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The publication of A Randomized Trial of Induction Versus Expectant Management (ARRIVE), conducted in the United States in 2018, heralded a paradigm shift within the obstetrical management of term pregnancy among people who have not previously given birth. ARRIVE finds its home among other canonical - and controversial - randomized controlled trials (RCTs) within obstetrics. We argue that RCTs have their own (after)life, both creating new subjects for biomedical intervention and recalibrating who reproductive health practitioners consider to be at risk of adverse health outcomes. These data have important consequences for medical social scientific engagement with RCTs to further interrogate the questions of risk and intervention within reproductive health.

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OBJECTIVES: To examine racial disparities in prenatal care (PNC) utilization and infant small for gestational age (SGA) among active duty US military women, a population with equal access to health care and known socioeconomic status. METHODS: Department of Defense Birth and Infant Health Research program data identified active duty women with singleton live births from January 2003 through August 2015. Administrative claims data were used to define PNC utilization and infant SGA, and log-binomial regression models estimated associations with race/ethnicity. To examine whether associations between maternal race/ethnicity and infant SGA were subject to effect measure modification, respective analyses were stratified by demographic and health characteristics. RESULTS: Overall, 12.2% of non-Hispanic White women initiated PNC after the first trimester, compared with 14.8% of American Indian/Alaska Native, 15.1% of Asian/Pacific Islander, 14.2% of non-Hispanic Black, and 13.0% of Hispanic women. Infant SGA prevalence was 2.4% and 1.6% among non-Hispanic Black and White women, respectively (aRR 1.52, 95% CI 1.40-1.64). This disparity persisted across stratified analyses, particularly among non-Hispanic Black versus White women with a preeclampsia or hypertension diagnosis in pregnancy (RR 1.96, 95% CI 1.67-2.29) and those aged 35 + years at infant birth (RR 2.04, 95% CI 1.56-2.67). CONCLUSIONS FOR PRACTICE: In multiple assessments of PNC utilization and infant SGA, non-Hispanic Black military women had consistently worse outcomes than their non-Hispanic White counterparts. This suggests that equal access to health care does not eliminate racial disparities in outcomes or utilization; additional research is needed to elucidate the underlying etiology of these disparities.

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OBJECTIVE: The objective of this study was to evaluate the readability, content, and quality of patient education materials addressing preeclampsia. METHODS: Websites of U.S. obstetrics and gynecology residency programs were searched for patient education materials. Readability, content, and quality were assessed. A one-sample t-test was used to evaluate mean readability level compared with the recommended 6th grade reading level. RESULTS: Mean readability levels were higher using all indices (p < 0.001). Content was variable with good website understandability, but poor actionability. CONCLUSIONS: The mean readability was above the recommended 6th grade reading level. The content, readability, and actionability of preeclampsia patient education materials should be improved.

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OBJECTIVE: To evaluate whether ondansetron or the combination of doxylamine and pyridoxine was superior for the treatment of nausea and vomiting of pregnancy. METHODS: This was a double-blind, randomized, controlled trial in which women with nausea and vomiting of pregnancy were assigned to 4 mg of ondansetron plus a placebo tablet or 25 mg pyridoxine plus 12.5 mg of doxylamine for 5 days. The primary outcome was an improvement in nausea as reported on a 100-mm visual analog scale (VAS). Secondary outcomes were a reduction in vomiting on the VAS and the proportion of patients reporting sedation or constipation while using either study regimen. RESULTS: Thirty-six women (18 in each group) were randomized to either ondansetron or pyridoxine and doxylamine, of whom 13 (72%) and 17 (94%) completed follow-up, respectively. There were no differences among the groups with regard to demographic characteristics or baseline nausea. Patients randomized to ondansetron were more likely to have an improvement in their baseline nausea as compared with those using pyridoxine and doxylamine over the course of 5 days of treatment (median VAS score decreased 51 mm [interquartile range 37-64] compared with 20 mm [8-51]; P=.019). Furthermore, women using ondansetron reported less vomiting (median VAS decreased 41 [interquartile range 17-57] compared with 17 [-4 to 38]; P=.049). There was no significant difference between the groups regarding sedation or constipation. CONCLUSION: Our investigation showed ondansetron to be superior to the combination of pyridoxine and doxylamine in the treatment of nausea and emesis in pregnancy. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT01668069. LEVEL OF EVIDENCE: : I.

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OBJECTIVE: To validate a five-factor scoring system that identifies parturients who experience near-miss morbidity. STUDY DESIGN AND SETTING: This study was conducted in an urban, tertiary care hospital over a 2-year period. A narrative case summary was prepared for women with high potential for significant obstetric morbidity. The summary was then reviewed by three physicians, and the extent of morbidity was assigned based on subjective assessment. The same cases were then scored using the proposed five-factor scoring system previously described by Geller et al. Test characteristics of the scoring system were assessed. RESULTS: Eight hundred fifteen cases with a high potential for significant morbidity were identified. Subjective review and the scoring system classified 4.5% and 4.2% as near-miss morbidity, respectively, with the scoring system having a corresponding sensitivity of 81.1% (95% confidence interval 64.8 to 92.0%) and a specificity of 99.5% (95% confidence interval 98.7 to 99.9%). CONCLUSION: The scoring system produced similar results to those obtained at its initial development and demonstrated acceptable sensitivity and specificity for identifying near-miss morbidity.

