Outpatient Foley Catheter for Induction of Labor in Parous Women: A Randomized Controlled Trial
Obstet Gynecol 2018;132:94–101
As noted in the first paragraph of the Kuper et al1 article (see page 94), almost one quarter of women in the United States undergo induction of labor. Efforts are underway on many fronts to determine the most efficacious, safe, and cost-effective way to accomplish a successful vaginal delivery for women undergoing induction. Kuper et al1 report a randomized controlled trial of outpatient overnight transcervical Foley catheter placement in parous women at low risk compared with a group who began their induction process with inpatient concurrent Foley catheter and oxytocin infusion. The results of the primary objective showed no difference in time from admission to delivery. There were no differences in any of their secondary outcomes, nor in maternal or neonatal outcomes. Safety outcomes could not be assessed owing to the small numbers.
Of course, this study was not a double-blind, randomized controlled trial, and it is this point that I think bears some examination. It is important to design a trial that answers an important question that is doable and to recognize and accept that it is not perfect. Research has to be able to be accomplished—by minimizing the burden, risk, and inconvenience for the research participants; by achieving recruitment goals in a reasonable period of time; by staying within budget; and by carefully considering data collection to provide enough information to answer the question. There are, of course, other factors. In this case, Kuper et al have taken all of these steps, and the lack of a blinded method does not negate the results. It should make us ask the question, “How could it make a difference that it wasn't blinded, and did the research team try to diminish that difference?”
Nancy C. Chescheir, MD
University of North Carolina, Chapel Hill, North Carolina
1. Kuper SG, Jauk VC, George DM, Edwards RK, Szychowski JF, Mazzoni SE, et al. Outpatient Foley catheter for induction of labor in parous women: a randomized controlled trial. Obstet Gynecol 2018;132:94–101.
The Most Critical Factor in Medicine? Human Bias
Mukherjee S. The most critical factor in medicine? Human bias. Available at: https://ideas.ted.com/the-most-critical-factor-in-medicine-human-bias/
In a TED talk, oncologist Dr. Siddhartha Mukherjee said, “Every science suffers from human biases. Even as we train machines to collect, store, and manipulate data for us, humans are the final interpreters of that data…we want our medicines to work. Hope is a beautiful thing in medicine—its most tender center—but also the most dangerous.”1 The advent of randomized controlled trials in medicine was a groundbreaking evolution in how we conduct research. Difficulties continually exist in conducting these trials, where blinding the physician or patient can become nearly impossible or unethical. For an objective outcome, such as the length of time for the delivery of a fetus, randomized control trials will achieve a high quality of evidence and leave little room for bias. Levine et al2 conducted a four-arm randomized clinical trial to evaluate the difference in time to delivery among four different induction methods: misoprostol–cervical Foley, cervical Foley–Pitocin, misoprostol alone, and cervical Foley alone. The randomization was stratified by parity, and the labor management was standardized. The outcome showed a significantly shorter time to delivery with both combined methods compared with the individual methods. In this circumstance, blinding the patient and the investigator may not have given any higher quality of evidence.
Kristina Martimucci, DO
Rutgers New Jersey Medical School, Newark New Jersey
Mukherjee S. The most critical factor in medicine? Human bias. Available at: https://ideas.ted.com/the-most-critical-factor-in-medicine-human-bias/. Retrieved May 3, 2018.
2. Levine LD, Sammel MD, Parry S, Williams CT, Elovitz MA, Srinivas K. Foley or misoprostol for the management of Induction (The “FOR MOMI” trial): a four-arm randomized clinical trial. Am J Obstet Gynecol 2016;214:S4.
Dos and Don'ts in Pregnancy: Truths and Myths
Obstet Gynecol 2018;131:713–21
As physicians and patient advocates, we find ourselves continually seeking out the best available evidence to help guide decision-making in regard to patient care. The normal pregnancy duration, as calculated from the first day of the last normal menstrual period, is very close to 280 days, or 40 weeks. The labor-induction process generally consumes less than 1% of this time, and, as noted in the previous dot, combined methods appear to significantly shorten the length of labor induction as compared with individual methods. Dr. Fox1 discusses the dos and don'ts of pregnancy in a Clinical Expert Series article that addresses evidence-based, common recommendations for the other 99% of the pregnancy duration. The article is written in a way that acts as a reference guide to health care providers as well as a resource patients may call on. Topics discussed cover a wide breadth of daily encounters or decisions pregnant women may face, including encouraging regular exercise, avoiding undercooked fish, and permitting air travel. Other topics covered include prenatal vitamins, nutrition and weight gain, alcohol, artificial sweeteners, caffeine, foods to avoid, smoking, nicotine, vaping, marijuana, bedrest, avoiding injury, oral health, hot tubs, swimming, insect repellants, hair dyes, travel, and sexual intercourse. In today's age of technology, pregnant women have access to an overabundance of information, some of which is truth and some of which is myth. It is imperative we do our best to provide the best evidence available.
Michael MacKelvie, DO
University of Texas Health Science Center, Houston, Texas
1. Fox NS. Dos and don'ts of pregnancy: truth and myths. Obstet Gynecol 2018;131:713–21.
The Effect of Paternal Factors on Perinatal and Paediatric Outcomes: A Systematic Review and Meta-analysis
Hum Reprod Update 2018;24:320–89
As noted in the previous dot, maternal health and lifestyle habits have long been shown to affect pregnancy outcomes. In comparison, relatively little is known about the influence of paternal factors on perinatal and pediatric health.
In a recently published systematic review and meta-analysis, Oldereid et al1 summarize the available evidence on the effects of paternal factors, including paternal age, smoking status, and obesity, on perinatal and pediatric outcomes. Their results demonstrate that advanced paternal age is associated with an increased risk of autism and autism spectrum disorders, schizophrenia, birth defects, trisomy 21, stillbirths, and infant mortality. Paternal smoking, on the other hand, is associated with an increase in small-for-gestational-age newborns, congenital heart disease and orofacial clefts, cancers, childhood brain tumors, and attention deficit hyperactivity disorder. Conversely, paternal obesity, though known to be linked to infertility, does not seem to exert any independent effect on the risk of preterm birth or small for gestational age.
As health care providers, we must continue to advocate for both maternal and paternal health. Whether it is at their prenatal visit or even preconceptionally, both partners should be informed of the dos and don'ts of pregnancy. As we counsel women about their fertility, we should also be mindful of their partners' lifestyle habits and advise accordingly.
Clara Q. Wu, MD
University of Saskatchewan, Regina, Saskatchewan