Misoprostol Group Research Articles

The Efficacy and Safety of Intrauterine Misoprostol During Cesarean Section in Prevention of Primary Post-Partum Hemorrhage - A Randomized Controlled Trial

Postpartum hemorrhage remains the most common cause of maternal death globally [1]. and has persisted in low-income countries due to the prevalence of home deliveries and limited access to life-saving uterotonic drugs in these countries [2-5]. Many of the global gains in reducing maternal mortality can be attributed to developments in preventing and treating Postpartum Hemorrhage (PPH) [6,7]. PPH is often associated with the failure of the uterus to contract after delivery and is categorized as blood loss of 500 mL or more following a vaginal delivery or 1,000 mL after cesarean delivery [8,9]. PPH is categorized as primary if it occurs within 24 hours of delivery and secondary if excessive blood loss occurs at 24 hours or more after delivery. To compare the efficacy and safety of intrauterine misoprostol with intravenous oxytocin during Cesarean Section (CS) in prevention of primary post-partum hemorrhage. A total of 150 pregnant women at term (37-40 weeks) gestation who were scheduled for either elective or emergency caesarean delivery were enrolled. They were equally randomized into two groups: women who received 400mcg intrauterine misoprostol in addition to intravenous infusion of 10 IU oxytocin as Group I while women who received an intravenous infusion of 10 IU oxytocin after delivery of the neonate as Group II. The Primary outcome measures were Estimated Blood Loss (EBL) during caesarean section and need for additional uterotonic drugs intraoperatively. Secondary outcomes included the occurrence of excessive blood loss (>1000mL) within the first 6 hours postoperatively and the occurrence of any maternal or fetal side effects. The difference in the postoperative haemoglobin and postoperative hematocrit was found to be highly significant between the two groups (10.12 ± 1.55 vs 9.24 ± 1.52; p < 0.01) and (2.48 ± 1.38 vs 3.75 ± 1.77; p < 0.001) respectively. Estimated blood loss in two groups was found to be very highly significant (440.19 ± 257.75 vs 677.38 ± 343.04; p < 0.001). Intraoperative blood loss was significantly lower in the group I compared to group II (408.27 ± 123.34 vs 486.04 ± 135.84; p < 0.001). Blood loss during the first 6 hours after delivery was also lower in the group I (58.87 ± 9.86 mL vs 63.29 ± 12.39 mL; p < 0.05). Fewer women in the intrauterine misoprostol group needed additional uterotonics (7 vs 11; p > 0.05). The difference in the side effects of both the groups was found to be statistically non-significant. Apgar scores at 1 and 5 minutes were comparable in both the groups. The combined use of intrauterine misoprostol (400 mg), when added to oxytocin infusion during caesarean section is effective in decreasing the intraoperative blood loss, post-operative blood loss and prevent postpartum hemorrhage. keywords: Intrauterine misoprostol; Intraoperative estimated blood loss; Cesarean section; Postpartum hemorrhage

Termination of pregnancy in the second trimester- the course of different therapy regimens.

To compare two prostaglandin analogs and two application intervals between mifepristone and the prostaglandin analog administration on the time to abortion in second trimester termination of pregnancy. Other endpoints were live birth rate and fetal lifetime after expulsion. Retrospective data of 373 abortions performed were evaluated. Four medical induction subgroups and two feticide subgroups were considered. The definition criteria of the subgroups were the choice of administered prostaglandin analog (misoprostol vs. sulprostone) and the time interval between mifepristone and prostaglandin analog administration (48 vs. 24h). The outcome parameters were the time to complete uterine evacuation (TCUE), the live birth rate and duration of fetal life. In the misoprostol subgroups, the median TCUE was 1.6h longer in the 24-h group than in the 48-h group (p=0.950). In the sulprostone subgroups, the median TCUE was 1.9h shorter in the 24-h group than in the 48-h group (p=0.950). The median TCUE was shorter for sulprostone than for misoprostol in all six subgroups (p<0.001). The rate of fetal live births ranged between 13.6and 15.9% within the medical induction subgroups (p=0.969). The median fetal lifetime was slightly shorter in the sulprostone groups than in the misoprostol groups (p=0.563). Both application intervals and prostaglandin analogs are similarly effective. The therapy regime should be adapted to the personal preferences of the woman, the situational and clinical conditions.

Cervical Ripening Efficacy of Synthetic Osmotic Cervical Dilator Compared With Oral Misoprostol at Term: A Randomized Controlled Trial.

