Search

(Abstracted from Am J Obstet Gynecol2023;229:439.e1–439.e11It is common for fetal oxygenation and pH to decline during labor. However, severe oxygen deprivation can cause fetuses to develop metabolic acidemia, a risk factor for moderate to severe neonatal encephalopathy that can progress to cerebral palsy.

Pregnant and lactating individuals historically have been excluded from research studies because of the ethical concerns surrounding potential harm to the fetus. Several National Institutes of Health and Food and Drug Administration initiatives have attempted to improve inclusion; however, clinical trials continue to exclude pregnant and lactating people. Drug labeling for safety and efficacy in pregnancy has thus been forced to rely on data from animal studies or limited case reports. Recent changes have sought to improve prescriber understanding of risks, benefits, and limitations of safety information on medications; however, confusion persists.

One of the foremost public health concerns in obstetrics is preterm birth (PTB), which carries substantial consequences for infants, families, and societies that are well-documented. Affecting approximately 15 million births worldwide, PTB is a leading cause of death for children younger than 5 years. Unfortunately, identifying strategies to reduce PTB has proven challenging, in part because multiple causes exist for spontaneous PTB. It is widely recognized that a history of PTB is one of the strongest risk factors for recurrence. It has been suggested that the onset of parturition occurs because of functional progesterone withdrawal, which has led to the use of progestogens as an agent for PTB prevention efforts. Currently, both the Society for Maternal-Fetal Medicine and the American College of Obstetricians and Gynecologists support progestogen therapy for prevention of recurrent PTB in select patients with singleton pregnancies. The purpose of this study was to report on the effectiveness of vaginal progesterone vaginal progesterone for PTB prevention in a single inner-city practice. The primary aim was to evaluate the association of vaginal progesterone with PTB prevention at a gestational age of 35 weeks or less. The authors hypothesized a reduction of recurrent PTB with vaginal progesterone–treated patients as compared with historical control subjects with similar numbers and frequency of prior PTBs. Additional examinations included clinical outcomes and therapy associated with severity of recurrent PTB, progesterone blood levels, and medication adherence.This study utilized an inception, cohort study format in which all clinic patients were offered vaginal progesterone beginning on May 15, 2017. A comparison of recurrent PTB in patients treated with vaginal progesterone with a historical cohort prior was the outcome of interest. Each patient underwent detailed obstetric history, including the number of confirmed previous births, perinatal outcome, reason(s) for PTB, gestational age at PTB, and birth weight. Patients with medically indicated PTB (such as those due to pregnancy-related hypertension) were excluded. Only the first pregnancy outcome was analyzed for patients with more than 1 pregnancy during the study period. Because of variation in risk levels for PTB based on race and ethnicity, this information was collected by research staff using patient self-report. Patients with prior spontaneous PTB at 35 weeks or less due to rupture of membranes or spontaneous labor during any prior pregnancy were eligible. Therapy included 90 mg of vaginal progesterone (8%, nightly) between 16 weeks 0 days and 20 weeks 6 days until 36 weeks and 6 days (or delivery).The primary outcome was PTB recurrence at 35 weeks or less for patients given vaginal progesterone as compared with the 3:1 matched historical cohort (untreated). An intention-to-treat principle was the basis for this analysis. Secondary outcomes included the following: (1) association of PTB recurrence rate with vaginal progesterone treatment adherence (defined as 80% or more of doses), (2) comparison of specific patients' gestational ages at prior PTBs with the gestational age at delivery following vaginal progesterone treatment, (3) ascertainment of whether PTB was associated with serum progesterone levels among vaginal progesterone–treated patients, (4) comparison of pregnancy outcomes for patients declining the use of progestogens, and (5) pregnancy outcomes during the era of 17-α hydroxyprogesterone caproate (17-OHP-C) use (2012–2017) as compared with the contemporary vaginal progesterone use and study.In the historical cohort, when progestogen was not in use, the PTB rate at 35 weeks or less was 16.8% (1394 of 8278). Between May 15, 2017, and May 7, 2019, 417 study patients were identified from a pool of 2883. The overall rate of recurrent PTB in this group was 24.0% (100 of 417) in the vaginal progesterone cohort compared with the expected historical rate of 16.8%. Further analysis indicated that adequate adherence was not associated with lower rates of recurrent PTB, and the use of vaginal progesterone was not associated with a decrease in the overall rate of recurrent PTB when examined according to intention-to-treat analysis. In addition, the PTB recurrence rates were not lower with the vaginal progesterone treatment when analyzed according to the specific sequence of prior PTBs and term births.The authors note that this study may lack generalizability because of its nature as a single-center report. The predominantly Hispanic and non-Hispanic Black patients with obesity served at Parkland Hospital represent a medically indigent population. In addition, therapy adherence was low, as 80% of participants discontinued therapy because of reported adverse effects from medication. However, blood progesterone levels failed to suggest differing therapy responses as compared with elevated physiological levels of normal pregnancy. In fact, the study results suggest that vaginal progesterone may increase recurrent PTB rates in this population. Finally, vaginal progesterone treatment in patients with a short cervical length was beyond the scope of this analysis.Vaginal progesterone treatment of patients with current singleton pregnancies within this prospective cohort study found that this intervention did not decrease the rate of recurrent PTB as compared with historically matched control subjects for sequence and number of prior PTBs. It additionally did not find an association with clinical improvement in outcomes due to adherence to medication, progesterone blood levels, or severity of PTB recurrence. In light of these findings, the authors recommend against offering vaginal progesterone for prevention of recurrent PTB using the personal PTB history alone as a basis.

