The effect of oral probiotics on glycemic control of women with gestational diabetes mellitus-a multicenter, randomized, double-blind, placebo-controlled trial.

BACKGROUND: Gestational diabetes mellitus should be treated adequately to avoid maternal hyperglycemia-related complications. Previously, probiotic supplements were suggested to improve fasting blood glucose in women with gestational diabetes mellitus. However, a major limitation of previous studies was that preprandial and especially postprandial glucose values, which are important predictors of pregnancy outcomes, were not studied. OBJECTIVE: This study aimed to examine the effect of a mixture of probiotic strains on maternal glycemic parameters, particularly preprandial and postprandial glucose values and pregnancy outcomes among women with gestational diabetes mellitus. STUDY DESIGN: A multicenter prospective randomized, double-blind, placebo-controlled trial was conducted. Women newly diagnosed with gestational diabetes mellitus were randomly allocated into a research group, receiving 2 capsules of oral probiotic formula containing Bifidobacterium bifidum, B lactis, Lactobacillus acidophilus, L paracasei, L rhamnosus, and Streptococcus thermophilus (>6 × 109/capsule), and a control group, receiving a placebo (2 capsules/day) until delivery. Glycemic control was evaluated by daily glucose charts. After 2 weeks, pharmacotherapy was started in case of poor glycemic control. The primary outcomes were the rate of women requiring medications for glycemic control and mean daily glucose charts after 2 weeks of treatment with the study products. RESULTS: Forty-one and 44 women were analyzed in the treatment and placebo cohorts, respectively. Mean daily glucose during the first 2 weeks in the probiotics and placebo groups was 99.7±7.9 and 98.0±9.3 mg/dL, respectively (P=.35). The rate of women needing pharmacotherapy because of poor glycemic control after 2 weeks of treatment in the probiotics and placebo groups was 24 (59%) and 18 (41%), respectively (P=.10). Mean preprandial and postprandial glucose levels throughout the study period were similar between the groups (P>.05). There were no differences in maternal and neonatal outcomes, including birthweight and adverse effect profile between the groups. CONCLUSION: The oral probiotic product tested in this study did not affect glycemic control of women with gestational diabetes mellitus.

The efficiency of cabergoline vs pyridoxine for lactation inhibition-a randomized controlled trial.

BACKGROUND: Some mothers may seek lactation inhibition on personal, social, or medical grounds. The common drug used for lactation inhibition is cabergoline. Several adverse effects and contraindications are known for this drug. Its use is contraindicated for patients with hypertensive disorders and fibrotic, cardiac, or hepatic diseases. In addition, pyridoxine (vitamin B6) has been used for this indication, with no significant adverse effect, following studies that demonstrated its efficacy. OBJECTIVE: This study aimed to compare the efficiency of cabergoline vs pyridoxine for lactation inhibition. STUDY DESIGN: A randomized controlled trial was conducted. Postpartum patients who requested lactation inhibition were randomly allocated to receive either cabergoline (1 mg once on postpartum day 1 or divided to 0.25 mg twice a day for 2 days thereafter, according to the departmental protocol, which is in line with the manufacturer recommendations) or pyridoxine (200 mg 3 times a day for 7 days). The patients enrolled were free of diseases in which contraindications to cabergoline are present. All patients completed a questionnaire for assessing breast engorgement, breast pain, and milk leakage on a scale of 0 (no symptom) to 5 (severe symptom) on days 0, 2, 7, and 14. The primary outcome was lactation inhibition success, defined as a score of 0 for both engorgement and pain on day 7. The secondary outcomes included the assessment of milk leakage, adverse effects, fever, mastitis, and treatment discontinuation or alteration. RESULTS: Of note, 45 and 43 patients received cabergoline or pyridoxine, respectively, and were included in the analysis following the intention-to-treat principle. Cabergoline was superior to pyridoxine in inhibiting lactation at day 7 (78% vs 35%, respectively; P<.0001). Mild symptoms, defined as a score of 0 to 2 for breast engorgement and pain, at day 7 were 40 (89%) in the cabergoline group and 29 (67%) in the pyridoxine group (P=.01). The incidence of milk leakage was lower in the cabergoline group after 7 and 14 days than in the pyridoxine group (9% vs 42% [P=.0003] and 11% vs 31% [P=.02], respectively). Cabergoline had more adverse effects than pyridoxine (31% vs 9%, respectively; P=.01), but all adverse effects were mild. The rates of mastitis and fever that were related to engorgement were similar in the cabergoline and pyridoxine groups (4 [9%] vs 2 [5%], respectively; P=.67). Furthermore, 9 patients (21%) in the pyridoxine group switched to or added cabergoline because of treatment failure. Accordingly, on day 7, the pyridoxine success rate was reduced from 35% (15 women) to 28% (12 women) and from 67% (29 women) to 53% (23 women) for a score of 0 and 0 to 2 for both engorgement and pain, respectively. CONCLUSION: Cabergoline was superior to pyridoxine in inhibiting lactation. Cabergoline had more adverse effects, but no major adverse effect was documented in either treatment group. As pyridoxine inhibited lactation successfully in previous studies and in 67% of patients in this study, its use should be considered in women with contraindications for cabergoline.