To evaluate whether a synthetic osmotic cervical dilator is noninferior to oral misoprostol for cervical ripening. In an open-label, noninferiority randomized trial, pregnant women undergoing induction of labor at 37 weeks of gestation or more with Bishop scores less than 6 were randomized to either mechanical cervical dilation or oral misoprostol. Participants in the mechanical dilation group underwent insertion of synthetic osmotic cervical dilator rods, and those in the misoprostol group received up to six doses of 25 micrograms orally every 2 hours. After 12 hours of ripening, oxytocin was initiated, with artificial rupture of membranes. Management of labor was at the physician's discretion. The primary outcome was the proportion of women achieving vaginal delivery within 36 hours of initiation of study intervention. Secondary outcomes included increase in Bishop score, mode of delivery, induction-to-delivery interval, total length of hospital stay, and patient satisfaction. On the basis of a noninferiority margin of 10%, an expected primary outcome frequency of 65% for misoprostol and 71% for mechanical methods, and 85% power, a sample size of 306 participants was needed. From November 2018 through January 2021, 307 women were randomized, with 151 evaluable participants in the synthetic osmotic cervical dilator group and 152 in the misoprostol group (there were four early withdrawals). The proportion of women achieving vaginal delivery within 36 hours was higher with mechanical cervical dilation compared with misoprostol (61.6% vs 59.2%), with an absolute difference of 2.4% (95% CI -9% to 13%), indicating noninferiority for the prespecified margin. No differences were noted in the mode of delivery. Tachysystole was more frequent in the misoprostol group (70 [46.4%] vs 35 [23.3%]; P=.01). Participants in the synthetic osmotic cervical dilator group reported better sleep, less unpleasant abdominal sensations, and lower pain scores (P<.05). Synthetic osmotic cervical dilator is noninferior to oral misoprostol for cervical ripening. Advantages of synthetic osmotic cervical dilator include a better safety profile and patient satisfaction, less tachysystole, lower pain scores, and U.S. Food and Drug Administration approval. ClinicalTrials.gov, NCT03670836. Medicem Technology s.r.o., Czech Republic.

Comparing the effects of vaginal misoprostol and isosorbide mononitrate on cervical ripening in abortions under 20 weeks: a randomized controlled trial

&lt;p class="abstract"&gt;&lt;strong&gt;Background:&lt;/strong&gt; In the first trimester of pregnancy, 15 to 20 percent of pregnancies result in miscarriage. Misoprostol is a widely medication that used for induction of labor in the second trimester; therapies, early termination of pregnancy and also used in duration of term delivery. The objective of this study was to comparing the effects of vaginal misoprostol and isosorbide menonitrate on cervical ripening in abortion under 20 weeks.&lt;/p&gt;&lt;p class="abstract"&gt;&lt;strong&gt;Methods:&lt;/strong&gt; In this prospective randomized clinical trial, 120 pregnant women with miscarriage were enrolled in the study and randomly divided into 3 groups: vaginal misoprostol, isosorbide mononitrate and control group. The effect of all drugs on cervical dilatation and ripening, time needed for abortion, and also their side effects were evaluated.&lt;/p&gt;&lt;p class="abstract"&gt;&lt;strong&gt;Results:&lt;/strong&gt; The mean of VAS in misoprostol group with 6.2±2.3 was significantly more than isosorbide mononitrate group with 3.4±1.5 and control group with 3.2±2.4. The rate of abortion in misoprostol group was significantly lower than other two groups. The change in dilation rate more than 3 cm in misoprostol group with 50% was significantly more than other two groups with 35% and 20%. Nausea, diarrhea, fever and bleeding rate were higher in the misoprostol group than other two groups. Headache in the isosorbide mononitrate group was significantly higher than the other groups. &lt;/p&gt;&lt;p class="abstract"&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;The results showed that we can use isosorbide mononitrate as a suitable alternative with better safety to vaginal misoprostol in cervical repining in abortions under 20 week.&lt;/p&gt;

Induction du travail par misoprostol oral versus misoprostol vaginal : étude avant-après

