Compare safety and efficacy of intramuscular progesterone versus vaginal progesterone in prevention of preterm labour

2021 ◽  
Vol 8 (4) ◽  
pp. 541-547
Author(s):  
Shilpa Chaudhari ◽  
Aparajita Mishra ◽  
Kishor Hol ◽  
Shraddha Shastri

Currently preterm labour is one of the most challenging problem faced by both obstetricians and perinatologists, this episode in the course of woman’s pregnancy takes a heavy tool for perinatal mortality which accounts for approximately 50-75%. The incidence of preterm labour is estimated to be 5-10% of all pregnancies. It was a prospective randomize control study. All the cases with inclusion and exclusion criteria were selected during the study period. The subjects were randomized into two groups with group A received vaginal micronized progesteron and group B intramuscular 17a hydroxyprogesteron caproate. Total of 100 cases were included in this study. All preterm pregnancy of more than 20 weeks were considered in this study. Initial nefidipine 10 mg, 4 tablets 15 min apart was given for tocolytic activity for 48 hours. Injection bethamethasone 12 mg I.M 2 doses in a duration of 24 hours apart is given for fetal lung maturity. One group will receive weekly intramuscular 17a hydroxyprogesteron (250 mg) injection while other group will receive daily micronized vaginal progesteron suppository (200mg). Subsequently compare the safety and efficacy of intramuscular progesterone versus micronized progesterone as a maintenance therapy in preventing preterm labour and analyse maternal and fetal factors.Subsequently compared the safety and efficacy of intramuscular progesterone versus micronized progesterone as a maintenance therapy in preventing preterm labour.This analysis showed that women who randomized to progesterone prophylaxis had a significantly increase in duration of pregnancy. The mean ± SD of birthweight in Group A and Group B was 2784.2 ± 490.7 gm and 2813.9 ± 363.3 gm respectively which confirmed the positive effects of progesterone on increasing infants’ weights at birth. Authors concluded that progesterone therapy had acceptable efficacy in the prevention of preterm labor in terms of prolongation of delivery and by increasing gestational age at delivery.

Author(s):  
Aparajita Ashok Mishra ◽  
Shilpa N. Chaudhari

Background: Currently preterm labour is one of the most challenging problem faced by both obstetricians and perinatologists, this episode in the course of woman’s pregnancy takes a heavy tool for perinatal mortality which accounts for approximately 50-75%. The incidence of preterm labour is estimated to be 5-10% of all pregnancies.Methods: It was a prospective randomize control trail over a period of 3 year at department of obstetrics and gynecology, tertiary care hospital Pune, Maharashtra, India. Total 100 subjects were randomized into two groups with group one receiving vaginal micronized progesterone and group two control group receiving only tocolytics and steroids. Subsequently authors compared the safety and efficacy of vaginal micronized progesterone versus placebo as a maintenance therapy in preventing preterm labour.Results: This analysis showed that women who randomized to progesterone prophylaxis had a significantly increase in duration of pregnancy. The mean of birthweight in Group A and Group B was 2963±36 gm and 2567±49 gm and respectively which confirmed the positive effects of progesterone on increasing infants’ weights at birth.Conclusions: Authors concluded that progesterone therapy had acceptable efficacy in the prevention of preterm labor in terms of prolongation of delivery and by increasing gestational age at delivery.


2018 ◽  
Vol 27 (6) ◽  
pp. 555-561 ◽  
Author(s):  
Michael F.E. Diejomaoh ◽  
Waleed Al-Jassar ◽  
Zainab Bello ◽  
Kavitha Karunakaran ◽  
Asiya Mohammed

