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Importance: Women with arrested preterm labor (APTL) are at very high risk for spontaneous preterm delivery (SPTD), the leading cause of neonatal mortality and morbidity. To date, no maintenance therapy has been found to be effective for pregnancy prolongation. A few clinical trials with considerable methodological limitations have demonstrated some efficacy for 400 mg vaginal micronized progesterone (VMP) in women with APTL. Objective: To investigate the effectiveness of daily 400 mg VMP for the prolongation of pregnancy after APTL. Design, Setting, and Participants: This randomized clinical trial was conducted between December 19, 2018, and February 27, 2023, in 3 university-affiliated medical centers in Israel. Participants included women with singleton and twin pregnancies after APTL following tocolysis at 24 weeks 0 days to 34 weeks 0 days' gestation. Women with a history of preterm delivery or asymptomatic cervical shortening in the current pregnancy were excluded. Interventions: Participants were randomly allocated to receive VMP 200 mg twice a day or no treatment until 36 weeks 6 days' gestation. Main Outcomes and Measures: The primary end points were mean number of days from study enrollment to delivery and the rate of SPTD prior to 37 weeks' gestation. Results: A total of 129 participants were enrolled (65 in the VMP group and 64 in the no-treatment group). Mean (SD) age was 27.6 (5.1) years. Between the VMP and no-treatment groups, there was no difference in pregnancy prolongation (mean [SD], 40.0 [17.8] vs 37.4 [20.3] days; P = .44) and the rate of SPTD (16 [25%] vs 19 [30%]; relative risk, 0.8; 95% CI, 0.5-1.5; P = .52). In twin pregnancies, including 12 and 15 pairs in the VMP and no-treatment groups, respectively, VMP prolonged pregnancy (mean [SD], 43.7 [18.1] vs 26.1 [15.2] days; P = .02), postponed the delivery week (36.5 [1.4] vs 34.7 [2.2] weeks; P = .01), shortened the length of stay in the neonatal intensive care unit (4.9 [10.6] vs 13.2 [18.5] days; P = .03) and overall hospital stay (8.3 [9.6] vs 15.1 [17.2] days; P = .03), and was associated with a higher birth weight (2444 [528] vs 2018 [430] g; P = .01). Conclusions and Relevance: These findings show that VMP given in a dosage of 200 mg twice a day following APTL is not an effective treatment to prolong pregnancy or prevent SPTD. However, VMP demonstrated beneficial effects in twin pregnancies, warranting further investigation. Trial Registration: ClinicalTrials.gov Identifier: NCT02430233.
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Trabajo de Parto Prematuro , Progesterona , Humanos , Femenino , Embarazo , Progesterona/administración & dosificación , Progesterona/uso terapéutico , Adulto , Administración Intravaginal , Trabajo de Parto Prematuro/tratamiento farmacológico , Trabajo de Parto Prematuro/prevención & control , Nacimiento Prematuro/prevención & control , Israel , Recién Nacido , Progestinas/administración & dosificación , Progestinas/uso terapéuticoRESUMEN
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 (>6â¯×â¯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.
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Diabetes Gestacional , Probióticos , Embarazo , Recién Nacido , Femenino , Humanos , Diabetes Gestacional/diagnóstico , Diabetes Gestacional/tratamiento farmacológico , Diabetes Gestacional/prevención & control , Estudios Prospectivos , Control Glucémico , Glucemia , Probióticos/uso terapéutico , GlucosaRESUMEN
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.
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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.
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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.
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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.
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Enoxaparina , Tromboembolia Venosa , Femenino , Humanos , Anticoagulantes/efectos adversos , Enoxaparina/efectos adversos , Periodo Posparto , Tromboembolia Venosa/diagnóstico , Tromboembolia Venosa/epidemiología , Tromboembolia Venosa/prevención & controlRESUMEN
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.
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Diabetes Gestacional , Resistencia a la Insulina , Insulinas , Probióticos , Embarazo , Recién Nacido , Femenino , Humanos , Peso al Nacer , Control Glucémico , Glucemia/metabolismo , Probióticos/uso terapéutico , Suplementos Dietéticos , TriglicéridosRESUMEN
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.
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COVID-19 , Complicaciones Infecciosas del Embarazo , Recién Nacido , Femenino , Embarazo , Humanos , COVID-19/diagnóstico , COVID-19/epidemiología , SARS-CoV-2 , Mujeres Embarazadas , Estudios Prospectivos , Estudios de Cohortes , Complicaciones Infecciosas del Embarazo/diagnóstico , Complicaciones Infecciosas del Embarazo/epidemiología , Resultado del Embarazo , Inmunoglobulina GRESUMEN
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.
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COVID-19 , SARS-CoV-2 , Anticuerpos Antivirales , Femenino , Humanos , Inmunidad Humoral , Inmunoglobulina G , Inmunoglobulina M , Recién Nacido , Embarazo , Estudios ProspectivosRESUMEN
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.
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Diabetes Mellitus Tipo 2 , Diabetes Gestacional , Índice de Masa Corporal , Estudios de Cohortes , Diabetes Mellitus Tipo 2/diagnóstico , Diabetes Mellitus Tipo 2/epidemiología , Diabetes Gestacional/diagnóstico , Diabetes Gestacional/epidemiología , Femenino , Prueba de Tolerancia a la Glucosa , Humanos , Masculino , Embarazo , Estudios Retrospectivos , Factores de RiesgoRESUMEN
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 .
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Analgesia , Morfina , Analgésicos Opioides , Cesárea/efectos adversos , Cesárea/métodos , Método Doble Ciego , Femenino , Humanos , Morfina/uso terapéutico , Dolor Postoperatorio/tratamiento farmacológico , Dolor Postoperatorio/etiología , EmbarazoRESUMEN
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.
