Comparison of doses of heparin for venous thromboembolism and bleeding in pregnant women

2021 ◽  
pp. jim-2021-002050
Author(s):  
Sha Xiao ◽  
Yuancai Luo ◽  
Lu Guo ◽  
Jing Zhang ◽  
Liping Mu ◽  
...  

The evaluation criteria for dosage of low-molecular-weight heparin (LMWH) for pregnant women at high risk of venous thromboembolism (VTE) remain unclear. A retrospective study was performed to investigate the relative appropriate LMWH administration strategy and dosage for pregnant women at risk of VTE. 219 pregnant women with perinatal and postpartum VTE were reviewed and divided into group A (fixed dose group: n=73, 5000 IU dalteparin daily for all women), group B (weight group: n=73, 2500 IU dalteparin daily for women less than 50 kg; 5000 IU dalteparin daily for women more than 50 kg), and group C (anti-factor Xa (FXa) + weight group: n=73, 5000 IU once daily for women less than 50 kg; 7500 IU once daily for women weighing 50–80 kg; 10,000 IU once daily for women weighing over 80 kg). Further dose administration was adjusted according to peak anti-FXa level, maintaining the peak at the 0.5–1.0 IU/mL range. Women in group C presented lower incidence of VTE and other pregnancy complications than group A and group B. Adjusting the dosage of LMWH according to both weight and anti-FXa level of pregnant women not only prevented VTE but also reduced the risk of postpartum hemorrhage induced by LMWH administration. In addition, adjusting the dose of LMWH according to anti-FXa level and body weight also affected the recurrence of VTE and the occurrence of postpartum hemorrhage in pregnant women.

Author(s):  
Riyaz Mohammed ◽  
Mohammed Azfar Ali

Background: DPP-4 is widely distributed in endothelial cells, pancreas, uterus, liver, salivary glands, lymph node, spleen, and thymus. DPP-4 regulates glucagon-like peptide (GLP)-1, and glucose-dependent insulin tropic peptide (GIP) which leads to glucose homeostasis via enhancing insulin secretion and suppression of glucagon, which results in control of post-prandial and fasting hyperglycemia.Methods: These 40 patients who were enrolled as per the inclusion criteria of receiving metformin dosage of 2 gram per day in established type 2 diabetes mellitus patients with no comorbidities. these patients were divided randomly into two groups comprising of 20 patients each, group A received linagliptin 5 mg per day in addition to metformin 1gm twice daily whereas group B received linagliptin 5 mg per day in a fixed dose (Linagliptin + metformin) of 2.5/1000 twice daily.Results: In the present observational study, the mean age in group A was 46.7±9.4 compared to 51.65±9.9 in group B, p >0.05, mean BMI in group A was 27.8±1.1 compared to 27.28±0.93 in group B p >0.05, Mean FBS in group A was 157.9±24.1 compared to 146.2±21.8 in group B p >0.05, Mean PPBS in group A was 245.8±32.7 compared to 246.2±39.3 in group B p >0.05 and Mean HbA1c in group A was 7.67±0.58 compared to 7.6±0.5 in group B p >0.05. Group A patients were initiated on once daily linagliptin, there was a significant reduction in FBS, PPBS and HbA1c at the end of 6 months p <0.001. Similarly, Group B patients who were initiated on twice daily linagliptin also showed a significant reduction in FBS, PPBS and HbA1c at the end of 6 months p <0.001.Conclusions: The addition of linagliptin to metformin treatment was effective and well tolerated in patients with type 2 diabetes. Linagliptin add-on to metformin during the early course of treatment helps in delaying the exhaustion of pancreatic islet function. Plasma concentrations of linagliptin decline in at least a biphasic manner with a long terminal half-life (>100 hours), related to the saturable binding of linagliptin to DPP-4. The prolonged elimination phase does not contribute to the accumulation of the drug. Addition of linagliptin to metformin has shown a significant reduction in FBS, PPBS and HbA1c.


PEDIATRICS ◽  
1989 ◽  
Vol 83 (6) ◽  
pp. 1041-1048
Author(s):  
Solko W. Schalm ◽  
J. Adriaan Mazel ◽  
Gijsbert C. de Gast ◽  
Rudolf A. Heijtink ◽  
Meindert J. Botman ◽  
...  

