Misoprostol versus methylergometrine: pharmacokinetics in human milk

OBJECTIVE: The purpose of this study to compare breast milk pharmacokinetics between misoprostol 200 mug and methylergometrine 250 mug after single oral dosing in women who require postpartum uterotonic therapy. STUDY DESIGN: Open prospective randomized phase I study measuring misoprostol and methylergometrine on postpartum days 3 to 6 in milk 0.5, 1, 2, 3, 4, and 5 hours postdose, and in maternal serum at 0.5 and 1 hours (misoprostol) and 1 and 2 hours (methylergometrine) in 10 lactating women per group. RESULTS: Milk misoprostol levels rose and declined rapidly, which gave a milk elimination half-life of less than one half that of methylergometrine (mean +/- SE, 1.1 +/- 0.3 hours [median, 0.6 hours] vs 2.33 +/- 0.3 hours [median, 1.9 hours]; P = .003). Milk/plasma ratios for misoprostol were one third of those for methylergometrine at 1 hour ( P < .0001) and 2 hours ( P < .0015). CONCLUSION: Misoprostol warrants further investigation as an alternative to postpartum methylergometrine because it enters and leaves breast milk at twice the rate, with one third of the milk/plasma ratio, which significantly lowers infant exposure and facilitates a timed dosing regimen.     

The misoprostol third stage of labour study: a randomised controlled comparison between orally administered misoprostol and standard management

Objective To compare misoprostol with standard oxytocic regimens in the prevention of postpartum haemorrhage.
Design Randomised controlled trial.
Setting Obstetric unit in a large teaching hospital.
Methods One thousand women randomised to 500 μg misoprostol given orally or to standard oxytocic regimens of oxytocin, oxytocin with ergometrine, or ergometrine.
Main outcome measures Incidence of postpartum haemorrhage and the incidence and severity of side effects.
Results Postpartum haemorrhage occurred in 12% of women given misoprostol and in 11% of women given standard oxytocic drugs (relative risk (RR) 1.10, 95% confidence interval (CI) 0.79, 1.55). Blood loss of 1000 mL or more occurred in 2% of women in each group. Nausea, headache, dizziness and tiredness were less frequent with misoprostol (RR (95% CI) 0.71 (0.59, 0.84); 0.53 (0.38, 0.74); 0.73 (0.61, 0.87) and 0.88 (0.83, 0.94) respectively). The main side effects of misoprostol were shivering (RR 1.95, 95% CI 1.69, 2.25) and a rise in temperature (difference in mean rise 0.34°C, 95% CI 0.26, 0.42).
Conclusion Oral misoprostol for the prevention of postpartum haemorrhage was comparable to standard oxytocics. Many side effects were less common with misoprostol but shivering and pyrexia were more common. Larger randomised trials are needed before establishing the equivalence between misoprostol and standard oxytocic drugs in the prevention of postpartum haemorrhage.     

Oral misoprostol for the prevention of primary post-partum hemorrhage during third stage of labor

AIM: To assess the effectiveness of oral misoprostol compared with methylergometrine in the prevention of primary post-partum hemorrhage during the third stage of labor. METHODS: This was a randomized controlled trial of 864 singleton low-risk pregnant women. The outcomes were total blood loss, duration of the third stage of labor and peripartal change in hematocrit. Comparisons were by the chi2-test and Student t-test. Relative risks were calculated for side-effects profile. A P-value of less than 0.05 was statistically significant. RESULTS: The biodata of all the participants were similar. The mean blood loss for the misoprostol and methylergometrine groups was 191.6 +/- 134.5 mL and 246.0 +/- 175.5 mL, respectively (95% CI: -79.3 to -39.5 mL). The mean duration of the third stage of labor was 19.6 +/- 2.4 min and 9.4 +/- 3.3 min in the misoprostol and methylergometrine groups, respectively (95% CI: 9.82-10.58 min). More subjects had blood loss >500 mL, 42 (9.7%) versus 6 (1.4%), and peripartal hematocrit change greater than 10%, 38 (8.8%) versus 5 (1.2%), in the methylergometrine group than in the misoprostol group, respectively. Also, more subjects received additional oxytocic in the methylergometrine group, compared to the misoprostol group (80 [18.5%] versus 33 [7.6%] patients, respectively). CONCLUSIONS: Orally administered misoprostol was more effective in reducing blood loss during the third stage of labor than intramuscular methylergometrine. However, there were more subjects in the misoprostol group in whom duration of the third stage of labor was greater than 15 min and who also had manual placental removal than in the methylergometrine group.     

