Pregnancy loss. Treatment options

2021 ◽  
Vol 20 (2) ◽  
pp. 75-84
Author(s):  
M.M. Astrakhantseva ◽  
◽  
A.I. Myasoutov ◽  
L.E. Breusenko ◽  
R.I. Shalina ◽  
...  

Objective. To justify the selection of the most effective gestagen with an optimal safety profile in the treatment of patients with pregnancy loss. Patients and methods. A retrospective study of 93 records of patients with recurrent pregnancy loss (RPL) who were prescribed gestagens was made. The first group included 49 patients taking dydrogesterone; the second – 44 patients who received micronized progesterone (19 – orally/subgroup 2a/ and 25 – intravaginally/subgroup 2b/). In order to assess the effectiveness of therapy, prolongation of pregnancy up to 22 weeks was the study’s primary endpoint. The secondary endpoint was prolongation of pregnancy up to 34 weeks of gestation and live birth. Results. A positive subjective evaluation was found in 94% of women taking dydrogesterone and in 79.5% of women taking micronized progesterone (68.4% – orally and 88% – intravaginally). The total number of observations with adverse effects when taking dydrogesterone was significantly lower than in case of micronized progesterone: in 7 (16%) and 31 (72%), respectively (p < 0.05). Dull lower abdominal pain was significantly more frequent in oral administration of micronized progesterone compared with dydrogesterone: in 15 (79%) and 11 (22%), respectively (p < 0.05). In dydrogesterone and intravaginal administration of micronized progesterone, pain syndrome occurred with the same frequency. Bloody vaginal discharge was 2.5 times more frequent in group 2: in 4 (8%) patients of group 1 and in 10 (23%) patients in group 2 (p < 0.05). Moreover, bloody discharge remained significantly more often in case of vaginal administration of micronized progesterone (p < 0.05). In oral micronized progesterone, the difference with dydrogesterone was not significant. According to ultrasound data, hematomas that were not accompanied by bloody discharge were registered in 6 (12%) patients taking micronized progesterone, equally for oral and intravaginal administration. Against the background of receiving dydrogesterone, no hematomas were revealed according to ultrasound data. Against the administration of dydrogesterone, both primary and secondary results were achieved in all women. With the use of micronized progesterone, the primary result was achieved in 39 (88.6%), the secondary – in 38 (86%) patients. Early pregnancy loss was in 6 (14%) women of group 2: 5 (11%) had a spontaneous miscarriage before 14 weeks of gestation (intravaginal drug administration), one had premature birth at 32 weeks (oral drug administration). Conclusion. Dydrogesterone has the highest efficacy and optimal safety profile in the treatment of RPL; therefore, it can be considered as the gestagen of choice in early pregnancy. If it is impossible to prescribe dydrogesterone, preference should be given to micronized progesterone – intravaginal route of administration. Key words: dydrogesterone, micronized progesterone, pregnancy loss, progesterone

2021 ◽  
Vol 13 (2) ◽  
pp. 97-105
Author(s):  
A. G. Prityko ◽  
K. V. Osipova ◽  
P. L. Sokolov ◽  
E. A. Ezhova ◽  
I. G. Kotel’nikova ◽  
...  

