Challenges in Conducting Clinical Trials for Preeclampsia.

PURPOSE OF REVIEW: To review recent data describing the challenges and innovations in therapeutic research focused on the prevention and treatment of preeclampsia. RECENT FINDINGS: Pregnant individuals have traditionally been excluded from therapeutic research, resulting in a paucity of innovation in therapeutics for pregnancy-specific medical conditions, especially preeclampsia. With the increased awareness of maternal morbidity and mortality, there is significant interest among researchers to expand therapeutic research in pregnancy. Several medications, including aspirin, pravastatin, metformin, and esomeprazole, which are commonly used in non-pregnant populations, are now being investigated for preeclampsia prevention. However, given the historic precedent of exclusion, along with the regulatory, ethical, and feasibility concerns that accompany this population, the study of these and novel medications has been complicated by numerous challenges. While complex, and laden with challenges, there is great ongoing need for therapeutic research to address preeclampsia. Aspirin, pravastatin, metformin, and esomeprazole have all shown promise as potential therapeutic agents; however, their use remains to be optimized, and innovative therapeutics need to be developed.

Association between glycemic control and group B streptococcus colonization among pregnant individuals with pregestational diabetes.

PROBLEM: Pregestational diabetes increases the risk of group B streptococcus (GBS) colonization in pregnancy. Whether glycemic control is associated with differences in this risk is unknown. We examined the association between glycemic control and GBS colonization among pregnant individuals with pregestational diabetes. METHOD OF STUDY: A retrospective cohort of pregnant individuals with pregestational diabetes at a tertiary care center. The exposure was glycemic control, measured as hemoglobin A1c (A1c) at >20 weeks and assessed categorically at thresholds of <6.5% and <6.0%, and secondarily, as a continuous percentage. The outcome was maternal GBS colonization. Multivariable logistic regression was used and adjusted for age, parity, race, and ethnicity as a social determinant, body mass index, type of diabetes, and gestational age at A1c assessment. RESULTS: Among 305 individuals (33% Type 1, 67% type 2), 45.0% (n = 140) were colonized with GBS. Individuals with an A1c < 6.5% were half as likely to be colonized with GBS compared with those with a A1c ≥ 6.5% (38.8% vs. 53.9%; adjusted odds ratio, AOR: 0.55; 95% CI: 0.33-0.91). Results were unchanged at an A1c threshold of <6.0% (35.7% vs. 48.5%; AOR: 0.60; 95% CI: 0.36-0.98). Individuals with a higher A1c as a continuous measure (%) were more likely to be colonized (AOR: 1.57 per 1%; 95% CI: 1.25-1.97). CONCLUSIONS: Pregnant individuals with pregestational diabetes with worse glycemic control were at an increased risk of GBS colonization. Further study is needed to understand if improved glycemic control leads to lower risk of GBS colonization.

Searching for a biochemical correlate of critical illness in obstetrics: a descriptive study of maternal lactate in patients presenting for acute care in pregnancy.

Obstetric physiology may alter lactate metabolism and affect the ability to use lactate as a discriminator of critical illness in pregnancy. This prospective, cross-sectional study describes venous lactate levels in women presenting for acute care during pregnancy as well as characteristics associated with elevated lactate. Obstetric patients >20-week gestation presenting for acute evaluation were included and a venous lactate sample was drawn for each patient. Elevated lactate was defined as ≥2 mmol/L. One hundred two women were enrolled and venous lactate samples were obtained for 100 participants. Median lactate level was 1.22 (IQR 0.95-1.49) and 86% of patients had normal lactate. Six patients presented with infectious complaints, none of whom had sepsis or elevated lactate. Of the 14 patients with elevated lactate, all presented with labor complaints and 10 (71.4%) were admitted in labor. Elevated lactate level was significantly associated with labor complaints and admission in labor (p < .01). Thus, lactate may not be able to discriminate severe infection consistently in pregnancy as it is confounded by labor. Further research is necessary to clarify how lactate may be used more effectively in pregnant patients and to identify alternate strategies for sepsis screening.