Is rectal misoprostol really effective in the treatment of third stage of labor? A randomized controlled trial

OBJECTIVE: The purpose of this study was to compare misoprostol 600 microg intrarectally with conventional oxytocics in the treatment of third stage of labor. STUDY DESIGN: In a controlled trial, 1606 women were randomly grouped to receive (1) oxytocin 10 IU plus rectal misoprostol, (2) rectal misoprostol, (3) oxytocin 10 IU, and (4) oxytocin 10 IU plus methylergometrine. The main outcome measures were the incidence of postpartum hemorrhage and a drop in hemoglobin concentration from before delivery to 24 hours after delivery. RESULTS: The incidence of postpartum hemorrhage was 9.8% in the group that received only rectal misoprostol therapy compared with 3.5% in the group that received oxytocin and methylergometrine therapy (P =.001). There were no significant differences among the 4 groups with regard to a drop in hemoglobin concentrations. Significantly more women needed additional oxytocin in the group that received only rectal misoprostol therapy, when compared with the group that received oxytocin and methylergometrine therapy (8.3% vs 2.2%; P <.001). The primary outcome measures were similar in the group that received only rectal misoprostol therapy and the group that received only oxytocin therapy. CONCLUSION: Rectal misoprostol is significantly less effective than oxytocin plus methylergometrine for the prevention of postpartum hemorrhage.     

Oral misoprostol for third stage of labor: a randomized placebo-controlled trial.

OBJECTIVE: To investigate whether orally administered misoprostol during the third stage of labor is efficient in reducing postpartum blood loss. METHODS: In a double-masked trial, during vaginal delivery women were randomly assigned to receive a single oral dose of misoprostol (600 microg) or placebo in third stage of labor, immediately after cord clamping. The third stage of labor was managed routinely by early cord clamping and controlled cord traction; oxytocin was administered only if blood loss seemed more than usual. Blood loss was estimated by the delivering physician and differences in hematocrit were measured before and after delivery. RESULTS: Mean (+/- standard error of the mean) estimated blood loss (345 +/- 19.5 mL versus 417 +/- 25.9 mL, P = .031) and hematocrit difference (4.5 +/- 0.9% versus 7.9 +/- 1.2%, P = .014) were significantly lower in women who received misoprostol than those who received placebo. Fewer women in the misoprostol group had postpartum hemorrhage (blood loss of at least 500 mL), but that difference was not statistically significant (7% versus 15%, P = .43). Additional oxytocin before or after placental separation was used less often in the misoprostol group (16% versus 38%, P = .047). There were no differences in the length of third stage of labor (8 +/- 0.9 minutes versus 9 +/- 1 minutes, P = .947). There were no differences in pain during third stage of labor, postpartum fever, or diarrhea, but shivering was more frequent in the misoprostol group. CONCLUSION: Oral misoprostol administered in the third stage of labor reduced postpartum blood loss and might be effective in reducing incidence of postpartum hemorrhage.     

Low-dose sublingual misoprostol versus methylergometrine for active management of the third stage of labor