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Anemia Ferropénica/tratamiento farmacológico , Compuestos Ferrosos/uso terapéutico , Hematínicos/uso terapéutico , Atención Prenatal , Trastornos Puerperales/tratamiento farmacológico , Administración Oral , Adulto , Femenino , Compuestos Ferrosos/administración & dosificación , Hematínicos/administración & dosificación , Humanos , Infusiones Intravenosas , Embarazo , Estudios Prospectivos , Resultado del TratamientoRESUMEN
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.
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Anemia Ferropénica/sangre , Anemia/sangre , Hemoglobinas/genética , Hierro/metabolismo , Adulto , Anemia/genética , Anemia/metabolismo , Anemia/patología , Anemia Ferropénica/genética , Anemia Ferropénica/metabolismo , Anemia Ferropénica/patología , Área Bajo la Curva , Recuento de Células Sanguíneas , Parto Obstétrico , Femenino , Hemoglobinas/aislamiento & purificación , Hemoglobinas/metabolismo , Humanos , Embarazo , Factores de RiesgoRESUMEN
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.
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Infecciones por Citomegalovirus , Oligohidramnios , Polihidramnios , Infecciones por Citomegalovirus/complicaciones , Infecciones por Citomegalovirus/epidemiología , Femenino , Feto , Humanos , Recién Nacido , Oligohidramnios/epidemiología , Polihidramnios/epidemiología , Embarazo , Estudios RetrospectivosRESUMEN
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.
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Diabetes Mellitus Tipo 2/epidemiología , Diabetes Gestacional/diagnóstico , Diagnóstico Prenatal , Adulto , Estudios de Cohortes , Diabetes Mellitus Tipo 2/etiología , Femenino , Prueba de Tolerancia a la Glucosa , Humanos , Israel/epidemiología , Embarazo , Estudios Retrospectivos , Factores de Riesgo , Adulto JovenRESUMEN
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.
Asunto(s)
Parto Obstétrico , Hemoglobinas/análisis , Hemorragia Posparto/diagnóstico , Adulto , Recuento de Células Sanguíneas , Femenino , Humanos , Hemorragia Posparto/sangre , Estudios Prospectivos , Adulto JovenRESUMEN
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.
Asunto(s)
Anemia/epidemiología , Política de Salud , Compuestos de Hierro/administración & dosificación , Complicaciones Hematológicas del Embarazo/epidemiología , Adulto , Anemia/etnología , Árabes/estadística & datos numéricos , Estudios de Cohortes , Bases de Datos Factuales , Femenino , Humanos , Israel , Judíos/estadística & datos numéricos , Cooperación del Paciente/etnología , Cooperación del Paciente/estadística & datos numéricos , Periodo Posparto , Embarazo , Complicaciones Hematológicas del Embarazo/etnología , Estudios Prospectivos , Adulto JovenRESUMEN
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.
Asunto(s)
Lacticaseibacillus rhamnosus , Limosilactobacillus reuteri , Trabajo de Parto Prematuro/prevención & control , Mujeres Embarazadas , Nacimiento Prematuro/prevención & control , Probióticos/administración & dosificación , Vigna/microbiología , Administración Oral , Adolescente , Adulto , Estudios Cruzados , Femenino , Humanos , Limosilactobacillus reuteri/aislamiento & purificación , Lacticaseibacillus rhamnosus/aislamiento & purificación , Trabajo de Parto Prematuro/etiología , Embarazo , Nacimiento Prematuro/etiología , Riesgo , Adulto JovenRESUMEN
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.
Asunto(s)
Biomarcadores/sangre , Diabetes Mellitus Tipo 2/sangre , Diabetes Gestacional/sangre , Prueba de Tolerancia a la Glucosa/métodos , Hemoglobina Glucada/metabolismo , Adulto , Diabetes Mellitus Tipo 2/diagnóstico , Diabetes Gestacional/diagnóstico , Femenino , Edad Gestacional , Humanos , Modelos Logísticos , Análisis Multivariante , Embarazo , Curva ROC , Estudios RetrospectivosRESUMEN
PURPOSE: A glycemic control marker to predict neonatal diabetic complications is unavailable. We aimed to examine if 1,5-anhydroglucitol (1,5-AG) can predict neonatal complications in women with diabetes in pregnancy. METHODS: Prospective observational study from December 2011 to August 2013. We recruited 105 women, 70 diabetic (gestational and pregestational) and 35 nondiabetic. 1,5-AG at birth was compared between the two groups. In the diabetic group 1,5-AG, HbA1c, and fructosamine were measured before glycemic control initiation (first visit), after 4-6 weeks (second visit), and at delivery. Women were divided to poor (1,5-AG values below median at birth) and good (1,5-AG values at median and above) glycemic control groups. Mean daily glucose charts were collected. The primary outcome was a composite of neonatal diabetic complications: respiratory distress, hypoglycemia, polycythemia, hyperbilirubinemia, and large for gestational age. RESULTS: Mean 1,5-AG in the nondiabetic group was similar to that of the diabetic group without the composite outcome and was significantly higher than in the diabetic group with the composite outcome. The rate of the composite outcome was higher in the poor glycemic control group compared with the good glycemic control group (adjusted odds ratio (OR) 3.8 95% CI [1.2-12.3]). Only 1,5-AG was inversely associated with the composite outcome at all time points; the second visit was the only independent risk factor in multivariable logistic regression (OR 0.7 95% CI 0.54-0.91). The rest of the glycemic markers were not associated with neonatal composite outcome. CONCLUSIONS: 1,5-AG is inversely associated with neonatal diabetic complications and is superior to other glycemic markers in predicting those complications.