ObjectiveThe rate of induction of labor represented 22 % of deliveries in 2016 in France. Oral misoprostol (Angusta®) was marketed in France in the last quarter of 2018. The objective of our study was to compare the efficacy and safety of induction of labor with oral misoprostol compared to vaginal misoprostol in women with an unripe cervix. Material and methodsWe carried out a retrospective study before and after the implementation of oral misoprostol including all women with an unripe cervix who benefited from an induction of labor with a viable infant in vertex presentation, without uterine scar. During the first two-year period, women received 50μg of misoprostol in the posterior fornix, repeated 6hours later if needed. If labor had not started after 24hours, women received another dose of 50μg, which was repeated every 4hours until labor was established, up to a total dose of 150μg. During the second two-year period, women received two tablets of oral misoprostol 25μg every four hours if necessary, up to a total dose of 200μg. The primary endpoints were mode of delivery and neonatal safety. ResultsDuring the two study periods, 1199 women received vaginal misoprostol and 1199 women received oral misoprostol including. The cesarean delivery rate was 21.8% during the first period and 21,3% during the second period (P=0.83). A 5-minutes Apgar score<7 was observed in 23 (1.9%) and 14 (1.2%) newborns in the vaginal misoprostol and oral misoprostol groups (P=0.14), respectively. An arterial cord pH<7.00 was observed in 6 (0.5%) and 7 (0.6%) newborns (P=0.99), respectively. ConclusionOral misoprostol administered at the dose of 50μg every 4hours (up to a total dose of 200μg) is as effective and safe as the vaginal misoprostol to induce labor in women with an unripe cervix.

Addition of isosorbide mononitrate to misoprostol for cervical ripening in post-term pregnancy: A randomized controlled trial

ObjectiveThe purpose of this paper is to compare the effect of vaginal isosorbide mononitrate added to misoprostol versus misoprostol alone in cervical ripening and labor induction in post-term pregnancy. MethodsIn this double-blind controlled trial study, 150 pregnant women in post-term pregnancy who were candidates for labor induction were selected. The participants were assigned randomly to receive either vaginal isosorbide mononitrate (IMN) (40mg) or placebo. Misoprostol (25mg) was added to both groups as needed. Time to full cervical ripening, time to delivery, and the amount of misoprostol used in each group were assessed. ResultsThe time interval from the administration of IMN to full cervical ripening was shown to be significantly lower in the IMN+ misoprostol groups versus the comparison group (p=.032). The adjusted analysis of this time interval after controlling for age, BMI, gravidity, and Bishop score on administration remained significantly less (p=.045),the mean difference being −4.85h, CI 95% −9.58 to −.12. Isosorbide treatment resulted in significantly less misoprostol used versus misoprostol alone (2.37±1.02 versus 3.08±1.29), adjusted p-value=.001, CI 95% −1.09 to −.32. We found no significant increase in maternal–fetal outcomes or side effects of the IMN+ misoprostol group compared with the misoprostol group. ConclusionThis study found that intravaginal IMN added to misoprostol is more effective in reducing time to full cervical ripening versus misoprostol alone in post-term pregnancy. It also reduces the need for more misoprostol.

Efficacy and Safety of Misoprostol for Prevention of Post-Partum Haemorrhage: A Comparative Study

Background: Post-partum haemorrhage condition is a serious condition after delivery.&#x0D; Objective: The purpose of the present study was to see the efficacy and safety of misoprostol for the prevention of post-partum haemorrhage.&#x0D; Methodology: This analytic cross-sectional study was carried out in the Department of Gynaecology and Obstetrics at Mymensingh Medical College Hospital (MMCH), Mymensingh, Bangladesh from January 2006 to June 2006 for a period of six months. Pregnant women who were admitted in MMCH during the above period and were expected to have vaginal delivery and women at term with singleton pregnancy were included as study population. Women were divided into 2 groups. Women were in the group A who were treated with misoprostol and women who were treated with oxytocin were in group B. Blood loss during delivery was estimated subjectively by the attending obstetrician.&#x0D; Results: A total number of 100 women were recruited for this study of which 50 women were in the group A and the rest of 50 women were in group B. In this study majority of the patients were belonged to age group 20 to 25 years in both the groups. In oxytocin group 2.0% have developed nausea, 4.0% patients have developed shivering. None have developed vomiting, diarrhoea, temperature. In misoprostol group 10.0% patients have developed nausea, 18.0% patients have developed shivering, 4.0% patients have developed rise of temperature, none have developed diarrhoea, vomiting. The differences were statistically significant. In this study 4.0% patients from oxytocin group and 2.0% patient from misoprostol group required blood transfusion.&#x0D; Conclusion: In conclusion less amount of blood loss is found in misoprostol group than oxytocin group.&#x0D; Journal of National Institute of Neurosciences Bangladesh, July 2021, Vol. 7, No. 2, pp. 152-155

Sublingual misoprostol versus manual vacuum aspiration for treatment of incomplete abortion in Nigeria: a randomized control study