OBJECTIVE: To compare the efficacy and side-effects of low-dose sublingual misoprostol and i.v. methylergometrine for active management of the third stage of labor. METHODS: The study subjects were three hundred low-risk women with term pregnancy and spontaneous onset of labor. These women received either one (100 microg/tablet) or two tablets of misoprostol (200 microg) sublingually or 1 mL (200 microg) of methylergometrine, i.v. injection, after the delivery of the anterior shoulder of the baby. The main outcome measures were the need for additional oxytocic drugs, blood loss >or=500 mL, change in hemoglobin levels and side-effects. RESULTS: Post-partum hemorrhage (>or=500 mL blood loss) did not occur in any of the women, but above-average bleeding occurred in 2.0% of cases in groups I, II (sublingual misoprostol 100 microg and 200 microg respectively) and III (methylergometrine), despite additional oxytocics used in 5.0%, 4.0% and 3.0% cases in groups I, II and III respectively (P>0.05). The change in hemoglobin levels at 24 h post-partum were 0.8%, 0.7% and 0.8% in groups I, II and III respectively (P>0.05). CONCLUSION: A low dose of sublingual misoprostol appears to be as effective as a low dose of i.v. methylergometrine in the prevention of post-partum hemorrhage in low-risk cases. So given the advantages of its stability at room temperature, low cost and easy route of administration, misoprostol appears to be a better choice, and a low dose is enough. However, larger studies in low-risk as well as high-risk cases are needed to advocate routine use of a low dose at the primary level.     

Misoprostol versus oxytocin in the third stage of labor.

OBJECTIVES: A double blind randomized controlled trial was performed at the tertiary hospital in Harare, Zimbabwe to compare oral misoprostol with intramuscular oxytocin in the management of third stage of labor. METHODS: A total of 499 women were randomized to receive either 400 microg misoprostol orally or 10 IU oxytocin intramuscularly. The incidences of postpartum hemorrhage and side effects were examined. RESULTS: The demographic and labor characteristics were comparable. Postpartum hemorrhage occurred in 15.2% of women given misoprostol and in 13.3% of those given oxytocin (P=0.534). Measured blood loss of more than 1000 ml occurred in 3.7% of the misoprostol group compared with 2% in the oxytocin group (P=0.237). There was no significant difference in the need for additional oxytocic drugs or blood transfusion in women given misoprostol (P values 0.137 and 0.600, respectively). Significant side effects of misoprostol were shivering [RR=1.32 (95% CI 1.11-1.58); P=0.002) and a rise in temperature [RR=2.02 (95% CI 1.75-2.33); P<0.001]. CONCLUSIONS: Oral misoprostol is as effective as intramuscular oxytocin in the prevention of PPH. Shivering and transient pyrexia were specific side effects of misoprostol. Misoprostol has potential in reducing the high incidence of PPH in developing countries.     

Use of oral misoprostol in the prevention of postpartum haemorrhage

Objective To investigate the use of the oral prostaglandin E₁ analogue, misoprostol in the prevention of postpartum haemorrhage.
Design A prospective observational study.
Setting A university teaching hospital.
Participants Two hundred and thirty-seven consecutive women undergoing vaginal delivery.
Methods All the women were given 600 μg oral misoprostol just after delivery.
Main outcome measures Rates of postpartum haemorrhage; need for therapeutic oxytocic drugs; retained placenta and length of the third stage of labour.
Results Postpartum haemorrhage occurred in 6% of the women; the need for therapeutic oxytocics in 5%, retained placenta in 2% and the median length of the third stage was 5 min. Vomiting and diarrhoea in the first hour after delivery occurred in 8% and 3% respectively and shivering in 60%.
Conclusions Misoprostol may be effective in the prevention of postpartum haemorrhage, and has few side effects. A double blind randomised trial is required.     

Misoprostol in the management of the third stage of labour in the home delivery setting in rural Gambia: a randomised controlled trial

OBJECTIVE: To assess the effectiveness of 600 microg oral misoprostol on postpartum haemorrhage (PPH) and postpartum anaemia in a low income country home birth situation. DESIGN: Double blind randomised controlled trial. SETTING: Twenty-six villages in rural Gambia with 52 traditional birth attendants (TBAs). SAMPLE: One thousand, two hundred and twenty-nine women delivering at home under the guidance of a trained TBA. METHODS: Active management of the third stage of labour using three 200-microg misoprostol tablets and placebo or four 0.5-mg ergometrine tablets (standard treatment) and placebo. Tablets were taken orally immediately after delivery. MAIN OUTCOME MEASURES: Measured blood loss, postpartum haemoglobin (Hb), difference between Hb at the last antenatal care visit and three to five days postpartum. RESULTS: The misoprostol group experienced lower incidence of measured blood loss > or =500 mL and postpartum Hb <8 g/dL, but the differences were not statistically significant. The reduction in postpartum (compared with pre-delivery) Hb > or = 2 g/dL was 16.4% with misoprostol and 21.2% with ergometrine [relative risk 0.77; 95% confidence interval (CI) 0.60-0.98; P= 0.02]. Shivering was significantly more common with misoprostol, while vomiting was more common with ergometrine. Only transient side effects were observed. CONCLUSIONS: Six hundred micrograms of oral misoprostol is a promising drug to prevent life-threatening PPH in this setting.     

