Daily meditation program for anxiety in individuals admitted to the antepartum unit: a multicenter randomized controlled trial (MEDITATE).

BACKGROUND: Inpatient antepartum women have higher levels of anxiety than outpatient. Former randomized trials using mindful meditation programs to decrease maternal anxiety have conflicting results; some studies showed a considerable decrease in anxiety levels, whereas others showed no difference. A paucity of trials exist using mindful meditation for maternal anxiety in the inpatient antepartum population; most studies focus on the outpatient clinic population. Because of inpatient acuity and anxiety factors, we conducted a randomized trial to target this population. OBJECTIVE: This study aimed to compare anxiety levels on day 4 of either routine care or routine care plus a twice-daily application-based mindful meditation program in women admitted to the antepartum unit. STUDY DESIGN: In a multisite randomized trial (ClinicalTrials.gov Identifier: NCT03737279), women admitted to the antepartum units were randomized to either routine care plus educational pamphlets (control arm) or routine care plus a twice-daily application-based mindful meditation program (intervention arm). The inclusion criteria were age of at least 18 years, gestational age of at least 23 weeks, planned inpatient care for >3 days from randomization, and care by our university physician team. The primary outcome was maternal state anxiety level (measured using the validated State-Trait Anxiety Inventory) on day 4 (randomization being day 1). The secondary outcomes included stress (measured using the Perceived Stress Scale) and depression (measured using the Edinburgh Depression Scale) on day 4, latency period from randomization to delivery, patient experience, number of meditation sessions, and total meditation time. A total of 56 women were needed for 90% power to detect a decrease in the primary outcome by 30% in the intervention group, compared with the control group. All women were observed using an intention-to-treat analysis. We compared the continuous variables using the Wilcoxon rank-sum test or t test and the categorical variables using the chi-squared test or the Fisher exact test. RESULTS: From March 4, 2019, to December 20, 2019, 412 women were screened for eligibility, 77 women (18.7%) were found eligible, and 56 women (72.7%) were randomized with 28 women in each group. Of note, 96.4% of women completed at least 1 meditation session, and 39.3% of women completed all meditation sessions. The mean score of the anxiety level using the State-Trait Anxiety Inventory on day 4 was not significantly different (P=.24) between the control group (42.0±10.8) and meditation group (37.5±13.1). A decreased anxiety score from day 1 to day 4 was seen in both the control group and meditation group (-4.7 vs -9.4, respectively; P=.12). The rate of abnormal State-Trait Anxiety Inventory scores on day 4 was not significantly different between the control group and meditation group (62% vs 45%, respectively; P=.28). When asked about the experience with the research trial, 88.8% of women in the control group and 89.5% of women in the meditation group reported a positive experience. CONCLUSION: Compared with the control group, a twice-daily application-based mindful meditation program for women admitted to the antepartum unit did not considerably decrease the anxiety score on day 4. However, >88% of women in both groups had a positive experience with the nonpharmacologic intervention.

Detemir vs neutral protamine Hagedorn insulin for diabetes mellitus in pregnancy: a comparative effectiveness, randomized controlled trial.

BACKGROUND: Insulin detemir, being used increasingly during pregnancy, may have pharmacologic benefits compared with neutral protamine Hagedorn. OBJECTIVE: We evaluated the probability that compared with treatment with neutral protamine Hagedorn, treatment with insulin detemir reduces the risk for adverse neonatal outcome among individuals with type 2 or overt type 2 diabetes mellitus (gestational diabetes mellitus diagnosed at <20 weeks' gestation). STUDY DESIGN: We performed a multiclinic randomized controlled trial (September 2018 to January 2020), which included women with singleton gestation with type 2 or overt type 2 diabetes mellitus who sought obstetrical care at ≤21 weeks' gestation. Participants were randomized to receive either insulin detemir or neutral protamine Hagedorn by a clinic-stratified scheme. The primary outcome was a composite of adverse neonatal outcomes, including shoulder dystocia, large for gestational age, neonatal intensive care unit admission, respiratory distress (defined as the need of at least 4 hours of respiratory support with supplemental oxygen, continuous positive airway pressure or ventilation at the first 24 hours of life), or hypoglycemia. The secondary neonatal outcomes included gestational age at delivery, small for gestational age, 5-minute Apgar score of <7, lowest glucose level, need for intravenous glucose, respiratory distress syndrome, need for mechanical ventilation or continuous positive airway pressure, neonatal jaundice requiring therapy, brachial plexus injury, and hospital length of stay. The secondary maternal outcomes included hypoglycemic events, hospital admission for glucose control, hypertensive disorder of pregnancy, maternal weight gain, cesarean delivery, and postpartum complications. We used the Bayesian statistics to estimate a sample size of 108 to have >75% probability of any reduction in the primary outcome, assuming 80% power and a hypothesized effect of 33% reduction with insulin detemir. All analyses were intent to treat under a Bayesian framework with neutral priors (a priori assumed a 50:50 likelihood of either intervention being better; National Clinical Trial identifier 03620890). RESULTS: There were 108 women randomized in this trial (57 in insulin detemir and 51 in neutral protamine Hagedorn), and 103 women were available for analysis of the primary outcome (n=5 for pregnancy loss before 24 weeks' gestation). Bayesian analysis indicated an 87% posterior probability of reduced primary outcome with insulin detemir compared with neutral protamine Hagedorn (posterior adjusted relative risk, 0.88; 95% credible interval, 0.61-1.12). Bayesian analyses for secondary outcomes showed consistent findings of lower adverse maternal outcomes with the use of insulin detemir vs neutral protamine Hagedorn: for example, maternal hypoglycemic events (97% probability of benefit; posterior adjusted relative risk, 0.59; 95% credible interval, 0.29-1.08) and hypertensive disorders (88% probability of benefit; posterior adjusted relative risk, 0.81; 95% credible interval, 0.54-1.16). CONCLUSION: In our comparative effectiveness trial involving individuals with type 2 or overt type 2 diabetes mellitus, use of insulin detemir resulted in lower rates of adverse neonatal and maternal outcomes compared with neutral protamine Hagedorn.