Abortion-related legislation on the state level has encroached on reproductive care access, disproportionately affecting underserved communities. This was first brought to the forefront following legislative actions such as Senate Bill 8 (SB8) in Texas, which bans abortions following detection of cardiac activity. Enforcement of this bill uses private plaintiffs through civil lawsuits based on the estimated gestational age. Senate Bill 4 not only expands abortion complication reporting, but it also renders all physician-administered medicine for the purpose of ending a pregnancy as felonies, punishable by jail time ranging from 180 days to 2 years and $10,000 fine (even in the case of maternal medical emergency). This publication reports an inner-city health care system experience in Texas following these legislative actions.The safety net hospital for Dallas County, Parkland Hospital and William P. Clements Jr University Hospital, are both level IV designated maternal care facilities, with annual delivery rates of approximately 14,000. The inclusion criteria included patients presenting with a fetus with cardiac motion at <22 weeks without preterm labor and with a medical indication for delivery, such as vaginal bleeding, preterm premature membrane rupture, and/or preeclampsia with severe features. Potential candidates were identified from direct patient care and electronic health records. Before the passage of SB4 and SB8, these conditions led to patients receiving counseling and being offered expectant management or labor induction. Following the effective date, expectant management occurred alongside medical intervention when faced with immediate threat to maternal life. All cases were managed by and discussed with maternal fetal medicine leadership due to the potential of a felony. Fetal or neonatal demise was the primary perinatal outcome of the review, whereas primary maternal outcomes included time from presentation to delivery, indications for delivery, and maternal morbidities.Study results determined that 28 pregnant patients met the inclusion criteria between September 2021 and May 2022. Preterm premature rupture of membranes affected 26 of 28 patients, 7 of which had fetal parts or umbilical cord prolapsed into the vagina. A mean of 9.2 days was recorded between presentation and delivery. A total of 27 patients experienced loss of the fetus or infant (96%). Of the 8 infants with cardiac motion at birth, 7 died within 24 hours, and 1 remains hospitalized. Some 12 of the 28 patients experienced clinical chorioamnionitis and hemorrhage, with 9 of these patients requiring intensive care unit admission, readmission, or dilatation and curettage. A single patient at 20 weeks' gestation required hysterectomy due to hemoperitoneum from uterine rupture with placenta accreta spectrum.This analysis concludes that in these 2 Texas hospitals, significant maternal morbidity was associated with state-mandated expectant management for periviable obstetric complications. It is clear that a high risk of serious morbidity exists for pregnant patients at <22 weeks presenting with medical indications for delivery, with simultaneous poor fetal outcomes. In fact, serious maternal morbidity due to expectant management occurred for 57% of patients, versus 33% for those with similar medical conditions electing immediate pregnancy interruption in other states. Questions raised by this analysis include “How imminent must death be?” and “What does the threat of death need to be?” Although the study is limited by its small sample size, it is clearly indicative of the possible imminent future for maternal health care as mandated by this legislation.