Beginning in 1982 all pregnant women undergoing prenatal routine blood analysis in three large city hospitals and one large rural area were tested for hepatitis B surface antigen (HBsAg). Infants of all HBsAg-positive mothers received hepatitis B immunoglobulin (HBIg), 0.5 mL/kg of body weight within two hours of birth and, after randomization, 10 µg of hepatitis B vaccine either at 0, 1, 2, and 11 months of age (schedule A) or at 3, 4, 5, and 11 months of age (schedule B). A second injection of HBIg (1 mL) was given to infants on schedule B at 3 months of age. Blood samples were obtained at 3, 6, 11, 12, 24, and 36 months. In a two-year period, 28,412 pregnant women were tested for HBsAg; screening efficiency varied between 85% and 98%. The overall prevalence of HBsAg was 0.8%, with a marked variation between urban centers (2.2%) and the rural area (0.3%). Vaccinations were received by 180 of 193 infants of HBsAg-positive mothers (90 on schedule A and 90 on schedule B). Concentrations of hepatitis B surface antibody less than 10 IU/L were observed in nine instances in five children from group A and in seven instances in six children from group B. Four hepatitis B viral infections (two HBsAg carriers, two who underwent antihepatitis B core seroconversions) were recorded in group A v one infection (antihepatitis B core seroconversion) in group B. The protective efficacy of the program (screening plus passive immunization and delayed vaccination) was 94%. The estimated cost of preventing one case of hepatitis B infection in neonates was $3,000 (US currency). It is concluded that screening all pregnant women for HBsAg can be introduced effectively at reasonable costs in a country with a low prevalence of HBsAg and a high proportion of home deliveries. Delayed active vaccination starting at 3 months of age may be an effective and, for reasons of high compliance and low cost, attractive alternative to early active vaccination.


2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e16035-e16035
Author(s):  
Shuichi Hironaka ◽  
Ryo Sadachi ◽  
Nozomu Machida ◽  
Satoru Iwasa ◽  
Yasuhide Yamada ◽  
...  

e16035 Background: A phase III study, JCOG1013, did not show the superiority of docetaxel plus cisplatin plus S-1 (DCS) to cisplatin plus S-1 (CS) in overall survival (OS) (Yamada Y, Lancet GH 2019). It is known that cisplatin and gimeracil (an inhibitor of dihydropyrimidine dehydrogenase contained in S-1) are excreted in urine. We previously reported (abstr 197, ASCO-GI 2021) exploratory analysis of JCOG1013 which showed creatinine clearance (CrCl) was associated with safety (Grade [G]4 hematological toxicity for CS, and G3-4 non-hematological toxicity for CS and DCS), but not with efficacy in either group. Here, we report the additional detail results of this exploratory analysis. Methods: Among 741 participants in JCOG1013, patients with serum creatinine level < 1.2 mg/dL were included in this analysis and categorized by CrCl and treatment into A1 (CrCl ≥ 80 mL/min, CS), A2 (60 < CrCl < 80, CS), A3 (CrCl < 60, CS), B1 (CrCl > 80, DCS), B2 (60 < CrCl < 80, DCS), and B3 (CrCl < 60, DCS). The dose (mg/m2) of C/S was 60/80 regardless renal function in group A (A1, A2 and A3), and that of D/C/S was adjusted in group B as follows: 40/60/80 in B1, 40/50/80 in B2, and 40/40/65 in B3. Adverse events, OS, progression-free survival (PFS), and objective response rate (ORR) were compared by CrCl in group A (A1 vs. A2 vs. A3) and group B (B1 vs B2 vs B3), respectively. Results: Of 723 pts (169/136/57 in A1/A2/A3 and 170/138/53 in B1/B2/B3), the median CrCl (mL/min) was 94.1/71.9/53.4 in A1/A2/A3 and 98.2/70.0/55.6 in B1/B2/B3. The relative dose intensity of C/S was 90.4/75.3%, 87.8/74.9% and 85.7/72.8% in A1, A2 and A3, and that of D/C/S was 87.5/77.7/74.9%, 85.8/61.2/72.7% and 87.8/49.4/58.3% in B1, B2 and B3. The incidence of G4 white blood cell decreased, G4 neutrophil count decreased, and G3-4 anorexia were 1.2/4.4/9.3% (P < 0.01), 4.8/11.1/18.5% (P < 0.01), 14.4/28.1/28.6% (P < 0.01) in A1/A2/A3, and 1.8/3.0/4.0% (P = 0.36), 27.3/24.8/20.0% (P = 0.28), 22.4/29.3/32.0% (P = 0.11) in B1/B2/B3, respectively. No significant association between CrCl and other adverse events was observed either in CS or in DCS group. The median OS was 15.4/15.5/15.4 months in A1/A2/A3 (P = 0.89) and 15.3/13.7/13.7 months in B1/B2/B3 (P = 0.72). The median PFS was comparable among A1/A2/A3 (7.1/6.8/6.2 months, P = 0.88) and B1/B2/B3 groups (7.5/7.2/7.8 months, P = 0.85). ORR showed no significant difference in A1/A2/A3 (58.9/57.8/46.9%, P = 0.31) and B1/B2/B3 groups (62.0/61.5/51.5%, P = 0.36). Conclusions: Dose modification according to renal function in the DCS arm could control the increase of severe toxicities, which were observed frequently in patients with low renal function in patients receiving fixed dose of CS. Clinical trial information: 000007652.


