Misoprostol Tablets Research Articles

A case of methotrexate toxicity in induced abortion

Background: Methotrexate is an anticancer drug from the antimetabolite class which is being used in cases of unruptured ectopic pregnancy and as an abortifacient as well. Giving correct dosage according to the body weight and body surface area is of utmost importance to avoid the complications.Case: A 29-year-old, G4P3L3 at 8+3 weeks of gestation with previous three cesarean sections, presented to our hospital with complaints of fever, abdominal pain, multiple episodes of diarrhea and vomiting and oral ulcers for two days. On enquiring, it was found that she received two doses of injection methotrexate (75 and 50 mg) as an abortifacient for an unwanted intrauterine pregnancy from a local doctor nearby. On presentation, her general condition was poor, she was dehydrated, temperature was 101.3°F, pulse rate was 130 beats/minute, blood pressure was 102/64mmHg, respiratory rate was 25/minute and SPO2 was 99% on room air. Her body weight was 55 kgs. Skin pigmentation and multiple oral ulcers were present. Per speculum and per vaginal examination was suggestive of minimal spotting and bulky uterus. Initial blood investigations revealed a hemoglobin level of 8.8 gm/dl, TLC of 1000/mm3, platelet count of 1.45L, INR of 1.37, and normal liver and renal function tests. A provisional diagnosis of methotrexate toxicity was made. Management of the patient was started in consultation with medical oncologist along with supportive treatment. She received IV fluids, antibiotics, and blood products (2-unit PCV and 12-RDP). She received oral leucoverin 15 mg QID and two doses of 300 mg granulocyte stimulating factor each. Gradually, her condition improved and thereafter tablet misoprostol was given for abortion. She was discharged after 13 days of hospital stay with contraceptive advice.Conclusion: The successful management of this case who presented with a constellation of symptoms and deteriorating hematological parameters exhibits the significance of a multidisciplinary approach and vigilant monitoring. Strategies to reduce the side effects and their early recognition include a safety checking procedure like SMART (safety of methotrexate therapy by assessing risks and toxicity) and determining plasma methotrexate concentrations.

Misoprostol as Oral Solution or Oral Tablet for Induction of Labour (MISOBEST): A Randomised Controlled Non-Inferiority Trial.

To assess if off-label oral solution of misoprostol compared with licensed oral tablet of misoprostol approved for induction of labour (IOL) is as efficient in resulting in vaginal delivery within 24 h, using a non-inferiority design. Prospective, randomised, non-inferiority, open-label, blinded endpoint trial. Two tertiary level hospitals, Stockholm, Sweden, January 2022 to May 2023. In all, 874 women, without previous caesarean section, with an unripe cervix and a singleton, cephalic foetus at 37 + 0 to 42 + 0 gestational weeks, with a normal cardiotocography, planned for IOL were included. Women were randomised 1:1 to intervention (25 μg oral solution of misoprostol) or control (25 μg oral tablet of misoprostol) two-hourly for a maximum of eight doses. Subsequent methods of induction followed clinical practice. The primary outcome was vaginal delivery within 24 h tested using non-inferiority testing procedures at a non-inferiority margin of 5 percentage points. Secondary efficacy outcomes were tested for superiority of either treatment. Analyses were by intention-to-treat. There were 207 (47.4%) vaginal deliveries within 24 h for women receiving oral solution and 192 (43.9%) vaginal deliveries within 24 h for women receiving oral tablet, establishing non-inferiority with an absolute risk difference of 3.4% (95% CI -3.2% to 10.0%). Women receiving oral solution required fewer doses to reach active labour than women receiving oral tablet (5.7 vs. 6.1, p = 0.007). There were no significant differences for other secondary or safety outcomes. Off-label oral solution of misoprostol was non-inferior to the licensed oral tablet regarding efficacy of IOL defined as vaginal delivery within 24 h. Clinicaltrials.gov identifier: NCT05424445.