Ultrasound (US) prediction of placenta accreta spectrum (PAS) in the first trimester may be aided by postprocessing mechanisms employing color pixel quantification near the bladder–uterine serosal interface. Our objective was to create a postprocessing algorithm of color images to identify findings associated with PAS and compare quantification to sonologist impression in prospectively obtained cine US images. Transverse transvaginal (TV) US color cines obtained in the first trimester as part of a prospective study were reviewed. Investigators blinded to clinical outcomes reviewed anonymized cines that were archived and labeled the bladder–uterine serosal interface. Color pixels within 2 cm of the defined bladder–uterine serosal interface were ascertained using a Python‐based plugin in the Horos open‐source DICOM viewer. A sonologist classified the findings as suspicious for invasion, indeterminate, or normal. Statistical analysis was performed using Wilcoxon rank‐sum test, Cochran‐Armitage trend test, and calculation of receiver‐operating characteristic (ROC) curves. Fifty‐four studies met inclusion criteria. Of those, six (11%) required hysterectomy with pathologic confirmation of PAS. Women requiring hysterectomy had a significantly higher color Doppler pixel area than those not requiring hysterectomy (P= .0205). A significant trend was identified in the sonologist impression of invasion (P= .0003). ROC's comparing sonologist impression to Doppler color imaging areas were comparable (P= .054). Color Doppler mapping in the first trimester showed an increase in color pixel area near the bladder–uterine serosal interface in women requiring cesarean hysterectomy with histologically confirmed PAS at time of delivery, compared to women without hysterectomy or pathologic evidence of PAS. Access the CME test hereand search by article title.

The placenta accreta spectrum (PAS) incidence has risen substantially over the past century, paralleling a rise in cesarean delivery (CD) rates. Prenatal diagnosis of PAS improves maternal outcomes. The Placenta Accreta Index (PAI) is a standardized approach to prenatal diagnosis of PAS incorporating clinical risk and ultrasound (US) findings suggestive of placental invasion. We sought to validate the PAI for prediction of PAS in pregnancies with prior CD. This work was a retrospective cohort study of pregnancies with 1 or more prior CDs that received a US diagnosis of placenta previa or low‐lying placenta in the third trimester. Images of third‐trimester US with a complete placental evaluation were read by 2 blinded physicians, and the PAI was applied. Surgical outcomes and pathologic findings were reviewed. Placenta accreta spectrum was diagnosed if clinical evidence of invasion was seen at time of delivery or if any placental invasion was identified histologically. International Federation of Gynecology and Obstetrics criteria were used. A total of 194 women met inclusion criteria. Cesarean hysterectomy was performed in 92 (47%), CD in 97 (50%), and vaginal delivery in 5 (3%). Of those who underwent hysterectomy, PAS was histologically confirmed in 79 (85%) pregnancies. Of the remaining 13 who underwent hysterectomy, all met International Federation of Gynecology and Obstetrics grade 1 clinical criteria for PAS. With a threshold of greater than 4, the PAI has a sensitivity of 87%, specificity of 77%, positive predictive value of 72%, and negative predictive value of 90% for PAS diagnosis. Contemporaneous application of the PAI, a standardized approach to US diagnosis, is useful in the prenatal prediction of PAS.