The Association between Gestational Diabetes Mellitus and Infections in Pregnancy-Systematic Review and Meta-Analysis.

We conducted a systematic review and meta-analysis to evaluate the association between gestational diabetes mellitus and infections during pregnancy. We included cross-sectional, case-control, cohort studies and clinical trials, evaluating the frequency of infections in women with and without gestational diabetes mellitus. A search was conducted in Embase, PubMed, and Web of Science electronic databases and by manually searching references, until 23 March 2022, resulting in 16 studies being selected for review, with 111,649 women in the gestational diabetes mellitus group, and 1,429,659 in the controls. Cochrane's Q test of heterogeneity and I² were used to assess heterogeneity. Pooled odds ratio (OR) was calculated. Funnel plots and Egger test were used for assessment of publication bias. The results showed a significant association between gestational diabetes mellitus and infections (pooled-OR 1.3 95% CI [1.2-1.5]). Sub-analyses showed a significant association for urinary tract infections (pooled-OR of 1.2 95% CI [1.1-1.3]), bacterial infections (pooled-OR were 1.2 95% CI [1.1-1.4]), and SARS-CoV-2 (pooled-OR 1.5 95% CI [1.2-2.0]) but not to gingivitis or vaginal candidiasis. The results underscore the significance of acknowledging gestational diabetes mellitus as a risk factor for infections.

Intermittent vs continuous catheterization for postpartum urinary retention: A multicenter randomized controlled trial.

BACKGROUND: Postpartum urinary retention is a common complication in the immediate postpartum period. However, there is no consensus regarding optimal management. OBJECTIVE: This study aimed to compare 2 catheterization strategies for the treatment of postpartum urinary retention. STUDY DESIGN: A multicenter prospective randomized controlled trial was conducted at 4 university-affiliated medical centers between January 2020 and June 2022. Individuals with postpartum urinary retention (bladder volume of >150 mL) up to 6 hours after vaginal or cesarean delivery were randomly allocated to 1 of 2 protocols: intermittent catheterization every 6 hours, up to 4 times, or continuous catheterization with an indwelling urinary catheter for 24 hours. If postpartum urinary retention was not resolved after 24 hours, an indwelling catheter was inserted for an additional 24 hours in both groups. The primary endpoint was the mean time to postpartum urinary retention resolution. The secondary endpoints included postcatheter urinary tract infection rate and length of hospital stay. The satisfaction rate was estimated using the 30-Item Birth Satisfaction Scale questionnaire. RESULTS: After randomization, 73 individuals were allocated to the intermittent catheterization group, and 74 individuals were allocated to the continuous catheterization group. The mean time to postpartum urinary retention resolution was significantly shorter in the intermittent catheterization group than in the continuous catheterization group (10.2±11.8 vs 26.5±9.0 hours; P<.001), with 75% and 93% resolution rates after 1 and 2 catheterizations, respectively. The number of individuals who achieved resolution at 24 hours was 72 (99%) in the intermittent catheterization group and 67 (91%) in the continuous catheterization group (P=.043). The satisfaction rate was higher in all categories in the intermittent catheterization group than in the continuous catheterization group (P<.001). No intercohort difference was found in the urinary tract infection rates (P=.89) or hospital stay length (P=.58). CONCLUSION: Compared with indwelling catheterization, intermittent catheterization for urinary retention after delivery was associated with quicker postpartum urinary retention resolution and a higher satisfaction rate without increasing the complication rates.

Comparison of postpartum anti-Xa levels following enoxaparin administration to prevent venous thromboembolism using 2 weight-based protocols: a randomized controlled trial.