Objective: The cesarean delivery rate has increased worldwide. The aim of our study was to assess the events associated with the second cesarean deliveries in our institution. Subjects and Methods: All cesarean deliveries at the Maternity Hospital, Kuwait, from January 1 to December 31, 2013, were identified. A comparative study was undertaken on patients having their first and second cesarean deliveries. The social and clinical characteristics of these patients were extracted from our records and the antenatal, intrapartum, and postpartum course of the pregnancies and their outcomes documented. Results: During the study period, 10,586 deliveries were recorded, including 3,676 cesarean deliveries, i.e., a cesarean delivery rate of 34.7%. 840 of these patients were undergoing their first cesarean delivery (group A) and 607 patients were undergoing their second (group B); 484 patients from group A and 341 patients from group B with complete records were analyzed. Mean age (30.89 ± 4.93 vs. 29.94 ± 5.56 years, p = 0.008), parity (1.49 ± 1.22 vs. 0.98 ± 1.60, p < 0.0001), gestational age at delivery (38.12 ± 2.61 vs. 37.66 ± 3.11 weeks, p = 0.02), and fetal birth weight (3,211.60 ± 691.51 vs. 2,829.73 ± 863.26 g, p < 0.001) were significantly higher in group B than in group A. 53.2% of the patients in group B requested repeat cesarean delivery, their second cesarean. The rate of maternal morbidity was low. Conclusions: The incidence of repeat cesarean delivery in group B is high, and its reduction should contribute to a lowering of the overall cesarean delivery rate.


2019 ◽  
Vol 2019 ◽  
pp. 1-9 ◽  
Author(s):  
Erica Shih-Wei Hung ◽  
Shih-Ching Chen ◽  
Fan-Chien Chang ◽  
Yaojung Shiao ◽  
Chih-Wei Peng ◽  
...  

Purpose. This study evaluated the effects of interactive video game-based (IVGB) exercise on balance in diabetic patients with peripheral neuropathy. Materials and Methods. Twenty-four patients were randomly assigned to two groups (12 participants per group). Group A received IVGB training for the first 6 weeks, with no exercise in the subsequent 6 weeks. Group B had no exercise for the first 6 weeks and then underwent IVGB training in the subsequent 6 weeks. For all participants, the Modified Falls Efficacy Scale (MFES), Time Up and Go (TUG) test, Berg Balance Scale (BBS), and Unipedal Stance Test (UST) were employed at weeks 0, 6, and 12 of the experiment. Results. BBS, right-leg UST, and TUG test scores significantly improved after IVGB intervention, whereas MFES and left-leg UST tended to improve after IVGB intervention. Conclusions. This study revealed that 6-week balance-based exercise training using the IVGB system exerted positive effects on functional balance in patients with diabetic peripheral neuropathy (DPN).


Author(s):  
Yeswanth Prasanna Kumar B ◽  
Praveen D ◽  
Vijey Aanandhi M

Aim and Objectives: The aim of the study was to study the serum zinc (Zn) levels, safety, and efficacy of Zn supplementation in pulmonary tuberculosis (PTB) patients.Methods: A randomized single-blinded study of two groups: Group A received conventional TB therapy while Group B received conventional TB therapy along with 15 mg of Zn tablet. 40 patients were assigned in each group by randomized permuted blocks.Results: After 8 weeks of treatment in Group A 27 patients and Group B 36 patients were found to be sputum negative with p=0.0421 and 0.0629. After 24 weeks of treatment in Group A 37 patients and Group B 40 patients were found to be sputum negative with p=0.00976 and 0.00971. By this, the given treatment was effective in the patients with PTB.Conclusion: Zn supplementation improves the effect of TB medication treatment and results in earlier sputum smear conversion.


2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 6041-6041 ◽  
Author(s):  
B. Krishnamurthyreddy ◽  
M. S. Vidyasagar ◽  
R. Koteshwar ◽  
A. Shenoy ◽  
L. Viswanath ◽  
...  

