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

Trial design 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. Methods 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. Results 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. Limitations 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 Future work should use existing data to assess and rank the relative clinical effectiveness and safety profiles for all methods of management of miscarriage. Conclusions 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. Trial registration Current Controlled Trials ISRCTN17405024. Funding 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.

Comparative study of intravaginal misoprostol versus dinoprostone gel for induction of labour in primigravida

Background: Labour is an inevitable consequence of pregnancy. The aim of the present research was to study the safety, efficacy and effect of intravaginal misoprostol and dinoprostone gel for induction of labour.Methods: 300 patients who required induction of labour in a tertiary care centre were included in this prospective randomized controlled study from August 2019 to August 2021 with a study duration of 12 months. 50% of cases received 25 µg of intravaginal misoprostol and repeated for a maximum of 6 doses every 4 hours as needed. 50% cases received 0.5 mg dinoprostone gel and repeated for maximum of 2 doses every 6 hours as needed. The patients selected were evaluated initially by modified Bishop’s score and admission test for fetal wellbeing. After drug insertion, patients were monitored for fetal heart rate, vital signs, progress of labour. A partogram was strictly maintained in all patients.Results: The highest number in both groups being below 40 weeks which were 74% and 76% in dinoprostone and misoprostol groups respectively. Rest were between 40.1-41.6 weeks. The mean induction delivery interval in dinoprostone was more (16.15±3.1) than in misoprostol (12.26±2.21). Requirement of oxytocin augmentation was less in misoprostol group than dinoprostone group. Caesarean section rate was less in misoprostol group. Maternal side effects were minimal in either groups and neonatal outcome was good in both the groups.Conclusions: Both misoprostol and dinoprostone gel are safe, effective for cervical ripening and induction but misoprostol is more cost effective and stable at room temperature.

Efficacy of Sublingual Administration Misoprostol 600 mcg Versus 800 mcg for Induced Abortion in Women with Early Pregnancy Loss: A Randomized Controlled Trial

Objective: To compare the complete abortion rate, the induction-to-abortion time, and side effects between 600 mcg and 800 mcg misoprostol sublingually. Materials and Methods: Total, of 108 pregnant women with gestational age less than 12 weeks with early pregnancy loss from March 2020 to February 2021 at the Department of Obstetrics and Gynecology, Queen Savang Vadhana Memorial Hospital, were included. For group 1 (n=54), 600 mcg misoprostol was administrated sublingually. For group 2 (n=54), 800 mcg misoprostol was administrated sublingually. If the abortion did not occur, the repeated misoprostol in the same dose would be administrated sublingually every 6 hours for a maximum of three doses. Results: There was no significant difference in the complete abortion rate between the two groups (55.6% in the 600 mcg misoprostol group, 64.7% in the 800 mcg misoprostol group, p=0.339, and 95% CI 0.082 to 1.862). The induction-to-abortion time was 9.5 hours (IQR 6.75 to 48.00) in the 600 mcg misoprostol group and 10 hours (IQR 6.00 to 60.00) in the 800 mcg misoprostol group. The side effects of both groups were similar, included abdominal pain, diarrhea, nausea and vomiting, fever, heavy bleeding, and headache. Conclusion: The efficacy of the 600 mcg misoprostol was noninferior to 800 mcg misoprostol. The adverse effects were similar in both groups. Mean induction-to-abortion time was also similar in both groups. Keywords: Early pregnancy loss; Misoprostol; Medical abortion

Combined Use of Vaginal Misoprostol with Intracervical Foley Catheter Versus Vaginal Misoprostol alone in Induction of Labor at Term Pregnancy

Background Induction of labor should be used in the most efficient way possible that will result in a favorable obstetric outcome with minimum fetal morbidity. Objectives The aim of this study is to compare the efficacy and safety of intravaginal misoprostol alone versus intra cervical Foley catheter combined with vaginal misoprostol in induction of labor at term pregnancy. Methods This study was conducted at Obstetrics & Gynecology Department; Ain Shams University, Maternity Hospital in the period between May 2017 to October 2017. The total number of patients studied was 120 patients, divided into two groups; the first group (A) included 60 patients who received vaginal misoprostol, the second group (B) included 60 patients who received vaginal misoprostol combined with trans cervical Foley catheter. Results The current study found that the combined group has a better chance for NVD 88.3% versus 78.3% in misoprostol alone group, a lesser probability to CS 11.7% in combined group versus 21.7% in misoprostol alone group and a shorter induction delivery interval within 12 hours after induction (81.6% in combined group versus 59.5% in misoprostol group). Regarding the effect of both methods on fetal safety, we found that non reassuring FHR was more common in combined group 8.3% than misoprostol alone group 1.7% but it’s statistically non-significant. There was statistically significant increase in tachysystole in combined group 28.3% versus 13.3% in misoprostol alone group. However, dystocia was more common in misoprostol group 15% than combined group 3.3% that is also statistically significant. Conclusion Both methods can be used in induction of labor at term pregnancy without forgetting the precautions and close observation to the mother and the fetus. Combined method results in a shorter induction-to delivery time, but misoprostol alone was safer for the mother and the fetus.