Comparison of the efficacy and safety of titrated oral misoprostol solution and conventional oral misoprostol tablet regimen for Induction of labor

Objective: To compare the efficacy and safety of titrated oral misoprostol solution (OMS) and conventional oral misoprostol tablet (OMT) regimen for induction of labor. Material and Methods: A cohort of two hundred pregnant women with term, singleton pregnancies with an indication for induction were included in the study. The study group(OMS) included hundred women who were allocated to receive 20 ml of oral misoprostol solution(1µg/ml) hourly maximum of 4 doses , then titrated to 40 ml (40µg) hourly maximum of 8 doses. In the control group (OMT) hundred women were induced with 50 µg of misoprostol tablet orally, 4 hourly maximum of 6 doses. The induction to delivery interval, requirement of oxytocin, dose of misoprostol used, mode of delivery, maternal and neonatal outcome were analyzed statistically. Results: The number of patients who delivered vaginally were more in study group i.e 81(81%) patients as compared to control group i.e 73(73%) patients and the difference was statistically significant(p value=0.03). The number of patients who had meconium stained liquor with non reassuring fetal heart rate were significantly higher in control group (OMT) as compared with study group(OMS)[26 {96%} versus 12{63%} p value =0.01].Whereas induction to delivery interval, proportion of patient delivered vaginally in 24 hours, need for oxytocin augmentation, maternal adverse reaction and neonatal outcome were not significantly different (p>0.05). Conclusion: Titrated oral solution is as effective as conventional oral tablet of misoprostol for labor induction in term pregnant women and small doses at frequent intervals seem to be safer in terms of risk of meconium stained liquor with abnormal fetal heart rate and caesarean section. Keywords: Titrated misoprostol, Induction of labor, Cesarean section, Efficacy and safety

Quality assessment of oxytocin injection and misoprostol tablets in Côte d’Ivoire and Senegal

Objective : To assess the quality of oxytocin and misoprostol products available in Côte d’Ivoire and Senegal. Methods : Samples of oxytocin injections and misoprostol tablets were collected from three different levels of the supply chain in Côte d’Ivoire and Senegal from August to December 2021. The sampling process was done by personnel from the National Medicines Regulatory Authorities, employing a methodology and sampling plan aligned with WHO guidelines

Mid-Trimester Termination of Pregnancy by Vaginal Misoprostol in Missed Abortion

The use of vaginal misoprostol, a prostaglandin analogue is an effective and safe management option for missed abortion. This study evaluated a low-dose (200 microgram) vaginally administered misoprostol four hourly to assess the success rate of medical management in mid-trimester missed abortion. A total of fifty patients with missed abortion, who had agreed to undergo medical treatment with vaginal misoprostol were enrolled. They were apparently healthy, between 18-40 years of age, less than 20 weeks of gestation, and had missed abortions verified by ultrasonogram report. All study women with missed abortion; misoprostol tablet (200 microgram) was applied in the posterior fornix of the vagina every four hourly. Complete abortion was confirmed by passage of products of conception and by clinical finding at the pelvic examination along with ultrasonogram report. In this study, we have demonstrated that 92% of patients were successfully treated by vaginal misoprostol. Only one patient needed oxytocin drip and three patients were managed by evacuation and curettage. This study showed that vaginal misoprostol is safe and effective method of treatment for mid-trimester missed abortion.

Influence of inventory management practices on the availability of emergency obstetric drugs in Rwandan public hospitals: a case of Rwanda Southern Province

BackgroundStock-outs of some life-saving drugs, such as emergency obstetric drugs, are evident in many health facilities and have been reported to be the leading cause of maternal mortality and morbidity for women from low and middle income countries (LMICs). For many cases, this situation is associated with poor inventory management practices. The aim of this study was to investigate the influence of inventory management practices on the availability of emergency obstetric drugs in Rwandan public hospitals: case of the Rwanda Southern Province. Moreover, to gain a better grasp of the problem and to suggest possible areas for improvement.MethodsAn institutional-based cross-sectional study was carried out in all ten district hospitals (DHs) providing maternal health care and dispensing emergency obstetric drugs namely; Kigeme DH, Munini DH, Kabutare DH, Kibilizi DH, Gakoma DH, Nyanza DH, Ruhango DH, Gitwe DH, Kabgayi DH and Remera Rukoma DH. Both quantitative and qualitative data were collected and analyzed. Oxytocin injection, Misoprostol tablet and Magnesium sulphate injection as recommended emergency obstetric drugs by WHO, UNFPA and Rwanda Essential Medicines list were included in the study.ResultsThe study revealed that keeping logistics management tools up to date is the backbone of inventory management practices in the availability of medicines and medical supplies. The results showed that hospitals with up-to-date logistics tools for their pharmaceutical management were 33.25 times more likely to have their emergency obstetric drugs in stock at all times compared to those that do not regularly update their logistics tools. The proper use of bin cards and electronic software (e-LMIS) contributed greatly to reducing the stock-out rate of emergency obstetric drugs by 89.9% and reduction of unusable to usable stock ratio by appropriate use of simple techniques such as the Min–Max inventory control model by 79%. Over an 18-month period, misoprostol tablet had the highest average days (32) of stock-outs (5.9%), followed by magnesium sulphate injection with an average of 31 days (5.7%), and oxytocin injection with an average of 13 days (2.4%).ConclusionProper use of pharmaceutical management tools within hospitals premises positively influence the availability of life-saving drugs, such as emergency obstetric drugs. Adequate supply chain staffing in health facilities is the most important key to improving inventory management practices and medicine availability.

