A comparison of 100 microg oral misoprostol every 3 hours and 6 hours for labor induction: a randomized controlled trial

OBJECTIVE: To compare the efficacy and safety of 100 microg oral misoprostol for induction of labor between the regimen of 3 hour and 6 hour interval administration. METHODS: Singleton pregnancies indicated for induction of labor between 34 and 42 weeks of gestation in the condition of unfavorable cervix (Bishop score < or = 4) and no contraindication for prostaglandins therapy were recruited into the study. All pregnant women were randomly assigned to receive 100 microg oral misoprostol every 3 hours or 6 hours until the cervix was favorable for amniotomy, spontaneous rupture of membranes or active labor occurred. RESULTS: The mean time interval from induction to vaginal delivery was significantly shorter in the 3 hour interval group, compared with the 6 hour interval group (13.82 +/- 6.98h and 17.66 +/- 7.48h, P = 0.0019). There was no significant difference between the groups with regard to mode of delivery, analgesic requirement, maternal complication and neonatal outcome. CONCLUSIONS: 100 microg oral misoprostol every 3 hours is more effective for labor induction than every 6 hours but there was no difference in mode of delivery, analgesic requirement, maternal complications and neonatal outcome. A dose of 100 microg misoprostol orally every 3 hours seems to be the optimum regimen and the new option for labor induction. However, further study should be performed.     

Mifepristone and misoprostol versus Dilapan and sulprostone for second trimester termination of pregnancy

Objective. To compare two methods for second trimester termination of pregnancy: mifepristone and misoprostol versus Dilapan® and sulprostone.

Methods. This was a randomized study involving 16 patients with a singleton live fetus with congenital malformations or genetic disorders. Eight patients were treated with 200 mg mifepristone orally followed by 200 μg misoprostol vaginally 3 hourly and eight patients received a sulprostone infusion after cervical dilatation with Dilapan.

Results. Mifepristone and misoprostol had a mean induction interval of 17.8 hours and sulprostone and Dilapan 20.9 hours. The mean induction interval did not differ significantly. Mean hospital stay was shorter in the patients treated with misoprostol: 2.1 vs. 3.3 days (p = 0.02) with a 95% confidence interval of ?2.1 to 0.3.

Conclusion. Mifepristone and misoprostol did not reduce the induction interval significantly compared to the sulprostone and Dilapan treatment for second trimester pregnancy termination. Hospital admission was significantly shorter in patients treated with mifepristone and misoprostol.     

Randomized comparison of dry tablet insertion versus gel form of vaginal misoprostol for second trimester pregnancy termination

AIM: To compare the effectiveness of vaginal misoprostol between dry tablet insertion and gel form for second trimester pregnancy termination. METHODS: A non-blinded block randomized controlled trial was conducted on 148 pregnant women with live fetuses in the second trimester undergoing pregnancy termination. They were randomly allocated to receive vaginal misoprostol (400 microg) either dry tablet insertion (n=72) or gel form (n=76). The same dose was then repeated every 3 h if adequate uterine contraction was not achieved until 48 h after the initiation of misoprostol. If abortion did not occur within this period, the treatment was considered a failure and other technique of termination was then given based on the decision of the attending physicians and the cervical status. RESULTS: The mean induction-abortion interval in group 1 (20.9+/-12.3 h) was not significantly different from that in group 2 (17.7+/-10.2 h). The mean total dose of misoprostol was also not significantly different between the two groups (group 1, 1556.9 microg; group 2, 1350.9 microg), but the adverse effects of misoprostol (chill and diarrhoea) were more common in the gel group. CONCLUSION: Tablet insertion or gel form of vaginal misoprostol have similar effectiveness but the gel form was associated with more common adverse effects.     

