Safety Of Sublingual Misoprostol Research Articles

Mifepristone and sublingual misoprostol versus sublingual misoprostol alone for missed abortion: Results of a randomized placebo-controlled trial

Introduction: Medical management of missed abortion has been demonstrated to be a safe and effective alternative to uterine aspiration. Regimens for medical management subjected to clinical trials using pretreatment with mifepristone followed by misoprostol have generally employed vaginal misoprostol. However, misoprostol-only regimens recommended by the World Health Organization also include sublingual misoprostol. We compared the efficacy and safety of pretreatment with mifepristone followed by sublingual misoprostol with the efficacy and safety of sublingual misoprostol alone for the management of missed abortion.

Effectiveness and safety of sublingual misoprostol in medical treatment of the 1st trimester miscarriage: experience of off-label use in Korea.

ObjectiveThis study was conducted to determine the effectiveness and safety of medical treatment with sublingual misoprostol (MS) in the 1st trimester miscarriage under the approval by Health Insurance Review and Assessment Service (HIRA) for off-label usage by the single medical center in Korea.MethodsA retrospective cohort study was performed in one institution between April 2013 and June 2016. Ninety-one patients diagnosed with miscarriage before 14 weeks of gestation and wanted to try medical treatment were included. A detailed ultrasound scan was performed to confirm the diagnosis. Patients took 600 microgram (mcg) of MS sublingually at initial dose, and repeated the same dose 4–6 hours apart. Successful medical abortion was defined as spontaneous expulsion of gestational products (including gestational sac, embryo, fetus, and placenta). If gestational products were not expelled, surgical evacuation was performed at least 24 hours later from the initial dose. Information about side effects was obtained by medical records.ResultsAbout two-thirds of patients had a successful outcome. The median interval time from pill to expulsion was 18 hours in the successful medical treatment group. There was no serious systemic side effect or massive vaginal bleeding. Presence or absence of vaginal spotting before diagnosis of miscarriage, uterine leiomyomas, subchorionic hematoma, or distorted shape of gestational sac on ultrasound scan were not statistically different between the two groups.ConclusionMedical treatment with sublingual MS can be a proper option for the 1st trimester miscarriage, especially for the patient who want to avoid surgical procedure. We can reduce the unnecessary sedation or surgical intervention in the patients with the 1st trimester miscarriage.

EP25.07: Effectiveness and safety of sublingual misoprostol in medical treatment of the first trimester miscarriage and related contributing factors

EP25.07: Effectiveness and safety of sublingual misoprostol in medical treatment of the first trimester miscarriage and related contributing factors

Comparison of the efficacy and safety of sublingual misoprostol with that of vaginal misoprostol for labour induction at term

Objective To compare the efficacy and safety of 50 mcg of sublingual misoprostol with 25 mcg of vaginal misoprostol for induction of labour at term. Method Non blinded randomized prospective control study. 200 women with singleton term pregnancy, admitted for induction of labour, were randomized to receive either 25 mcg of vaginal misoprostol or 50 mcg of sublingual misoprostol. Outcome measures compared were the number of vaginal deliveries, induction-delivery interval, caesarean section for foetal distress, oxytocin for acceleration, number of doses required, side effects and neonatal outcome. Result Mean dose was smaller and induction to delivery interval was significantly shorter in the sublingual group (13.1 ± 4.1 h) compared with the vaginal group (17.9 ± 5.4 h), p value 0.001. There were no statistically significant differences in the other secondary outcome measures. Conclusion 50 mcg of sublingual misoprostol was more effective than and as safe as 25 mcg vaginal misoprostol for labour induction at term.

Role of sublingual misoprostol for cervical priming in first trimester medical termination of pregnancy.

To evaluate the efficacy and safety of sublingual misoprostol as facilitator in first trimester medical termination of pregnancy (MTP) by surgical method. This was a prospective open label study conducted at a tertiary center. A total 150 patients at 6-12 wks gestation requesting for MTP were randomized into two groups. Patients in study group (n=75) received sublingual misoprostol three hours before surgical abortion and in control group (n=75) directly underwent surgical abortion without prior cervical priming with misoprostol. The outcomes of both groups were recorded in terms of baseline cervical dilatation, need of additional cervical dilatation, intraoperative blood loss, operative time and procedure related complications. The results were statistically analyzed using student-t test and chi-square test. p-value of <0.05 and <0.001 were considered significant and highly significant respectively. The mean baseline cervical dilatation was significantly more in study group compared to control group (8.6±1.3mm versus 5±2.3mm; p <0.001) and the operative time and intraoperative blood loss were also less (p<0.001). Higher incidence of side effects like nausea, vomiting and pyrexia were recorded in sublingual misoprostol group but were well tolerable to the patients. Sublingual misoprostol is an effective and safe drug for cervical priming prior to surgical evacuation and has good patient acceptability.

