Torsemide for Prevention of Persistent Postpartum Hypertension in Women With Preeclampsia: A Randomized Controlled Trial.

OBJECTIVE: To evaluate whether torsemide reduces the rate of persistent postpartum hypertension in women with preeclampsia. METHODS: We conducted a randomized, double-blind, placebo-controlled trial of women with preeclampsia at a tertiary center from August 2016 to September 2017. Those with gestational hypertension or renal or cardiopulmonary failure were excluded. Within 24 hours of delivery, women were randomized one to one to oral torsemide, 20 mg/d, or placebo, for 5 days. Our primary outcome was blood pressure greater than or equal to 150 mm Hg systolic or 100 mm Hg diastolic (or both) on two occasions at least 4 hours apart by postpartum day 5 or by the time of hospital discharge. Assuming a 50% rate of persistent hypertension in women with preeclampsia, 118 participants were required to detect a 50% rate reduction. Analyses were by intention to treat. RESULTS: From August 2016 to September 2017, 118 women were randomized: 59 were allocated to torsemide and 59 to placebo. Overall, 43 (73%) women in the torsemide and 45 (76%) in the placebo group had either preeclampsia with severe features or preeclampsia superimposed on chronic hypertension. The rate of persistent postpartum hypertension was 44% in the torsemide and 58% in the placebo group (relative risk 0.76, 95% CI 0.5-1.1). No differences were seen in rate of hypertension 7-10 days or 6 weeks postpartum, severe hypertension, length of postpartum hospital stay, readmission for hypertension, or adverse events. There were no cases of severe composite morbidity or deaths. CONCLUSION: In this trial of women with preeclampsia, a 5-day course of postpartum torsemide did not have a significant effect on the rate of postpartum hypertension. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT02813551.

Randomized Quality Improvement Trial of Opting-In Versus Opting-Out to Increase Influenza Vaccination Rates during Pregnancy.

Introduction Despite strong recommendations, only 40.6% of pregnant women attending two prenatal clinics were vaccinated against influenza during the 2009 pandemic. We tested whether an opting-out approach would improve vaccine uptake. Methods We conducted a randomized quality improvement (QI) trial to compare opting-out with conventional opting-in consent for influenza immunization. Women age ≥ 18 years attending the University of Texas Health Science Center at Houston (UTHealth) or UT-Medical Branch (UTMB) prenatal clinics during the 2010-2011 influenza season, were eligible. Results We enrolled 280 women (140 UTHealth, 140 UTMB). Both groups had similar mean age (26.0 ± 5.5 years), mean gestational age (19.4 ± 9.5 weeks), and percent with underlying health conditions (20.7%). Vaccination rates with opting-in and opting-out were similar among all (83 vs. 84%), UTHealth (87 vs. 93%), and UTMB patients (79 vs.76%) ( p > 0.05). In subsamples of patients assessed, consent strategy did not significantly affect maternal recall of information provided. Conclusion While prenatal influenza vaccination uptake doubled from the 2009-2010 influenza season, opting-out did not perform better than opting-in, a conclusion opposite that we would have reached had this been a nonconcurrent trial. Vaccination rates dropped posttrial; hence, continued research is needed to increase the prenatal influenza immunizations.

Liberal versus Indicated Maternal Oxygen Supplementation in Labor: A Before-and-After Trial.