Acute feTal behavioral Response to prenatal Yoga: a single, blinded, randomized controlled trial (TRY yoga).

BACKGROUND: In 2012, yoga was practiced by 20 million Americans, of whom 82% were women. A recent literature review on prenatal yoga noted a reduction in some pregnancy complications (ie, preterm birth, lumbar pain, and growth restriction) in those who practiced yoga; to date, there is no evidence on fetal response after yoga. OBJECTIVES: We aimed to characterize the acute changes in maternal and fetal response to prenatal yoga exercises using common standardized tests to assess the well-being of the maternal-fetal unit. STUDY DESIGN: We conducted a single, blinded, randomized controlled trial. Uncomplicated pregnancies between 28 0/7 and 36 6/7 weeks with a nonanomalous singleton fetus of women who did not smoke, use narcotics, or have prior experience with yoga were included. A computer-generated simple randomization sequence with a 1:1 allocation ratio was used to randomize participants into the yoga or control group. Women in the yoga group participated in a 1-time, 1 hour yoga class with a certified instructor who taught a predetermined yoga sequence. In the control group, each participant attended a 1-time, 1 hour PowerPoint presentation by an obstetrician on American Congress of Obstetricians and Gynecologists recommendations for exercise, nutrition, and obesity in pregnancy. All participants underwent pre- and postintervention testing, which consisted of umbilical and uterine artery Doppler ultrasound, nonstress testing, a biophysical profile, maternal blood pressure, and maternal heart rate. A board-certified maternal-fetal medicine specialist, at a different tertiary center, interpreted all nonstress tests and biophysical profile data and was blinded to group assignment and pre- or postintervention testing. The primary outcome was a change in umbilical artery Doppler systolic to diastolic ratio. Sample size calculations indicated 19 women per group would be sufficient to detect this difference in Doppler indices (alpha, 0.05; power, 80%). Data were analyzed using a repeated-measures analysis of variance, a χ(2), and a Fisher exact test. A value of P < .05 was considered significant. RESULTS: Of the 52 women randomized, 46 (88%) completed the study. There was no clinically significant change in umbilical artery systolic to diastolic ratio (P = .34), pulsatility index (P = .53), or resistance index (P = .66) between the 2 groups before and after the intervention. Fetal and maternal heart rate, maternal blood pressure, and uterine artery Dopplers remained unchanged over time. When umbilical artery indices were individually compared with gestational age references, there was no difference between those who improved or worsened between the groups. CONCLUSION: There was no significant change in fetal blood flow acutely after performing yoga for the first time in pregnancy. Yoga can be recommended for low-risk women to begin during pregnancy.

Obesity Before, During, and After Pregnancy: A Review and Comparison of Five National Guidelines.

OBJECTIVE: This study aims to compare how national guidelines approach the management of obesity in reproductive age women. STUDY DESIGN: We conducted a search for national guidelines in the English language on the topic of obesity surrounding the time of a pregnancy. We identified six primary source documents and several secondary source documents from five countries. Each document was then reviewed to identify: (1) statements acknowledging increased health risks related to obesity and reproductive outcomes, (2) recommendations for the management of obesity before, during, or after pregnancy. RESULTS: All guidelines cited an increased risk for miscarriage, birth defects, gestational diabetes, hypertension, fetal growth abnormalities, cesarean sections, difficulty with anesthesia, postpartum hemorrhage, and obesity in offspring. Counseling on the risks of obesity and weight loss before pregnancy were universal recommendations. There were substantial differences in the recommendations pertaining to gestational weight gain goals, nutrient and vitamin supplements, screening for gestational diabetes, and thromboprophylaxis among the guidelines. CONCLUSION: Stronger evidence from randomized trials is needed to devise consistent recommendations for obese reproductive age women. This research may also assist clinicians in overcoming one of the many obstacles they encounter when providing care to obese women.