BACKGROUND: During the postpartum period, enoxaparin is given to high-risk women to prevent venous thromboembolism, a leading cause of maternal mortality. Enoxaparin activity is measured by peak plasma anti-Xa levels. The prophylactic range of anti-Xa is 0.2 to 0.6 IU/mL. Values above and below this range represent subprophylactic and supraprophylactic levels, respectively. Weight-based enoxaparin administration was superior to fixed-dose enoxaparin administration in achieving an anti-Xa prophylactic range. However, it is unknown which weight-based enoxaparin administration is superior (once daily weight categories vs 1 mg/kg body weight). OBJECTIVE: This study aimed to compare the efficacy in reaching prophylactic anti-Xa levels and adverse effects profile of the 2 weight-based enoxaparin dosing protocols. STUDY DESIGN: A randomized open-label controlled trial was conducted. Women after delivery, who were intended to receive enoxaparin, were randomized to receive either enoxaparin treatment according to 1 mg/kg (up to 100 mg) or weight categories (≤90 kg, 40 mg; 91-130 kg, 60 mg; 131-170 kg, 80 mg; >170 kg, 100 mg). Plasma anti-Xa levels were obtained 4 hours after the second enoxaparin administration (day 2 of enoxaparin treatment). If the woman was still hospitalized, anti-Xa levels were also obtained on day 4. The primary endpoint was the proportion of women with anti-Xa levels within the prophylactic range at day 2. In addition, data regarding anti-Xa levels in different weight groups and rates of venous thromboembolism and adverse effects were evaluated. RESULTS: Of note, 60 and 64 women received enoxaparin according to 1 mg/kg and weight categories, respectively; moreover, 55 (92%) and 27 (42%) women reached the prophylactic range of anti-Xa at day 2, respectively (P<.0001). The mean anti-Xa levels on day 2 were 0.34±0.09 and 0.19±0.06 IU/mL, respectively (P<.0001). The anti-Xa levels were higher in the 1 mg/kg group than in the weight categories group in the subanalysis of different weight categories (51-70, 71-90, and 91-130 kg). There was no difference in anti-Xa levels on day 4 compared with day 2 in both cohorts (n=25). There was no case of supraprophylactic anti-Xa levels, venous thromboembolism events, or serious hemorrhage. CONCLUSION: Postpartum enoxaparin administration at 1 mg/kg was superior to weight categories in reaching anti-Xa prophylactic levels without leading to serious adverse effects. Given the high efficacy and safety profile, enoxaparin at 1 mg/kg once daily should be considered the preferred protocol for postpartum venous thromboembolism prophylaxis.

Effects of Probiotics on Glycemic Control and Metabolic Parameters in Gestational Diabetes Mellitus: Systematic Review and Meta-Analysis.

OBJECTIVES: To assess the effects of probiotic supplements on glycemic control and metabolic parameters in women with gestational diabetes mellitus (GDM) by performing a systematic review and meta-analysis of randomized controlled trials. The primary outcome was glycemic control, i.e., serum glucose and insulin levels. Secondary outcomes were maternal weight gain, neonatal birth weight, and lipid parameters. Weighted mean difference (WMD) was used. Cochrane's Q test of heterogeneity and I2 were used to assess heterogeneity. RESULTS: Of the 843 papers retrieved, 14 (n = 854 women) met the inclusion criteria and were analyzed. When compared with placebo, women receiving probiotic supplements had significantly lower mean fasting serum glucose, fasting serum insulin, homeostatic model assessment for insulin resistance (HOMA-IR), triglycerides, total cholesterol, and VLDL levels. Decreased neonatal birth weight was witnessed in supplements containing Lactobacillus acidophilus. CONCLUSION: Probiotic supplements may improve glycemic control and lipid profile and reduce neonatal birth weight in women with GDM.

Should pregnant women be screened for SARS-CoV-2 infection? A prospective multicenter cohort study.

OBJECTIVE: Coronavirus disease 2019 (COVID-19), caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), ranges from asymptomatic to severe infection. We aimed to compare the prevalence of COVID-19 in asymptomatic pregnant versus nonpregnant women in order to establish recommendations for a COVID-19 screening strategy. METHODS: A prospective multicenter cohort study was conducted. Asymptomatic pregnant or nonpregnant women after March 2020 (the time when COVID-19 was first detected in north Israel) were tested for SARS-CoV-2 using nasopharyngeal reverse transcription polymerase chain reaction test, anti-nucleocapsid IgG, and anti-spike IgG. Diagnosis was made if at least one test result was positive. Pregnant women were tested between 34 and 42 weeks, mostly at birth. RESULTS: Among the 297 participating women, 152 were pregnant and 145 were nonpregnant. The prevalence of asymptomatic COVID-19 was similar between the groups (4 [2.6%] and 8 [5.5%], respectively; P = 0.2). All women with COVID-19 delivered healthy appropriate-for-gestational-age babies without malformations, at term. CONCLUSIONS: The rate of asymptomatic COVID-19 in pregnant women is low and comparable to the rate among nonpregnant women. Pregnancy outcomes are favorable. Future screening programs should consider that one of 25 screened asymptomatic women will be positive.

Cultural and Digital Health Literacy Appropriateness of App- and Web-Based Systems Designed for Pregnant Women With Gestational Diabetes Mellitus: Scoping Review.