2021 ◽  
Vol 15 (10) ◽  
pp. 3423-3425
Author(s):  
Amna Najam ◽  
Samreen Fakeer Muhammad ◽  
Samia Saifullah ◽  
Maryam Shoaib ◽  
Maria Anwar

Objective: The aim of this study is to compare the fetal and maternal outcomes in between asymptomatic and symptomatic COVID positive pregnant women. Study Design: Retrospective cohort study Place and Duration: The study was conducted at Gynae and Obs department of Sandeman Provincial Hospital, Quetta for duration of six months from November 2020 to April 2021. Methods: One hundred and ten pregnant women with ages 18-45 years had corona virus disease were presented. Informed written consent was taken from all patients for detailed demographics. COVID -19 was diagnosed by PCR. 55 patients had symptoms of coronavirus were included in group A and 55 patients did not show symptoms were included in group B. Frequency of pre-eclampsia, gestational diabetes mellitus and post-partum haemorrhage were calculated. Maternal adverse outcomes (cesarean section, instrumental delivery, induction of labor and prolong labor, hypertensive disorder) were calculated among both groups. Fetal outcomes perinatal mortality, Low birth weight, Low Apgar score and NICU admission were observed. SPSS 20.0 version was used to analyze all data. Results: Mean age of the patients in group A was 28.47±3.18 years with mean BMI 24.03±5.24 Kg/m2 and in group B mean age was 27.99±4.17 years with mean BMI 24.44±6.41 Kg/m2. Maternal outcomes (cesarean section, instrumental delivery, induction of labor and prolong labor,) in symptomatic group were significantly higher than that of asymptomatic group. Fetal outcomes, perinatal mortality in group A 9 (16.4%) and in group B was 5 (9.1%), low birth weight in group A was among 21 (38.2%) and in group B was 10 (18.2%), low apgar score in group A was 11 (20%) and in group B was 8 (14.4%), 15 (27.3%) in group A went to NICU admission and 3 (5.5%) patient in group II admitted to NICU. Conclusion: In this study we concluded that adverse outcomes among symptomatic COVID pregnant women were higher than that of asymptomatic coronavirus pregnant women in terms maternal and perinatal outcomes. Keywords: Pregnant women, Coronavirus, Symptomatic, Asymptomatic, Adverse Outcomes


2014 ◽  
Vol 2 (2) ◽  
pp. 21-27
Author(s):  
P Basnet ◽  
N Aggrawal ◽  
V Suri ◽  
P Dutta ◽  
K Mukhopadhyay

BACKGROUND: Thyroid disorder is one of commonest endocrine disorder in women and hence constitutes a common endocrine disorder complicating pregnancy. Diagnosing and treating hypothyroidism preconceptionally and during early pregnancy appears to be a useful strategy to improve maternal and fetal outcome. OBJECTIVE: To compare the maternal and perinatal outcome in pregnant women with hypothyroidism diagnosed preconceptionally with hypothyroidism diagnosed during pregnancy. METHODS: A prospective study. One hundred pregnant women with hypothyroidism at less than 20 weeks Period of Gestation (POG) were recruited for the study and grouped into two groups: Group A-hypothyroidism diagnosed and on treatment before conception, Group B-hypothyroidism diagnosed and started on treatment during pregnancy. Both groups were intensively monitored during pregnancy with serial Thyroid Function Test (TFT) and thyroxine replacement doses were adjusted accordingly. Various maternal, perinatal and fetal outcome measures were studied in both groups prospectively till delivery. RESULTS: The maternal and fetal complications were comparable in the two groups, however the fetal birth weight was significantly higher in Group A versus Group B (2.89±0.485kg vs. 2.70±0.453kg; p=0.039). All the new born babies had normal thyroid function. CONCLUSION: Hypothyroidism diagnosed preconceptionally or during early pregnancy and treated appropriately has beneficial effect on fetal birth weight, and hence the total pregnancy outcome. Screening for thyroid dysfunction should be judiciously performed in all high risk women prior to a planned conception or during their first antenatal visit. DOI: http://dx.doi.org/10.3126/jucms.v2i2.11170   Journal of Universal College of Medical Sciences (2014) Vol.2(2): 21-27