Introductionsingle-dose of sublingual misoprostol 400mcg with the participant followed-up at the gynecology clinic one week after with an ultrasound scan for the completeness of the uterine evacuation. Objective: to compare the effectiveness of single-dose sublingual misoprostol to manual vacuum aspiration in the treatment of incomplete spontaneous abortion in Enugu, Nigeria.Methodsthe primary outcome measure was the incidence of complete uterine evacuation (complete abortion) after one week of treatment while the secondary outcome measures included incidence, types, and tolerability of treatment side effects as well as participants' satisfaction with the treatment received.Resultstwo hundred and three participants who met the study criteria and completed the study were randomised into the intervention group (n=102) received single-dose sublingual misoprostol 400mcg and the control group (n= 101) received manual vacuum aspiration. Incidence of complete abortion was 86.3% for the misoprostol group and 100.0% for the control group, RR = 0.86, (CI 95%: 0.80 - 0.93), p <0.001. The most common side effect was abdominal pain with an incidence of 27.5% versus 48.55 for the misoprostol and control groups respectively (p = 0.002). Most participants in each group (81.1% versus 77.6% for the misoprostol and control groups respectively) considered the side effects as tolerable. The mean visual analogue scale score for maternal satisfaction was higher in the misoprostol group (86.7 ± 14.11) than the control group (81.36 ± 11.10), p < 0.001.Conclusionthe treatment of incomplete spontaneous abortion with single-dose sublingual misoprostol 400mcg produced a high rate of complete abortion among women in Enugu, Nigeria. Despite having a lower complete abortion rate, maternal satisfaction was higher when compared with women that had manual vacuum aspiration of the uterus. Trial registration: trial registration number - PACTR202009857889210, date of registration - September 23rd, 2020. Retrospectively registered.

Rectal vs. sublingual misoprostol in cesarean section: Three‑arm, randomized clinical trial.

Background:Misoprostol is a myometrial stimulant with uterotonic properties and can be administered rectally, vaginally, or sublingually. Numerous studies have investigated the effect of misoprostol on the prevention and treatment of PPH (postpartum hemorrhage) after vaginal delivery, but its use to control PPH during cesarean section has not been widely studied.Methods:In this clinical trial study, 180 pregnant women who were candidates for cesarean section were included in the study. They were divided into 3 groups of 60 people (sublingual misoprostol group, rectal misoprostol group, control group). In all three groups, the volume of blood lost was recorded in the checklist at the end of surgery. Data were entered into SPSS software and analyzed.Results:The mean bleeding in the control group was 225.4±63.9, while it was 137.9±33.8 and 118.9±28.5 in the sublingual misoprostol group and rectal misoprostol group, respectively. We had significantly more bleeding in the control group (p<0.001) compared to the other two groups.Conclusion:These results confirm the positive effect of misoprostol in reducing bleeding and show the superiority of using rectal misoprostol compared to other methods of reducing bleeding during cesarean section.

Evaluation of Low-dose and High-dose Intravaginal Misoprostol for Induction of Labour: A Randomised, Double-blinded, Single Centre Study

Introduction: Misoprostol is a synthetic prostaglandin E1 analogue widely used for cervical ripening and labour induction. However, misoprostol optimal dose required to induce labour is still controversial. Aim: To determine the efficacy and safety of 25 µg and 50 µg of intravaginal misoprostol for induction of labour at term and to evaluate maternal and neonatal complications. Materials and Methods: The present study was a prospective, randomised, double blind, single centre study carried out during March 2019 to December 2020. All the selected participants were randomised (1:1) to group 1 which received 25 µg of intravaginal misoprostol (n=70) and group 2 received 50 µg of intravaginal misoprostol (n=70). Based on the Bishop’s score, misoprostol was chosen as labour inducing agent. Number of misoprostol doses, mode of delivery, vaginal delivery duration, maternal and neonatal complications was recorded. Statistical significance among study groups were analyzed by using Chi-square test. Results: Postdatism was most frequently reported indication in both the study groups (57.1% and 52.9%). A total of 14 and 4 participants in group 2 and group 1 received only single dose of misoprostol (p&lt;0.01). Participants who received misoprostol 50 µg (n=60, 85.7%) has slightly showed higher vaginal deliveries compared to misoprostol 25 µg (n=57, 81.4%). The mean duration of induction time in group 2 was 10.12 hours and group 1 women showed 13.56 hours (p&lt;0.0001). Maternal and neonatal complications were slightly higher in 50 µg misoprostol group. Maternal complications such as uterine tachysystole (n=4), Postpartum Haemorrhage (PPH) (n=3) and uterine hyperstimulation syndrome (n=2). Neonatal complications with 50 µg misoprostol were Apgar &lt;7 at 1 min (n=4), Apgar &lt;7 at 5 min (n=3), Special Care Baby Unit (SCBU) admissions (n=2) and severe birth asphyxia (n=1). Misoprostol with 25 µg has showed Apgar &lt;7 at 1 min (n=2), Apgar &lt;7 at 5 min (n=2), SCBU admissions (n=1). Conclusion: The efficacy and safety results of 25 µg intravaginal misoprostol were comparable with 50 µg of intravaginal misoprostol for labour induction. The advantages of 50 µg misoprostol were it favours the vaginal deliveries, lesser active induction time and decrease number of misoprostol doses required to induce labour. However, higher dose of misoprostol showed higher frequencies of both maternal and neonatal complications.