BACKGROUND: The prevalence of women diagnosed with gestational diabetes mellitus (GDM) is increasing dramatically. Mobile technologies to enhance patient self-management offer many advantages for women diagnosed with GDM. However, to our knowledge, although mobile health (mHealth) and telemedicine systems for GDM management exist, evidence on their cultural and digital health literacy appropriateness levels is limited. OBJECTIVE: This review aimed to search and assess the literature on mHealth and telemedicine systems designed for women diagnosed with GDM. Our assessment of these technologies focused on their cultural and digital health literacy appropriateness as well as the systems' effectiveness in improving glycemic control and maternal and infant outcomes. METHODS: We conducted a scoping review using a framework adapted from Arksey and O'Malley. Four electronic databases were searched for relevant studies: PubMed, MEDLINE (EBSCO), Web of Science, and Scopus. The databases were searched between January 2010 and January 2022. The inclusion criteria were pregnant women diagnosed with GDM, use of telemedicine for monitoring and management, and vulnerable or disadvantaged patients. We used terms related to mobile apps and telemedicine: GDM, vulnerable populations, periphery, cultural appropriateness, and digital health literacy. Studies were screened and selected independently by 2 authors. We extracted the study data on a Microsoft Excel charting table and categorized them into final themes. The results were categorized according to the cultural and digital health literacy features presented. RESULTS: We identified 17 studies that reported on 12 telemedicine and mHealth app interventions. We assessed the studies in three domains: cultural appropriateness, digital health literacy, and maternal and infant outcomes. In the literature, we found that existing digital technologies may improve glycemic control and diabetes self-management. However, there is a lack of assessment of cultural and digital health literacy appropriateness for pregnant women diagnosed with GDM. Considerations in app design regarding cultural appropriateness were found in only 12% (2/17) of the studies, and only 25% (3/12) of the interventions scored ≥3 out of 5 in our assessment of digital health literacy. CONCLUSIONS: mHealth and telemedicine can be an effective platform to improve the clinical management of women with GDM. Although studies published on the use of mHealth and telemedicine systems exist, there is a limited body of knowledge on the digital health literacy and cultural appropriateness of the systems designed for women diagnosed with GDM. In addition, as our study was restricted to the English language, relevant studies may have been excluded. Further research is needed to evaluate, design, and implement better tailored apps regarding cultural and digital literacy appropriateness for enhancing pregnant women's self-management as well as the effectiveness of these apps in improving maternal and infant health outcomes.

Vertical transmission and humoral immune response following maternal infection with SARS-CoV-2: a prospective multicenter cohort study.

OBJECTIVE: To explore maternal humoral immune responses to SARS-CoV-2 infection and the rate of vertical transmission. METHODS: A prospective cohort study was conducted at two university-affiliated medical centers in Israel. Women positive for SARS-CoV-2 reverse-transcription-polymerase-chain-reaction (RT-PCR) test during pregnancy were enrolled just prior to delivery. Levels of anti-SARS-CoV-2 spike-IgM, spike IgG, and nucleocapsid IgG were tested in maternal and cord blood at delivery, and neonatal nasopharyngeal swabs were subjected to PCR testing. The primary endpoint was the rate of vertical transmission, defined as either positive neonatal IgM or positive neonatal PCR. RESULTS: Among 72 women, 36 (50%), 39 (54%) and 30 (42%) were positive for anti-spike-IgM, anti-spike-IgG, and anti-nucleocapsid-IgG, respectively. Among 36 neonates in which nasopharyngeal swabs were taken, one neonate (3%, 95% confidence interval 0.1-15%) had a positive PCR result. IgM was not detected in cord blood. Seven neonates had positive IgG antibodies while their mothers were seronegative for the same IgG. Anti-nucleocapsid-IgG and anti-spike-IgG were detected in 25/30 (83%) and in 33/39 (85%) of neonates of seropositive mothers, respectively. According to the serology test results during delivery with respect to the time of SARS-CoV-2 infection, the highest rate of positive maternal serology tests was 8 to 12 weeks post-infection (89% anti-spike IgG, 78% anti-spike IgM, and 67% anti-nucleocapsid IgG). Thereafter, the rate of positive serology tests declined gradually; at 20 weeks post-infection, only anti-spike IgG was detected in 33 to 50%. DISCUSSION: The rate of vertical transmission of SARS-CoV-2 was at least 3% (95% confidence interval 0.1-15%). Vaccination should be considered no later than 3 months post-infection in pregnant women due to a decline in antibody levels.

An informative video before planned cesarean delivery and maternal anxiety-a multicenter randomized controlled trial.