6041 Background: Patients (pt) with advanced inoperable squamous cell carcinoma of the head and neck (SCCHN) have poor radiotherapy alone (RT) outcome. EGFR is over-expressed in >90% SCCHN. h-R3mAb (BIOMAb/nimotuzumab/TheraCIM) is a humanized monoclonal antibody, a validated oncotherapeutic-targeting EGFR. Objective: To investigate the safety and efficacy of concurrent h-R3mAb in combination with chemoradiotherapy of SCCHN. Methods: September 2004–2005, pt 18–70 yrs, SCCHN stageIII-IVA, 113 screened, 92 enrolled and randomly asssigned to, Group A: radical radiotherapy (pt) and Group B: chemoradiotherapy (pt). Randomization within Group A: [RT]v/s[RT+h-R3mAb] and within Group B: [RT+CT]v/s[RT+CT+ h-R3mAb] (n = 23 in each arm). Protocol: Radiotherapy: TD: 66 Gy,2Gy/Fr,5Fr/w,6.5wks. Radiation sensitizer (chemotherapy): CDDP-50mg/wk x 6wks. Study Drug (h-R3mAb): 200 mg/wk I.V.60min x 6weeks. Results: Evaluable (n = 76) in Group A-36 and Group B-40. F/u Analysis at 30 months after end of RT. Survival rate ITT: Group B: CT+RT+hR3- 69.5% v/s CT+RT-21.7% (p - 0.0011), Group A: RT alone - 21.7% v/s RT+ hR3–39.1% (ns). Progression-free survival: RT alone - 3(13.04 %) v/s RT+hR3mAb-8 (34.78 %), RT+CT-5 (21.74 %) v/s RT+CT+hR3mAb-13 (56.52%). Median overall survival (OS): CT+RT+hR3 - NR* v/s CT+RT- 21.96 months (hazard ratio [HR]-0.337, p - 0.0018) and RT alone - 25.02 v/s RT+hR3 - NR*(HR-0.678, p - 0.39). Disease-free survival: CT+RT+hR3- NR*v/sCT+RT-21.30 mths (HR-0.344, p - 0.0052) and RT alone-25.02 v/s RT+hR3- NA* (HR-0.599, p - 0.32). (NR*- median OS is yet to be reached). Safety: few grade - 1/2AE, no HAMA observed. OS per protocol - adding h-R3mAb to chemoradiation resulted in a reduction in risk of death (rrd) by 85% (HR 0.15, p - 0.0006) and to RT a 36 % rrd (HR0.64, p - 0.33). Conclusions: Concurrent use of h-R3mAb with RT or RT+CT is safe and efficacious. It enhances radiation and chemotherapy responses. Concurrent use of h-R3mAb with chemoradiotherapy enhances long-term loco-regional control and survival. Adding biological agents to physically targeted modality improves long-term therapeutic outcome of SCCHN. No significant financial relationships to disclose.


Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 5821-5821 ◽  
Author(s):  
Sara Farshchi Zarabi ◽  
Esther Masih-Khan ◽  
Christine Chen ◽  
Vishal Kukreti ◽  
Anca Prica ◽  
...  

