Foley catheter placement for induction of labor with or without stylette: a randomized clinical trial.

BACKGROUND: Foley catheters are used for cervical ripening during induction of labor. Previous studies suggest that use of a stylette (a thin, rigid wire) to guide catheter insertion decreases insertion failure. However, stylette effects on insertion outcomes have been sparsely studied. OBJECTIVE: The purpose of this study was to compare catheter insertion times, patient-assessed pain levels, and insertion failure rates between women who received a digitally placed Foley catheter for cervical ripening with the aid of a stylette and women who received the catheter without a stylette. STUDY DESIGN: We conducted a randomized clinical trial of women aged ≥ 18 years who presented for induction of labor. Inclusion criteria were singletons with intact membranes and cephalic presentation. Women received a computer-generated random assignment of a Foley catheter insertion with a stylette (treatment group, n = 62) or without a stylette (control group, n = 61). For all women, a standard insertion technique protocol was used. Three primary outcomes were of interest, including the following: (1) insertion time (total minutes to successful catheter placement), (2) patient-assessed pain level (0-10), and (3) failure rate of the randomly assigned insertion method. Treatment control differences were first examined using the Pearson's test of independence and the Student t test. Per outcome, we also constructed 4 regression models, each including the random effect of physician and fixed effects of stylette use with patient nulliparity, a history of vaginal delivery, cervical dilation at presentation, or postgraduate year of the performing resident physician. RESULTS: Women who received the Foley catheter with the stylette vs without the stylette did not differ by age, race/ethnicity, body mass index, or any of several other characteristics. Regression models revealed that insertion time, patient pain, and insertion failure were unrelated to stylette use, nulliparity, and history of vaginal delivery. However, overall insertion time and failure were significantly influenced by cervical dilation, with insertion time decreasing by 21% (95% confidence interval [CI], 5-34%) and odds of failure decreasing by 71% (odds ratio, 0.29; 95% CI, 0.10-0.86) per 1 cm dilation. Resident postgraduate year also significantly influenced insertion time, with greater time required of physicians with less experience. Mean insertion time was 51% (95% CI, 23-69%) shorter for fourth-year than second-year residents. Statistically nonsignificant but prominent patterns in outcomes were also observed, suggesting stylette use may lengthen the overall insertion procedure but minimize variability in pain levels and decrease insertion failure. CONCLUSIONS: The randomized trial suggests that, even after accounting for nulliparity, history of vaginal delivery, cervical dilation, and physician experience, Foley catheter insertions with and without a stylette are equivalent in insertion times, patient pain levels, and failure of catheter placement.

Participant Personal Characteristics and Adherence to Oral Capsules: A Secondary Analysis of a Randomized Placebo-Controlled Trial of Antenatal Probiotics.

BACKGROUND: Adherence to study interventions is critical to the conduct of randomized controlled trials (RCTs). The relationships between participant characteristics and intervention adherence are understudied in pregnant populations. The purpose of this study was to conduct a secondary analysis of adherence to study capsules in a double-masked, placebo-controlled RCT of a probiotic intervention to reduce antenatal Group B Streptococcus colonization, in relationship to participant characteristics. METHODS: We analyzed the relationship between capsule adherence rates and demographic characteristics among 81 RCT participants. Categorical variables were reported using counts and percentages, and continuous variables were expressed as means along with their standard deviations. For the univariate analyses, we compared demographic variables with adherence scores. A multivariate linear regression model was used to identify predictors of adherence. RESULTS: Average adherence was similar for control and probiotic group participants (P = .86) Univariate analysis showed that average adherence increased directly with age, education, and income. Participants who were partnered or living with others had higher average adherence compared with those who were single and living alone. Asian and White participants had the highest and Black participants had the lowest average, and there was no difference based on Hispanic ethnicity. Adjusting for all the variables in the regression, participants who identified as Black were significantly less likely to adhere to capsules than White participants, and those who were married or living with partners were more likely to adhere than the single participants. DISCUSSION: Diverse participants are critically important to RCTs. This secondary analysis provides evidence that participant characteristics and the social determinants of health play an important role in adherence to self-administered interventions in RCTs, although more research is needed. Our findings suggest that intentional consideration of RCT participant characteristics may allow for the development and tailoring of strategies to enhance intervention adherence. The study was registered on ClinicalTrials.gov (NCT03696953) on January 10, 2018.