Objective: to confirm a therapeutic equivalence and similar safety profile of “Midazolam, oromucosal (buccal) solution” and “Sibazon, solution for intravenous and intramuscular administration” used in children aged from 1 year to 18 years suffering from primary generalized and bilateral tonic, clonic and tonic-clonic seizures.Material and methods. An open-label, randomized clinical trial on efficacy and safety was conducted with 25 patients having primary generalized and bilateral tonic, clonic and tonic-clonic seizures due to epilepsy or epileptic syndrome. The study used age-appropriate doses of Midazolam with a single buccal administration as well as diazepam (Sibazon) for single intramuscular administration. Midazolam dosing was as follows: 5 mg for children of the younger age group (1 tube-dropper 5 mg/ml), 7.5 mg for children of the middle age group (1 tube-dropper 5 mg/ml and 1 tube-dropper 2.5 mg/ml), 10 mg for older children (2 tube-droppers 5 mg/ml). The drug effectiveness was assessed by primary and secondary criteria. The number of cases of drug administration in each group was used as the primary criteria, in which the convulsions ended up within 10 minutes after using the drug and did not resume within 60 minutes after drug administration. The following criteria were used as secondary: no repeated convulsive seizures within 24 hours after drug administration, no repeated convulsive seizure within 48 hours after drug administration, time before repeated convulsive seizure within 48 hours after drug administration. Clinical assessment was carried out according to clinical data, electroneurophysiologic (electroencephalographic) studies, electrocardiography, clinical blood and urine tests, aswell as biochemical blood tests by measuring glucose, total protein, albumin, total bilirubin, cholesterol, aspartate aminotransferase, alanine aminotransferase, creatine phosphokinase, alkaline phosphatase, creatinine, urea, and creatinine clearance level.Results. Compliance with the first efficacy criterion after using Midazolam and Sibazon was observed in 11 (84.6%) and 9 (75%) patients in Group 1 and Group 2, respectively, showing insignificant differences (Fisher's exact test (FET): p=0.645). The number of no cases of repeated convulsive seizure within 24 hours after drug administration differed significantly and was 12 (92.3%) and 6 (50%), respectively (FET: p=0.030). The number of cases with no second seizures within 48 hours after drug administration in Group 1 and Group 2 was 12 (92.3%) and 5 (41.7%), respectively, showing insignificant differences (FET: p=0.0112). No serious adverse events were reported during the study. No patients cancelled participation in the study due to developed adverse event.Conclusion. The data obtained evidence about compatibility of therapeutic efficacy profile and similar safety profile for “Midazolam, oromucosal (buccal) solution” and “Sibazon, solution for intravenous and intramuscular administration” that agrees with multiple data of earlier studies.


Reproduction ◽  
2000 ◽  
pp. 387-395 ◽  
Author(s):  
KJ Demmers ◽  
HN Jabbour ◽  
DW Deakin ◽  
AP Flint

The role of interferon in early pregnancy in red deer was investigated by (a) measuring production of interferon by the conceptus, (b) testing the anti-luteolytic effect of recombinant interferon-tau in non-pregnant hinds, and (c) treatment of hinds with interferon after asynchronous embryo transfer. Blastocysts were collected from 34 hinds by uterine flushing 14 (n = 2), 16 (n = 2), 18 (n = 8), 20 (n = 13) or 22 (n = 9) days after synchronization of oestrus with progesterone withdrawal. Interferon anti-viral activity was detectable in uterine flushings from day 16 to day 22, and increased with duration of gestation (P < 0.01) and developmental stage (P < 0.01). When interferon-tau was administered daily between day 14 and day 20 to non-pregnant hinds to mimic natural blastocyst production, luteolysis was delayed by a dose of 0.2 mg day(-1) (27.3 +/- 1.3 days after synchronization, n = 4 versus 21 +/- 0 days in control hinds, n = 3; P < 0.05). Interferon-tau was administered to hinds after asynchronous embryo transfer to determine whether it protects the conceptus against early pregnancy loss. Embryos (n = 24) collected on day 6 from naturally mated, superovulated donors (n = 15) were transferred into synchronized recipients on day 10 or day 11. Interferon-tau treatment (0.2 mg daily from day 14 to 20) increased calving rate from 0 to 64% in all recipients (0/11 versus 7/11, P < 0.005), and from 0 to 67% in day 10 recipients (0/8 versus 6/9, P < 0.01). The increased success rate of asynchronous embryo transfer after interferon-tau treatment in cervids may be of benefit where mismatched embryo-maternal signalling leads to failure in the establishment of pregnancy.


2000 ◽  
Vol 79 (1) ◽  
pp. 43-48 ◽  
Author(s):  
PÉTER FEDORCSÁK ◽  
RITSA STORENG ◽  
PER OLAV DALE ◽  
TOM TANBO ◽  
THOMAS ÅBYHOLM

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