Comparing labour induction outcomes using misoprostol and dinoprostone in term pregnancies: A retrospective study at Kiambu Level 5 Hospital between 2018 and 2020.

The Maternal and Perinatal Death Surveillance and Response (MPDSR) was introduced in Kenya in 2016 and implemented at Kiambu Level 5 Hospital (KL5H) three years later in 2019. During a routine MPDSR meeting at KL5H, committee members identified a possible link between the off-label use of 200mcg misoprostol tablets divided eight times to achieve the necessary dose for labour induction (25mcg) and maternal deaths. Following this, an administrative decision was made to switch from misoprostol to dinoprostone for the induction of labour in June of 2019. This study aimed to assess the overall impact of MPDSR as well as the effect of replacing misoprostol with dinoprostone on uterine rupture, maternal and neonatal deaths at KL5H. We conducted a retrospective cohort study of women who gave birth at KL5H between January 2018 and December 2020. We defined the pre-intervention period as January 2018-June 2019, and the intervention period as July 2019-December 2020. We randomly selected the records of 411 mothers, 167 from the pre-intervention period and 208 from the intervention period, all of whom were induced. We used Bayes-Poisson Generalised Linear Models to fit the risk of uterine rupture, maternal and perinatal death. 12 semi-structured key person questionnaires was used to describe staff perspectives regarding the switch from misoprostol to dinoprostone. Inductive and deductive data analysis was done to capture the salient emerging themes. We reviewed 411 patient records and carried out 12 key informant interviews. Mothers induced with misoprostol (IRR = 3.89; CI = 0.21-71.6) had an increased risk of death while mothers were less likely to die if they were induced with dinoprostone (IRR = 0.23; CI = 0.01-7.12) or had uterine rupture (IRR = 0.56; CI = 0.02-18.2). The risk of dying during childbearing increased during Jul 2019-Dec 2020 (IRR = 5.43, CI = 0.68-43.2) when the MPDSR activities were strengthened. Induction of labour (IRR = 1.01; CI = 0.06-17.1) had no effect on the risk of dying from childbirth in our setting. The qualitative results exposed that maternity unit staff preferred dinoprostone to misoprostol as it was thought to be more effective (fewer failed inductions) and safer, regardless of being more expensive compared to misoprostol. While the period immediately following the implementation of MPDSR at KL5H was associated with an increased risk of death, the switch to dinoprostone for labour induction was associated with a lower risk of maternal and perinatal death. The use of dinoprostone, however, was linked to an increased risk of uterine rupture, possibly attributed to reduced labour monitoring given that staff held the belief that it is inherently safer than misoprostol. Consequently, even though the changeover was warranted, further investigation is needed to determine the reasons behind the rise in maternal mortalities, even though the MPDSR framework appeared to have been put in place to quell such an increase.

Induction of abortion in the first trimester of pregnancy using letrozole and misoprostol combination versus misoprostol alone - A comparative observational study

Background: Medical abortion is safer than surgical abortion. Several studies have shown that combination of antiprogesterone drug mifepristone and prostaglandin misoprostol can increase complete abortion rate in medical management of first-trimester miscarriage compared to misoprostol alone. Letrozole, an aromatase inhibitor, has emerged as an alternative to mifepristone for induction of medical abortion as mifepristone is expensive and not registered in many countries. Aims and Objectives: The aim of the present study was to evaluate the safety and efficacy of combined regimen of letrozole and misoprostol in first-trimester medical abortion compared to misoprostol alone. Materials and Methods: It was a comparative observational study conducted at R. G. Kar Medical College, a tertiary care hospital in West Bengal, India. The study population was the antenatal mothers booked at antenatal clinic willing for termination of pregnancy at <12 weeks of gestational age. Participants were allocated, 39 in each group in a non-randomized manner. Patients in one group (Group A) were posted for medical abortion with combination regimen of tablet letrozole (10 mg) once daily for 3 days followed by application of tablet misoprostol 800 mcg sublingually on day 4. In other group (Group B), patients were on misoprostol-only regimen with the application of tablet misoprostol 800 mcg sublingually. Results: Induction-abortion time was significantly less in the letrozole group (11±0.79 h) than the misoprostol group (13.23±0.81 h), P=0.0001. Complete abortion rate was significantly higher in the letrozole group compared to misoprostol group (84.62% and 64.10%, respectively, P=0.03). 15.38% patients in the letrozole group and 35.90% patients in the misoprostol group had excessive vaginal bleeding and the difference was statistically significant, P=0.03. The duration of vaginal bleeding was also significantly less in the letrozole group (2.45±0.29 days) than the misoprostol group (2.82±0.37 days), P<0.0001. Incidence of side-effects was comparable and the severity of side-effects was not significantly different between the groups. Conclusion: Letrozole and misoprostol combination regimen leads to significant increase in complete abortion rate and also significant reduction of the duration of vaginal bleeding, induction-abortion time, and need for surgical intervention when compared to misoprostol regimen.

