Comparison of the Efficacy and Safety of Sublingual Versus Oral Misoprostol for the Induction of Labor: A Randomized Open-Label Study.

Introduction Misoprostol (prostaglandin E1 analog) is being used for the induction of labor by vaginal, oral, and sublingual routes. Oral misoprostol is the preferred route for induction of labor, but the use of sublingual misoprostol appears promising due to a faster onset of action. This study was done to compare the efficacy and safety of oral and sublingual misoprostol for induction of labor in term pregnancy. Materials and methods One hundred and sixty patients were randomly allocated to one of the two groups to receive 50 micrograms of oral and sublingual misoprostol four hourly for a maximum of six doses. Primigravida at 37-42 weeks of gestation with singleton pregnancy, cephalic presentation, Bishop score (<5), and reassuring fetal heart rate were included in the study. Misoprostol dose was withheld if the active phase of labor was reached or if the cervix was favorable for amniotomy (Bishop score greater than or equal to eight). The change in the Bishop score with misoprostol was studied along with adverse effects and neonatal outcomes. Results The mean number of 50 mcg misoprostol doses required was significantly less in the sublingual group (2.94±0.97 versus 2.13±0.92; p<0.0001). The rate of change of the mean Bishop score was faster in the sublingual group. After four hours of the first dose, the mean Bishop score changed to 3.52±2.14 versus 4.68±2.34 (p=0.001), and, similarly, after eight hours, it was 10.48±2.59 versus 11.39±2.06, and this difference was statistically significant (p=0.015). The mean induction delivery interval was significantly lower in the sublingual group. The need for labor augmentation, mode of delivery, and adverse effects were similar in both groups. The incidence of meconium-stained liquor and NICU admission was also similar in both groups. Conclusion Sublingmisoprostolstol has a short induction delivery interval and comparable side effects when compared to omisoprostolstol. Sublingmisoprostolstol is recommended for induction of labor at term.

Preoperative versus postoperative misoprostol use for prevention of blood loss during caesarean section in pregnant women at term: a multi-centre randomised controlled trial.

OBJECTIVE: Caesarean section is associated with higher blood loss than vaginal delivery. This study was performed to compare the safety and efficacy of preoperative versus postoperative rectal and sublingual misoprostol use for prevention of blood loss in women undergoing elective caesarean delivery. METHODS: Eligible patients in Southeast Nigeria were randomly classified into those that received 600 µg of preoperative rectal, postoperative rectal, preoperative sublingual, and postoperative sublingual misoprostol. All patients received 10 units of intravenous oxytocin immediately after delivery. Data were analysed with SPSS Version 23. RESULTS: Preoperative sublingual misoprostol use caused the highest postoperative packed cell volume, least change in the packed cell volume, and lowest intraoperative blood loss. Preoperative sublingual and rectal misoprostol use was associated with better haematological indices and maternal outcomes than postoperative use by these routes. However, preoperative sublingual and rectal use caused more maternal side effects than postoperative use by these routes. CONCLUSION: Preoperative sublingual misoprostol was associated with the most favourable haematological indices. Although preoperative sublingual and rectal misoprostol use caused more maternal side effects, these routes were associated with better haematological indices and maternal outcomes than postoperative sublingual and rectal misoprostol use.

A Comparative Study of Sublingual Misoprostol Versus Intramuscular Oxytocin in the Active Management of Third Stage of Labor.