A randomized clinical trial comparing oral misoprostol with synthetic oxytocin or syntometrine in the third stage of labour

This is a multicentre, blocked, randomized trial to compare the efficacy of oral misoprostol 400 microg with current injectable uterotonic agents (oxytocin/ Syntometrine) used prophylactically in the third stage of labour. Main outcome measures were blood loss, use of a second uterotonic agent and difference in haemoglobin level from antepartum to postpartum. Data analysis from 863 women showed a statistically significant increase in both the mean blood loss (p < 0.001) and the rate of postpartum haemorrhage > 500 mL, (RR 2.72: 95% C1 1.73-4.27) in the misoprostol group compared to the oxytocin/Syntometrine group. The use of a second uterotonic agent was higher in the misoprostol group (RR 2.89: 95% Cl 2.00-4.18) as well as a greater decrease in postpartum haemoglobin (p = 0.015). Oral misoprostol 400 microg is significantly less effective than the traditional intramuscular uterotonic agents currently used and therefore cannot be considered as a viable option to these agents in the management of the third stage of labour.     

Vaginal misoprostol for cervical priming before hysteroscopy in perimenopausal and postmenopausal women.

OBJECTIVE: To evaluate the effectiveness and possible adverse effects of vaginal misoprostol for cervical priming before hysteroscopy in perimenopausal and postmenopausal women. METHODS: A total of 105 women scheduled for hysteroscopy were randomly assigned to 2 groups. The study group (n=51) received 400 microg of vaginal misoprostol at least 12 h before the procedure and the control group (n=54) received no cervical priming agent. The primary outcome measure was the number of women who required cervical dilation. Secondary outcomes were cervical width (the largest size of Hegar dilator inserted without resistance) as well as complications and adverse effects. RESULTS: In the misoprostol group 27 women (52.9%) required cervical dilation vs. 53 (98.1%) in the control group (P<0.0001). The largest size of Hegar dilator inserted without resistance was 7.6+/-1.4 mm in the misoprostol group vs. 5.0+/-1.1 mm in the control group (P<0.0001). A similar effect of misoprostol on cervical dilation was also found in the subgroup of treated postmenopausal women. Only 2 women (3.9%) experienced mild lower abdominal pain after misoprostol application. CONCLUSION: Vaginal misoprostol applied before hysteroscopy reduced cervical resistance and the need for cervical dilation in perimenopausal and postmenopausal women, with only mild adverse effects.     

Misoprostol versus oxytocin for the reduction of postpartum blood loss.

OBJECTIVE: To compare the effect of 400 mug of oral misoprostol with 5 U of intravenous oxytocin in the reduction of postpartum blood loss and prevention of postpartum hemorrhage. METHODS: In a prospective, double-blind, randomized controlled trial conducted in a tertiary maternity hospital 622 women received either 400 mug of oral misoprostol or 5 U of intravenous oxytocin after delivery of the anterior shoulder or within 1 min of delivery. The primary outcome was a hematocrit drop of 10% or greater 24 h postpartum. The secondary outcomes were a hemoglobin drop of 30 mg/L or greater, the use of additional oxytocin, an estimated blood loss greater than 1000 mL, manual removal of the placenta, a blood transfusion, and shivering and fever (>or=38 degrees C) as adverse effects of misoprostol. RESULTS: There was no difference between the 2 groups regarding the primary outcome (a >or=10% hematocrit drop occurred in 3.4% and 3.7% of the participants in the oxytocin and misoprostol groups, P=0.98). The rate of use of additional oxytocin was higher in the misoprostol group (51% versus 40.5%, P=0.01). Shivering was confined to the misoprostol group (6.8%), and fever occurred in 12.5% of the women in the misoprostol group and 0.3% of the women in the oxytocin group. CONCLUSION: The routine use of 400 microg of oral misoprostol was no less effective than 5 U of intravenous oxytocin in reducing blood loss after delivery, as assessed by change in postpartum hematocrit. The adverse effects of misoprostol were mild and self-limiting.     