Diagnosis and management of non-communicating rudimentary horn pregnancy.

Non-communicating rudimentary horn pregnancy is a rare condition associated with serious complications and consequences. We reported a case of a 44-day non-communicating rudimentary horn pregnancy who was diagnosed by three-dimensional ultrasound (3D-US) and pelvic magnetic resonance imaging (MRI), followed by treatment via laparoscopic resection. The 3D-US and pelvic MRI scan showed a consistent result. Serious complications and consequences were avoided. Postoperative diagnosis showed that the malformation was classified as type IIc. For such diagnosis as a unicornuate uterus with a rudimentary horn, if there are no symptoms, it cannot be treated. Once pregnancy is in the rudimentary horn, 3D-US or MRI should be conducted to determine the implantation location of the pregnancy capsule and the operation should be performed as soon as possible to avoid uterine rupture. Laparoscopic surgery can be chosen in the early stage.

Castor oil Induces Morphological Changes in Endometrium and Biochemical Parameters in Pregnant Wistar Rats

Background: Misoprostol is a synthetic prostaglandin E1 analogue, used for the management of miscarriages and labour. Castor oil is a natural plant extract that has been reported to have some abortifacient Properties Objectives: This study investigated the labour induction and abortifacient properties of castor oil, as well as possible effects on the electrolytes and hormones that regulate pregnancy, as well as to compare these effects with a standard labour inducing drug misoprostol, in Wistar rats. Methods: The study was conducted out in 2 phases. The pregnant rats were administered varying Castor oil doses of low (12.4ml/kg), medium (18.6ml/kg) and high (24.8ml/kg), which were compared with misoprostol group as well as a control group. All animals were euthanized on gestational day 15 and day 20 respectively for the two phases and blood samples collected via cardiac puncture from the apex of the heart for hormonal assay, electrolyte and kidney function tests. The uterus was also removed for histological processing. Results: The abortifacient effect of castor oil is dose dependent with high dose castor oil group seen to have significantly reduced serum progesterone level (32.8±4.25 and 40.8±0.70 compared with 51.0±2.00 of controls), resulted in weight loss and interference with kidney function (increase in serum potassium while decrease in sodium electrolytes). Castor oil also exhibited labor inducing properties. Conclusion: Castor oil has the potential to induce abortion. This study has demonstrated a possible usage of castor oil in medical induction of labor in rats as it exerted uterotonic principle on the uterus.

Misoprostol and oxytocin versus oxytocin alone in the active management of the third stage of labour: a randomised, double-blind, placebo-controlled trial

We investigated whether the use of misoprostol plus oxytocin in the active management of the third of stage of labour (AMTSL) would reduce the rate of primary postpartum haemorrhage (PPH) compared with intramuscular oxytocin alone. This was a multicentre, double-blind, placebo-controlled, randomised trial where 1036 pregnant women, in addition to intramuscular oxytocin (10 IU) in the third stage of labour, randomly received either 400 µg sublingual misoprostol (519 women) or a placebo (517 women). The primary outcome measure was the mean blood loss (MBL) within 1 h of delivery. The trial was registered with ClinicalTrials.gov (NCT02424201). The MBL in the oxytocin plus misoprostol group was 229.73 ± 108.12 compared to 274.58 ± 121.09 in the oxytocin plus placebo group (t = 6.289, p < .001). Twenty-eight (5.4%) women in the misoprostol group had a blood loss ≥500 ml versus 39 (7.5%) women in the placebo group (risk-ratio [RR] − 0·72, 95%CI 0.45–1.14; p = .1616). The combination of misoprostol with oxytocin in the AMTSL reduces MBL post-delivery but is not superior to oxytocin alone in the reduction of the rate of PPH. IMPACT STATEMENT What is already known on this subject? The routine use of 10IU of intramuscular oxytocin in the active management of the third stage of labour reduces the rates of postpartum haemorrhage. What do the results of this study add? The addition of 400ug of sublingual misoprostol to the routine use of 10IU of intramuscular oxytocin in the active management of the third stage of labour reduces mean blood loss when compared with intramuscular oxytocin alone, but is not better in reducing the rates of postpartum haemorrhage. What are the implications of these findings for clinical practice and/or further research? Routine use of misoprostol as adjuncts to the active management of the third stage of labour does not reduce the rate of PPH.