Objective Misoprostol has attracted low-income low-resource countries for the active management of the third stage of labor. The objective of this study was to compare the efficacy of sublingual misoprostol and intramuscular oxytocin in the active management of the third stage of labor. Study design This was a prospective randomized controlled trial in which a total of 407 healthy pregnant women having singleton pregnancy, cephalic presentation, and normal vaginal delivery were divided into two groups. In the first group (n=203), women received 600 µg misoprostol tablet sublingually, and in the second group (n=204), women received 10 IU of intramuscular oxytocin, within 1 minute of the delivery of the baby during the third stage of labor. Three patients from the first group and four patients from the second group were excluded from the analysis due to traumatic postpartum hemorrhage (PPH). The primary outcome was an incidence of PPH. Secondary outcomes were the duration of the third stage of labor, amount of blood loss, fall in hemoglobin concentration after 48 hours of delivery, need for additional uterotonics, and side effects of the drugs. Data were compared using the chi-square and independent samples t-test. Results The incidence of PPH was 6.5% in the misoprostol group as compared to 2% in the oxytocin group (p=0.026). The misoprostol group also had significantly higher blood loss (293.75±125.8 mL) and a greater fall in hemoglobin level (0.58±0.25 g/dL) as compared to that in the oxytocin group (226.13±98.44 mL and 0.45±0.20 g/dL) (p<0.001). The mean duration of the third stage of labor was significantly higher in the misoprostol group (5.31±2.1 min) as compared to that in the oxytocin group (3.65±1.75 min) (p<0.001). The additional need for uterotonics was recorded in 15% of the study participants in the misoprostol group as compared to 8% in the oxytocin group (p=0.028). The incidence of side effects such as shivering and fever was significantly higher in the misoprostol group as compared to the oxytocin group. No significant difference between the two groups was observed concerning the incidence of nausea, vomiting, diarrhea, and headache. Conclusion Intramuscular oxytocin is a safe and useful alternative to sublingual misoprostol in facilitating the third stage of labor with minimal blood loss, fewer incidences of hemorrhage, and fewer adverse effects.

Efficacy of combination of transcervical Foley catheter and sublingual misoprostol versus sublingual misoprostol for labor induction in pre-eclampsia at 28-34 weeks.

OBJECTIVE: To compare the efficacy of using a combination of transcervical Foley catheter and sublingual misoprostol with sublingual misoprostol alone for induction of labor (IOL) in women with pre-eclampsia between 28 and 34 weeks of pregnancy. METHODS: This randomized controlled trial was conducted on women with pre-eclampsia at 28-34 weeks of pregnancy, with unfavorable cervix, admitted to a tertiary hospital in south India. They were randomized to receive either a combination of transcervical Foley catheter and sublingual misoprostol, or sublingual misoprostol alone. Vaginal birth within 24 h of induction, induction to delivery interval, and neonatal morbidity/mortality were the main outcome measures. RESULTS: Vaginal birth within 24 h was higher with the combination of Foley catheter and sublingual misoprostol compared with sublingual misoprostol alone (60% versus 41.4%, P = 0.028). Overall vaginal delivery rates were comparable between the groups (90% versus 80%, P = 0.051). There was no difference in number of doses of misoprostol, and induction to delivery interval between groups. After excluding those with lower likelihood of neonatal survival, live birth rates, mean birth weight, and neonatal intensive care unit admission rates were similar in both groups. CONCLUSIONS: Combination of transcervical Foley catheter and sublingual misoprostol was found to be more effective in achieving vaginal birth within 24 h compared with sublingual misoprostol for IOL in pre-eclampsia between 28 and 34 weeks of pregnancy. TRIAL REGISTRATION NUMBER: CTRI/2018/09/015766; http://ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=27984.

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

Introduction: single-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. Methods: the 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. Results: two 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. Conclusion: the 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.

Efficacy of sublingual misoprostol for induction of labor at term and post term according to parity and membrane integrity: a prospective observational study.

OBJECTIVE: To evaluate the effectiveness and safety of 25 mcg sublingual misoprostol for induction of Labor at term according to parity and membrane integrity. METHODS: We conducted a prospective observational study on singleton pregnancies undergoing induction of Labor at term. Twenty-five mcg of misoprostol were administered sublingually every 4 h. Main outcomes were vaginal deliveries within 24 h, time-to-vaginal-delivery, hyper-stimulation syndrome, cesarean section rate, arterial pH< 7.0 and NICU admission rate. RESULTS: We studied 508 patients, 375 nulliparous and 133 multiparous women. Sixty-five percent and 78%, respectively, delivered vaginally within 24 h from first administration. Median time-to-vaginal-delivery was significantly shorter in PROM than in women with intact membranes (p < 0.001). Epidural analgesia prolonged time-to-vaginal-delivery among nulliparous women (p < 0.0005). A positive correlation between BMI and time to delivery was observed in both nulliparous and multiparous women (p < 0.05). Cesarean section rate was 22% in nulliparous and 6% in multiparous group. Induction failure was 1.4% and uterine hyper-stimulation 1%. No pH≤ 7.00 was recorded; overall 7 (1.4%) newborns were admitted to NICU. CONCLUSIONS: Sublingually administered misoprostol is an effective and safe method for induction of Labor at term. Parity, status of membranes and BMI significantly affect time to delivery.