IMPORTANCE: Investing in the next generation of researchers is essential, as recently highlighted in the 21st Century Cures Act. From its inception, the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) has supported training and career development to ensure a robust pipeline of investigators who are prepared to lead their respective fields of inquiry. In recent years, the NICHD has emphasized institutional over individual training awards to a greater degree than many other National Institutes of Health institutes of similar size. OBJECTIVE: To evaluate the success of individuals supported by NICHD career development and training awards, as measured by subsequent application and receipt of independent National Institutes of Health research project grant funding. DESIGN, SETTING, AND PARTICIPANTS: This retrospective cohort study identified 417 physician-scholars who were supported by NICHD career development awards between October 1, 1999, and September 30, 2001. This period was selected to allow adequate follow-up of research project grant applications and funding. Among these physician-scholars, 355 met inclusion criteria. MAIN OUTCOMES AND MEASURES: The primary outcomes were the numbers of research project grant applications submitted and, of these, the numbers that were successfully funded. RESULTS: Among 355 physician-scientists, scholars who had an MD degree only and received a K award or both an individual K award and institutional K12 support were more likely than those who received only K12 support (individual K only vs institutional K12 only: odds ratio [OR], 4.86; 95% CI, 1.83-13.62; both K and K12 vs K12 only: OR, 3.19; 95% CI, 1.46-7.10) to apply for subsequent project grant funding (88.0% vs 82.8% vs 60.1%, respectively; P &lt; .001) and to receive it (60.0% vs 60.9% vs 32.9%, respectively; P &lt; .001). For physicians with both MD and PhD degrees, neither application nor funding rates were statistically significantly different whether their career development was supported by individual or institutional awards. CONCLUSIONS AND RELEVANCE: Physician-scholars are more likely to apply for and receive a National Institutes of Health research grant if they are trained on an individual career development award, with or without an institutional training award. Based on the data, the NICHD intends to provide a greater proportion of its career development fund allocation to individual awards. The NICHD recognizes the importance of institutional awards and will continue to support them. The NICHD remains committed to training and intends to maintain its investment in training and career development awards going forward.

IMPORTANCE: The Zika virus (ZIKV) epidemic has profoundly affected the lives of children and families across the Americas. As the number of children born with ZIKV-related complications continues to grow, the long-term developmental trajectory for these children and the effect on their families remains largely unknown. In September 2016, the Eunice Kennedy Shriver National Institute of Child Health and Human Development and partner National Institutes of Health institutes convened a workshop to develop a research agenda to improve the evaluation, monitoring, and management of neonates, infants, or children affected by ZIKV and its complications. The agenda also aims to optimally address the prospective effect of ZIKV exposure on the developing child. OBSERVATIONS: The full clinical spectrum of congenital ZIKV syndrome has yet to be elucidated. In addition to the well-described anatomic and neurologic manifestations, clinicians are now describing infants with exaggerated primitive reflexes, epilepsy, acquired hydrocephalus and microcephaly, neurodevelopmental delay, gastrointestinal motility problems, and respiratory complications, such as pneumonia. While we are still learning more about the myriad clinical presentations in these severely affected children, it is also paramount to address the larger proportion of ZIKV-exposed infants who are asymptomatic at birth but, we assume, may develop problems later in life. The available evidence for neurologic, neurodevelopmental, neurobehavioral, auditory, and vision assessments and management for infants with congenital ZIKV syndrome was critically evaluated. Lessons from other congenital infections provide valuable clues about the complexities of management and the optimal approaches for evaluating, treating, and caring for the children, which include engaging and involving parents and caregivers in their treatment. CONCLUSIONS AND RELEVANCE: Rigorous research is key to improving the identification of ZIKV-infected mothers and babies. Research also is critical to increasing basic understanding of the neuropathogenesis of congenital ZIKV disease and of the spectrum of clinical presentations of ZIKV infection so that agents to prevent and treat this devastating disease can be rapidly developed and studied.

One in five Americans experiences disability that affects their daily function because of impairments in mobility, cognitive function, sensory impairment, or communication impairment. The need for rehabilitation strategies to optimize function and reduce disability is a clear priority for research to address this public health challenge. The National Institutes of Health (NIH) recently published a Research Plan on Rehabilitation that provides a set of priorities to guide the field over the next 5 years. The plan was developed with input from multiple Institutes and Centers within the NIH, the National Advisory Board for Medical Rehabilitation Research, and the public. This article provides an overview of the need for this research plan, an outline of its development, and a listing of six priority areas for research. The NIH is committed to working with all stakeholder communities engaged in rehabilitation research to track progress made on these priorities and to work to advance the science of medical rehabilitation.This article is being published almost simultaneously in the following six journals: American Journal of Occupational Therapy, American Journal of Physical Medicine and Rehabilitation, Archives of Physical Medicine and Rehabilitation, Neurorehabilitation and Neural Repair, Physical Therapy, and Rehabilitation Psychology. Citation information is as follows: NIH Medical Rehabilitation Coordinating Committee. Am J Phys Med Rehabil. 2017;97(4):404—407.