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BACKGROUND: Herpes simplex virus (HSV) is an unusual cause of postpartum endometritis. We describe a rare case of primary disseminated maternal HSV in the postpartum period associated with endometritis. CASE: A previously healthy patient developed fundal tenderness and postpartum fevers after an uncomplicated vaginal delivery. Despite traditional broad-spectrum antimicrobial therapy, she had persistent fevers and systemic symptoms. Concurrently, her neonate developed fevers and a nonvesicular rash, with viral cultures ultimately returning positive for HSV. The patient developed active pharyngeal and genital herpetic lesions and was diagnosed with HSV endometritis and disseminated HSV. Symptoms and fevers in both the mother and neonate responded to antiviral therapy. CONCLUSION: Herpes simplex virus endometritis should be included in the differential diagnosis for postpartum fevers and fundal tenderness that are unresponsive to broad-spectrum antimicrobial treatment.

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OBJECTIVE: We developed a standardized educational tool to inform women about preeclampsia. The objective of this study was to assess whether exposure to this tool led to superior understanding of the syndrome. STUDY DESIGN: This was a randomized controlled trial in which 120 women were assigned to (1) a newly developed preeclampsia educational tool, (2) a standard pamphlet addressing preeclampsia that had been created by the American College of Obstetricians and Gynecologists, or (3) no additional information. Preeclampsia knowledge was assessed with the use of a previously validated questionnaire. RESULTS: There were no demographic differences among the groups. Patients who received the tool scored significantly better on the preeclampsia questionnaire than those who received the American College of Obstetricians and Gynecologists pamphlet or no additional information (71%, 63%, 49%, respectively; P < .05). This improved understanding was evident equally among women with and without adequate health literacy (interaction: P > .05). CONCLUSION: Patients who were exposed to a graphics-based educational tool demonstrated superior preeclampsia-related knowledge, compared with those patients who were exposed to standard materials or no education.

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OBJECTIVE: To explore the extent to which pregnant women understand the symptoms and potential complications related to preeclampsia and to determine the factors that are associated with better understanding. METHODS: This was a cross-sectional study in which 112 pregnant patients were interviewed to determine their preeclampsia knowledge. Knowledge was evaluated using a 25-item survey addressing the symptoms, consequences, and proper patient actions associated with preeclampsia. Patients were also asked in an open-ended question to define preeclampsia; all responses were rated by three obstetricians. Information about demographics, medical and obstetrical history, and health literacy was also obtained. Health literacy was assessed using the short Test of Functional Health Literacy in Adults (S-TOFHLA). RESULTS: Patients correctly answered only 43% of the 25 questions assessing preeclampsia knowledge. Moreover, only 14% of the patients were able to provide a definition that correctly reflected the syndrome. Factors associated with a greater proportion of correct answers on the questionnaire were higher literacy, multiparity, history of preeclampsia, and receipt of information about preeclampsia from a clinician or another information source (e.g., the Internet, television, a book, or a friend). CONCLUSIONS: Pregnant patients have a generally poor understanding of preeclampsia, although improved understanding is associated with having received information about the disease. Further investigation will be needed to determine how best to educate patients and whether this education can also decrease adverse outcomes associated with this syndrome.

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OBJECTIVE: We sought to evaluate the effectiveness of a pharmaceutical labeling strategy intended to improve comprehension of a teratogen warning. STUDY DESIGN: This is a secondary analysis that evaluated women of childbearing age who were assigned prescription containers with the current teratogen warning, a label with simplified text, or a label with simplified text and icons. The association between label type and understanding of label instructions was assessed. RESULTS: A total of 132 women were interviewed. Comprehension of the icon label (94%) was higher than for the standard and enhanced text-only labels (76% and 79%), respectively (P < .05). Adjustment for age, race/ethnicity, education, literacy, and number of current medications revealed that the label with the enhanced text and icon yielded superior comprehension (risk ratio vs standard, 1.26; 95% confidence interval, 1.04-1.53; risk ratio vs enhanced, 1.22; 95% confidence interval, 1.02-1.46). CONCLUSION: In our study, a teratogen warning label that had easy-to-read messages with icons significantly improved comprehension.

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OBJECTIVE: The purpose of this study was to determine whether lymph-vascular space invasion (LVSI) that is discovered in cervical biopsy and excision specimens is associated with LVSI in the hysterectomy specimen of patients with cervical cancer. STUDY DESIGN: A retrospective pathologic review to determine the presence of LVSI in cervical biopsy specimens, cold-knife cone biopsy (CKC biopsy), and loop electrical excision procedure (LEEP) specimens that contained cervical cancer was performed if subsequent hysterectomy results were available for review. Data were analyzed with chi-square analysis testing. RESULTS: One hundred six patients were identified. The negative predictive value of the biopsy is lower at 0.45 than either the CKC biopsy (0.83) or LEEP (0.57); however, the positive predictive value (0.83) is higher than either CKC biopsy (0.50) or LEEP (0.75). LVSI, when present in cervical biopsy (odds ratio, 4.13; 95% CI, 0.414-98.446), CKC biopsy (odds ratio, 4.8; 95% CI, 0.542-46.280), and LEEP (odds ratio, 4.0; 95% CI, 0.439-43.793) specimens, is associated with a statistically insignificant increased risk of LVSI in the hysterectomy specimen. CONCLUSION: Cervical biopsy and excision specimens lack sufficient negative predictive value for the detection of LVSI in the hysterectomy specimen.

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