Receiving gestational weight gain recommendations and associated risks: A qualitative study among low-income women.

Appropriate weight gain goals promote healthy gestational weight gain (GWG). Despite receiving recommendations from their providers, most women do not know how much weight they should gain during pregnancy. This study sought to describe the experiences of pregnant women when given GWG recommendations. The research proceeded using a phenomenological approach. With Institutional Review Board approval, primigravida women with a healthy singleton pregnancy at 8-20 weeks gestation were recruited from the community and purposively from a low-income obstetrics clinic. Within 60-minutes, trained interviewers 1) presented GWG recommendations and associated risks; and 2) interviewed participants using a semi-structured guide. Participants received a $40 gift card. Interviews were recorded and transcribed. Two trained coders used Braun and Clarke's (2020) reflexive thematic analysis procedures. When presented with GWG information, participants (n = 29, Mage = 25.5, 4.7 SD) proceeded to: 1) make sense of the information, 2) evaluate the credibility of the information, 3) weigh the importance of the information, 4) predict likely outcomes, and 5) plan behaviors. Participants who were able to understand the information, found it to be credible and important, and who predicted adverse outcomes for failing to adhere to recommendations reported intentions for health promoting behaviors. Future research should test GWG counseling methods based on these cognitive processes. Clinicians should consider these 5 cognitive processes when providing initial GWG counseling.

Facilitating treatment initiation and reproductive care postpartum to prevent substance-exposed pregnancies: A randomized bayesian pilot trial.

BACKGROUND: For non-treatment-seeking women who use substances during pregnancy, immediately postpartum may be an optimum time for intervention. Our study tested a novel, brief, hospital-initiated, adaptive motivational interviewing plus acceptance and commitment therapy (MIACT) intervention to facilitate treatment initiation and reproductive planning postpartum among mothers who used substances during pregnancy. METHODS: Mothers (N = 64) with an infant admitted to a neonatal intensive care unit were enrolled if they or their infant tested positive for an illicit substance at delivery or had a documented positive drug screen during pregnancy. A parallel group, randomized controlled design assigned participants to MIACT or conventional care (CC), with assessments at week 2 and 4 during treatment and follow-up at 2 and 6 months post treatment. Bayesian generalized linear modeling was used to evaluate outcomes as a function of treatment. RESULTS: Results indicated that during treatment the MIACT group demonstrated an 84% probability of benefit relative to CC with regard to initiating treatment (RR=1.5), however the effect was not seen at follow-up. MIACT was also associated with an increased probability of attending a postpartum obstetrics visit (RR=1.4), and receiving contraception during treatment and at both follow-ups, with posterior probabilities of 96% or higher and relative risks ranging from 1.5 to 5.1 at varying timepoints. Substance use rates for the MIACT versus CC were higher at follow-up. CONCLUSIONS: Brief, hospital-initiated interventions can assist postpartum mothers who use substances to enter treatment and obtain contraception in order to reduce future substance-exposed pregnancies.

Academy of Breastfeeding Medicine Clinical Protocol #36: The Mastitis Spectrum, Revised 2022.

A central goal of the Academy of Breastfeeding Medicine is the development of clinical protocols for managing common medical problems that may impact breastfeeding success. These protocols serve only as guidelines for the care of breastfeeding mothers and infants and do not delineate an exclusive course of treatment or serve as standards of medical care. Variations in treatment may be appropriate according to the needs of an individual patient. The Academy of Breastfeeding Medicine recognizes that not all lactating individuals identify as women. Using gender-inclusive language, however, is not possible in all languages and all countries and for all readers. The position of the Academy of Breastfeeding Medicine (https://doi.org/10.1089/bfm.2021.29188.abm) is to interpret clinical protocols within the framework of inclusivity of all breastfeeding, chestfeeding, and human milk-feeding individuals.

Development of a Generic Physiologically-Based Pharmacokinetic Model for Lactation and Prediction of Maternal and Infant Exposure to Ondansetron via Breast Milk.