BACKGROUND: Although supplemental oxygen (SO2) is routinely administered to laboring gravidas, benefits and harms are not well studied. OBJECTIVE: This article compares strategies of liberal versus indicated SO2 therapy during labor on cesarean delivery (CD) rate and neonatal outcomes. STUDY DESIGN: A controlled, before-and-after trial of laboring women with term, singleton pregnancies. During an initial 8-week period, maternal SO2 was administered at the discretion of the provider followed by an 8-week period where SO2 was to be given only for protocol indications. RESULTS: Our study included 844 women. There was no difference in number of women receiving SO2 (53% liberal vs. 50% indicated; p = 0.33). For those receiving SO2, there was no difference in SO2 duration (median, 89 minutes [interquartile range, 42-172] vs. 87 minutes [36-152]; p = 0.42). There were no differences in overall CD rate (20% vs. 17%; p = 0.70), CD for nonreassuring fetal status, or use of intrauterine resuscitative measures. There were more 5-minute APGAR < 7 in the indicated group, but no difference in umbilical artery pH < 7.1 or neonatal intensive care unit (NICU) admission. CONCLUSION: Approximately half of women receive SO2 intrapartum regardless of a strategy of liberal or indicated oxygen use. There were no clinically significant differences in outcomes between strategies.

Potential of Metformin to Improve Cardiac Risk in Postpartum Women with Gestational Diabetes.

OBJECTIVE: Pregnancy is associated with an increase in total cholesterol, high density lipoproteins (HDL), and low-density lipoproteins (LDL). Postpartum, HDL and LDL decrease over the first 12 weeks postpartum. Oxidized LDL (ox-LDL) is a marker of oxidative stress-related inflammation, which is associated with obesity and also with development of cardiovascular disease. Cardiovascular protection and weight loss are benefits from metformin, especially in women with diabetes. The objective of this study was to compare changes in lipid profiles and biomarkers for obesity during the initial 6 weeks postpartum between women with gestational diabetes mellitus (GDM) treated with metformin versus placebo. METHODS: This was a planned ancillary study of a randomized controlled trial compares metformin versus placebo in women with GDM for postpartum weight loss. Two 3 mL blood samples were collected within 24 h of delivery and 6 weeks postpartum immediately processed after collection then stored at -20°C until completion of clinical trial prior to analysis. Change in the median plasma concentrations of total cholesterol, HDL, ox-LDL, glucose, insulin, leptin, and unacylated ghrelin were compared between study groups. RESULTS: Of the 77 postpartum women were included, 35 received metformin and 42 received placebo. There was less of a reduction in HDL in the metformin group compared to placebo (-2.3 versus -7.5 mg/dL, p = 0.019). In addition, there was a greater reduction in ox-LDL in those receiving metformin (-12.2 versus -3.8 mg/dL, p = 0.038). No other differences were observed in the selected biomarkers evaluated. CONCLUSION: Biomarker levels of HDL and ox-LDL were positively affected during the initial 6 weeks postpartum in GDM women treated with metformin. Additional studies with a longer duration of metformin treatment in the postpartum period are warranted to evaluate long-term potential benefits.

Intravenous Acetaminophen versus Morphine for Analgesia in Labor: A Randomized Trial.

Objective To compare the effectiveness of intravenous acetaminophen with that of morphine in reducing pain in the first stage of labor. Methods An open-label, randomized controlled trial of women ≥ 34 weeks gestation in the first stage of labor, assigned to either intravenous acetaminophen or morphine. The primary outcome was improved analgesia measured by difference of visual analog scale (VAS) score at 120 minutes from baseline. Secondary outcomes were request for rescue analgesia, maternal side effects, and fetal heart rate changes. Statistical analyses performed were chi-square, Student's t-test, and Kaplan-Meier survival analysis. Results Of 40 women randomized, 18 received acetaminophen (2 did not receive study drug), and 20 received morphine. Because of difficulties in recruitment, the sample size of 88 was not achieved. The primary outcome was similar between groups (p = 0.53). Within 120 minutes of initial treatment, more women receiving intravenous acetaminophen required rescue analgesia (acetaminophen: 52.9% vs. morphine: 17.6%, p < 0.01). Maternal and fetal side effects were similar between groups. Conclusion There was no difference in VAS scores between groups. However, as half of women receiving intravenous acetaminophen required rescue analgesia within 120 minutes of treatment, intravenous acetaminophen may be less effective for analgesia in early labor compared with intravenous morphine.

A pilot randomized, controlled trial of metformin versus insulin in women with type 2 diabetes mellitus during pregnancy.