Efficacy and Safety of Vaginal Misoprostol for Cervical Ripening and Labour Induction in Late Pregnancy

Background: Induction of labor is its intentional initiation before spontaneous onset, with the aim of vaginal birth which is safe for mother and newborn. The well documented effectiveness of misoprostol in several gynecological and obstetric applications has resulted in enthusiasm for its use. Objective: To see the efficacy and safety vaginal Misoprostal for cervical ripening and labour induction in late pregnancy. Materials and Methods: This single center clinical trial was carried out in the Department of Obstetrics and Gynaecology at Khwaja Yunus Ali Medical College and Hospital in Sirajgonj, Bangladesh from June 2019 to May 2020 for a period of one year. A total of 90 women requiring indicated induction of labour with an unfavourable cervix (Bishop score ≤ 4) were included in the study. They were randomly divided into two groups: 53 women induced with intravaginal misoprostol (Group I) and 37 women induced with transcervical Foley catheter (Group II). Results: Spontaneous vaginal delivery was 35(66.0%) in misoprostol group and 15(40.5%) in Foley catheter group. Caesarean section was higher in Foley catheter group than misoprostol group (37.8% vs 18.9%). The mean birth weight, APGAR score 1 minute, 5 minute, admission in neonatal intensive care unit and meconium aspiration syndrome were not statistically significant between two groups (p>0.05). Only one baby was died in Foley catheter group, but the difference was not statistically significant between two groups (p>0.05). Conclusion: The present study suggests intravaginal Misoprostol results in a shorter induction to delivery time, a reduction in the rate of caesarean delivery. KYAMC Journal.2021;12(02): 78-83

COMPARISON OF MISOPROSTOLAND DINOPROSTONE FOR ELECTIVE INDUCTION OF LABOUR IN NULLIPAROUS WOMEN AT FULL TERM: A RANDOMIZED PROSPECTIVE STUDY

Background: The objective of this randomized prospective study was to compare the efcacy of 50 mcg vaginal misoprostol and 3 mg dinoprostone, administered every nine hours for a maximum of three doses, for elective induction of labor in nulliparous women with an unfavorable cervix and more than 40 weeks of gestation. Material And Methods: One hundred and sixty-three pregnant women with more than 285 days of gestation were recruited and analyzed. The main outcome measures were time from induction to delivery and incidence of vaginal delivery within 12 and 24 hours. Admission rate to the neonatal intensive care unit within 24 hours post delivery was a secondary outcome. Results: The induction-delivery interval was signicantly lower in the misoprostol group than in the dinoprostone group (11.9 h vs. 15.5 h, p < 0.001). With misoprostol, more women delivered within 12 hours (57.5% vs. 32.5%, p < 0.01) and 24 hours (98.7% vs. 91.4%, p < 0.05), spontaneous rupture of the membranes occurred more frequently (38.8% vs. 20.5%, p < 0.05), there was less need for oxytocin augmentation (65.8% vs. 81.5%, p < 0.05) and fewer additional doses were required (7.5% vs. 22%, p < 0.05). Although not statistically signicant, a lower Caesarean section (CS) rate was observed with misoprostol (7.5% vs. 13.3%, p > 0.05) but with the disadvantage of higher abnormal fetal heart rate (FHR) tracings (22.5% vs. 12%, p > 0.05). From the misoprostol group more neonates were admitted to the intensive neonatal unit, than from the dinoprostone group (13.5% vs. 4.8%, p > 0.05). One woman had an unexplained stillbirth following the administration of one dose of dinoprostone. Conclusions: Vaginal misoprostol, compared with dinoprostone in the regimens used, is more effective in elective inductions of labor beyond 40 weeks of gestation. Nevertheless, this is at the expense of more abnormal FHR tracings and more admissions to the neonatal unit, indicating that the faster approach is not necessarily the better approach to childbirth

Comparison of Misoprostol With Tranexamic Acid in Preventing Post-Partum Hemorrhage

Aim: To compare the amount of average blood loss in transamine and misoprostol groups in patients undergoing spontaneous vaginal delivery in third stage of labour. Method: We conducted the randomized controlled trial from July 26th 2016 to 25th of January 2017. Results: In my study the mean age of the patients undergoing normal vaginal delivery was 28.47 years, parity wise, 31%, 33%, 24% and 11% of participants were para 1, para 2, para 3 and para 4 respectively. Mean blood loss in group A was 224.08 +/- 20.81mls and in group B 331 +/- 398 mls. Conclusion: This study has demonstrated that the blood loss in transamine group (group A) is less than the mean blood loss in misoprostol group (group B). Keywords: Transamine, misoprostol, normal vaginal delivery

