate may obscure significant differences between asphyxia and intrapartum death resulting from home birth. Prenatal deaths are obviously increased in pregnancies followed by hospital perinatal centers because of obligate referral of high-risk patients, including fetal patients with malformations, to these centers.

Reporting from the United States, Ecker and Minkoff28 focus on the absolute risk of planned home birth, rather than the relative risk, and claim that the “potentially small increment in absolute risk that a particular patient choice carries” is ethically acceptable. The data above support a different clinical and ethical assessment: the increment is far from small and is not ethically acceptable.

We therefore emphatically disagree with Ecker and Minkoff28 and all others who judge the adverse outcomes of planned home vs hospital birth to be ethically acceptable. The professional responsibility response demands adherence to accepted standards of care.29

The adverse outcomes described above can be reduced in their incidence by access to timely cesarean delivery. In the United States, there has been a “rule” of 30 minutes from “decision to incision.”30 ACOG has revised this to state that “when a decision for operative delivery in the setting of a Category III EFM tracing is made, it should be accomplished as expeditiously as feasible.”30, 31, 32 In Germany, a 20-minute interval from decision to delivery is used for quality assessment of perinatal centers.

None of these standards can be consistently met if pregnant patients have to be transported. This is true even in the case of the Netherlands, where the infrastructure of transport systems is highly developed and distances within the country are small. In the rest of the world the interval for time of transport can be more lengthy. This will be true, for example, in countries such as the United States that have emergency services but not dedicated, well developed maternal transport services. More to the point, the inherent problems with transport are in large measure irremediable, even with a huge investment of capital. Professional responsibility is defined prospectively because of the inherent and unpredictable risk to maternal, fetal, and neonatal patients in any pregnancy, including uncomplicated pregnancy at the onset of attended labor.

In summary, planned home birth does not meet current standards for patient safety in obstetrics, as illustrated by the recent preventable death from hemorrhage of an Australian midwife home-birth advocate while attempting delivery of her own child at home.20 There is increased relative risk and a persistent absolute risk both of which can be reduced in their incidence by having access to professional standards of perinatal care. To regard these risks as ethically acceptable relegates pregnant and fetal patients who experience adverse events to the category of collateral damage. It is antithetical to professional responsibility to intentionally assign any damaged or dead pregnant, fetal, or neonatal patient to this category, even if the number is small. Obstetricians who nonetheless do so should be subject to peer review and justifiably incur professional liability and sanction from state medical boards. Policy makers who do so should be exposed as threats to professional responsibility.

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