BACKGROUND: Cesarean delivery is one of the most common procedures performed in obstetrics, and although cesarean delivery is a blissful occasion, it is commonly associated with fear and anxiety for the new mother. OBJECTIVE: We aimed to study the impact of watching a detailed, informative video on maternal anxiety levels, childbirth experience, and patient satisfaction in patients undergoing a primary cesarean delivery. STUDY DESIGN: We performed a multicenter randomized control trial. Women scheduled to undergo a primary nonemergent cesarean delivery were recruited. All participants in the intervention group watched an informative video on recruitment. This 4-minute video described in detail the expected cesarean delivery process: preparations before entering the operation room, regional anesthesia administration, sterile covering, the surgical procedure itself, and recovery (including mobilization and lactation). Situation-specific anxiety was measured at recruitment, before exposure to the video (S1), at the day of the operation (S2), and at postpartum day 1 (S3) using the State-Trait Anxiety Inventory score. In addition, participants answered a 10-item Childbirth Experience Questionnaire. A sample size of 63 per group was planned to achieve 80% power to detect a difference of 5 points in the primary outcome (State-Trait Anxiety Inventory score on the day of the operation). RESULTS: Overall, 154 participants from 4 medical centers were randomized, and 132 participants were analyzed after completing all questionnaires, 64 participants in the video group and 68 participants in the control group. The groups did not differ in demographics and delivery characteristics and had similar baseline anxiety levels (S1). On operation day (S2, the primary outcome), significantly lower anxiety levels were reported in the video group than in the control group (State-Trait Anxiety Inventory scores, 41.3±9.5 vs 49.3±10.3; P<.001). Moreover, anxiety levels in postpartum day 1 (S3) remained significantly lower in the video group (P<.001). No difference between the groups in childbirth experience score or patient satisfaction was demonstrated. CONCLUSION: A detailed informative video shown to patients before primary cesarean delivery decreased maternal anxiety levels before and after the procedure.

Characteristics of pregnancy with gestational diabetes mellitus and the consecutive pregnancy as predictors for future diabetes mellitus type 2.

AIM: To explore possible obstetrical history-related, modifiable risk factors of future type 2 diabetes mellitus (T2DM), with focus on characteristics of the index gestational diabetes mellitus (GDM) pregnancy and the consecutive pregnancy. METHODS: This retrospective, population-based, cohort study included 788 women with GDM, who had consecutive deliveries at Emek Medical Center during 1991-2012. Women with pre-existing diabetes were excluded. Factors associated with T2DM development were examined using stepwise multiple Cox regression model. RESULTS: Overall 178 women developed T2DM (23%). Multivariable analysis demonstrated that the most significant independent risk factors for T2DM development were birth weight ≥ 4000 g (HRadj1.7 95% CI [1.001-2.8]), fasting oral glucose tolerance test value (OGTT, HRadj1.03 95% CI [1.01-1.04], 1-hour post-OGTT glucose value (HRadj1.01 95% CI [1.006-1.02]), earlier gestational week in which GDM was diagnosed (HRadj 0.96 95% CI [0.93-0.99]), higher parity (HRadj 1.15 95% CI [1.06-1.25] and GDM recurrence in the consecutive delivery (HRadj2.4 95% CI [1.6-3.7]). Kaplan Meier survival curve of the time from the consecutive pregnancy until T2DM development showed a statistically significant effect of GDM recurrence and the risk for T2DM. Body mass index (BMI) gain between pregnancies and inter-pregnancy interval were not independent risk factors for T2DM. CONCLUSIONS: Obstetric characteristics of women with GDM and particularly GDM recurrence are associated with increased risk for T2DM. Strategies to prevent those factors and especially GDM recurrence might reduce the risk of future T2DM.

Oral analgesia in fixed-time interval administration versus spinal morphine for post-Cesarean pain: a randomised controlled trial.

PURPOSE: To compare the efficacy of fixed-time-interval oral analgesia and spinal-morphine for management of post-Cesarean pain. METHODS: In this open-label, parallel-group, randomized, controlled trial, 200 women due to undergo elective Caesarean section with spinal anaesthesia were enrolled between July 2015 and April 2016. Patients were randomly assigned to receive either spinal fentanyl followed by oral doses of tramadol, paracetamol, and diclofenac at predetermined regular intervals of 6 h for the first 48 h, and rescue treatment with percocet (oxycodone and paracetamol; oral analgesia group), or spinal morphine and rescue treatment with oral tramadol, paracetamol, and diclofenac (spinal-morphine group). The primary outcomes were pain intensity during the postoperative 48 h, measured on a 10-point numeric rating scale (NRS) and expressed as area under the curve (AUC), and the number of breakthrough events of moderate to severe pain (defined as NRS score ≥ 4). RESULTS: The oral analgesia group compared to the spinal-morphine group had similar mean pain intensity (AUC (120 ± 35 versus 121 ± 31, respectively; p = 0.8) but more events of moderate-to-severe breakthrough pain (4.8 ± 2 versus 3.8 ± 1.7, respectively; p = 0.0002). Higher rates and longer durations of pruritus, nausea, and vomiting were reported among patients receiving spinal morphine, as compared with oral analgesia. Satisfaction scores were high in both groups (8.2 ± 2.4 versus 8.7 ± 1.8 in the oral analgesia and spinal morphine, respectively; p = 0.23). CONCLUSIONS: Both oral analgesia at fixed time intervals and spinal morphine are satisfactory methods for treating post-Caesarean pain. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02440399, date of registration: 07/05/ 2015. URL: https://clinicaltrials.gov/ct2/show/NCT02440399?term=enav+yefet&rank=7 .