米索前列醇预防剖宫产术后出血的临床研究

目的观察米索前列醇用于剖宫产预防产后出血的效果。方法选择１８２例剖宫产者,随机分为米索前列醇组、米索前列醇＋催产素组及催产素组。米索前列醇组６０例,术中打开腹膜时口服米索前列醇６００μｇ。米索前列醇＋催产素组６４例,术中打开腹膜时口服米索前列醇６００μｇ,胎儿娩出后宫体肌内注射催产素２０ＩＵ。催产素组５８例,胎儿娩出后宫体肌内注射催产素２０ＩＵ,再静脉滴注催产素２０ＵＩ。以上各组观察术中及术后２小时内出血量。结果术中及术后２小时平均出血量,米索前列醇组为２１２±５６０ｍｌ;米索前列醇＋催产素组为２０８±５５４ｍｌ;催产素组为３４５±６４７ｍｌ。米索前列醇组与催产素组比较,差异有极显著性（Ｐ＜００１）。米索前列醇组与米索前列醇＋催产素组比较,差异无显著性（Ｐ＞００５）。结论米索前列醇促进子宫收缩作用强于催产素,能较好地预防剖宫产术后出血,且用药方便、安全。     

The routine use of oxytocin after oral misoprostol for labour induction in women with an unfavourable cervix is not of benefit

BACKGROUND: Induction of labour with misoprostol is often augmented with oxytocin with the possible consequence of uterine hypercontractility. It is important to determine whether the use of oxytocin in this circumstance has benefit as well as risk. AIM: To compare two regimens for labour induction in women with an unfavourable cervix: oral misoprostol vs. oral misoprostol routinely followed by oxytocin. METHODS: A prospective randomised trial in which 200 women with an unfavourable cervix received either oral misoprostol 25 microg every 3 h (group 1, n = 100) or two such doses routinely followed by oxytocin (group 2, n = 100). Outcomes included change in Bishop score, induction delivery interval, oxytocin requirement, contraction abnormalities, mode of delivery and neonatal outcome. RESULT: The improvement in Bishop score with two misoprostol doses in all 200 women was highly significant (2.9 +/- 1.5 to 6.6 +/- 1.9, P < 0.0001). The induction delivery interval, Caesarean delivery rate, vaginal delivery rate within 24 h, contraction abnormalities and neonatal outcome were similar in both groups. Contraction abnormalities were remarkably low with either regimen (1%). Routine addition of oxytocin 3 h after the second misoprostol dose (group 2) resulted in the maximum oxytocin dose (64 mU/min) being given to more women (66% in group 2; 36% in group 1). CONCLUSION: There was no benefit of routine addition of oxytocin after two doses of misoprostol. Reduced oxytocin requirement was observed when it was added only if needed. Both regimens achieved 85-87% vaginal deliveries with low incidence of hypercontractility.     

Misoprostol for prevention of postpartum hemorrhage.

OBJECTIVE: To compare the effectiveness of 400 microg rectal misoprostol in 5 cm(3) of saline with oxytocin 10 IU, i.m., in reducing bleeding during the third stage of labor. DESIGN: A double blind, randomized, clinical trial including 663 women with uncomplicated vaginal delivery who received misoprostol (n=324) or oxytocin (n=339). MAIN OUTCOME MEASURES: Changes in hemoglobin and hematocrit from before to 72 h postpartum; blood loss during the third stage; duration of the third stage of labor; need for additional oxytocic drug; frequency of requisition and of administration of blood; changes in blood pressure; and occurrence of side effects. RESULTS: No significant differences were observed between groups, before and 72 h postpartum, in mean hemoglobin and hematocrit, on volume of blood loss and duration of third stage of labor. The incidence of shivering and mean temperature (P<0.01) was significantly greater among women receiving misoprostol than oxytocin. CONCLUSIONS: Misoprostol administered as a micro-enema, 400 microg in 5 ml of saline during the third stage of labor, appears to be as effective as oxytocin 10 IU, i.m., but misoprostol produced more side effects than oxytocin.     