1999 ◽  
Vol 17 (7) ◽  
pp. 2160-2160 ◽  
Author(s):  
Monika Engelhardt ◽  
Hartmut Bertz ◽  
Matthias Afting ◽  
Cornelius F. Waller ◽  
Jürgen Finke

PURPOSE: The efficacy of a high- versus a standard-dose filgrastim (recombinant human granulocyte colony-stimulating factor, or rhG-CSF) regimen to mobilize peripheral-blood progenitor cells (PBPCs) for allogeneic transplantation was investigated in 75 healthy donors. PATIENTS AND METHODS: From December 1994 to December 1997, 75 consecutive donors (median age, 38 years; range, 17 to 67 years) were assigned to two different schedules of rhG-CSF for PBPC mobilization. Fifty donors received 24 μg rhG-CSF/kg body weight (BW) divided into two daily subcutaneous injections (two doses of 12 μg, group A), whereas 25 were treated with 10 μg rhG-CSF once daily (group B). Apheresis was started on day 4 in group A and on day 5 in group B. Target CD34+ cell numbers in apheresis products were ≥ 4 × 106/kg recipient BW. RESULTS: Cytokine priming and collection of PBPCs were equally well tolerated in both groups. Significantly higher CD34+ cell numbers in group A with 3.7 × 106/kg recipient BW/apheresis (0.47 × 106/L apheresis) compared with 2 × 106/kg recipient BW/apheresis (0.25 × 106/L apharesis) in group B were obtained (P < .05). Using standard aphereses (median, 9 L), two doses of 12 μg rhG-CSF/kg allowed collection of ≥ 4 × 106/kg CD34+ cells with two aphereses (range, one to three) in group A versus three aphereses (range, one to six) in group B (P < .015). Donor age, sex, and BW influenced the collection of CD34+ cell numbers: in particular, significantly higher apheresis results were obtained in donors younger than 40 years compared with donors older than 40 years of age (P < .05). In 65 CD34+ selection procedures using avidin-biotin immunoabsorption columns (Ceprate SC System, CellPro, Bothell, WA), a median CD34+ purity of 53%, CD34+ recovery of 40%, and the collection of 2 × 106/kg CD34+ cells/selection were achieved. In group A with higher CD34+ cells/kg/apheresis, CD34+ purity, recovery, and cell yields were 60%, 45%, and 2.3 × 106/kg/selection, respectively, as compared with 48%, 31%, and 0.7 × 106/kg in group B (P < .05). CONCLUSION: Our results demonstrate that twice daily rhG-CSF (two doses of 12 μg/kg BM) compared with once daily rhG-CSF (10 μg/kg BW), in addition to being well tolerated, significantly improves PBPC mobilization, allows the collection of higher numbers of CD34+ cells with one or two standard aphereses, and facilitates subsequent selection procedures in healthy allogeneic donors.


Author(s):  
Priyanka . ◽  
Shashi Bala Arya ◽  
Mirdu Sinha ◽  
J. K. Goel

Background: Induction of labour implies stimulation of uterine contraction before spontaneous onset of labour with or without ruptured membranes. Aim of this study was to compare the efficacy and safety of intracervical Foley’s catheter with oxytocin and vaginal misoprostol for labour induction at term.Methods: A total 100 term pregnant women were chosen with bishop score <6 and divided into two groups: Foley’s catheter with oxytocin (Group A) and vaginal misoprostol (Group B). In Group A, a 16 F Foley’s catheter introduced beyond internal os and traction applied every 4 hourly to check for expulsion with simultaneous oxytocin infusion (2 mU/min up to 32 mU/min). In Group B, 25 mcg misoprostol administered every 4 hourly (maximum 6 doses or 150 mcg). Data analysed using SPSS software 20.0. A p value <0.05 was considered statistically significant.Results: No statistical difference found between demographic variables between two groups. Both primigravida and multigravida had poor pre-induction bishop score in both groups. Foley’s catheter (80%) and misoprostol group (96%) had successful induction and was statistically significant (p<0.05). Foley’s catheter took more time from induction-delivery both in primigravida and post-dated pregnant women. The rate of cesarean in Foley’s catheter group was high (62.5%) including 33% cases with failed induction. Foley’s catheter had less maternal and neonatal complications, less NICU admission as compared to misoprostol (p>0.05).Conclusions: Misoprostol was found better for successful induction, decreases induction-to-delivery interval and increases vaginal delivery as compared to Foley’s catheter but it needs constant supervision in view of hyperstimulation and tachysystole.