Addition of oral iron bisglycinate to intravenous iron sucrose for the treatment of postpartum anemia-randomized controlled trial.

BACKGROUND: Studies that have compared the effectiveness of oral with intravenous iron supplements to treat postpartum anemia have shown mixed results. The superiority of one mode of treatment vs the other has yet to be demonstrated. Therefore, despite guidelines and standards of care, treatment approaches vary across practices. A single 500 mg dose of iron sucrose, which is higher than what is usually administered, has not been evaluated to treat postpartum moderate to severe anemia. OBJECTIVE: This study aimed to compare the efficacy of intravenous iron sucrose alone with intravenous iron sucrose in combination with oral iron bisglycinate supplementation in treating moderate to severe postpartum anemia. STUDY DESIGN: A randomized controlled trial was conducted between February 2015 and June 2020. Women with postpartum hemoglobin level of ≤9.5 g/dL were treated with 500 mg intravenous iron sucrose after an anemia workup, which ruled out other causes for anemia. In addition to receiving intravenous iron, women were randomly allocated to receive either 60 mg of oral iron bisglycinate for 45 days or no further iron supplementation. The primary outcome was hemoglobin level at 6 weeks after delivery. Secondary outcomes were iron storage parameters and quality of life. RESULTS: Of 158 patients who participated, 63 women receiving intravenous and oral iron, and 44 women receiving intravenous iron-only, completed the study and were included in the analysis. Baseline and obstetrical characteristics were similar between the study cohorts. Although statistically significant, postpartum hemoglobin levels were only 0.4 g/dL higher in the intravenous and oral iron than intravenous iron-only cohort (12.4 g/dL vs 12.0 g/dL, respectively; P=.03), with a respective increase from baseline of 4.2 g/dL vs 3.7 g/dL (P=.03). There was no difference in the rate of women with hemoglobin level of <12.0 or 11.0 g/dL. Iron storage and health quality were not different between the cohorts. Oral iron treatment was associated with 29% rate of adverse effects. Compliance and satisfaction from treatment protocol were high in both cohorts. CONCLUSION: Intravenous 500 mg iron sucrose treatment alone is sufficient to treat postpartum anemia without the necessity of adding oral iron treatment.

Prediction of anemia at delivery.

We aimed to assess risk factors for anemia at delivery by conducting a secondary analysis of a prospective cohort study database including 1527 women who delivered vaginally ≥ 36 gestational weeks. Anemia (Hemoglobin (Hb) < 10.5 g/dL) was assessed at delivery. A complete blood count results during pregnancy as well as maternal and obstetrical characteristics were collected. The primary endpoint was to determine the Hb cutoff between 24 and 30 gestational weeks that is predictive of anemia at delivery by using the area under the curve (AUC) of the receiver operating characteristic curve. Independent risk factors for anemia at delivery were assessed using stepwise multivariable logistic regression. Hb and infrequent iron supplement treatment were independent risk factors for anemia at delivery (OR 0.3 95%CI [0.2-0.4] and OR 2.4 95%CI [1.2-4.8], respectively; C statistics 83%). Hb 10.6 g/dL was an accurate cutoff to predict anemia at delivery (AUC 80% 95%CI 75-84%; sensitivity 75% and specificity 74%). Iron supplement was beneficial to prevent anemia regardless of Hb value. Altogether, Hb should be routinely tested between 24 and 30 gestational weeks to screen for anemia. A flow chart for anemia screening and treatment during pregnancy is proposed in the manuscript.Trial registration: ClinicalTrials.gov Identifier: NCT02434653.

The association between polyhydramnios and CMV infection - retrospective cohort study.

OBJECTIVE: Polyhydramnios was suggested to be associated with CMV infection, resulting in polyhydramnios being common indication for CMV testing. However, the literature does not provide a robust evidence to support this management. We aimed to examine the association between congenital CMV infection and polyhydramnios. METHODS: A retrospective cohort study was conducted. The rate of polyhydramnios was analyzed in 63 neonates/fetuses with CMV between 2013 and 2017 and compared to 351 neonates without CMV using PCR targeted to the viral DNA. The rate of oligohydramnios and small for gestational age was also evaluated. RESULTS: All cases of polyhydramnios were of isolated polyhydramnios without malformations. The rate of polyhydramnios was six (9.5%) and 23 (6.6%) pregnancies with and without congenital CMV, respectively (p = .42). Persistent polyhydramnios (more than one documented event) was evident in one (1.6%) and 13 (3.7%) pregnancies in the positive and negative CMV groups, respectively (p = .36). The rate of congenital CMV was similar with and without oligohydramnios (6, 9.5% versus 17, 4.8%, respectively; p = .14) and with or without small for gestational age neonate (7, 11% versus 63, 18%, respectively; p = .18). CONCLUSION: The results of this study do not support an association between CMV infection and polyhydramnios. The need for CMV testing in isolated polyhydramnios should be reevaluated.