Sublingual Misoprostol (PGE1) Versus Intracervical Dinoprostone (PGE2) Gel for Induction of Labour: A Randomized Control Trail.

BACKGROUND: Prostaglandins are popular agents for induction of labour, owing to their dual action of cervical ripening and inducing uterine contractions. Sublingual misoprostol offers high efficacy as it bypasses first-pass metabolism. Researchers have proved that intracervical PGE1 is as effective as PGE2 except for increased caesarean rate and hyperstimulation. Limited knowledge is available on the efficacy of sublingual PGE1 and intracervical PGE2. This study was designed to compare the effectiveness of sublingual PGE1 with intracervical PGE2. METHODS: A randomized control trial was conducted in Bangalore Baptist Hospital, Bangalore. One hundred and ninety women with singleton, term pregnancy were equally divided into PGE1 and PGE2 groups, and primary outcome was measured. RESULTS: Post-induction mean Bishop's score in PGE1 group was statistically significant (t = 6.57, p < 0.05). Failed induction rate (1 vs 13.6 %) and need for augmentation (46.3 vs 62.1 %) were lower with PGE1 than those with PGE2 (p < 0.05). Significant (p < 0.05) maternal and foetal outcomes like higher rate of NVD (35.8 vs 26 %), lower LSCS rate (15.8 vs 32.6 %), lower incidence of foetal complications (7.3 vs 21 %) were noted with PGE1. APGAR scores at 1 and 5 min were not significant. Mean cost of induction with PGE1 was 12.55+/4.15 INR and with PGE2 470.65+/126.5. CONCLUSION: Sublingual PGE1 is a better cervical ripening agent, faster and more effective, with a shorter induction-to-delivery interval as compared to intracervical PGE2. We also noted lower incidence of caesarean section and foetal distress with sublingual PGE1 compared to oral or vaginally administered PGE1.

Sublingual misoprostol is as effective as intravenous oxytocin to reduce intra-operative blood loss during cesarean delivery in women living at high altitude.

OBJECTIVE: To assess the effect of sublingual misoprostol compared to intravenous oxytocin for blood loss during cesarean delivery in women living at high altitude. STUDY DESIGN: In a randomized trial, conducted in Quito, Ecuador (2800 m above sea level), 100 women received either sublingual misoprostol (400 µg) or intravenous oxytocin (10 IU). RESULTS: Bleeding in the misoprostol was no different than in the oxytocin group. Shivering was reported in 66% of women in the misoprostol group. CONCLUSION: Sublingual misoprostol might be a valid alternative to oxytocin reduce intra-operative blood loss during cesarean section in women living at high altitude.

A randomized controlled trial of sublingual misoprostol and intramuscular oxytocin for prevention of postpartum hemorrhage.