Lower and extended dosage of misoprostol for cervical ripening in 1st trimester miscarriage (MISO200): A randomized clinical trial

ObjectiveTo compare the efficacy of priming the uterine cervix before Manual Vaccum Aspiration (MVA) using 200 µg or 400 µg of vaginal misoprostol, inserted a mean time of 6 h before MVA in first trimester miscarriage. Study designRandomized, triple-blind, non-inferiority clinical trial. Patients between 18 and 50 years old, with a diagnosis of miscarriage, were eligible for the study. Patients were allocated to receive either 200 μg or 400 µg of misoprostol before the MVA. The primary outcome was the need to dilate the uterine cervix with mechanical dilators (Hegar dilators). As a secondary outcome, cervical dilatation ≥8 mm before the procedure was considered successful. A difference of <25% was considered as non-inferior. ResultsBetween December 21, 2016 and October 6, 2019, 269 women were screened. After screening, 105 and 106 women received 200 µg and 400 µg of misoprostol, respectively. Mechanical cervical dilatation was not necessary in 84.8% (95%CI 77% to 90%) and 96.2% (95%CI 91% to 99%), in the 200 µg and 400 µg groups, respectively [difference = 11.5% (95%CI 3.7% to 19.2%). Cervical dilatation of ≥8 mm was 52.4% (95%CI 42.9% to 61.7%) in the 200 µg misoprostol group, while in the 400 µg group was 71.7% (95%CI 62.5% to 79.4%) [difference = 19.3% (95%CI 6.5 to 32.2). ConclusionAfter a mean time of 6 h, 200 µg of vaginal misoprostol is not inferior to 400 µg of misoprostol for cervical priming before MVA, in first trimester miscarriage. This non-inferiority was not observed when the ≥8 mm criterion was considered.

Ameliorative role of misoprostol on hematological and biochemical parameters of male rats’ treated with ciprofloxacin

Ciprofloxacin (CPX) is one of the most frequently used fluoroquinolone drugs used in treatment of infections caused by gram negative microbes. The currant aim of this study to ensure the defense action of misoprostol (MP) against undesirable effect induced by ciprofloxacin. Thirty white male rats were divided into three equal groups (first group: control group, second group: Ciprofloxacin group, which given ciprofloxacin at a dose 100mg/kg/day orally for 14 days, and third group: ciprofloxacin and misoprostol group, which given combination of ciprofloxacin at a dose 100mg/kg/day orally and misoprostol at a dose 200µg/kg/day orally for 14 days. After 14 day of treated, the rats were scarified, blood taken for measured RBC count, HB concentration, platelet number. WBC count and liver enzymes (ALT, AST, ALP). The results indicated a significant decrease (p &lt; 0.05) of RBC, Hb, platelets and WBC in male rats treated with CPX compared with control group, also liver enzymes were increased significantly (p &lt; 0.05) in CPX group compared with control group, while co-administration of misoprostol with CPX administration produce improving effects on hematological parameters and liver enzymes when compared with first and second group.

Efficacité et tolérance du misoprostol oral 25 μg vs dinoprostone vaginale dans le déclenchement du travail à terme

ObjectiveTo compare the efficacy and safety of oral misoprostol 25μg compared to vaginal dinoprostone in the induction of labor at term. MethodsAnalytic, retrospective study of patients induced at term by prostaglandins with an unfavorable cervix, over two consecutive periods from 01/01/2019 to 19/02/2020 and from 20/02/2020 to 07/04/2021, within a regional level III university hospital center. We compared the safety and the efficacy between the oral misoprostol Angusta® used since 20/02/2020 and the vaginal dinoprostone previously used in gel or diffuser. The primary endpoint was the rate of vaginal deliveries within 24h. Secondary endpoints were cesarean section rate, indications for cesarean section, uterine contractility abnormalities and neonatal outcomes. ResultsOur study found no difference in terms of efficacy with similar rates of vaginal deliveries within 24h (51.88% vs. 51.25%; P=0.87) and caesarean sections (misoprostol group: 19.42% vs. dinoprostone group: 16.62%; P=0.33). However, the tolerance criteria revealed in the dinoprostone group an increase in tachysystole (misoprostol group: 9.28% vs. dinoprostone group: 16.90%; P=0.003) and acidosis (arterial pH<7.10, misoprostol group: 3.83% vs. dinoprostone group: 9.29%; P=0.006). ConclusionNo difference in efficacy was found between the two induction techniques. Oral misoprostol 25μg seems to be better tolerated from a maternal and fetal point of view.