Ondansetron is commonly used in breastfeeding mothers to treat nausea and vomiting. There is limited information in humans regarding safety of ondansetron exposure to nursing infants and no adequate study looking at ondansetron pharmacokinetics during lactation. We developed a generic physiologically-based pharmacokinetic lactation model for small molecule drugs and applied this model to predict ondansetron transfer into breast milk and characterize infant exposure. Drug-specific model inputs were parameterized using data from the literature. Population-specific inputs were derived from a previously conducted systematic literature review of anatomic and physiologic changes in postpartum women. Model predictions were evaluated using ondansetron plasma and breast milk concentration data collected prospectively from 78 women in the Commonly Used Drugs During Lactation and infant Exposure (CUDDLE) study. The final model predicted breast milk and plasma exposures following a single 4 mg dose of intravenous ondansetron in 1,000 simulated women who were 2 days postpartum. Model predictions showed good agreement with observed data. Breast milk median prediction error (MPE) was 18.4% and median absolute prediction error (MAPE) was 53.0%. Plasma MPE was 32.5% and MAPE was 43.2%. The model-predicted daily and relative infant doses were 0.005 mg/kg/day and 3.0%, respectively. This model adequately predicted ondansetron passage into breast milk. The calculated low relative infant dose indicates that mothers receiving ondansetron can safely breastfeed. The model building blocks and population database are open-source and can be adapted to other drugs.

Characterization of urinary concentrations of heavy metals among socioeconomically disadvantaged black pregnant women.

The objective of this study was to characterize exposures to metals using biological samples collected on socioeconomically disadvantaged black pregnant women. We obtained 131 anonymous urine samples provided by black pregnant women visiting a Medicaid-serving prenatal clinic in Houston, TX, from March 27, 2017 to April 11, 2017. We analyzed urine samples for 15 metals including cadmium (Cd), arsenic (As), lead (Pb), and nickel (Ni) and for creatinine and cotinine. We found that median concentrations of zinc (Zn), selenium (Se), and aluminum (Al) among black pregnant women in this study were 1.5 to 3 times higher than levels reported among a cohort of well-educated non-Hispanic white pregnancy planners. We also observed elevated levels of urinary Cd and antimony (Sb) as compared with those reported for a nationally representative sample of adult women in the USA. Based on the results of an exploratory factor analysis, potential sources of metal exposures in this population may arise in home environments or be due to diet, industrial and natural sources, or traffic.

Management and reproductive counseling in cervical, caesarean scar and interstitial ectopic pregnancies over 11 years: identifying the need for a modern management algorithm.

STUDY QUESTION: Do management strategies (treatment type and order), including provision of reproductive counseling, differ in patients with non-tubal pregnancies? SUMMARY ANSWER: Medical and surgical treatment strategies varied widely for each type of non-tubal pregnancy and reproductive counseling in this patient population is lacking. WHAT IS KNOWN ALREADY: Owing to the rarity of non-tubal pregnancies, there is no consensus regarding treatment strategies or protocol. Furthermore, there is limited data on how patients with a non-tubal pregnancy are counseled about future fertility. STUDY DESIGN SIZE DURATION: This is a descriptive retrospective study. Data were collected from January 2006 to December 2017. A total of 50 patients were included in the study. PARTICIPANTS/MATERIALS SETTING METHODS: Patients with an ultrasound diagnosis of a non-tubal ectopic pregnancy (e.g. cervical ectopic pregnancy [CEP], Caesarean scar pregnancy [CSP] or interstitial ectopic pregnancy [IEP]) were included. This study was performed at a university-based institution tertiary referral center. Demographic and clinical characteristics, treatment type and order, reproductive counseling and outcomes were collected. Descriptive statistics were used for analyses. MAIN RESULTS AND THE ROLE OF CHANCE: Of the 50 patients identified, 13 were CEP (26%), 8 were CSP (16%) and 29 were IEP (58%). Patients with a CSP had a higher parity (median = 3, P = 0.02) and number of prior Caesarean deliveries (mean = 2.1, P < 0.001). A total of 66% (23/35) of patients expressed a desire for future fertility prior to treatment and only 56% (28/50) of patients received reproductive counseling according to the electronic medical records. Among all non-tubal pregnancies, there were variations in the type and the order of treatments that patients received. LIMITATIONS REASONS FOR CAUTION: This study was performed in a tertiary referral center therefore the management strategy could have been influenced by the prior interventions and patient response. The descriptive retrospective design precluded any assumption of causation. WIDER IMPLICATIONS OF THE FINDINGS: The management for non-tubal pregnancies has wide variations. Reproductive counseling in this patient population is lacking. The findings highlight the need for the development of a treatment algorithm and a reproductive counseling protocol for each non-tubal pregnancy to better standardize treatment strategy. STUDY FUNDING/COMPETING INTERESTS: There was no funding for this study. The authors have no conflict of interest to report.