Abstract Background: A second (salvage) ASCT has frequently been offered to MM patients with relapsed disease who experience benefit from the first procedure. We have previously reported that pts undergoing a salvage ASCT in the era of VAD or thalidomide (thal) have a median progression-free survival (PFS) of 19 months (mos). The best results were observed in pts who experienced ≥ 2 year benefit after their first ASCT (Jimenez-Zepeda VH et al. Biol Blood Marrow Transplant 2012; 18: 773-9). However, the utility of this approach after the introduction of novel chemotherapeutic agents--such as bortezomib (BTZ)--remains unclear. Initially, provincial funding for BTZ in Ontario was provided only for relapsed disease. However, in 2007, the combination of either BTZ + dexamethasone (BTZ-dex) or cyclophosphamide, BTZ + dex (CyBorD) was adopted as the standard induction regimen for newly diagnosed pts before ASCT performed as part of first-line therapy. We now examine the results of salvage ASCT in our centre after the availability of BTZ. Methods: We used the Princess Margaret Myeloma Database to identify and characterize patients with relapsed MM who had received a bortezomib (BTZ)-based regimen for remission induction prior to their first ASCT or for re-induction before salvage ASCT. A retrospective chart review was performed to investigate the PFS and overall survival (OS) outcomes of these pts. Results: Between 01/2005 and 07/2015, 64 pts with MM who had previously received BTZ-based therapies underwent salvage ASCT for relapsed disease at our centre (Table 1). Median age was 56.9 yrs (range 37-67.3); 37 (58%) were male. ISS stage was 1 in 32 (50%), 2 in 16 (25%), 3 in 14 (22%) and NA in 2 (3%). The median interval between first and salvage ASCT for all pts was 48.6 mos (range 26.9-130.3), reflecting our policy of preferentially offering salvage ASCT to pts with at least a 2-yr benefit from the first transplant; the median time between re- induction therapy and salvage ASCT was 6.3 mos (range 0.3-95.9). Group A pts (n=27) had received BTZ-based therapy before their first ASCT; 48% of these also received BTZ-based regimens again prior to salvage ASCT. Pts in Group B (n=37) received BTZ-based regimens before the salvage transplant only, while induction therapy before the first ASCT consisted of VAD (21), dex alone (8), thal + dex or other regimens (5). Twenty-two (34%) of the pts received maintenance therapy between the first and salvage ASCT (most often thal-based), while 35 (55%) of the pts received maintenance therapy following salvage ASCT (most frequently lenalidomide [len]-based). The survival outcomes are summarized in Table 2. Median duration of follow-up (F/U) following salvage ASCT was 19.1 mos (range 0.8-96.4). One patient (1.6%) died several days following salvage ASCT. No other transplant-related mortality occurred. The median PFS following salvage ASCT was 19.1 mos (range 0.8- 87.5) with a median OS of 26.5 mos (range 0.8-101.9) in all pts. The median PFS after salvage ASCT was 15.8 mos for Group A and 25.2 mos for Group B pts. Conclusions: Even in the era of novel agents, salvage ASCT may provide PFS benefit to pts with relapsed MM who were previously treated with a BTZ-based regimen. However, the details of the optimal approach in this setting are not certain, including the impact of maintenance therapy given after the first and/or salvage ASCT. We are performing additional analyses of this population to try to identify factors associated with the best outcomes. Disclosures Kukreti: Celgene: Honoraria; Lundbeck: Honoraria; Amgen: Honoraria. Prica:Janssen: Honoraria. Tiedemann:Novartis: Honoraria; Celgene: Honoraria; Takeda Oncology: Honoraria; BMS Canada: Honoraria; Amgen: Honoraria; Janssen: Honoraria. Trudel:Celgene: Honoraria; Novartis: Honoraria; Glaxo Smith Kline: Honoraria, Research Funding; Oncoethix: Research Funding. Reece:Merck: Research Funding; Takeda: Consultancy, Honoraria, Research Funding; BMS: Honoraria, Research Funding; Celgene: Consultancy, Honoraria, Research Funding; Otsuka: Honoraria, Research Funding; Novartis: Honoraria, Research Funding; Janssen: Consultancy, Honoraria, Research Funding; Amgen: Consultancy, Honoraria, Research Funding.


2021 ◽  
Vol 106 (2) ◽  
pp. 28-35
Author(s):  
V. Batig ◽  
◽  
O. Tokar ◽  
I. Burdenyuk ◽  
◽  
...  