Mifepristone and second trimester pregnancy termination for fetal abnormality in Western Australia: Worth the effort

Objective:  To determine the impact on the process of second trimester medical termination for fetal abnormality following the introduction of adjunctive mifepristone in an Australian tertiary hospital.
Methods:  All second trimester medical terminations for fetal abnormality between July 2006 and June 2009 were prospectively identified. Two temporal therapeutic cohorts were created: the first (1 July 2006 to 31 December 2007) using vaginal misoprostol alone and the second (1 January 2008 to 30 June 2009) using mifepristone priming prior to the administration of misoprostol. The primary outcome was to evaluate the impact of mifepristone priming upon the duration of pregnancy termination.
Results:  During the study period, 388 women with prenatally recognised fetal anomalies between 14 and 24 weeks gestation underwent medical termination: 189 with misoprostol alone and 199 with mifepristone priming followed by misoprostol. There was no difference between the groups for maternal age, parity or prior caesarean delivery. The median abortion duration was 15.5 h (interquartile ranges (IQR) 11.2–22.7) in the misoprostol group and 8.6 h (IQR 5.6–13.8) in the mifepristone primed group ( P  < 0.001). In both the groups, nulliparity and advancing gestation were associated with a significant prolongation of the abortion interval. Duration of hospitalisation was significantly longer in the misoprostol alone group (31.5 h (27–48.9) vs 27.2 h (22–31.5), misoprostol vs mifepristone priming, respectively, P  < 0.001).
Conclusions:  The introduction of mifepristone priming prior to second trimester medical termination with misoprostol has resulted in a significant reduction in the duration of the termination procedure and length of inpatient stay. These observed benefits of mifepristone provide objective support for the decision to permit use of this medication in Australia.     

Comparison of intravaginal misoprostol and intracervical Foley catheter alone or in combination for termination of second trimester pregnancy

Objectives: To examine the effectiveness, safety and acceptability of intravaginal misoprostol and intracervical Foley catheter alone or in combination for termination of second trimester pregnancy.

Methods: This clinical study was conducted on 90 pregnant patients intended for termination of pregnancy between 13 and 24 gestational weeks for any indication. Enrolled women are equally allocated into three groups:

??Group I (Misoprostol group): a standard regimen of moistened misoprostol (400?μg) 4 hourly inserted vaginally.

??Group II (Catheter group): intracervical Foley catheter inserted, inflated and placed on traction.

??Group III (Combined group): intracervical Foley catheter inserted with a standard regimen of moistened misoprostol (400?μg) 4 hourly intravaginally was used.

Procedure efficacy (defined as complete abortion performed on site), safety and acceptability were assessed.

Results: The induction to abortion interval was 7.5?±?1.25?h in the combined group, compared to 11.76?±?1.63?h in the misoprostol group and 19.76?±?1.52?h in the catheter group (p value?Conclusions: The present results confirmed the high success rate with the shortest induction to abortion interval with a combined use of intracervical Foley catheter and misoprostol for termination of second trimester pregnancy.     

Misoprostol in second and early third trimester for termination of pregnancies with fetal anomalies.

OBJECTIVES: To assess the effectiveness of a prostaglandin E1 analog, misoprostol, using different regimens compared with dinoprostone in termination of pregnancies in second and early third trimester complicated by either congenital fetal anomalies or intrauterine fetal demise. METHODS: A retrospective review of 59 pregnancies between 15 and 30 weeks was performed which were terminated due to congenital fetal anomalies or intrauterine fetal demise. In group 1 (n=29) 400 microg oral and 600 microg vaginal misoprostol, in group 2 (n=12) 600 microg vaginal misoprostol and in group 3 (n=18) 0.5 mg dinoprostone gel were given for the termination of the pregnancies. All these groups were evaluated for demographic characteristics and delivery findings. Statistical analysis were performed by one-way ANOVA, Kruskal-Wallis and chi(2)-test. RESULTS: No significant statistical difference was observed in terms of age, gravidity, parity, previous abortion, gestational week, frequency of prostaglandin usage, and birth weights among the three groups. The time intervals between the first administration and delivery were 20.3 h for oral vaginal misoprostol, 17.3 h for vaginal misoprostol and 22.5 h for the dinoprostone group (P=0.594). Evacuation rates after single doses were similar in all groups (83%, 73% and 72%, respectively). Uterine tachysystole was the only major side effect encountered in the oral-vaginal misoprostol group. CONCLUSIONS: All three regimens yielded similar results for termination of pregnancies in second and third trimester. The major advantage of misoprostol was the cost.     