A comparison of common practices for identifying substance use during pregnancy in obstetric clinics.

BACKGROUND: Substance use during pregnancy has been linked to adverse birth and other outcomes. Screening and intervention in the prenatal clinic are recommended, and reliance on patient reports or selective urine drug screening is inadequate. The aim of this prospective project was to determine substance use identification rates associated with common screening practices, compared to universal screening, among pregnant women seeking care at an urban, academic obstetric clinic. METHODS: Women attending their first prenatal visit (N = 275) completed a self-report questionnaire on lifetime and current substance use. A urine drug screening was also conducted, the results of which were not reported to providers. Participants' charts were reviewed to obtain the results of provider-ordered screens. RESULTS: The sample was primarily African-American and Latino, with Medicaid insurance. Ten women (4.6%) reported current marijuana use, while more than double that number (n = 27; 11.6%) screened positive for marijuana via universal screening. The majority of women who screened positive via universal screening did not have a provider-ordered urine drug screening, and less than one-third (29.3%) of clinician-ordered screens were positive for at least one substance. Finally, 90% of women who reported they were using marijuana were not selected by providers for a screen. DISCUSSION: Data demonstrate the high proportion of women using marijuana and the limitations of patient self-report and selective, nonroutine screening to identify substance use during pregnancy. Effective, standardized, clinic-wide strategies are needed to support providers in identifying pregnant women who use substances in order to increase the frequency of education and intervention.

The Trend, Feasibility, and Safety of Salpingectomy as a form of Permanent Sterilization.

STUDY OBJECTIVE: To assess the change in the rate of laparoscopic salpingectomy for sterilization after the release of the November 2013 Society of Gynecologic Oncology Clinical Practice Statement and the January 2015 American College of Obstetricians and Gynecologists Committee Opinion: Salpingectomy for Ovarian Cancer Prevention. We hypothesized there would be an increase in salpingectomy as a percentage of total laparoscopic sterilizations performed without an increase in complications when compared with conventional bilateral tubal ligation (BTL). DESIGN: A retrospective cohort study. SETTING: Four university-affiliated hospitals in Houston, TX, and New York, NY. PATIENTS: All women 21 years or older who underwent interval laparoscopic permanent sterilization between April 2013 and September 2016. INTERVENTIONS: Sterilization by bilateral salpingectomy or conventional tubal ligation. MEASUREMENTS AND MAIN RESULTS: There were 454 sterilization procedures identified; 60% were BTLs, whereas 40% were salpingectomies. The rate of use of salpingectomy significantly increased from 5% to 9% in 2013 to 2014 to 78% by 2016. There was no significant difference in intraoperative or postoperative complications or estimated blood loss. The mean procedure time was 54 minutes for salpingectomy compared with 45 minutes for BTL (p <.0001). Salpingectomy was more likely to require 3 ports compared with 2 ports for BTL (p <.0001). CONCLUSIONS: The Society of Gynecologic Oncology and the American College of Obstetricians and Gynecologists' support of salpingectomy for ovarian cancer prevention increased its use for sterilization. Based on this study, laparoscopic bilateral salpingectomy is a safe method of sterilization without an increase in perioperative risk compared with conventional tubal ligation. Physicians should incorporate these findings and implications when counseling patients regarding contraception and permanent sterilization.

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.

Quality Improvement to Demonstrate the Lack of Reliability of the Human Papillomavirus mRNA Assay to Identify Women With Latent Human Papillomavirus Infections.