Goal. Improving the scheme of treatment and prevention of periodontal diseases in workers of the woodworking industry of Chernivtsi region, who in the process of professional activity have long-term contact with unfavorable factors of the production environment. Materials and methods. 70 workers of the woodworking industry with diagnosed chronic generalized periodontitis of the I degree were treated (35 people – the main group (A); 35 people – comparison group (B)), age – from 25 to 45 years. To compare the results of laboratory studies, an additional survey of 25 healthy individuals of the same age with an intact periodontium were conducted. They formed the control group (C). Clinical examination of patients was performed according to standart methods: subjective (complaints, medical history, life history) and objective (examination, periodontal indices, determination of the level of gingival attachment). Laboratory methods of research included determination of urease and lysozyme activity in saliva, degree of dysbiosis of oral cavity. As maintenance therapy, patients of the main group were prescribed the proposed composition DEPE. Results. After the treatment, a significant improvement in the hygienic status of patients in both groups was observed, but difference between groups A and B in the indicators of oral hygiene after treatment was no statistically significant (pA2–B2 > 0.05). There was a significant improvement in periodontal indices after treatment in patients of both groups (PMA index according to C. Parma, bleeding index according to Muhlemann in Cowell I. modification, Russell periodontal index, PSR-test), but the indicators in patients of the main group were significantly better – pA2–B2 < 0.05. In patients of the main group (A) the level of attachment loss decreased by 1.83 times, comparison group (B) – by 1.71 times. The difference in levels of attachment loss after treatment between groups A and B is statistically significant (pA2–B2 < 0.05). The activity of the enzyme urease in patients of the main group (A) and comparison group (B) after treatment was significantly reduced (pA1–A2 < 0.001, pB1–B2 < 0.001), but only in the main group it reached the level in the control group (C) (pA2–C > 0.05). The level of lysozyme after treatment was significantly increased in patients of both observation groups (pA1–A2 < 0.001, pB1–B2 < 0.001), and reached the level of lysozyme in patients of the control group (C) (pA2–C > 0.05, pB2–C > 0.05). The degree of oral dysbiosis in patients of the main group (A) was significantly reduced by 5.43 times (pA1–A2 < 0.001), and its difference from the degree of dysbiosis in patients of the control group (C) is statistically insignificant (pA2–C > 0.05 ). The degree of oral dysbiosis in patients of the comparison group (B) was significantly reduced by 3.04 times (pB1–B2 < 0.001), but still remained significantly different from oral dysbiosis in patients of the control group (C) (pB2–C < 0.05). Conclusion. The proposed pharmacological composition DEPE is an effective antiseptic solution and can be used in the phase of maintenance therapy to improve the treatment and prevention of periodontal disease in workers of woodworking industry. Key words: decamethoxine, propolis, ethonium, generalized periodontitis, woodworking industry.


Author(s):  
Xin-Yu Li ◽  
Cong-Hui Li ◽  
Ji-Wei Wang ◽  
Jian-Feng Liu ◽  
Hui Li ◽  
...  

Abstract Purpose The purpose of the study was to investigate the safety and efficacy of endovascular embolization of ruptured intracranial aneurysms within 72 hours of subarachnoid hemorrhage (SAH). Materials and methods Patients with intracranial aneurysms treated with embolization were divided into group A (n = 277), patients with ruptured aneurysms treated within 72 hours of SAH; group B (n = 138), patients with ruptured aneurysms treated beyond 72 hours; and group C (n = 93), patients with unruptured aneurysms. Results Embolization was successful in all but four patients (99.2%). The periprocedural complication rate was 36.2% in group B, significantly (p < 0.05) greater than that in group A (24.5%) or group C (11.8%). The rebleeding rate was 9.7% (6/62 patients) in groups A and B after embolization and only 0.3% (1/346 patients) in aneurysms with total or subtotal occlusion. Of these three groups of patients, 69.7% in group A, 58.7% in group B, and 76.3% in group C achieved Glasgow Outcome Scale (GOS) score of 5 or modified Rankin Scale (mRS) score of 0– to 1 at discharge. A significant difference (p < 0.05) existed in the clinical outcome between the three groups. The percentages of patients without deficits (GOS 5 or mRS 0–1) and slight disability (mRS 2) were 80.2% in group A, 81.2% in group B, and 96.7% in group C. The mortality rate was 4.3% (12/277 patients) in group A and 7.2% (10/138 patients) in group B with no significant (p = 0.21) difference. Follow-up was performed at 3 to 54 months (mean 23.2), and the recanalization rate was 28.6% (32/112 patients) in group A, 22.4% (11/49 patients) in group B, and 28.6% (16/56 patients) in group C, with no significant differences (p = 0.15). Hydrocephalus occurred in 30.5% (39/128 patients) in group B, which was significantly (p < 0.01) greater than that in group A (9.4%) or group C (2.2%). Conclusion Early embolization of ruptured cerebral aneurysms within 72 hours of rupture is safe and effective and can significantly decrease periprocedural complications compared with management beyond 72 hours. Timely management of cisternal and ventricular blood can reduce hydrocephalus incidence and improve prognosis.