Use of misoprostol for the termination of second trimester pregnancies

Surgical termination of pregnancy is of high risk for the woman’s health and safe medical ways are required. The use of prostaglandins may substantially reduce this risk. The efficacy and safety of misoprostol as a medication for the termination of the second trimester pregnancies were studied. During a 15-month period ninety-eight healthy pregnant women (13–24 weeks) wishing to terminate their pregnancy due to medical reasons participated voluntarily in this study. Misoprostol was administered 400 μg per os and 400 μg vaginally. Dose was repeated every 6 hours until adequate contractions and cervical ripening were achieved. Outcome measures included successful termination rates, mean expulsion time and side effects of the medication. The efficacy of the method was as high as 91.8% (90/98 cases 95%, CI 86–97%). Mean expulsion time was 10.2 h (range 3–23.4 h) for primigravida and 9.2 h (range 2.5–22.2 h) for multigravida. In 9 cases (9.2%) placenta remnants and in 8 (8.2%) placenta retention were found. Most common side effect was shivering in 17.3% of cases, vomiting and nausea (10.2%), headache and dizziness (7.1%), abdominal pain (79.6%), while diarrhea was noticed in 4.1%. The high efficacy and low incidence of side effects make misoprostol a useful alternative method for medical termination of second trimester pregnancies. Received: 6 October 2000 / Accepted: 22 January 2001     

Randomized comparison of second trimester pregnancy termination utilizing saline moistened or dry misoprostol

Objective The aim of this randomized prospective study was to compare efficacy and side effects of saline moistened misoprostol with dry misoprostol, administered 800 μg intravaginally every 6 h up to a maximum of 3 doses in 24 h for second trimester pregnancy termination. Materials and methods A total of 81 women seeking termination of second trimester pregnancy (55 fetal death, 17 fetal structural anomaly, 5 chromosomal abnormality, 4 other reasons) were randomly assigned to one of two treatment groups: (1) intravaginal non-moistened (dry) misoprostol in group A (n = 40) or (2) misoprostol moistened with 3 ml of saline in group B (n = 41). Results All of the patients in either group aborted within 48 h (100% success rate). Delivery was achieved in a median (interquartile range) of 13 (40) h with the group A protocol and 12 (36) h with the group B protocol (P = 0.652). Delivery with first dose, delivery within 12 h and delivery within 24 h were similar (P > 0.05) in group B (34.1, 87.5 and 60%, respectively) and group A (25, 82.9, 46.3, respectively). Both treatment regimens were tolerable and with similar side effects. Conclusion Misoprostol moistened with saline was not more effective than dry misoprostol for second trimester pregnancy termination.     

A randomised trial of two regimens of vaginal misoprostol to manage termination of pregnancy of up to 16 weeks

OBJECTIVE: The purpose of this study was to compare the efficacy and side-effects of two regimens of vaginal misoprostol for pregnancy termination of up to 16 weeks. METHODS: A randomised clinical trial of medical pregnancy termination of up to 16 weeks was conducted. A hundred pregnant women requesting legal termination of pregnancy were randomised into two groups to receive either 200 microg (50 women) or 400 microg (50 women)--vaginal misoprostol every six hours up to four doses. Outcome of abortion and side-effects were assessed. RESULTS: The groups were similar in maternal age, gestational age, parity and indication for pregnancy termination. There were no statistically significant differences between the two groups in abortion (P = 0.084) and mean induction to abortion time (P = 0.35). However, the side-effects in the 400 microg group were significantly higher than in the 200 microg group (P = 0.000). Conclusion: In pregnancy termination of up to 16 weeks, 200 microg vaginal misoprostol every six hours up to four doses was as effective as 400 microg, but side-effects were more common in 400 microg regimen.     