OBJECTIVE: To assess the consistency between human papillomavirus (HPV) mRNA testing in women with a history of previous HPV infections diagnosed by HPV DNA assay and the potential effects on follow-up HPV screening. METHODS: This was a quality improvement study that used data from a pathology laboratory software database reviewed from November 2014 to June 2016 to identify female patients aged 30 years or older with greater than one HPV-positive result, including one or more HPV mRNA assay results and one or more documented HPV DNA assay results for comparison. Previous correlative cytology and colposcopic histopathology were also documented. American College of Obstetricians and Gynecologists' cervical cancer screening guidelines were used to compare potential differences in follow-up recommendations. RESULTS: Four hundred twenty-five charts for female patients 30 years of age or older were identified with one or more prior high-risk HPV infections by DNA assay. There was a 69.3% difference in HPV mRNA results compared with previous HPV DNA-positive results. There was a potential change in follow-up for 71.7% of patients with one prior high-risk-HPV-positive result and 60.0% of patients with two or more prior high-risk HPV-positive results. There were 231 colposcopy reports evaluated in this study. Of these, 62 (26.8%) were abnormal colposcopy reports, including 45 low-grade squamous intraepithelial lesions, 15 high-grade squamous intraepithelial lesions, and two cancers. Twenty-five (40.3%) abnormal colposcopy findings were in patients with a history of at least than two prior HPV DNA-positive results and a report of currently being HPV-negative with the mRNA assay. CONCLUSION: The HPV mRNA assays are less sensitive for detection of latent HPV infections compared with HPV DNA assays. Based on these data and the potential change in follow-up care, the HPV mRNA assay should not be used for a primary screening tool for cervical cancer. Many pathology laboratories have shifted to using the HPV mRNA assay without clear discussion with gynecologists about the effects on patient follow-up. The type of HPV assay being used should be documented and any HPV mRNA result confirmed by HPV DNA assay.

Association Between Health Beliefs and Gestational Weight Gain.

BACKGROUND: The Institute of Medicine (IOM) provides recommendations for optimal weight gain during pregnancy to minimize complications associated with obesity and excessive weight gain. The Health Belief Model and prior research suggest knowledge of health recommendations and associated risks motivate health behaviors. This study determined whether knowledge of maternal and infant obesity risks during pregnancy (ORDP) and knowledge of IOM gestational weight gain (GWG) recommendations were associated with total GWG and likelihood of adhering to IOM recommendations. MATERIALS AND METHODS: In this prospective survey study, healthy women with a singleton pregnancy were recruited from prenatal clinic waiting rooms of a university medical center to complete a one-time survey of prepregnancy weight and height, demographic variables, knowledge of infant-related ORDP (e.g., large for gestational age), knowledge of maternal-related ORDP (e.g., Cesarean delivery), and knowledge of IOM GWG recommendations. Total GWG was obtained from clinic medical records. Logistic and multiple regression analyses were performed. RESULTS: The sample consisted of 159 women with average age of 25 and prepregnancy body mass index of 28. Women in the sample were predominantly African American (57%) and from low socioeconomic conditions. Results showed (1) knowledge of GWG recommendations was inversely related to total GWG among normal and underweight women and (2) knowledge of infant-related ORDP was positively related to total GWG among overweight and obese women and the likelihood of exceeding recommendations among normal and underweight women. Knowledge of maternal-related ORDP was not related to GWG. CONCLUSION: As the Health Belief Model suggests, knowledge appears to be a modifiable factor in preventing excess GWG. However, there may be misinformation regarding how to adhere to clinical recommendations.

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.

Accessing Disadvantaged Pregnant Women in Houston, Texas, and Characterizing Biomarkers of Metal Exposure: A Feasibility Study.

Abstract: Communities of color or low socioeconomic status are disproportionately affected by metal exposure given spatial variability of the ambient levels of these contaminants. Despite this, there is little research characterizing metal concentrations in blood among disadvantaged populations in the U.S., especially among pregnant women who are particularly vulnerable and difficult to access. Thus, we conducted a pilot study among disadvantaged pregnant women in Houston, Texas to assess willingness to participate in key activities of an epidemiologic study and characterize exposures to 16 metals. Thirty-one women attending a Medicaid-serving prenatal clinic were included in this pilot study and completed an interviewer-administered questionnaire. We obtained and measured metal compounds in whole blood samples for 22 of these women during third-trimester prenatal visits. Median whole blood concentrations of Ni, As, Cd, and Pb were 27, 1.4, 0.6, and 6.3 µg/L, respectively. Most women were willing to participate in critical aspects of a research study, including wearing a personal air-sampling badge for 2-3 days (87.1%), receiving ultrasounds (83.9%), and providing blood draws (64.5%). Despite the small sample, our results provide evidence of women's metal exposure and their willingness to participate in future research studies to elucidate exposure pathways and explore related health effects experienced among this population of disadvantaged pregnant women.