Exercise and yoga during pregnancy: a survey.

The primary objective of this survey was to ascertain the opinions, practices and knowledge about exercise, including yoga, during pregnancy; the secondary objective to compare the responses among women with body mass index (BMI) <30 kg/m(2) versus ≥30 kg/m(2). Survey consisted of 20 multiple choice questions assessing demographics and exercise practices, and five questions testing their knowledge about it during pregnancy (ACOG Committee Opinion # 267). Of the 500 surveys distributed, 84% (422) responses were analyzed. While 86% of women responded that exercise during pregnancy is beneficial, 83% felt it was beneficial to start prior to pregnancy, and walking was considered the most beneficial (62%). The majority (64%) of respondents were currently exercising during pregnancy and 51% exercised 2-3 times/week. Among the five questions testing knowledge about prenatal exercise, majority (range 60 to 92%) were aware of ACOG recommendations. About half had a BMI ≥30. Knowledge about benefits of exercise during pregnancy did not differ significantly between obese and non-obese. Yoga was tried significantly more among non-obese, 65% believed it is beneficial, and 40% had attempted yoga before pregnancy. In our population, the majority believes that exercise, including yoga, is beneficial and they are active.

Yoga during pregnancy: a review.

The purpose of this review article is to evaluate the peripartum outcomes of yoga during pregnancy, including the postpartum period and lactation. The PubMed database was analyzed from January 1970 to January 2011. We identified five prospective observational studies (n = 575) and three randomized clinical trials (RCTs; n = 298), which were analyzed separately. The nonrandomized trials indicated a significant reduction in rates of preterm labor (p < 0.0006), intrauterine growth retardation (p <0.003), low birth weight (p < 0.01), pregnancy discomforts (p = 0.01), and perceived sleep disturbances (p = 0.03) in those who practiced yoga during pregnancy. Results of the RCTs indicated that doing yoga during pregnancy can significantly lower pain and discomfort (p < 0.05) and perceived stress (p = 0.001) and improve quality of life in physical domains (p = 0.001). All three RCTs were poorly compliant with the Consolidated Standard of Reporting Trials statement. While awaiting an appropriately designed RCT to determine the benefits of yoga during pregnancy, it remains a viable exercise option.

Evidence-based labor and delivery management.

Our objective was to provide evidence-based guidance for management decisions during labor and delivery. We performed MEDLINE, PubMed, and COCHRANE searches with the terms labor, delivery, pregnancy, randomized trials, plus each management aspect of labor and delivery (eg, early admission). Each management step of labor and delivery was reviewed separately. Evidence-based good quality data favor hospital births, delayed admission, support by doula, training birth assistants in developing countries, and upright position in the second stage. Home-like births, enema, shaving, routine vaginal irrigation, early amniotomy, "hands-on" method, fundal pressure, and episiotomy can be associated with complications without sufficient benefits and should probably be avoided. We conclude that labor and delivery interventions supported by good quality data as just described should be routinely performed. All aspects with lower data quality should be researched with adequately powered and designed trials.

Sonographic estimate of birth weight among high-risk patients: feasibility and factors influencing accuracy.

OBJECTIVE: This study was undertaken to determine the feasibility of detecting abnormal fetal growth among patients undergoing biophysical profile (BPP) and to identify the factors those influence the accuracy. STUDY DESIGN: Retrospectively singletons with reliable gestational age (GA) having a BPP were identified. Fetal growth restriction (FGR) and large-for-gestational age (LGA) were based on estimated or actual birth weight 10% or less or 90% or greater for GA, respectively. Likelihood ratio (LR), odds ratio (OR) and 95% CIs were calculated and multivariate predictive models used. RESULTS: Among the 1934 consecutive patients that met the inclusion criteria, the LR of detecting FGR was 10.9 and of LGA, 17.4. Multivariate analysis indicates that accurate classification of fetal growth is significantly better with hydramnios (OR 1.78, 95% CI 2.68), if the GA is less than 32 weeks (OR 3.71, 95% CI 1.50-9.16) or GA is between 32.1 and 36.9 weeks (OR 1.43, 95% CI 1.05-1.96). CONCLUSION: It is feasible to accurately identify abnormal growth among high-risk patients and to delineate factors that influence the correct classification of fetal growth.

Use of calcium channel antagonists for preterm labor.

There is dispute in the United States about what should be the first line of tocolytics for preterm labor. In Europe, the initial choice to prevent preterm birth is a calcium channel antagonist (CCA). Randomized studies have noted that CCAs are as efficacious as other tocolytics and a meta-analysis concluded that use of these blockers is associated with significantly lower likelihood of delivery before 34 weeks and reduction in rate of respiratory distress syndrome, intraventricular hemorrhage, and necrotizing enterocolitis. It is time that CCAs become the preferred tocolytics in the United States.