Calcium Carbonate as a Potential Intervention to Prevent Labor Dystocia: Narrative Review of the Literature.

Anecdotally, there are attestations from clinicians of calcium carbonate being used successfully for laboring people experiencing labor dystocia. The goal of this narrative review was to provide a synopsis of pertinent literature on calcium use in obstetrics to explore the potential benefit of calcium carbonate as a simple and low-cost intervention for prevention or treatment of labor dystocia. To answer how calcium and carbonate physiologically contribute to myometrium contractility, we conducted a literature search of English-language peer-reviewed articles, with no year limitation, consisting of the keywords "calcium," "calcium carbonate," "calcium gluconate," "pregnancy," "hemorrhage," and variations of "smooth muscle contractility" and "uterine contractions." Though no overt evidence on calcium carbonate's ability to prevent labor dystocia was identified; relevant information was found regarding smooth muscle contractility, calcium's influence on uterine muscle contractility, and carbonate's potential impact on reducing amniotic fluid lactate levels to restore uterine contractility during labor. Studies reporting the potential effectiveness of calcium gluconate and sodium bicarbonate in preventing labor dystocia offer background, safety information, and rationale for a future randomized control trial to evaluate the ability of calcium carbonate to prevent labor dystocia and reduce rates of cesarean section.

A randomized controlled trial of an oral probiotic to reduce antepartum group B Streptococcus colonization and gastrointestinal symptoms.

BACKGROUND: Probiotics have been suggested as a strategy to reduce antenatal group B Streptococcus colonization. Although probiotics are known to improve gastrointestinal symptoms, this has not been studied during pregnancy. OBJECTIVE: This study aimed to evaluate the efficacy of a probiotic to reduce: (1) standard-of-care antenatal group B Streptococcus colonization and colony counts and (2) gastrointestinal symptoms of pregnancy. STUDY DESIGN: In a double-blind fashion, 109 healthy adult pregnant people were randomized to Florajen3 probiotic or placebo capsules once daily from 28 weeks' gestation until labor onset. Baseline vaginal and rectal study swabs for group B Streptococcus colony-forming units and microbiome analysis were collected at 28 and 36 weeks' gestation. Standard-of-care vaginal to rectal group B Streptococcus swabs were collected from all participants at 36 weeks' gestation and determined the need for intrapartum antibiotic prophylaxis. Data collection included solicitation of adverse events, demographic information, Antepartum Gastrointestinal Symptom Assessment score, yogurt ingestion, sexual activity, and vaginal cleaning practices. RESULTS: A total of 83 participants completed the study to 36 weeks' gestation with no adverse events. Standard-of-care group B Streptococcus colonization was 20.4% in the control group and 15.4% in probiotic group participants (-5%; P=.73). The relative risk for positive standard-of-care vaginal-rectal group B Streptococcus colonization was 1.33 (95% confidence interval, 0.5-3.40) times higher in the control group than in the probiotic group (P=.55). There were no differences in median vaginal (P=.16) or rectal (P=.20) group B streptococcus colony-forming units at baseline or at 36 weeks (vaginal P>.999; rectal P=.56). Antepartum Gastrointestinal Symptom Assessment scores were similar at baseline (P=.19), but significantly decreased in probiotic group participants at 36 weeks (P=.02). No covariates significantly altered group B Streptococcus colonization. Significantly more Florajen3 bacteria components were recovered from the vaginal-rectal samples of probiotic group participants (32%; P=.04) compared with controls. CONCLUSION: The findings of this study provided insufficient evidence for the clinical application of the Florajen3 probiotic intervention to reduce standard-of-care vaginal-rectal group B Streptococcus colonization. The prevalence of group B Streptococcus was lower than expected in the study population, and intervention adherence was poor. Probiotic bacteria colonization of the genitourinary tract occurred more in intervention group participants than in controls and significantly reduced gastrointestinal symptoms of pregnancy.