OBJECTIVE: Few studies support oral diabetic treatment in pregnant women with type 2 diabetes mellitus (T2DM). The objective of this study was to compare the effects of metformin versus insulin on achieving glycemic control and improving maternal and neonatal outcomes in pregnant women with T2DM. STUDY DESIGN: A pilot randomized, controlled trial was conducted of metformin versus insulin for the treatment of T2DM during pregnancy. The primary outcome was glycemic control measured with hemoglobin A1c < 7% at delivery. Maternal and neonatal outcomes were compared between groups. RESULTS: In this study, 8 women received metformin and 11 received insulin. All women in both groups achieved glycemic control by delivery (HgbA1c: metformin 5.96 ± 5.88 vs. insulin 6.34 ± 0.92%). There were similar rates of cesarean delivery, birth weights, neonatal intensive care unit admissions, respiratory distress syndrome, and neonatal dextrose treatment between groups. There was one case of fetal macrosomia in the insulin group, one case of shoulder dystocia in the metformin group and no cases of failed metformin therapy. CONCLUSION: In this pilot study, glycemic control was achieved in women who received metformin and insulin. Larger studies are needed to determine whether metformin can be considered a reasonable alternative to insulin in pregnant women with T2DM.

The effects of metformin on weight loss in women with gestational diabetes: a pilot randomized, placebo-controlled trial.

OBJECTIVE: We sought to compare weight loss in the first 6 weeks postpartum among women with gestational diabetes mellitus (GDM) treated with metformin or placebo, a promising therapy to reduce later risk of progression to diabetes mellitus. STUDY DESIGN: We conducted a pilot, randomized trial of metformin vs placebo in postpartum women with GDM. Women with pre-GDM, unable to tolerate metformin, resumed on insulin or oral hypoglycemic agent, delivered <34 weeks' gestation, or with a body mass index <20 kg/m(2) were excluded. Women were randomized to either metformin 850 mg daily for 7 days, then metformin 850 mg twice a day for the next 5 weeks or placebo prescribed in a similar frequency. The subject, health care provider, and research staff were blinded to the treatment. The primary outcome was weight change from delivery to 6 weeks postpartum. Secondary outcomes included the percentage of women achieving their self-reported prepregnancy weight, reported medication adherence, adverse effects, and satisfaction. Differences in weight change between groups were determined by Wilcoxon rank sum test and in achieving prepregnancy weight by χ(2) test. RESULTS: Of 114 women randomized, 79 (69.3%) completed the 6 weeks; 36 (45.6%) were randomized to metformin and 43 (54.4%) to placebo. Metformin and placebo groups were similar in median weight loss (6.3 kg [range, -0.3 to 19.8] vs 6.5 kg [range, -0.3 to 12.1], P = .988) and percentage of women achieving reported prepregnancy weight (41.7 vs 37.2%, P = .69). Self-reported adherence in taking >50% of medication was 75% at 3 weeks and 97% at 6 weeks. Nausea, diarrhea, and hypoglycemia were reported in approximately 11-17% of women and 56-63% reported dissatisfaction with the medication. CONCLUSION: Women with GDM lost approximately 6 kg by 6 weeks' postpartum. This was similar in both groups and resulted in <50% of women achieving their prepregnancy weight. Although the reported adherence and satisfaction with the medication was high, adverse effects were reported with nearly 1 in 5 women including nausea, diarrhea, and hypoglycemia. Contrary to expectation, we found no evidence of benefit from metformin. However, longer treatment periods and larger studies with minimal attrition may be warranted.

Families at risk: home and car smoking among pregnant women attending a low-income, urban prenatal clinic.