Termination of Pregnancy: Misoprostol Versus Prostaglandin E2

Objective: To compare the efficacy of vaginal Misoprostol and vaginal prostaglandin E2 in termination of pregnancy.
 Study Design: Quasi-experimental study.
 Place and Duration of Study: Department of Obstetrics & Gynecology, Fauji Foundation Hospital, Islamabad, Pakistan, from Apr to Oct 2021.
 Methodology: After taking informed consent, a total of 80 women between the age of 20-40 years were included in the study for termination of pregnancy. Molar or ectopic pregnancy, signs of septic abortion, Chronic Liver Disease, and bleeding disorders were excluded. In group A, a 200µgm tablet of Misoprostol was inserted intravaginal every 6 hours, a total of 4 doses, while in group B patients, a PGE2 3 mg tablet was inserted intravaginal, a total of 4 doses. All patients in both groups were evaluated after 24 hours, at which efficacy was noted. 
 Results: The mean age of women in Group-A was 27.18±3.81 years, and in Group-B was 27.18±4.96 years. The mean gestational age in Group-A was 11.83±3.24 weeks, and in Group-B was 12.20±3.30 weeks. In this study, efficacy (complete expulsion of the fetus within 24 hours of medication) was seen in 37 (92.50%) women in Group-A (Vaginal Misoprostol) and 29 (72.50%) women in Group-B (Vaginal prostaglandin E2) with a p-value of 0.019.
 Conclusion: This study concluded that the efficacy of vaginal Misoprostol is better in termination of pregnancy as compared to vaginal prostaglandin E2.

An integrated newborn care kit (iNCK) to save newborn lives and improve health outcomes in Gilgit Baltistan (GB), Pakistan: study protocol for a cluster randomized controlled trial

BackgroundOngoing high neonatal mortality rates (NMRs) represent a global challenge. In 2021, of the 5 million deaths reported worldwide for children under five years of age, 47% were newborns. Pakistan has one of the five highest national NMRs in the world, with an estimated 39 neonatal deaths per 1,000 live births. Reducing newborn deaths requires sustainable, evidence-based, and cost-effective interventions that can be integrated within existing community healthcare infrastructure across regions with high NMR.MethodsThis pragmatic, community-based, parallel-arm, open-label, cluster randomized controlled trial aims to estimate the effect of Lady Health Workers (LHWs) providing an integrated newborn care kit (iNCK) with educational instructions to pregnant women in their third trimester, compared to the local standard of care in Gilgit-Baltistan, Pakistan, on neonatal mortality and other newborn and maternal health outcomes. The iNCK contains a clean birth kit, 4% chlorhexidine topical gel, sunflower oil emollient, a ThermoSpot™ temperature monitoring sticker, a fleece blanket, a click-to-heat reusable warmer, three 200 μg misoprostol tablets, and a pictorial instruction guide and diary. LHWs are also provided with a handheld scale to weigh the newborn. The primary study outcome is neonatal mortality, defined as a newborn death in the first 28 days of life.DiscussionThis study will generate policy-relevant knowledge on the effectiveness of integrating evidence-based maternal and newborn interventions and delivering them directly to pregnant women via existing community health infrastructure, for reducing neonatal mortality and morbidity, in a remote, mountainous area with a high NMR.Trial registrationNCT04798833, March 15, 2021.