Probiotic interventions to reduce antepartum Group B streptococcus colonization: A systematic review and meta-analysis.

OBJECTIVE: To systematically review and meta-analyse studies of the efficacy of probiotics to reduce antenatal Group B Streptococcus (GBS) colonisation. PARTICIPANTS: Antenatal participants with known positive GBS colonisation or unknown GBS status. INTERVENTION: Probiotic interventions containing species of Lactobacillus or Streptococcus. DESIGN: Systematic review and meta-analysis. MEASUREMENTS AND FINDINGS: The systematic review included 10 studies. Five articles contained in vitro studies of probiotic interventions to determine antagonistic activity against GBS. Six clinical trials of probiotics to reduce antenatal GBS were systematically reviewed and meta-analysed. The meta-analysis revealed that the use of an antenatal probiotic decreased the probability of a positive GBS result by 44% (OR = 0.56, 95% CI = 8.7%, 194.1%, p = 0.02) (n = 709). However, only one clinical trial of 10 had a low risk of bias. KEY CONCLUSIONS: The probiotic interventions subjected to in vitro testing showed antagonistic activity against GBS through the mechanisms of acidification, immune modulation, and adhesion. The findings of the meta-analysis of the clinical trials revealed that probiotics are a moderately effective intervention to reduce antenatal GBS colonisation. More well-controlled trials with diverse participants and with better elucidation of variables influencing GBS colonisation rates are needed. IMPLICATIONS FOR PRACTICE: Probiotic interventions appear to be a safe and effective primary prevention strategy for antenatal GBS colonisation. Application of this low-risk intervention needs more study but may reduce the need for intrapartum antibiotic prophylaxis in countries or regions where antenatal GBS screening is used. Midwives can be instrumental in conducting and supporting larger well-controlled clinical trials.

Family-centered cesarean delivery: a randomized controlled trial.

BACKGROUND: Women who undergo cesarean delivery report that they are less satisfied with their child birthing experience and have a later skin-to-skin contact. Because cesarean deliveries account for nearly one-fifth of all births globally, improving the child birthing experience is imperative. One delivery technique that may improve the child birthing experience, termed the family-centered cesarean, allows the mother to view the birth of her baby and to have the baby immediately placed on her chest following delivery. OBJECTIVE: Our primary outcome was to compare satisfaction with birthing experiences between women who underwent either a family-centered or traditional cesarean delivery. Our secondary outcomes compared timing of skin-to-skin contact, and maternal and neonatal outcomes between the 2 methods of cesarean delivery. STUDY DESIGN: Pregnant women aged ≥18 years who had been admitted to Labor and Delivery with a planned cesarean delivery at 1 of 2 delivery units were prospectively enrolled. Women were randomized 1:1, but not blinded, to either the family-centered cesarean (Method 1; N=68) or traditional cesarean (Method 2; N=61). Time to skin-to-skin interactions and newborn vitals were recorded by a nurse at time of delivery. A self-administered questionnaire was provided to participants in the hospital on postpartum to obtain satisfaction with the birthing experience using a modified Likert scale, ranging from 1 (lowest) to 5 (highest). Baseline characteristics and all other variables of interest were abstracted from the electronic medical record. Baseline characteristics, maternal satisfaction, and maternal or neonatal outcomes between methods of delivery were compared using t tests and Pearson chi-squared (or Fisher exact), as appropriate. RESULTS: Between June 2016 and July 2018, women who were randomized to either Method 1 or Method 2 did not significantly differ by baseline characteristics. This study was unable to detect a difference in satisfaction (4.6 Method 1 vs 4.4 Method 2; P=.27). However, mean time to skin-to-skin contact was significantly different. Patients in Method 1 established skin-to-skin contact on average 11.2 minutes earlier than those in Method 2 (5.1 vs 16.3; P<.01). No other differences in maternal and neonatal outcomes were identified. CONCLUSION: Although our study did not find statistical differences in maternal or newborn outcomes, including maternal satisfaction, the family-centered cesarean was significantly associated with earlier skin-to-skin contact. Given the known benefits of earlier skin-to-skin contact without associated harm, women should be allowed to choose either method of cesarean delivery based on their personal preference.

