Ben Schwartz is Associate Editor, Contemporary OB/GYN.
Longitudinal data from a prospective cohort study indicate that being born early term may negatively affect a child’s cardiorespiratory fitness. Plus: Is there a difference in PTB rate between branded and compounded 17P? Also, a review analyzes whether or not there are any benefits to placentophagy.
Longitudinal data from a prospective cohort study indicate that being born early term may negatively affect a child’s cardiorespiratory fitness (CRF). The trend, the authors say, continues into young adulthood and provides another rationale for deterring avoidable deliveries at lower gestational ages.
Published in The Journal of the American Heart Association, the findings are based on analysis of data from participants in the Northern Ireland Young Hearts Study, all of whom were singletons born at term. The prospective cohort study was designed to investigate development of lifestyle and biological cardiovascular risk factors through adolescence to young adulthood. A total of 791 boys and girls aged 12 to 15 were enrolled in 1989 and examined repeatedly until 1999.
When the participants were aged 12, 15 and 22, their mean levels of CRF were 45.6, 43.7 and 33.0 mL/kg per minute, respectively. After adjustment, each week increase in gestational age was associated with a 0.46 mL/kg per minute increase in CRF (95% confidence interval [CI], 0.14-0.79), or a 14% risk reduction. Those born at 37 to 38 weeks (considered early term by the authors) had a 57% higher incidence of poor CRF (risk ratio, 1.57; 95% CI, 1.14-2.16) than did the participants born at 39 to 40 weeks (full term) or 41 to 42 weeks (late term). Changes in CRF through adolescence to young adulthood were similar across groups, with those born early term consistently displaying lowest CRF.
Confounders considered by the researchers included maternal age, mode of delivery, occupation of the main breadwinner in a child’s family, and birthweight. A parental questionnaire at the study start was used to gather information on breastfeeding duration and maternal height, weight, and smoking history. The authors said adjustments for growth, maturation, and adiposity did not appreciably change their findings.
In commenting on the reasons for the connection between early-term birth and CRF, the authors said that “earlier births may interrupt normal development and lead to permanent changes of tissues and organs, such as fewer alveoli, lower capillary density, and a smaller vascular tree, which, in turn, may lead to long-lasting impairments in maximal oxygen uptake and transport, muscular power, and motor coordination.” They suggested a future research focus on “how current rates of [early term] affect offspring’s CRF in younger cohorts and how these associations may be modified by recent improvement in breastfeeding rates (or deterioration in other postnatal feeding practices).”
Is there a difference in PTB rate between branded and compounded 17P?
A study published online in JAMA Internal Medicine found a variation of as much as 5000% in the cost of 17-alpha hydroxyprogesterone caproate (17P), depending on whether the brand-name drug is used or a compounded version. clinician prescribes. No statistically significant difference was found in the preterm birth (PTB) rate for the two versions of 17P.
In 2011, Lumara Health (then named KV Pharmaceuticals) received approval from the US Food and Drug Administration to manufacture and market 17P as Makena. At that time, the prepackaged drug cost approximately 100 times more than the original compounded formulation.
The new study used the insurance claims database to examine prescriptions for 17P among 4000 commercially insured pregnant women from January 1, 2008 to December 31, 2015. The researchers used National Drug Code descriptors to identify women who had a pharmacy claim for either the branded or the compounded formulation. To illustrate costs, the researcher calculated the total allowed cost for each woman from the first drug injection to delivery. Associated outcomes between compounded and branded versions of the drug were characterized by comparing PTB using logistic regression to control for maternal age (mean maternal age for the branded drug was 33.0 and 32.7 for the compounded drug). Preterm deliveries were identified using ICD-9-CM and ICD-10-CM codes.
During the time period evaluated, 535 women received the branded drug while 3350 women received the compounded drug. The mean (SD) per pregnancy costs of the branded drug were $10917 ($4248) and $206 ($115) for the compounded drug. No statistically significant difference in PTB rates was found between women receiving the different versions. With the branded drug, 129 (23.9%) PTBs occurred and 878 (25.2%) PTBs occurred with the compounded drug.
Due to the retrospective nature of the study, there were some limits. The authors were unable to identify differences in gestational age at birth between the groups or what if any side effects were observed between the two groups. The researchers also emphasize that physicians are not to blame for prescribing the branded drug over the generic, but note that they do have a choice, which may be limited by many factors, including proximity to the nearest compounding facility. They also note that while the process of compounding drugs does carry a slightly higher risk of contamination, compounding facilities have faced higher scrutiny along with tighter federal regulations as a result of the 2012 New England Compounding Center contamination incident that led to a meningitis outbreak. Ultimately, the authors estimate that the annual cost of treating all medically eligible women with the brand version would exceed $1.4 billion, while the compounded form would cost just $26.5 million per year.
Researchers are advising ob/gyns to discourage their patients from engaging in placentophagy based on analysis of several studies. The review, published online in American Journal of Obstetrics and Gynecology, found no scientific evidence of any clinical benefit to consuming placenta and note that custom can actually cause harm to the mother and child.
According to the review, placentophagy has seen an increase in interest over the last 10 years, as evidenced by the rising number of Google searches for placenta encapsulation. The placenta can be eaten in many forms (raw, cooked, dehydrated, encapsulated, or mixed into other foods) and several companies offer to prepare the placenta for consumption. Individuals who promote placentophagy claim that it is associated with both physical and psychosocial benefits. The Centers for Disease Control and Prevention (CDC), however, reject this claim and issued a warning against the practice following a case in which a newborn developed recurrent neonatal group B Streptococcus sepsis after the mother consumed contaminated placenta capsules containing Streptococus agalactiae. As a result, the CDC has issued a warning that placenta capsules should be avoided due to inadequate eradication of infectious pathogens during the encapsulation process. The U.S. Food and Drug Administration has also released a statement that placental tissue does not belong to any of the dietary ingredient categories defined in section 201 (ff) of the Federal Food, Drug and Cosmetic Act.
The review notes that physicians should warn patients interested in placentophagy of the reported risks and lack of clinical benefits associated with the practice. Clinicians should also inquire regarding a history of placenta consumption in cases of maternal or neonatal infections among post-partum patients. The study also calls on health care organizations to develop clear guidelines in order to implement a scientific approach to advising on human placentophagy.