To Study the Efficacy of Intraamniotic Prostaglandin F2 Alpha versus Mifepristone and Misoprostol Combination for Mid-trimester Medical Termination of Pregnancy

Abstract Context: Aims: This study aims to compare the effectiveness, induction to abortion interval, blood loss, and side effect profile between administration of intraamniotic prostaglandin F2 alpha (PGF2α) with a combination of mifepristone and misoprostol for medical termination of pregnancy in mid-trimester. Prospective observational study. Subjects and Methods: The study was conducted by dividing the women with indicated mid-trimester abortions into two groups of 20 women each. Group-I received Tablet Mifepristone 200 mg orally on day 1 and then after 48 h, Tablet Misoprostol 400 μg given per vaginally every 4 h till abortion was completed or a maximum of 5 doses whichever was earlier. Group-II received a single injection of PGF2α (250 μg) intra-amniotically under ultrasonography guidance. Group comparisons were made using t-test/Mann–Whitney U-test for normally/nonnormally distributed continuous data, respectively, and Chi-square test for categorical variables. SPSS version 23 was used for analysis. P < 0.05 was taken as the cut-off for statistical significance. Results: The success rate was 100% in both the groups. There was a significant difference in the mean induction to abortion interval between Group-I, the mean being 12.92 ± 2.68 h compared to Group-II being 33.08 ± 6.35 h (P < 0.001). Group-I had a mean blood loss of 221 ± 55.15 mL, significantly more than Group-II 160 ± 25.13 mL (P < 0.001). Twenty-five percent of the Group-I woman had retained products of conception with none in Group-II (P = 0.029). The pain score was better in Group II (pain score 4.4 vs. 5.7, P < 0.001). Fewer women developed chills in Group II compared to Group I (0% vs. 50%, P < 0.001). Conclusions: PGF2α is equally effective as a combination of Mifepristone and Misoprostol in mid-trimester abortion. Although it has a longer induction to abortion interval, it appears to be better with respect to the completeness of evacuation, lesser blood loss, and better patient tolerance.

Quality testing of mifepristone and misoprostol in 11 countries.

Previous studies have demonstrated quality concerns with misoprostol. Mifepristone, however, has not been extensively assessed for quality. Between 2020 and 2021, Concept Foundation and the International Planned Parenthood Federation conducted a study to determine the quality of these medical abortion drugs in low- and middle-income countries (LMIC). The collection of batch samples of misoprostol and mifepristone was carried out by trained sampling agents in selected LMIC. Single drug packs and combipacks were sampled. A World Health Organization prequalified laboratory conducted testing method verifications and subsequent sample analysis. Tests included identification, assay, related substances, and content uniformity for misoprostol, and identification, assay, related substances, and dissolution for mifepristone. Samples were collected from Burkina Faso, Cambodia, Democratic Republic of Congo, India, Kyrgyzstan, Moldova, Nepal, Nigeria, Pakistan, Uganda and Vietnam. Sixty-four pooled batch samples were tested, consisting of 31 combipacks, 26 misoprostol-only and seven mifepristone-only products. Overall, 54.7% of samples were non-compliant with one or more of the specifications, representing 51.6% of combipack products, 57.1% of misoprostol tablets analyzed and 23.7% of mifepristone tablets. One falsified misoprostol-only product was found. The present study confirms that a significant problem still exists in relation to the quality of medical abortion drugs in LMIC. For misoprostol, our findings suggest that historical concerns around primary packaging may have been largely resolved but that manufacturing processes for both finished product and active pharmaceutical ingredient need to be improved. The present study also provides evidence of mifepristone quality issues.

Efficacy Analysis of Misoprostol Tablets for Painless Abortion

Objective: To analyze the application value of misoprostol tablets in painless abortion. Methods: 40 patients who received painless abortion from January 2022 to August 2023 were randomly divided into two groups; those who received misoprostol tablets before the operation were included in group A, and those who did not use misoprostol tablets before the operation were included in group B. Differences in cervical laxity, cervical dilatation time, uterine aspiration time, surgical blood loss, complications, and satisfaction were recorded. Results: The excellent and good rate of cervical dilation in group A was higher than that in group B (P < 0.05); the dilatation time, uterine suction time, surgical blood loss, and other indicators in group A were better than those in group B (P < 0.05); the complication rate after abortion in group A was lower than that of group B (P < 0.05); satisfaction rate in group A was higher than that of group B (P < 0.05). Conclusion: Oral administration of misoprostol tablets before painless abortion can relax the cervix, shorten the dilation time of the cervix, reduce intraoperative bleeding, and have higher patient satisfaction.