Dancing During Labor: Are Women Down to Boogie?

Recent social media trends have demonstrated increased interest in dancing during the final weeks of pregnancy and labor. However, there is limited evidence about dancing during labor and its impact on labor pain and duration as well as patient satisfaction. Before conducting a prospective study, given that enrollment is often challenging, our feasibility study aimed to assess the willingness of pregnant women to participate in a future study evaluating low-impact dance during labor. We anonymously surveyed a convenience sample of English-speaking/reading pregnant women who presented for prenatal care at 1 of 3 clinics from June 2019 to July 2019. Questions related to women's interest in dancing during labor and limited demographic information were collected and analyzed. Overall, 88.6% of pregnant women who completed the survey expressed interest in participating in a future study on low-impact dance during labor, with Caucasian patients and those ≥35 years of age being less interested in future participation (P<0.05 for both). Interest in participating was not influenced by any other demographic characteristic, pregnancy history, or current activity level. Given sufficient interest among pregnant women in participating in a study aimed at evaluating the potential benefits of low-impact dance during labor, enrollment numbers may be easier to achieve than previously expected.

Dancing During Labor: Social Media Trend or Future Practice?

Over the past 30 years, medical interventions in pregnancy and childbirth have increased. Some pregnant women seek less invasive and nonpharmacological options to manage discomforts during labor. While exercise during pregnancy is recommended, less is known about exercise, specifically dancing, during labor. While anecdotal evidence is supportive, little is known about the implications of exercise and dance during the first stage of labor for pain reduction and labor progression. Some movements common in dance, such as expanding hip circles that loosen and relax muscles of the pelvic floor, may be beneficial to women during labor. Available evidence suggests that dancing during the first stage of labor may decrease duration and intensity of pain and increase patient satisfaction, but further study is warranted. Ultimately, before assessing the implications of dance during labor, a feasibility study should be conducted to determine pregnant women's willingness to participate in a prospective or randomized controlled trial.

Management of the third stage of labor in second-trimester deliveries: How long is too long?

BACKGROUND: Retained placenta is the most common second-trimester delivery complication. As the optimal third stage of labor duration remains undefined, complications associated with retained placentas are difficult to study. OBJECTIVE(S): To determine the optimal third stage of labor duration in second-trimester deliveries based on estimates of time-specific probabilities of placental delivery, placental intervention, and postpartum complication. STUDY DESIGN: We retrospectively studied adult women with singleton second-trimester vaginal deliveries. We identified third stage of labor duration, placental delivery method (spontaneous vs. manual/operative intervention), and indication for intervention. Postpartum complication was examined as a composite outcome. Differences among groups defined by delivery method and postpartum complication were tested using parametric and nonparametric tests. Probability curves describing the time-specific probabilities of placental delivery were derived using lifetable methods with group differences tested using the log-rank test. Probability of placental intervention and complication by time to placental delivery were examined using logistic regression with adjustment for confounders and other predictors. RESULTS: We identified 215 second-trimester placental deliveries (77% spontaneous, 23% intervention). Overall, 27% experienced postpartum complication, primarily hemorrhage (91%). Complication rates differed significantly between spontaneous placental deliveries (16%) and interventions (61%, P < 0.01). Both placental intervention and postpartum complication were strongly associated with longer time to placental delivery. Spontaneous placental deliveries occurred earlier than deliveries requiring intervention (P < 0.01). At 2 h, placental delivery rates were 93% in spontaneous deliveries and 39% in those requiring intervention. The overall postpartum complication rate for spontaneous placental deliveries (16%) was used as the threshold of tolerable risk and the criterion for placental intervention. Adjusted probability curves for deliveries of average gestational age (21.6 weeks) suggested that most patients (63.9%) may not require intervention until approximately 2 h following fetal delivery. Patients with PPROM would require intervention by 34 min, and those with intrapartum fever or delivery EBL ≥500 mL would already exceed the risk threshold at fetal delivery. CONCLUSIONS: Our study suggests that an optimal third stage of labor duration of approximately 2 h maximizes probability of spontaneous delivery and minimizes complication risk. Timing of intervention may be further individualized for patients based on maternal characteristics and intrapartum conditions.

