Association Between Sleep-Disordered Breathing and Hypertensive Disorders of Pregnancy and Gestational Diabetes Mellitus
Obstet Gynecol 2017;129:31–41
In this substudy of the Nulliparous Pregnancy Outcomes Study: Monitoring Mothers-to-be (nuMoM2b) Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) trial (see p. 31),1 3,705 nulliparous women self-applied home apnea monitors in the first and second trimesters of pregnancy. Sleep-disordered breathing, primarily obstructive sleep apnea, was diagnosed in 3.6% of women in the first trimester and in 8.3% in the second trimester. The primary outcome showed an approximate 1.9-fold increased rate of preeclampsia when sleep-disordered breathing was found at either time point and a 1.7-fold increased rate with any hypertensive disorder only with second-trimester diagnoses. The strongest association was with gestational diabetes mellitus, with an increased rate when sleep-disordered breathing was diagnosed in the first trimester (odds ratio 3.5) and an increased rate with second-trimester sleep-disordered breathing (odds ratio 2.8).
The researchers controlled for race, ethnicity, body mass index, gestational weight gain, and other variables, and the results held, showing independent associations of sleep-disordered breathing with preeclampsia, hypertensive disorders of pregnancy, and gestational diabetes mellitus.
This report is one of many well-planned and executed studies that will result from the nuMoM2b study. The overall study includes about 10,000 nulliparous women, with the primary foci of preterm birth, preeclampsia, fetal growth restriction, and stillbirth. The aims of the nuMoM2b study include examining maternal characteristics and biomarkers (such as sleep-disordered breathing) and placental and fetal characteristics associated with adverse pregnancy outcomes.1
Nancy C. Chescheir, MD
University of North Carolina, Chapel Hill, North Carolina
A Randomized Trial of Intrapartum Fetal ECG ST-Segment Analysis
N Engl J Med 2015;373:632–41
I can never forget the disappointment on the faces of many obstetricians on February 6, 2015, at the Society for Maternal-Fetal Medicine conference in San Diego, when Dr. George Saade presented the findings of the largest randomized controlled trial of fetal electrocardiogram ST segment analysis, saying “We found no differences in the effect of ST segment analysis on the primary outcome or on cesarean or operative delivery.” ST segment analysis is widely used in Europe as an adjunct to conventional fetal heart rate monitoring.
The NICHD created the Maternal-Fetal Medicine Units (MFMU) Network in 1986 to focus on clinical questions in obstetrics, particularly with respect to preterm birth using well-designed clinical trials. Currently, the MFMU network includes 14 clinical centers at U.S. hospitals. The advantages of the network include uniformity of methods and large sample size, as well as the collaboration it produces.
Several MFMU trials have changed obstetric practice. These include the Antenatal Late Preterm Steroids,1 Prevention of Recurrent Preterm Birth by 17-alpha-Hydroxyprogesterone Caproate,2 and Beneficial Effects of Antenatal Magnesium Sulfate3 trials. As we await the results of ongoing MFMU trials, practice will continue to change. Undoubtedly, I believe the nuMoM2b trial will change practice as it pertains to nulliparous women.
Ahizechukwu C. Eke, MD, MPH
Johns Hopkins University, Baltimore, Maryland
NIH Recognizes LGBTQ Community as “Health Disparity Population”
Available athttp://www.nbcnews.com/feature/nbc-out/nih-recognizes-lgbtq-community-health-disparity-population-n661161. Accessed October 12, 2016
As mentioned in the previous Dot, research collaboration creates more robust data and improves clinical practice. Unfortunately, such collaboration often is missing for stigmatized or marginalized patient populations. Lesbian, Gay, Bisexual, Transgender, and Queer or Questioning (LGBTQ) individuals, and especially LGBTQ women, have long suffered from a lack of well-powered research on health and health disparities. In light of these issues, the National Institutes of Health announced in October 2016 that sexual and gender minorities would be formally designated as a health disparity population for NIH research.1 The director of the National Institute on Minority Health and Health Disparities, Dr. Eliseo Pérez-Stable, cited mounting evidence that LGBTQ individuals experience less access to health care and higher incidence of certain diseases; however, the reasons for these disparities and strategies to close the gaps are not fully understood.
With this designation, it is hoped that research on LGBTQ populations will be better funded, more effectively coordinated, and taken more seriously in general. Lesbian, bisexual, and transgender women deserve equitable representation in research and attention from the scientific community in addressing the health disparities that affect LBGTQ women's lives. With this new designation, NIH reviewers can no longer ignore the existence of these health disparities and must work to promote high-quality research to advance the health of all Americans.
Kyle Bukowski, MD
University of California, Los Angeles, Los Angeles, California
The Refractory Overactive Bladder: Sacral NEuromodulation vs. BoTulinum Toxin Assessment: ROSETTA Trial
Contemp Clin Trials 2014;37:272–83
Taking research collaboration further, the NICHD continues to support the Pelvic Floor Disorder Network's efforts to design and implement high-quality, multicenter, randomized trials to improve outcomes for women with urinary incontinence. Refractory urgency urinary incontinence (UUI) is a stigmatizing condition afflicting many women, yet optimal treatments regimens are unclear. A recent trial, “Refractory Overactive Bladder: Sacral NEuromodulation versus BoTulinum Toxin Assessment: ROSETTA” compared two commonly used treatments for UUI in a multicenter, open-label, randomized controlled superiority trial. Three hundred sixty-four women with refractory UUI who had tried at least two bladder medications and recorded six incontinence episodes in a 3-day diary were randomized to receive intravesical onabotulinumtoxinA (200 units) or sacral neuromodulation. The onabotulinumtoxinA arm showed a statistically significant decrease in daily incontinence episodes over 6 months (primary outcome) (−3.9 compared with −3.3, P=.01). Although the clinical significance of a less than one incontinence episode per day difference is arguably of little relevance to patients, several patient-reported outcomes were also better in the onaobotulinumtoxinA arm.
Women in the onabotulinumtoxinA arm were more likely to report complete symptom resolution (20% compared with 4%, P=.002), greater satisfaction (68% compared with 60%, P=.01), and superior improvements in symptom bother on the Overactive Bladder Questionnaire Short Form (−46.7 compared with −38.6, P=.002). However, onaobotulinumtoxinA was associated with a higher rate of urinary tract infections and urinary retention requiring intermittent straight catheterization. It also requires repeat injections for durable treatment effectiveness.
The ROSETTA trial offers clinicians and patients important information about the efficacy and adverse events of two important treatments for UUI. These data show modest differences in several patient-reported outcomes and complications that will help clinicians counsel individual women to select to the best treatment option. Regardless of the method, it is imperative that women with this condition feel comfortable seeking care from their physicians and are shown the myriad options for treatment.
Evelyn Hall, MD
Northwestern University School of Medicine, Chicago, Illinois