Observational Case Series Evaluation of the Granisetron Transdermal Patch System (Sancuso) for the Management of Nausea/Vomiting of Pregnancy.

Objective The objective of this study was to observe the efficacy of antiemetic therapy (no emesis/retching episodes and no rescue medication use) when granisetron is administered via a transdermal patch system (TDS) in women who are 6 to 14 weeks pregnant when compared with oral ondansetron by evaluating the frequency of the use of rescue medications for control of nausea/vomiting of pregnancy (NVP). Methods This was an observational case series study to observe the potential benefits of granisetron TDS compared with oral ondansetron for management of NVP in pregnant patients during the first trimester. Dates of data collection were September 1, 2014, through December 31, 2015. There was no direct contact with patient. The oral ondansetron and granisetron TDS patients were matched by age, 4:1. The proportion of patients who received rescue antiemetics was calculated from those patients who continued to experience NVP. Risk factors for NVP were identified and compared between groups. Descriptive statistics were used to describe study results. Results Patients were prescribed rescue antiemetics in 0/3 patients in the granisetron TDS group compared with 2/12 patients in the oral ondansetron group. Conclusion Prospective efficacy studies on the use of granisetron TDS for management of NVP are needed to confirm this clinical observation.

ABM Clinical Protocol #20: Engorgement, Revised 2016.

A central goal of The Academy of Breastfeeding Medicine is the development of clinical protocols for managing common medical problems that may impact breastfeeding success. These protocols serve only as guidelines for the care of breastfeeding mothers and infants and do not delineate an exclusive course of treatment or serve as standards of medical care. Variations in treatment may be appropriate according to the needs of an individual patient.

ABM Clinical Protocol #26: Persistent Pain with Breastfeeding.

A central goal of The Academy of Breastfeeding Medicine is the development of clinical protocols for managing common medical problems that may impact breastfeeding success. These protocols serve only as guidelines for the care of breastfeeding mothers and infants and do not delineate an exclusive course of treatment or serve as standards of medical care. Variations in treatment may be appropriate according to the needs of an individual patient.

Effect of Delayed Cord Clamping Above Versus Below the Perineum on Neonatal Hematocrit: A Randomized Controlled Trial.

OBJECTIVE: The purpose of this study was to determine if there is a difference in neonatal hematocrit at 24 hours of life in full-term newborns for which delayed cord clamping is performed above versus below the perineum. MATERIALS AND METHODS: One hundred one patients with singleton pregnancies >37 weeks of gestation presenting for delivery were randomized to delayed cord clamping above or below the perineum. At 24 hours of life, neonatal hematocrit was determined, and the difference was compared using statistical analysis. Secondary outcomes measured were need for phototherapy, transfusion, and neonatal intensive care unit (NICU) admission. RESULTS: Of 101 patients recruited for the study, 53 were randomized to the above group, and 48 were randomized to the below group. Twenty-seven patients in the above group and 26 patients in the below group completed the study. The above group had an average neonatal hematocrit of 52.7% (± 2.58%). The below group had an average neonatal hematocrit of 55.8% (± 2.42%). There was no statistical difference between groups (p = 0.10). Similarly, differences in secondary outcomes did not reach statistical significance. Three infants in the above group and one infant in the below group required phototherapy. None of the infants required blood transfusion. Three infants in the above group and one infant in the below group required NICU admission. CONCLUSIONS: When comparing delayed cord clamping above versus below the perineum, there is no difference in the neonatal hematocrit at 24 hours of life.

Breast Pain: Engorgement, Nipple Pain, and Mastitis.

This review explores current concepts surrounding breastfeeding complications including nipple pain and trauma, breast engorgement, mastitis, and breast abscess. The review discusses possible etiologies, risk factors, incidence, differential diagnosis, and suggested treatment strategies. The evidence that supports these management options is discussed.