A STUDY OF VAGINAL MISOPROSTOL TABLET VERSUS INTRACERVICAL DINOPROSTONE FOR INDUCTION OF LABOUR

Background:Induction of labour is the process of initiating the labour by articial means post 24 weeks of gestation. This study was undertaken to compare the efcacy and safety of vaginal Misoprostol [25-50ug] with intracervical Dinoprostone gel (0.5mg) for induction of labour at term in terms of efcacy of drug, feto-maternal outcome, side effects and complications of drugs. Methods: 400 nulliparas at term admitted in the OBG ward were included in this study. They were randomly allocated to two groups A& B. Group A (200 women) received tablet Misoprostol 25 micrograms vaginally 4 hrly to a maximum of 3 doses and Group B (200 women) received Dinoprostone gel 0.5mg intracervically 6 hrly to a maximum of 3 doses. Comparison was done in terms of induction to delivery interval, rates of instrumental and LSCS delivery, need for NICU care and cost-effectiveness. ADRs, if any were documented and proper care taken. Results: The mean induction to delivery interval was less in the Misoprostol group than Dinoprostone group (12 hrs vs. 22 hrs). 82% patients delivered in the rst 24 hrs in Misoprostol group compared to 54 % patients in Dinoprostone group. Group A had a higher success rate (80% vs.75%) and also required less augmentation of labor ( 35% vs. 65%) compared to group B. Need for LSCS was also lower in Misoprostol group (13% vs. 18%). Need for instrumentation and incidence of NICU admission was similar in both groups. Misoprostol was more cost effective compared to Dinoprostone. Conclusions: The Misoprostol group had a shorter induction to delivery interval, more number of deliveries in the rst 24 hrs of induction and a reduced need of augmentation of labor with oxytocin. There was no signicant difference in the rate of caesarean section, hyper-stimulation syndrome, neonatal and maternal morbidity between the two groups. Thus, Misoprostol appears to be safer, cheaper and more efcacious alternative for induction of labor especially for non-fetal indications as compared to Dinoprostone gel.

COMPARATIVE STUDY BETWEEN COMBINED USE OF INTRACERVICAL FOLEY CATHETER WITH VAGINAL MISOPROSTOL VERSUS VAGINAL MISOPROSTOL FOR MID TRIMESTER ABORTIONS IN PATIENTS WITH PREVIOUS CAESAREAN SECTIONS

Background:There is a gradual increase in second-trimester abortion because of wide scale introduction of prenatal screening programs detecting women whose pregnancies are complicated by serious fetal abnormalities suchas aneuploidy, cardiovascular and skeletal malformation. It constitutes 10-15% of all induced abortions.With the global trend of raised cesarean section rate, obstetricians are faced with the challenge of termination of pregnancy in women with a scarred uterus.Termination of pregnancy in second trimester is associated with much more morbidity and mortality than when it is done in the first trimester. The various methods for second trimester termination of pregnancy are still controversial and the search for the ideal method which is the safest, easiest, cheapest and most effective is still going on. Search for alternative and effective method is the need of hour. In our study, we aimed at assessing the effectiveness and safety of intracervical foleys catheter with vaginal misoprost and comparing it with the vaginal misoprost for mid trimester abortions in patients with previous caesarean. Methods: This was a prospective randomized controlled trial conducted on 108 women undergoing mid trimester abortions at Patna medical college and hospital in 2019. Patients were randomly allocated in 2 groups Group I ( intracervical foleys and Misoprostol group): Intracervical Foley catheter inserted with a standard regimen of moistened misoprostol tablets (200 μg) 6 hourly intravaginally was used. Group II (misoprostol group): moistened misoprostol tablets (200 μg) 6 hourly inserted vaginally. Procedure efficacy (defined as complete abortion within 48 hours of first dose of misoprostol), safety and reduction in side effects ,acceptability, dose of misoprost required were assessed in both the groups. Results:The induction to abortion interval was 24.16 ± 1.52 hours in the combined group compared to 45.76 ± 1.63 hours in the misoprostol group (P value<0.021) with success rate of 96% in the combined group and 80 % in misoprostol group. Total dose of misoprostol required in combined group was (682.33+_ 245) micrograms and (1100 +_ 212) micrograms in misoprost group with p value < 0.001 No significant difference as regard occurrence of advere effects between the two groups. Conclusions:Combined use of intracervical foley catheter and vaginal misoprostol is a novel safe, effective and acceptable method for termination of second trimester in patients with previous caesarean sectionpregnancy.