Fluvoxamine Provide a Gastro-Protection Against Vitiated Insult

The etiology of peptic ulcer disease is multifactorial and remains an enigma over the last decades. The central parameter is the acid secretion; whose control is under the coordination of gastrin, acetylcholine, histamine, and prostaglandin. The treatment of peptic ulcers is a bi-armed tool, directed toward fighting microbial growth alongside acid suppression. However recent studies reported failure of the therapy due to recurrence of symptoms. Therefore, additional parameters should be considered including patient mood and psychological status. The present study aimed to introduce a new approach to the therapeutic regimen of ulcer disease using commonly used antidepressant drugs (fluvoxamine and fluoxetine) in a laboratory animal model of peptic ulcer induced by stress insult to act as a mood upset model in an attempt to mimic mood changes in human. The study was conducted on 4 groups of laboratory animals using control negative and control positive (misoprostol) against the tested drugs group (fluvoxamine and fluoxetine group). The result confirmed that fluvoxamine confers gastroprotective effects against ulcer insult compared to both fluoxetine or misoprostol groups. These results might significantly mean that antidepressant drugs could be utilized in peptic ulcer diseases or added at low doses to prevent ulcer insults due to whatever precipitating factors, such as, infection, alcohol, smoking, NSAIDs, and stress ulcer.

A randomized prospective comparative study to evaluate the efficacy of prostaglandin E2 (Dinoprostone) controlled release vaginal insert versus sublingual prostaglandin E1(Misoprostol) in induction of labor in term gestation

In modern obstetrics, one of the common challenges is induction of labour (IOL). WHO Global Survey reported that IOL accounted for 9.6% of all deliveries. Prostaglandins have evolved and frequently used pharmacologic agents for IOL, owing to their dual action of cervical ripening and uterine contraction inducing effect. : 1. To compare the efficacy and induction to delivery interval (IDI) of PGE2 vaginal insert and Sublingual PGE1 in induction of labor in term pregnant women; 2. To study the maternal and fetal outcome in both groups.: This a randomized, prospective, comparative study of 100 term pregnant women for induction of labour. Group 1-(50 women) PGE2-10mg vaginal insert and group 2-(50 women) PE1 Sublingual tablets – maximum 200 mcg in 24 hrs, at Dr LH Hiranandani Hospital, Mumbai, India.: In my study the mean induction to delivery interval in Dinoprostone group was 17.47 hours and 23.44 hours in Misoprostol group. So the mean IDI was shorter in Dinoprostone insert group than Misoprostol group by about 6 hours. There was no significant difference noted in terms of overall incidence of caesarean deliveries among the groups. Our study concluded that Dinoprostone 10mg vaginal insert was more efficacious than sublingual Misoprostol in reducing induction to delivery interval without maternal and fetal complications.Our study suggests that the Dinoprostone vaginal insert can be used as both inducing as well as augmentating agent in labour. Dinoprostone vaginal insert maybe more effective in reducing the incidence of caesarean sections.

Mifepristone and misoprostol versus placebo and misoprostol for resolution of miscarriage in women diagnosed with missed miscarriage: the MifeMiso RCT.