Manejo activo de la tercera fase del parto más 400 μg de misoprostol sublingual y 200 μg de misoprostol rectal frente a manejo activo solo en la prevención de la hemorragia posparto. Ensayo clínico aleatorizado

Objectives

To evaluate the efficacy and safety of 400 μg sublingual misoprostol and 200 μg rectal misoprostol plus active management of the third stage of labour versus active management only to prevent postpartum haemorrhage.

Subjects and methods

A total of 1400 women were randomly assigned to receive misoprostol plus active management (group I) or active management only (group II). The variables studied were incidence of postpartum haemorrhage, blood volume lost and need of additional uterotonics.

Results

In group I there were 28/702 (4.0%) haemorrhages and in group II 50/698 (7.2%), P=.005; RR =.538; 95% CI for RR (0.335-0.866). In women having postpartum haemorrhage the lost blood volume was 981 ± 309 cc and 888 ± 326 cc. P=.225 in groups I and II, respectively.Additional uterotonics were needed in 33 women in group I (4.7%) vs. 54(7.7%) women in group II (P=.025).

Conclusions

The use of sublingual/rectal misoprostol plus active management appears to be useful for the prevention of postpartum haemorrhage.     

A randomized controlled trial of vaginal misoprostol for cervical priming before hysteroscopy.

OBJECTIVE: To evaluate the effectiveness and side effects of vaginal misoprostol for cervical dilation in nonpregnant women before hysteroscopy. METHODS: Ninety-one women scheduled to have hysteroscopy were randomized to receive either vaginal misoprostol or placebo. Cervical response, outcome of hysteroscopy, and side effects of vaginal misoprostol were assessed. RESULTS: The mean cervical dilatation estimated by Hegar dilator and the mean duration of hysteroscopy were significantly different between the treated group (7.0+/-1.0 mm [range 6-8.5] and 90.0+/-38.4 seconds [range 60-240], respectively) and the control group (3.8+/-1.2 mm [range 2-5.5] and 142.0+/-38.7 seconds [range 60-270]). In the misoprostol group, only three women (6.5%) needed cervical dilation before hysteroscopy, compared with 14 (31.1%) in the placebo group (P = .006). Cervical tears during hysteroscopy occurred in two patients (4.4%) in the control group and none in the misoprostol group. The two most common side effects of vaginal misoprostol were mild lower abdominal pain in 15 women (32.6%) and slight vaginal bleeding in 12 (26.1%). Both side effects were significantly different when compared with placebo (P<.001). CONCLUSION: Vaginal misoprostol lessens the cervical resistance in women undergoing hysteroscopy and facilitates the procedure, with only mild side effects.     

A double-blind placebo controlled randomised trial of misoprostol and oxytocin in the management of the third stage of labour

Objective To compare oral misoprostol 400 μg with intramuscular oxytocin 10 IU in the routine management of the third stage.
Design Double-blind placebo controlled trial.
Setting Main referral hospital and its associated polyclinics in Accra, Ghana.
Population Four hundred and one low risk women, in the second stage of labour with anticipated vaginal delivery, who entered labour spontaneously.
Methods After delivery of the anterior shoulder of the baby, the women were randomised to receive either: 1. misoprostol 400 μg powder in water orally and 1 mL normal saline intramuscular injection (placebo); or 2. powdered cellulose in water orally (placebo) and 1 mL oxytocin 10 IU intramuscular injection.
Main outcome measures Change in haemoglobin concentration from before delivery to 12 hours postpartum. Secondary outcomes included need for additional oxytocics, blood loss > 500 mL and > 1000 mL, operative intervention for postpartum haemorrhage, and side effects, including nausea, vomiting, diarrhoea, shivering and elevated temperature.
Results Demographic characteristics were similar. There was no significant difference in change in haemoglobin concentration between the two groups (0.60 g/dL for misoprostol and 0.55 g/dL for oxytocin; relative difference 9.6%; 95% CI 20.5–39.6%;   P = 0.54  ). There were no significant differences in secondary outcomes with the exception of shivering, which occurred more frequently in the misoprostol group (22.2% vs 5.7%; relative risk 4.73; 95% CI 2.31–9.68;   P < 0.0001  ).
Conclusions In low risk women oral misoprostol appears to be as effective in minimising blood loss in the third stage of labour as intramuscular oxytocin. Shivering was noted more frequently with misoprostol use, but no other side effects were noted. Misoprostol has great potential for use in the third stage of labour especially in developing countries.     