INTRODUCTION: Secondhand smoke exposure (SHSe) has been identified as a distinct risk factor for adverse obstetric and gynecological outcomes. This study examined the prevalence of SHSe reduction practices (i.e., home and car smoking bans) among pregnant women in a large U.S. prenatal clinic serving low-income women. METHODS: Pregnant women (N = 820) attending a university-based, urban prenatal clinic in Houston, Texas, completed a prenatal questionnaire assessing bans on household and car smoking and a qualitative urine cotinine test as part of usual care. Data were collected from April 2011 to August 2012. RESULTS: Nearly one-third (n = 257) of the sample reported at least 1 smoker living in the home. About a quarter of the women in the full sample did not have a total smoking ban in their home and car. Within smoking households, 44% of the pregnant women reported smoking, 56% reported smoking by another household member, and in 26% of smoking households both the pregnant woman and at least one other person were smoking. Only 43% of women with a household smoker reported a total ban on smoking, with higher rates among Hispanic women. Smoking bans were less common when the pregnant women smoked, when more than 1 smoker resided in the home, and when pregnant with her first child. CONCLUSIONS: SHSe among low-income pregnant women is high, and interventions to raise awareness and increase the establishment of smoking bans in homes and cars are warranted.

Maternal development experiences of women hospitalized to prevent preterm birth.

OBJECTIVE: To examine ways that women's experience of hospitalization with bed rest to prevent preterm birth impacts prenatal maternal development. METHOD: Interviews based on the Interview Schedules for Dimensions of Maternal Development in Psychosocial Adaptation to Pregnancy were conducted at a hospital in the southwestern United States with a convenience sample of 41 women during confinement to bed rest to prevent preterm birth. The interviews were recorded, and verbatim transcripts were submitted to thematic analysis. RESULTS: Five themes were mapped from the women's narratives: (1) acceptance of pregnancy, but with fears specific to elevated risks to self and baby; (2) heightened identification with motherhood and fatherhood protector roles; (3) renewal or deepening of mother-daughter closeness intensified by high-risk pregnancy; (4) enhanced couple support and collaboration; and (5) acceptance of responsibility to perform in remaining pregnant and preparing for labor, but willingness to accept help from doctors and nurses. CONCLUSIONS: This study of hospitalization to prevent preterm birth showed that women experience hospitalization as a burden to be endured to meet future goals, but that it also can facilitate prenatal maternal development in psychosocial adaptation to high risk pregnancy. Implications for research and practice are discussed.

Population standards of birth weight underestimate fetal growth abnormalities in diabetic pregnancies.

The objective of this study was to compare the frequency of abnormal fetal growth in women with diabetes mellitus (DM) using population-based birth weight (pop BW) percentiles compared with customized birth weight (cust BW) percentiles, which include adjustments for maternal race, parity, height, weight, and fetal sex. The study design comprised a retrospective cohort of singleton DM pregnancies delivered over a 1-year period (June 2007 to May 2008) from a single tertiary care university-based medical center. Inclusion criteria were gestational age >20 weeks at delivery, live birth, and absence of major chromosomal/structural abnormalities. Small for gestational age (SGA), <10th percentile, and large for gestational age (LGA), >90th percentile pregnancies were categorized based on pop BW or cust BW standards. There were significant differences in the rates of SGA (p < 0.004) and LGA (p < 0.001) between cust BW and pop BW methods. When comparing the two methods, pop BW did not identify 13/16 (81%) of SGA and 23/39 (59%) of LGA babies defined by cust BW methods. The use of cust BW calculation in a diabetic population identified a greater percentage of neonates with pathologic fetal growth compared with pop BW standards, suggesting that the population standard may underdiagnose abnormal fetal growth in diabetic pregnancies.

Assessment of the concordance among 2-tier, 3-tier, and 5-tier fetal heart rate classification systems.