2020 ◽  
Vol 86 (4) ◽  
pp. 369-376
Author(s):  
Simon G. Rodier ◽  
Mirhee Kim ◽  
Samantha Moore ◽  
Spiros G. Frangos ◽  
Manish Tandon ◽  
...  

This study evaluated the safety of early anti-factor Xa assay–guided enoxaparin dosing for chemoprophylaxis in patients with TBI. We hypothesized that assay-guided chemoprophylaxis would be comparable in the risk of intracranial hemorrhage (ICH) progression to fixed dosing. An observational analysis of adult patients with blunt traumatic brain injury (TBI) was performed at a Level I trauma center from August 2016 to September 2017. Patients in the assay-guided group were treated with an initial enoxaparin dose of 0.5 mg/kg, with peak anti-factor Xa activity measured four hours after the third dose. Prophylactic range was defined as 0.2 to 0.5 IU/mL with a dose adjustment of ± 10 mg based on the assay result. The assay-guided group was compared with historical fixed-dose controls and to a TBI cohort from the most recent Trauma Quality Improvement Project dataset. Of 179 patients included in the study, 85 were in the assay-guided group and 94 were in the fixed-dose group. Compared with the fixed-dose group, the assay-guided group had a lower Glasgow Coma Score and higher Injury Severity Score. The proportion of severe (Abbreviated Injury Score, head ≥3) TBI, ICH progression, and venous thromboembolism rates were similar between all groups. The assay-guided and fixed-dose groups had chemoprophylaxis initiated earlier than the Trauma Quality Improvement Project group. The assay-guided group had the highest percentage of low molecular weight heparin use. Early initiation of enoxaparin anti-factor Xa assay–guided venous thromboembolism chemoprophylaxis has a comparable risk of ICH progression to fixed dosing in patients with TBI. These findings should be validated prospectively in a multicenter study.


Author(s):  
Ahmed N. Fetih ◽  
Ahmed M. Abbas ◽  
Fatma A. Kamel ◽  
Ihab H. El Nashar

Background: The current study aims to compare the use of tamoxifen and oral contraceptive pills in women using implanon and complain with irregular uterine bleeding.Methods: Women attended family planning clinic using implanon presented by bleeding were invited to participate in the study. They were randomized into two groups: Group A: 100 women received Tamoxifen 10 mg twice daily for 10 days taken at the onset of an episode of bleeding or spotting episode. Group B: 100 women received Combined oral contraceptive pills (microcept) once daily for 21 days take at the onset of an episode of bleeding or spotting episode.Results: No difference regarding the baseline criteria of both groups. No difference between both groups regarding the duration of irregular bleeding in the implanon users (p=0.090). Additionally, the number of bleeding days and spotting in the last month was similar in both groups (p=0.554). The percentage of women who stopped bleeding during the period of treatment is 84% in the tamoxifen group and 92% in the COCs group, but the COCs needs longer treatment time, where the mean of days required to stop bleeding is 5.03±1.8 days in the tamoxifen group and 6.5±2.5 in the COCs group. Headache and nausea were the most prominent adverse effects found in the COCs group (p=0.000).Conclusions: Oral administration of tamoxifen 10 mg twice daily for 10 days is effective on stopping bleeding attacks in implanon users.


Author(s):  
Shubha Rao ◽  
Shylabhirami Sridharan ◽  
Akhila Vasudeva ◽  
Roopa P. S.

Background: Controlling the process of childbirth has disabled the parturient to embrace the most spontaneous position of delivery but constricting her to assume a recumbent position. Objective of this study was to study if alternating comfortable maternal positioning i.e., recumbent and alternative position have any influence in the process of labor, type of delivery, neonatal well-being.Methods: Study conducted an observation study on term pregnant women. Study inclusion criteria included all term pregnant women. Exclusion criteria included multiple pregnancies, preterm patient, severe pre-eclampsia, and eclampsia, preterm premature rupture of membranes, sever intrauterine growth restricted fetus. The measured date were maternal general characteristics, duration of labor process, type of delivery and neonatal outcome. Patients were divided into two groups. Group A - if they spent more than 50% in a recumbent position and Group B - any other alternating position.Results: A total 250 women were equally included in this study. The demographic characteristics were matched in both groups and found no significant difference. In the process of labor, Group B had a difference of 1 hours as compared to Group A and the rate of cervical dilation was also faster in Group B. Both of these variables were found to be statistically significant. However, there were no significant difference in the terms of type of delivery and neonatal outcome.Conclusions: The ancient practice of recumbent position during labor is to be discarded as alternating maternal position during the process of labor may a positive influence on the total duration labor. However even though it may or may not have an influence on the other outcome such as route of delivery and neonatal outcome, it is best to encourage women to move and deliver in the most comfortable position.


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