Comparison of Intracervical Foley's Catheter With Vaginal Misoprostol Versus Intravaginal Misoprostol Alone for Cervical Ripening and Induction of Labor.

Introduction Induction of labor implies stimulation of contractions before the spontaneous onset of labor, with or without membranes. Augmentation refers to the enhancement of spontaneous contractions that are considered inadequate because of failed cervical and fetal descent. This study compared the effectiveness of intracervical Foley catheter insertion and vaginal misoprostol versus only vaginal misoprostol in the induction of labor and other outcomes relted to it. Methods The present study was a randomized controlled trial that included 148 women divided into two groups: (i) Group A, which received intracervical Foley catheter insertion and vaginal misoprostol (25 µg), and (ii) Group B, which received intravaginal administration of tablet misoprostol (25 µg) alone. We compared the median time from the time of induction to vaginal delivery, incidence of cesarean delivery, chorioamnionitis, puerperal infection, uterine tachysystole, neonatal information at delivery, and discharge status (i.e., birth weight, neonatal intensive care unit (NICU) admission, and neonatal death) between groups. Results We found that the rates of puerperal infection (n=36; 48.6%) and meconium-stained amniotic fluid (n=45; 60.8%) were higher in Group B than in Group A (n=20; 27.0% and n=25; 33.8%, respectively), which were statistically significant differences (p=0.0066 and p=0.0009, respectively). In addition, NICU admission was higher in Group B (n=47; 63.5%) than in Group A (n=30; 40.5%), which was a statistically significant difference (p=0.0051). Conclusion An intracervical Foley catheter with 25 µg of misoprostol was more effective for induction of labor than 25 µg of intravaginal misoprostol alone every six hours for a maximum of four doses in terms of induction to delivery interval, meconium-stained amniotic fluid, mode of delivery, intrapartum complications, and puerperal infection.

The difference of Bishop score change and labor event between oral and vaginal misoprostol in pregnancy beyond 41 weeks

HIGHLIGHTS Oral misoprostol is more effective than vaginal misoprostol in cervical ripening as a part of induction of labor. Oral misoprostol is as safe as vaginal misoprostol. ABSTRACT Objective: To compare Bishop score changes and labor event between oral and vaginal misoprostol in pregnancy beyond 41 weeks. Materials and Methods: A total of 52 pregnant women with more than 41 weeks of gestation, had a Bishop score less than 5, and were undergoing induction labor were randomly divided into two groups: oral and vaginal misoprostol. In the oral misoprostol group, participants were given 25 mg of misoprostol in a solution with a concentration of 1 ug/ml every 2 hours. In the vaginal misoprostol group, a 25 mg misoprostol tablet was inserted into the posterior fornix every 6 hours. The two groups were compared in terms of Bishop score during the first 6 hours, changes in Bishop score, labor at term events, neonatal outcomes, complications, and side effects after the administration of misoprostol. Results: The oral group showed significantly higher changes in Bishop score compared to the vaginal group (5.5 vs 3.6; p=0.0001). The median interval times for induction of labor at term, induction at stage II, and induction at birth were found to be shorter in the oral misoprostol group compared to the vaginal group (7.3 hours vs 10.6 hours, 14.0 hours vs 16.8 hours, and 14.6 hours vs 17.6 hours; p=0.002, 0.003, 0.002). Labor at term occurred much more frequently in the oral group (53.8% vs 15.4%). Additionally, the oral misoprostol group had a 3.5 times higher likelihood of experiencing labor at term within the first 6 hours after the initial administration compared to the vaginal group (OR 3.5, 95% CI 1.33-9.23). Conclusion: Oral administration of misoprostol for cervical ripening has been demonstrated to be more effective than vaginal administration, greater bishop score changes while maintaining an equivalent level of safety.

Critical analysis of misoprostol versus mifepristone with misoprostol in medical termination of pregnancy