One elevated oral glucose tolerance test value in pregnancy increases the risk for future diabetes mellitus type 2.

PURPOSE: Women with only one elevated 100 g OGTT value are not considered as having gestational diabetes mellitus (GDM) and therefore there are no recommendations to address this population as a risk group for type 2 diabetes mellitus (T2DM). We aimed to elucidate whether one elevated OGTT value increases the risk for T2DM. METHODS: A retrospective population-based cohort study of women with a first diagnosis of GDM who delivered between 1991 and 2011 was conducted. Women were divided according to GDM diagnosis criteria into three groups: (1) at least two elevated values of Carpenter and Coustan criteria (C&C; N = 209), (2) At least two elevated values of the National Diabetes Data Group (NDDG) criteria (NDDG2; N = 290) and (3) only one elevated value of the NDDG criteria (NDDG1; N = 226). A fourth group comprising women without GDM was included (control; N = 352). The primary outcome was the development of T2DM. RESULTS: The mean follow-up was 12.4 ± 5.3 years and the mean age at follow-up was 43.0 ± 5.7 years. The rate of T2DM in the control, C&C, NDDG1 and NDDG2 groups were 5%, 18%, 19% and 31%, respectively. All GDM diagnoses were independent risk factors for T2DM in multivariable Cox regression when compared to controls, adjusted hazard ratio and 95% CI: C&C 7.8 [95% CI 3.7-16.4], NDDG1 5.5 [2.6-11.6], and NDDG2 10.5 [5.2-21.4]. Additional independent risk factors were parity, fasting and 1-h post-glucose load of the OGTT and insulin use. CONCLUSIONS: Women with one elevated OGTT value using the NDDG criteria are at increased risk for T2DM. Further studies are needed to decide whether those women should be considered a focus group for long-term surveillance and T2DM prevention interventions.

Relationship between patient ethnicity and prevalence of anemia during pregnancy and the puerperium period and compliance with healthcare recommendations - implications for targeted health policy.

BACKGROUND: Anemia is common during pregnancy and the puerperium. The association of ethnicity as well as other characteristics with anemia and compliance with healthcare recommendations has not been studied sufficiently and needs to be explored in order to implement a targeted health policy. We examined the association between ethnicity and the risk for prenatal and puerperium anemia and the compliance with healthcare recommendations. This effort aims to guide reforms in policies and practices that will assist in decreasing anemia prevalence in Israel. METHODS: This study was a secondary analysis of a prospective cohort study database including 1558 women who delivered vaginally at Emek Medical Center. Anemia was assessed before delivery by obtaining a complete blood count (CBC). After delivery, CBCs were taken in cases of postpartum hemorrhage, symptoms consistent with anemia, prenatal anemia or other clinical indications. The study population was divided according to their ethnicity (Jews and Arabs). The primary outcomes were anemia before delivery, anemia in the immediate postpartum and 6 weeks postpartum, and compliance with healthcare recommendations, which was defined as the rate of women who performed a routine CBC test 6-weeks-postpartum. RESULTS: The rates of anemia before delivery and in the puerperium period were similar between Jews and Arabs (before delivery: 88 (11%) versus 98 (14%); 6 weeks postpartum: 55 (21%) vs 68 (28%), respectively;p > 0.05). Iron supplementation was high in both groups during pregnancy (~ 90%) and lower during the postpartum for Jews compared to Arabs (72% vs 83%,respectively; P < .0001). Only one third of the patients performed a CBC 6-weeks-postpartum regardless of ethnicity. CONCLUSION: Overall compliance with health recommendation was high during pregnancy but low postpartum and was reflected in anemia persistence regardless of ethnicity. Because of the adverse long term impact of anemia on patient's health, new policies need to be developed to improve patient's compliance postpartum. A possible strategy is to combine the follow-up of the mother with the one of the newborn in the family health stations (Tipat Halav) and the community clinics similarly to the close follow-up during pregnancy. Additional methods may include active summoning for CBC test and assuring iron supplement consumption.

Hemoglobin drop following postpartum hemorrhage.