PURPOSE: In India, two third of maternal deaths occur in rural areas where there is lack of transportation facilities, lack of refrigeration to store the injectable uterotonic drug such as oxytocin, lack of skilled personnel to administer them and lack of sterile syringes and needles. Hence, this study was conceived to evaluate misoprostol as a safe, effective, easily administered non-parenteral drug in the prevention of postpartum hemorrhage. METHODS: This study was conducted during the period from August 2012 to July 2014. Low risk women with singleton pregnancy at term admitted for vaginal delivery were eligible for the study. A total of 500 women were randomized to two groups, 250 in each group, either to receive 400 mcg misoprostol sublingually or 10 units oxytocin intramuscularly at the delivery of anterior shoulder. Patient factors, labor parameters, blood loss and side effects were noted. RESULTS: The women in both the groups were well matched with respect to age, parity, gestational age and labor parameters. There was statistical significance in the blood loss (p = 0.04) between the two groups. The average blood loss was 70 ml in misoprostol group and 75 ml in oxytocin group. Shivering was the statistically significant side effect (p = 0.004) in the misoprostol group and nausea was the statistically significant side effect (p = 0.003) in the oxytocin group. CONCLUSIONS: Sublingual misoprostol is as effective as intramuscular oxytocin as a prophylactic oxytocic in the active management of third stage of labor for prevention of postpartum hemorrhage.

Provision of medical abortion using telemedicine in Brazil.

OBJECTIVE: To evaluate the need for and outcome of self-administered medical abortion with mifepristone and misoprostol in Brazil, provided through Women on Web, a global telemedicine abortion service. STUDY DESIGN: A retrospective case review of women from Brazil who contacted Women on Web in 2011. Information from the online consultation, follow-up questionnaire and emails were used to analyze data including demographics, gestational age, outcome of the medical abortion and symptoms that lead to surgical interventions. RESULTS: The Women on Web website had 109779 unique visitors from Brazil, 2104 women contacted the helpdesk by email. Of the 1401 women who completed the online consultation, 602 women continued their request for a medical abortion. Of the 370 women who used the medicines, 307 women gave follow-up information about the outcome of the medical abortion. Of these, 207 (67.4%) women were 9 weeks or less pregnant, 71 (23.1%) were 10, 11 or 12 weeks pregnant, and 29 (9.5%) women were 13 weeks or more pregnant. There was a significant difference in surgical intervention rates after the medical abortion (19.3% at <9 weeks, 15.5% at 11-12 weeks and 44.8% at >13 weeks, p=.06). However, 42.2% of the women who had a surgical intervention had no symptoms of a complication. CONCLUSION: There is large need for medical abortion in Brazil. Home use of mifepristone and misoprostol provided through telemedicine is safe and effective. However, after 13 weeks gestation, there is an increased risk of surgical intervention that may be due to the regimen used and local clinical practices in Brazil. IMPLICATIONS: The current study shows that there is an unmet need for medical abortion in Brazil, a country with legal restrictions on access to safe abortion services. Telemedicine can help fulfill the need and self administration of medical abortion is safe and effective even at late first trimester abortion. Prospective trials are needed to establish safety, effectiveness and acceptability of home use of medical abortion beyond 12 weeks of pregnancy.

Sublingual misoprostol to reduce blood loss at cesarean delivery.

OBJECTIVE: This prospective randomized controlled study was carried out with the purpose of assessing the efficacy of sublingual misoprostol in decreasing intraoperative blood loss and the need for additional uterotonic agents at cesarean delivery. METHODS: One hundred seventy-four women undergoing elective or emergency cesarean delivery were assigned randomly to receive either 400 µg misoprostol or placebo sublingually at the time of cord clamping. An intravenous infusion of 20 units of oxytocin was started in all women at the same time. The primary outcome measures were intraoperative blood loss, need for additional uterotonic agents, and perioperative hemoglobin (Hb) fall. RESULTS: The maternal demographic factors, indications for cesarean delivery, and high-risk factors were similar between the two groups. Mean intraoperative blood loss was significantly less in misoprostol group as compared with placebo group (595 ± 108 vs. 651 ± 118 ml, P = 0.025). Fewer women needed additional uterotonic agents in misoprostol group (22.2 vs. 42.8 %; P = 0.0035; RR 0.52, 95 % CI 0.33-0.82). Perioperative Hb fall was significantly less in misoprostol group (0.87 ± 0.29 vs. 1.01 ± 0.26 g, P = 0.0018). CONCLUSION: Sublingual misoprostol decreases intraoperative blood loss and the need for additional uterotonic agents at cesarean delivery.