Termination of pregnancy by any method before the viable period is called abortion. Medical methods can avoid complications of surgical method of abortion which has many disadvantages like perforation of uterus, hemorrhage, sepsis and increased morbidity. The WHO has approved mifepristone and misoprostol combination for medical abortion. 1. To compare the efficacy of Misoprostol versus combination of mifepristone with Misoprostol. 2. To asses the side effects of Misoprostol and combinationion of Mifepristone and Misoprostol.It is prospective observational study consisting of two groups with each 61 subjects of MTP patients. Group A (Misoprostol alone): Receive tablet misoprostol 600 microgram start placed per vaginally followed by 400 microgram misoprostol tablet placed per vaginally every 4 hourly up to maximum five doses. In case of first trimester cases 800 microgram tablet misoprostol placed per vaginally followed by 400 microgram misoprostol tablet placed per vaginally every 4 hourly up to maximum four doses. Group B (Mifepristone and Misoprostol): Receive tablet mifepristone 200mg orally on empty stomach. After 24 hours will receive tablet misoprostol as mentioned in group A. Misoprostol alone has success rate of 78.69% whereas combination with Mifepristone success was 93.44%. The mean Induction - abortion interval in misoprostol alone group was 11.803 hours and with mifepristone combination it was B5.623 hours. Medical termination of pregnancy by sequential administration of mifepristone with misoprostol has less induction abortion interval compared to using misoprostol alone. This combination has more success rate and also has lesser side effects.

Comparison of oral mifepristone with intracervical foleys catheterisation for induction of labour in term pregnancy: A randomized control trial

The purpose of this study is to compare the efficacy of oral Mifepristone with the efficacy of intracervical Foley catheterisation for induction of labour in term pregnancy. The primary outcome of this study is to compare both methods of induction of labour in terms of induction to delivery interval and the secondary outcome is to compare the two methods in terms of route of delivery, indications of caesarean section and the neonatal outcomes. This study is a randomized control trial conducted from May 2022 to December 2022 in Department of Obstetrics and Gynecology, SSG Hospital, Baroda Medical College. 180 term pregnant patients were enrolled in this study based on a pre-established criteria. Patients were randomised into group A and B. Group A included patients who were given Tablet Mifepristone 200 mg PO followed by per vaginum Tablet Misoprostol and Group B included patients who underwent intracervical Foleys catheterisation followed by placement of per vaginum Tablet Misoprostol. The study concluded that there was significantly decreased induction-delivery interval in women induced with intracervical Foleys catheterisation (Group B) as compared to those given oral Tablet Mifepristone (Group A). There was no significant difference between the two groups in terms of the route of delivery, rate of C Sections and neonatal outcomes.Mifepristone is effective for inducing indicated term pregnancies, despite no decrease in induction delivery interval. Incidence of fetal distress with oral Mifepristone is comparable to intracervical foley's catheterization. Further research is needed to assess tachysystole/hyperstimulation and fetal distress caused by Mifepristone.

Comparison of the effect of vaginal misoprostol and evening primrose oil capsule with misoprostol alone on the consequences of abortion in women with intrauterine fetal death: a randomized clinical trial

BackgroundMisoprostol is the choice drug for inducing an abortion with intrauterine fetal death, but it has several side effects that increase with accumulating the dose received. Induction abortion with cheap and non-invasive methods with minimal complications is essential. This study aimed to compare the effect vaginal misoprostol plus vaginal evening primrose oil capsule with vaginal misoprostol alone on the consequences of abortion in pregnant women with intrauterine fetal death at 12–20 weeks of pregnancy.MethodsThis study is a randomized, triple-blind clinical trial with two parallel groups at a ratio of 1:1. We randomized 82 women with indications of termination of pregnancy due to intrauterine fetal death into two groups. The experimental group (n = 42) received 200 mcg of misoprostol tablet with 1000 mg evening primrose oil capsule intravaginal. The control group (n = 40) received 200 mcg of misoprostol tablet with 1000 mg evening primrose oil placebo capsule intravaginal. Both groups received the drugs every 4 h for up to five doses. The primary outcome was the mean induction-to-fetal expulsion interval. Secondary outcomes were the mean dose of misoprostol, the highest pain intensity in the induction-to-fetal expulsion interval, the frequency of participants requiring blood transfusion, curettage, and the frequency of side effects of misoprostol or evening primrose oil. Pain intensity was measured through the Visual Analog Scale.ResultsThe mean age of the experimental group was 32.30 ± 6.19 years, and the control group was 30.27 ± 7.68 years. The mean gestational age of the experimental group was 15.29 ± 2.26 weeks, and the control group was 15.10 ± 1.89 weeks. The mean induction-to-fetal expulsion interval in the experimental group (3.12 ± 2.17 h) was significantly lower than that in the control group (8.40 ± 4.1 h) (p < 0.001). The mean dose of misoprostol received in the experimental group (271.42 ± 115.39 mcg) was significantly lower than that in the control group (520 ± 201.53 mcg) (p < 0.001). Also, the mean pain intensity in the experimental group (5.02 ± 0.60) was significantly lower than that in the control group (8.65 ± 1.001) (p < 0.001). The two groups were not significantly different in the frequency of blood transfusion requirements, analgesia and drug side effects. The need for curettage in the experimental group (4.8%) was significantly lower than that in the control group (47.5%) (p < 0.001).ConclusionsVaginal administration of evening primrose oil with misoprostol reduced duration of time of fetal expulsion, pain intensity, mean dose of misoprostol received, and the need for curettage in participants. Therefore, we suggest this method for induced abortion in women with intrauterine fetal death.Trial registrationIRCT20181207041873N3. Dated 16/2/2021 prospectively registered https://en.irct.ir/user/trial/53681/view.