Does current cefazolin dosing achieve adequate tissue and blood concentrations in obese women undergoing cesarean section?

BACKGROUND: Prophylactic administration of antibiotics preceding cesarean delivery is the most effective measure taken for preventing postpartum infection. While obese women are at greater risk for infection than non-obese women, evidence-based recommendations for modifying dosing in these women are limited. OBJECTIVES: The purpose of this study was to determine whether obese women undergoing cesarean delivery similarly reach adequate cefazolin concentrations within tissue and blood when weighing <120kg and dosed 2g versus weighing ≥120kg and dosed 3g. STUDY DESIGN: We prospectively studied women ≥18 years old with body mass index ≥30kg/m2 who underwent scheduled cesarean delivery with singleton pregnancy from August 2014 through March 2016. Women were dosed with 2g and 3g of cefazolin for body weights <120kg and ≥120kg, respectively. Samples of subcutaneous adipose tissue (following skin incision and before skin closure), myometrial tissue, fetal cord blood, and maternal blood were collected to assess whether cefazolin concentrations were adequate, i.e., at/above the minimum inhibitory concentration (MIC). Concentrations, based on inhibition zones for Streptococcus sanguinis, were calculated per gram of solid tissue and milliliter of blood. For all sample types, log-transformed concentrations were compared between dosage groups. Using a range of published MICs (1-8µg/mL or µg/g), odds ratios, describing differential odds of falling below the MIC between dosage groups, were also computed. RESULTS: Women who received 2g (n=65) versus 3g (n=19) of cefazolin did not significantly differ by maternal or gestational age, race/ethnicity, pre-operative hemoglobin, estimated blood loss, fluid administration, duration of surgery, or timing of sample collections relative to cefazolin administration (Ps>0.05). Dosage groups also did not differ in cefazolin concentration (median [interquartile range]) within adipose tissue following skin incision (5.30µg/g [3.00-9.60] vs. 6.35µg/g [3.90-8.40]; P=0.551), adipose tissue before skin closure (4.45µg/g [2.78-7.25] vs. 6.90µg/g [2.60-10.6]; P=0.342), myometrial tissue (13.1µg/g [8.60-19.6] vs. 15.7µg/g [10.8-21.7]; P=0.116), or maternal blood (41.6µg/mL [26.3-57.0] vs. 45.3µg/mL [36.7-68.3]; P=0.143). However, cord blood concentrations differed significantly (19.5µg/mL [13.7-28.5] vs. 27.9µg/mL [15.8-39.4]; P=0.032), and, in 3 of 5 sample types, group concentrations differed at the dosing cut-point of 120kg (Ps<0.02). Within the range of MICs considered, differences in the odds of concentration inadequacy were not detected between dosage groups for any sample type. Across all patients, inadequate concentrations in one or more solid tissue types were observed in 1.19%, 17.9%, 59.5%, and 86.9% of patients, given the MICs of 1µg/g, 2µg/g, 4µg/g and 8µg/g, respectively. In adipose tissues, specifically, and both dosage groups, mean concentrations were significantly lower than the MIC of 8µg/g (Ps<0.03). Concentrations in one or both blood sample types were inadequate for only 8.33% of patients, given the 8-µg/mL MIC. CONCLUSIONS: Adequate cefazolin concentrations were achieved in blood for the majority of our patients. However, concentration adequacy was not achieved in solid tissue for a nearly equally large proportion of patients. Larger scale studies for determining modified protocols for dosing and applying MICs are warranted.