A randomised, parallel-group, double-blind, placebo-controlled multicentre study with health economic and nested qualitative studies to determine if mifepristone (Mifegyne®, Exelgyn, Paris, France) plus misoprostol is superior to misoprostol alone for the resolution of missed miscarriage. Women diagnosed with missed miscarriage in the first 14 weeks of pregnancy were randomly assigned (1 : 1 ratio) to receive 200 mg of oral mifepristone or matched placebo, followed by 800 μg of misoprostol 2 days later. A web-based randomisation system allocated the women to the two groups, with minimisation for age, body mass index, parity, gestational age, amount of bleeding and randomising centre. The primary outcome was failure to pass the gestational sac within 7 days after randomisation. The prespecified key secondary outcome was requirement for surgery to resolve the miscarriage. A within-trial cost-effectiveness study and a nested qualitative study were also conducted. Women who completed the trial protocol were purposively approached to take part in an interview to explore their satisfaction with and the acceptability of medical management of missed miscarriage. A total of 711 women, from 28 hospitals in the UK, were randomised to receive either mifepristone plus misoprostol (357 women) or placebo plus misoprostol (354 women). The follow-up rate for the primary outcome was 98% (696 out of 711 women). The risk of failure to pass the gestational sac within 7 days was 17% (59 out of 348 women) in the mifepristone plus misoprostol group, compared with 24% (82 out of 348 women) in the placebo plus misoprostol group (risk ratio 0.73, 95% confidence interval 0.54 to 0.98; p = 0.04). Surgical intervention to resolve the miscarriage was needed in 17% (62 out of 355 women) in the mifepristone plus misoprostol group, compared with 25% (87 out of 353 women) in the placebo plus misoprostol group (risk ratio 0.70, 95% confidence interval 0.52 to 0.94; p = 0.02). There was no evidence of a difference in the incidence of adverse events between the two groups. A total of 42 women, 19 in the mifepristone plus misoprostol group and 23 in the placebo plus misoprostol group, took part in an interview. Women appeared to have a preference for active management of their miscarriage. Overall, when women experienced care that supported their psychological well-being throughout the care pathway, and information was delivered in a skilled and sensitive manner such that women felt informed and in control, they were more likely to express satisfaction with medical management. The use of mifepristone and misoprostol showed an absolute effect difference of 6.6% (95% confidence interval 0.7% to 12.5%). The average cost per woman was lower in the mifepristone plus misoprostol group, with a cost saving of £182 (95% confidence interval £26 to £338). Therefore, the use of mifepristone and misoprostol for the medical management of a missed miscarriage dominated the use of misoprostol alone. The results from this trial are not generalisable to women diagnosed with incomplete miscarriage and the study does not allow for a comparison with expectant or surgical management of miscarriage. Future work should use existing data to assess and rank the relative clinical effectiveness and safety profiles for all methods of management of miscarriage. Our trial showed that pre-treatment with mifepristone followed by misoprostol resulted in a higher rate of resolution of missed miscarriage than misoprostol treatment alone. Women were largely satisfied with medical management of missed miscarriage and would choose it again. The mifepristone and misoprostol intervention was shown to be cost-effective in comparison to misoprostol alone. Current Controlled Trials ISRCTN17405024. This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 68. See the NIHR Journals Library website for further project information.

A COMPARATIVE STUDY OF 25 MICROGRAMS VERSUS 50 MICROGRAMS OF INTRAVAGINAL MISOPROSTOL FOR CERVICAL RIPENING AND INDUCTION OF LABOUR (IOL)

Background- Misoprostol is a safe drug and increasing the dose needed to be tried for decreasing Induction- delivery- interval (IDI). ObjectivesTo compare 25µG versus 50µG of intravaginal Misoprostol for cervical ripening and induction of labor (IOL). Methods- A prospective observational comparative study was done in the Department of Obstetrics &amp; Gynecology of a tertiary institute of northern India from January 2018 to June 2019. One hundred pregnant women with Bishop's Score &lt;6 for induction of labour were randomized : Group A (50 Odd No.) Tab.25µG Misoprostol pervaginum and Group B ( 50 Even No.) Tab.50µG Misoprostol pervaginum. In both groups, a thorough history, physical and obstetrical examination including Bishop's score was done. The same dose was repeated 4 hourly with monitoring the progress of labor and FHS. Number of doses required, induction-delivery- interval, need for oxytocin augmentation, mode of delivery, complications and fetal outcome were recorded. Statistical Analysis: by using chi-square, one sample t-test between percents, and McNemar test on Epi Info 7.2.31.Results- Both groups were comparable for all the outcome variables. (P&gt;0.05.) However signicantly greater number of women delivered with only one dose of 50µG versus 25µG i.e., 40% versus 20% (P=0.008). Also, more women delivered in &lt;12 hours with 50µG (41.86%) than 25µG (22.73%) Misoprostol pervaginum (P=0.016). Furthermore, more women delivered in &lt;12 hours and with only a single dose of 50µG (41.86%) than 25µG(22.73%) Misoprostol pervaginum (P=0.016). Conclusions- 50µG is more effective than 25µG Misoprostol pervaginum in all women for induction of labor especially signicantly more where delivery needs to be expedited like HDPas signicantly more women delivered in &lt;12 hours (P=0.016)with single dose only(P=0.008).