OBJECTIVE: In 2008, a National Institute of Child Health and Human Development/Society for Maternal-Fetal Medicine-sponsored workshop on electronic fetal monitoring recommended a new fetal heart tracing interpretation system. Comparison of this 3-tier system with other systems is lacking. Our purpose was to determine the relationships between fetal heart rate categories for the 3 existing systems. METHODS: Three Maternal-Fetal Medicine specialists reviewed 120 fetal heart rates. All tracings were from term, singleton pregnancies with known umbilical artery pH. The fetal heart rates were classified by a 2-tier, 3-tier, and 5-tier system. RESULTS: Each Maternal-Fetal Medicine examiner reviewed 120 fetal heart rate segments. When compared with the 2-tier system, 0%, 54%, and 100% tracings in categories 1, 2, and 3 were "nonreassuring." There was strong concordance between category 1 and "green" as well as category 3 and "red" tracings. CONCLUSION: The 3-tier and 5-tier systems were similar in fetal heart rate interpretations for tracings that were either very normal or very abnormal. Whether one system is superior to the others in predicting fetal acidemia remains unknown.

Interobserver and intraobserver reliability of the NICHD 3-Tier Fetal Heart Rate Interpretation System.

OBJECTIVE: Our purpose was to test the reliability of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) 3-Tier Fetal Heart Rate (FHR) classification system. STUDY DESIGN: Individual 15- to 20-minute FHR segments (n = 154) were independently reviewed without clinical data by 3 maternal-fetal medicine examiners and classified by NICHD category (I, II, III). RESULTS: Interobserver reliability was moderate (kappa 0.45) and varied by NICHD category (category I moderate [kappa 0.48], category II moderate [kappa 0.44], and category III poor [kappa 0.0]). The intraobserver agreement ranged from substantial to perfect (kappa 0.74-1.0). CONCLUSION: Interobserver agreement of 3-Tier FHR classification System was moderate for NICHD categories I and II. Agreement for category III tracings was poor mainly due to lack of agreement regarding absent vs minimal variability.

Excessive gestational weight gain in women with gestational and pregestational diabetes.

We sought to determine the frequency of excessive gestational weight gain (GWG) and its impact on perinatal outcomes in women with gestational (GDM) and pregestational diabetes mellitus (DM). A retrospective cohort of diabetic women was studied. GWG was categorized by the 2009 Institute of Medicine guidelines. Perinatal outcomes were compared between those women with and without excessive GWG. There were 153 women who met study criteria. There was no difference in excessive GWG between women with GDM and pregestational DM (44.4% versus 38.5%, P = 0.51) or based on White's class ( P = 0.17). After adjusting for confounders, excessive GWG was not associated with an increased rate of adverse perinatal outcomes (odds ratio 1.49, 95% confidence interval 0.56 to 2.35) and had similar associations with both pregestational DM and GDM. Although excessive GWG was common in our diabetic population, it was not associated with an increased rate of adverse perinatal outcomes.

In the eyes of the Dunedin public, what constitutes professionalism in medicine?

INTRODUCTION: There has been much debate over the last two decades about professionalism in medicine. Opinions are diverse but, problematically, most are from the academic and medical viewpoints. There is substantially less discourse from the public perspective. AIM: To explore the Dunedin public's perspective of important professional qualities in the medical profession. METHODS: Customers in pharmacies around Dunedin rated 18 different professional qualities on a five-point scale of importance in a self-administered anonymous survey. They also ranked their top five qualities, including their own ideas. RESULTS: Participants rated professional qualities categorised as patient autonomy (mean 4.6) and patient welfare (mean 4.7) of higher importance than qualities categorised as social justice (mean 3.9) and appearance (mean 3.7). Honesty was the top ranked professional quality overall (10.6% of respondents had it in their top five) and the next two top ranked were both concerning patient autonomy (listens carefully and treats you with respect). The most significant difference found between demographic groups and choices was that 53% of people with a highest educational qualification of secondary school or below rated 'accepts a leadership role in the community' as a very important or important quality, compared with 29.4% of people with a post-secondary school qualification (p-value <0.001). DISCUSSION: This has implications for the current move to make doctors take on more social responsibility within the health care system. It is imperative to have both society and the medical profession aiming for common goals and the challenge of this decade will be striking the balance.