2021 ◽  
Vol 9 (1) ◽  
pp. e001787
Author(s):  
Kohjiro Ueki ◽  
Yukio Tanizawa ◽  
Jiro Nakamura ◽  
Yuichiro Yamada ◽  
Nobuya Inagaki ◽  
...  

IntroductionGiven an increasing use of dipeptidyl peptidase-4 (DPP-4) inhibitors to treat patients with type 2 diabetes mellitus in the real-world setting, we conducted a prospective observational study (Japan-based Clinical Research Network for Diabetes Registry: J-BRAND Registry) to elucidate the safety and efficacy profile of long-term usage of alogliptin.Research design and methodsWe registered 5969 patients from April 2012 through September 2014, who started receiving alogliptin (group A) or other classes of oral hypoglycemic agents (OHAs; group B), and were followed for 3 years at 239 sites nationwide. Safety was the primary outcome. Symptomatic hypoglycemia, pancreatitis, skin disorders of non-extrinsic origin, severe infections, and cancer were collected as major adverse events (AEs). Efficacy assessment was the secondary outcome and included changes in hemoglobin A1c (HbA1c), fasting blood glucose, fasting insulin and urinary albumin.ResultsOf the registered, 5150 (group A: 3395 and group B: 1755) and 5096 (3358 and 1738) were included for safety and efficacy analysis, respectively. Group A patients mostly (>90%) continued to use alogliptin. In group B, biguanides were the primary agents, while DPP-4 inhibitors were added in up to ~36% of patients. The overall incidence of AEs was similar between the two groups (42.7% vs 42.2%). Kaplan-Meier analysis revealed the incidence of cancer was significantly higher in group A than in group B (7.4% vs 4.8%, p=0.040), while no significant incidence difference was observed in the individual cancer. Multivariate Cox regression analysis revealed that the imbalanced patient distribution (more elderly patients in group A than in group B), but not alogliptin usage per se, contributed to cancer development. The incidence of other major AE categories was with no between-group difference. Between-group difference was not detected, either, in the incidence of microvascular and macrovascular complications. HbA1c and fasting glucose decreased significantly at the 0.5-year visit and nearly plateaued thereafter in both groups.ConclusionsAlogliptin as a representative of DPP-4 inhibitors was safe and durably efficacious when used alone or with other OHAs for patients with type 2 diabetes in the real world setting.


2007 ◽  
Vol 14 (02) ◽  
pp. 263-265
Author(s):  
RAHEELA FARHAT ◽  
DR. MAHNAAZ ROOHI

Objective: To evaluate the safety and efficacy of intra venous iron sucrose(venofer) as comparedto oral iron in treatment of iron deficiency anaemia during pregnancy. Study Design: Prospective study. Pregnantwomen with iron deficiency anaemia were selected from ante natal clinic. Patients were divided into two groups. GroupA: These patients were given oral iron. Group B: These patients were given intravenous sucrose. All patients wereevaluated for adverse effects, clinical and laboratory response >. Results: Intravenous group achieved a higher Hblevel in a shorter period. Group B showed no major side effects while (80%) of patients in Group A developedgastrointestinal symptoms. Conclusion: Intravenous iron sucrose is safe and effective in treatment of iron deficiencyanemia during pregnancy.


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