A PROSPECTIVE STUDY TO COMPARE COMBINED USE OF INTRAVAGINAL MISOPROSTOL AND INTRACERVICAL FOLEY CATHETER VERSUS INTRAVAGINAL MISOPROSTOL ALONE FOR TERMINATION OF MID-TRIMESTER PREGNANCY IN DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY SMS MEDICAL COLLEGE, JAIPUR

Aims and Objectives: The aims and objectives of the study are to compare the mean induction to abortion interval and efficacy of intra-vaginal misoprostol alone versus combined use of intravaginal misoprostol and intracervical Foley catheter in termination of mid-trimester pregnancy. Methods: This was prospective, comparative study conducted during March 2021 to April 2022 at Department of Obstetrics and Gynaecology, SMS Medical College, Jaipur. The study included sample size of 60 cases (30 cases in each group). 60 cases were randomly allocated to either intravaginal misoprostol alone (Group A) or combined use of intravaginal misoprostol and Foley catheter (Group B) for termination of mid-trimester pregnancy. The study included all pregnant females between 14 and 20 weeks of gestation who were admitted for termination of pregnancy. Results: Mean induction to abortion interval±standard deviation for Group A was 20.79±2.01 h and for Group B, it was 17.29±3.58 h. Mean dose of tablet misoprostol required for Group A±standard deviation was 1453.3±267.47 mcg and for Group B, it was 1053.33±267.47 mcg. Conclusion: In this study, we found that with the combined use of intravaginal misoprostol and intracervical Foley catheter, there was a significant reduction in duration of induction to abortion, total dose misoprostol required, and hospital stay than in intravagnial misoprostol alone in termination of mid-trimester pregnancy.

A Comparative Study of the Efficacy and Safety of Oral Misoprostol, Intravenous Oxytocin, and Intravaginal Dinoprostone for Labor Induction in Pakistani Women.

A frequent medical procedure to accelerate labor is the induction of labor. There are different methods of labor induction, including the use of medications such as misoprostol, oxytocin, and dinoprostone. This research compared the effectiveness and safety of oral misoprostol, intravenous oxytocin, and intravaginal dinoprostone for labor induction in Pakistani women. A study was conducted in the Department of Obstetrics and Gynaecology, Hayatabad Medical Complex-Medical Teaching Institute (MTI) and Lady Reading Hospital-MTI, Peshawar, Pakistan, over two years. It included 378 women between 38 and 42 gestational weeks, divided into three groups of 126 women each. The oral misoprostol group was given a maximum of six doses of a 25 μg oral misoprostol solution (oral misoprostol tablet of 200 μg dissolved in 200 ml) at intervals of two hours. The drip rate for the intravenous oxytocin group ranged from 6 mIU/minute to 37 mIU/minute. The intravaginal dinoprostone group received a controlled-release vaginal insert containing 10mg of intravaginal dinoprostone, which was left in place for 12 hours. More women in the oral misoprostol group (n=94; 74.6%) had successful inductions when compared to the intravaginal dinoprostone (n=83; 65.9%) and intravenous oxytocin (n = 77; 64.71%) groups. Oral misoprostol had the greatest proportion of normal vaginal deliveries (n=62; 65.95%), followed by intravaginal dinoprostone (n=47; 56.63%), and intravenous oxytocin had the lowest rate (n=33; 42.85%). Cesarean section rates were greatest in the intravenous oxytocin group (n=31; 40.26%), followed by the intravaginal dinoprostone group (n=29; 34.94%), and lowest in the oral misoprostol group (n=24; 25.53%). Oral misoprostol induces labor in women safely and effectively, resulting in the lowest percentage of cesarean deliveries and the highest percentage of normal vaginal deliveries, respectively. Intravaginal dinoprostone showed the lowest rate of side effects, followed by oral misoprostol while intravenous oxytocin had the highest rate of side effects.