Misoprostol 50 microg sublingually versus vaginally for labor induction at term: a randomized study

OBJECTIVE: To compare the efficacy of misoprostol 50 mug vaginally and 50 mug sublingually for labor induction at term. MATERIALS AND METHODS: One hundred and sixty women were randomized to receive misoprostol 50 microg vaginally (n = 80) or 50 microg sublingually misoprostol (n = 80). The doses were given every 4 h (maximum 6 doses). Primary outcome measure was number of cesarean deliveries. Induction to delivery time, delivery within 24 h, the number of misoprostol doses given; the need for oxytocin augmentation, tachysystole and uterine hyperstimulation rates and neonatal outcomes were secondary outcome measures. RESULTS: The mean induction to delivery time was 748 +/- 379 min in the vaginal group and 711 +/- 425 in the sublingual group (p = 0.56). The number of women delivering within 24 h was 73 (91.3%) in the vaginal group and 74 (92.5%) in the sublingual group (p = 0.78). The mean number of misoprostol doses required was significantly higher in the sublingual group (1.9 +/- 1.2) compared with the vaginal group (1.1 +/- 0.4; p < 0.001). More women in the sublingual group experienced tachysystole (n = 14, 17.5%) compared with the vaginal group (n = 3, 3.8%; p = 0.005). Seven cases (8.8%) in the vaginal group and 12 cases in the sublingual group (15%) required emergent cesarean delivery for fetal heart rate abnormalities (p = 0.22). Other neonatal outcomes including umbilical artery pH, Apgar scores and intensive care unit admission were similar in the two groups. CONCLUSION: Sublingual misoprostol is as efficacious as vaginal misoprostol for induction of labor. More frequent tachysystole is observed with misoprostol 50 microg sublingually, but neonatal outcomes are similar.     

Six hourly vaginal misoprostol versus intracervical dinoprostone for cervical ripening and labor induction

AIM: Prospective clinical trials were conducted to assess the safety and efficacy of 6-hourly vaginal misoprostol versus intracervical dinoprostone for induction of labor. METHODS: A total of 120 pregnant women requiring induction of labor were recruited. Cases were randomized to receive either 50 microg vaginal misoprostol 6 hourly (group 1, n = 60) or 0.5 mg intracervical dinoprostone 6 hourly (group II, n = 60). Outcome measures, such as change in Bishop's score, need of oxytocin, induction delivery interval; complications like tachysystoly, hyperstimulation, abnormal fetal heart rate, and meconium passage were compared between two groups. Statistical analysis was performed by Wilcoxan's Rank sum and Student's t-test. RESULTS: Bishop score rise, after 6 h of initiation of therapy was significantly higher in the misoprostol group than dinoprostone, 2.98 +/- 2.57 versus 2.05 +/- 1.83 (P = 0.04). The need of oxytocin augmentation was reduced in misoprostol versus dinoprostone group, 16.6% versus 78.3% (P = <0.001). Induction delivery interval was shorter in misoprostol; 12.8 +/- 6.4 h versus 18.53 +/- 8.5 h in dinoprostone group (P = <0.01). One case (1.6%) in misoprostol group, but none in dinoprostone had tachystole (P = 1.00). Abnormal heart rate pattern was found more in misoprostol than dinoprostone 16.6% versus 4.9% (P = 0.14) and so was the incidence of cesarean section, 26.6 versus 15%, respectively (P = 0.47). Meconium passage was the same in both groups, 10% in each group. CONCLUSION: Vaginal misoprostol 50 microg 6-hourly is safe and effective for induction of labor with lesser need of oxytocin augmentation and shorter induction delivery interval.