Effect of sublingual misoprostol versus intravenous oxytocin on reducing blood loss at cesarean section in Nigeria: A randomized controlled trial

The aim of this study was to compare the effectiveness and safety of sublingual misoprostol with i.v. oxytocin infusion administered after delivery in reducing blood loss at cesarean section in Nigeria. One hundred women with term singleton pregnancy undergoing elective or emergency cesarean section under spinal anesthesia in Nigeria were randomly allocated to receive either misoprostol 400 µg sublingually or i.v. infusion of 20 units oxytocin soon after delivery of the baby. Estimated blood loss at surgery and within the first 4 h post-operation were measured in both groups. No significant difference was found in mean blood loss between the oxytocin and misoprostol groups. Similarly, no significant difference occurred between preoperative and postoperative hematocrit levels in both groups. The need for additional oxytocin was similar in both groups. There was significantly less blood loss in the first 4 h after surgery in the misoprostol group than in the oxytocin group (58.2 ± 20.7 vs 80.5 ± 26.8; P-value = 0.02). The incidence of adverse effects like shivering/pyrexia was significantly higher in the misoprostol group than in the oxytocin group (27/50 vs 1/50, P < 0.001). Sublingual misoprostol was as effective as i.v. oxytocin infusion in reducing blood loss at cesarean section. It offers several advantages over oxytocin, including long shelf life, stability at room temperature, and oral administration, which make it a suitable uterotonic agent in low-resource areas.

Sublingual versus vaginal misoprostol for induction of labor at term: A randomized prospective placebo‐controlled study

To assess the effectiveness and safety of sublingual misoprostol (50 microg), compared with the same dose administered vaginally every 6 h for cervical ripening and labor induction in women with a viable fetus in the third trimester of pregnancy. This double-blind randomized prospective placebo-controlled trial included 480 women with medical or obstetric indications for labor induction and undilated, uneffaced cervices. The patients were assigned randomly to receive 50 microg of sublingual or 50 microg of vaginal misoprostol every 6 h for 24 h. Maternal and neonatal outcome were analyzed. A total of 169 (70.4%) patients delivered vaginally in the sublingual group compared to 160 (66.7%) in the vaginal group. The main indications for cesarean section in both groups were fetal distress (33/71 [46.4%] vs 38/80 [47.5%]), followed by failure of labor progress. Thirty three (13.8%) patients in the sublingual group had meconium staining of the amniotic fluid compared to 39 (16.3%) in the vaginal group. There was no difference between the groups regarding the induction-to-delivery interval, duration of labor, neonatal outcome or maternal side-effects. Sublingual misoprostol is as effective as vaginal misoprostol for induction of labor at term. Moreover, the sublingual route is associated with a significantly higher patient satisfaction rate than vaginal misoprostol.

Nova formulação de misoprostol sublingual na indução do trabalho de parto

To determine effectiveness and safety of sublingual misoprostol in tablets of 25 mcg, given every 6 hours for induction of labor in high-risk pregnant women hospitalized in two teaching hospitals in the Northeast of Brazil. An open, non-randomized clinical trial was conducted, including 40 women with high-risk pregnancies hospitalized at "Maternidade-Escola Assis Chateaubriand" and "Instituto Materno-Infantil de Pernambuco". All of them had gestational age >or= 37 weeks, alive fetus with good vitality and Bishop scores <or= 7. A tablet of 25 mcg of misoprostol was administered every 6 hours, up to a maximum of 4, until active labor. Statistical analysis was performed using the public domain software Epi-Info 3.2.2. Active labor occurred in 100% of cases after misoprostol administration. The mean (+/-SD) induction-to-labor interval was 4.8(+/-3.8 hours. Interval from induction-to-delivery varied from 8 to 31 hours with 95% of the deliveries occurring in the first 24 hours with 75% of vaginal deliveries. The frequency of tachysystole was 12.5%. The women did not present relevant side effects neither were there any neonatal complications. The sublingual tablet of misoprostol of 25 mcg was shown to be effective for induction of labor in high-risk pregnant women. The efficacy and acceptability of this new route should be compared to vaginal administration of misoprostol in future prospective randomized clinical trials.