Postpartum hemorrhage (PPH) is defined as blood loss of ≥ 500-1000 ml within 24 h after delivery. Yet, assessment of blood loss is imprecise. The present study aimed to profile the hemoglobin (Hb) drop after vaginal delivery with versus without PPH. This was a secondary analysis of a prospective cohort study of women who delivered vaginally. Women were included if complete blood counts (CBC) before and after delivery were taken until stabilization (N = 419). Women were categorized into the PPH group and controls, for whom post-delivery CBCs were performed due to indications unrelated to bleeding. The PPH patients were then classified as either overt or occult PPH (symptoms related to hypovolemia without overt bleeding) subgroups. The primary endpoint was mean Hb drop after delivery. One hundred and ten (26%) and 158 (38%) women presented with overt PPH or occult PPH, respectively; 151 (36%) women were included in the control group. Mean Hb decrease from baseline was 3.0 ± 1.6, 2.0 ± 1.4 and 0.9 ± 1.0 g/dl, respectively (p < 0.0001). In all groups, maximal rate of Hb decline was in the first 6-12 h postpartum and plateaued after 24-48 h. At 48 h post-delivery, 95% and 86% of women who had dropped to Hb ≤ 9.5 and < 7 g/dl, respectively, reached those thresholds. Taken together, an Hb decrease ≥ 2 g/dl was consistent with PPH diagnosis and should be followed for at least 48 h after delivery.

A Randomized Controlled Open Label Crossover Trial to Study Vaginal Colonization of Orally Administered Lactobacillus Reuteri RC-14 and Rhamnosus GR-1 in Pregnant Women at High Risk for Preterm Labor.

Lactobacilli administration has been suggested for the treatment and prevention of bacterial vaginosis, which increases the risk for preterm birth. We aimed to evaluate the vaginal colonization of lactobacilli orally administered to pregnant women at risk for preterm birth. We performed a randomized and controlled crossover study between January 2016 and May 2017. Forty pregnant women at high risk for preterm birth with normal vaginal flora (Nugent score ≤ 3) were randomized to either receive two oral capsules/day each containing 5 × 109 Lactobacilli (L.) rhamnosus GR-1 and L. reuteri RC-14 (n = 20) or no treatment (n = 20) for 2 months. Treatments were then crossed over for an additional two months. A vaginal examination and swabbing were performed for assessment of bacterial vaginosis at baseline and every month until study completion. At the same time points, vaginal samples were cultured and subjected to matrix-assisted-laser-desorption/ionization-time-of-flight-mass-spectrometry (MALDI TOF-MS) for the detection of the specific bacterial strains contained in the capsules. The primary endpoint was the presence of the administered lactobacilli strains in the vagina during the first two months of follow-up. Thirty-eight women completed the study. During the first two months of treatment, L. rhamnosus GR-1 was detected in one (5%) woman on the probiotic treatment and 2 (11%) women receiving no treatment (p = 0.6). L. rhamnosus GR-1 was detected in vaginal samples of 4 (11%) women during probiotic treatment (of both groups) and L. reuteri RC-14 was not detected in any samples. The rest of the endpoints were not different between the groups. Altogether, vaginal colonization of lactobacilli following oral administration is low during pregnancy.

Markers for undiagnosed type 2 diabetes mellitus during pregnancy-A population-based retrospective cohort study.

BACKGROUND: To examine possible markers for undiagnosed type 2 diabetes in early-onset gestational diabetes mellitus (GDM). METHODS: A population-based retrospective cohort study of women with GDM diagnosed prior to the 24th week, who delivered between 2005 and 2018, was conducted. The results of the 50-g glucose challenge test, 100-g oral glucose tolerance test, and the first available glycosylated hemoglobin (HbA1c) were examined as markers for type 2 diabetes diagnosed 6 to 12 weeks post pregnancy, which is suggestive of pregestational diabetes. This was done by calculating the area under the curve (AUC) of the receiver operating characteristic (ROC) curve for each marker. These markers and additional ones were evaluated for independency by stepwise multivariate logistic regression. RESULTS: Of 69 417 pregnancies, 3321 (5%) pregnancies were with GDM. Of them, in 261 (8%) women GDM was diagnosed prior to the 24th week, and 219 (84%) women had available data for analysis. Among them, 11 (5%) women had type 2 diabetes post pregnancy. Elevated HbA1c was the most accurate marker for undiagnosed type 2 diabetes (AUC 91% with 95% CI [81%-100%]) and the only independent marker for undiagnosed type 2 diabetes in multivariate analysis (odds ratio [OR] 19; 95% CI [3.2-109], C statistic = 88%). Using the ROC curve, a cutoff of 5.8% predicted type 2 diabetes with 89% sensitivity, 86% specificity, 99.4% negative predictive value, and 23% positive predictive value. CONCLUSIONS: Early-onset GDM with HbA1c ≥ 5.8% should be managed as type 2 diabetes. Definitive diagnosis should be done after delivery.