Placental retention in late first and second trimester pregnancy termination using misoprostol: a retrospective analysis

Objective: Termination of pregnancy (TOP) for medical reasons is regularly performed using misoprostol. Presence of placental remnants followed by curettage, frequently complicate the procedure. Aim of this analysis is to audit our current policy for medical termination in late first and second trimester, looking at the management of third stage. Methods: A retrospective analysis of patient data was performed. Included were patients that underwent medical TOP in late first or second trimester. Patients were reviewed 6 weeks postdelivery. Characteristics of procedure, patient and pregnancy were analysed to determine factors associated with an increased risk of retained placenta/placental remnants. Results: We included 175 patients. Eighty-five patients (48%) underwent curettage immediately after delivery because of retained placenta or because placental remnants were suspected. Nineteen patients (11%) underwent curettage at later stage. All tissue was examined microscopically for confirmation of placental tissue. Analysis of characteristics of procedure, patients and pregnancies did not identify factors associated with an increased risk of retained placenta or placental remnants. Conclusion: A large number of immediate and late curettages was seen after medical TOP. Misoprostol-dose might play a role and the role of ultrasonographic assessment of the uterine cavity immediately post-placenta-delivery needs to be studied.     

Efficacy of concurrent administration of mifepristone and misoprostol for termination of pregnancy

In this prospective randomized parallel group study, subjects with a pregnancy of less than 63 d were randomized to receive either (i) 200?mg oral mifepristone plus 400?μg misoprostol per vaginally concurrently (group A); (ii) or the administration of misoprostol after 48?h (group B). Transvaginal sonography was performed on the 14th day of misoprostol administration to confirm complete abortion. The primary outcome was to compare the rates of complete abortion in two groups. Secondary outcomes were to compare induction abortion interval, side effects and compliance. A total of 200 subjects included in the study were randomized into groups A and B (100 each). Both the groups were comparable for age, parity, gestational age and history of previous abortion. The complete expulsion rate in group A was 96% (95% confidence interval (CI) 95.1–98.2%) and group B was 95% (95% CI 93.0–96.8%) (p?>?0.100). A gestational age of more than 56 d was found to predict failure of treatment in both groups. The adverse effect profile in the two groups was the same. Efficacy of concurrent mifepristone and misoprostol in combination is similar to that when misoprostol is given 48?h later (ctri.nic.in CTRI/2010/091/001422).     

Treatment of suction termination of pregnancy-retained products with misoprostol markedly reduces the repeat operation rate

A six-year audit of clinical outcomes following the treatment of suction termination of pregnancy-retained products of conception symptoms with 200 µg of misoprostol orally or sublingually three times a day for six doses showed that it was 93% effective and it reduced the repeat dilation and curettage rate by 79.6% ( P  < 0.001).     

Randomised controlled trial comparing the efficacy of same-day administration of mifepristone and misoprostol for termination of pregnancy with the standard 36 to 48 hour protocol

OBJECTIVE: To determine the efficacy of oral mifepristone followed by vaginal misoprostol 6 hours later compared with the standard 36- to 48-hour regimen for medical termination of pregnancy. DESIGN: Single centre, two arm, parallel, open randomised controlled trial. SETTING: Medical termination service at a teaching hospital. SAMPLE: Four hundred and fifty women undergoing medical termination of pregnancy at up to 63 days of gestation. METHODS: Eligible women were randomised to receive mifepristone 200 mg orally followed by vaginal misoprostol 800 micrograms either 6 hours (n=225) or 36-48 hours (n=225) later. All participants were invited to attend for a follow-up pelvic ultrasound scan within 7 days following the misoprostol administration. For those women in whom products of conception remained at the follow-up ultrasound scan, expectant management ensued with weekly follow-up ultrasound scans until the termination was complete. They could elect to undergo an evacuation of uterus at any stage following the scan. Those women with a nonviable gestation sac at the follow-up scan were offered a further dose of vaginal misoprostol 800 micrograms or suction termination of pregnancy. Women with a continuing pregnancy were managed with surgical termination. MAIN OUTCOME MEASURE: Successful medical abortion defined as no requirement for medical or surgical intervention beyond the initial dose of misoprostol. RESULTS: One hundred and sixty-five women (79%) in the 6-hour group and 197 women (92%) in the 36- to 48-hour group had a successful termination at first follow-up ultrasound or presumed on the basis of other considerations (those not seen for ultrasound but deemed successful by negative pregnancy test, products passed on ward or long-term assessment of notes). Twenty-two women (10%) in the 6-hour regimen required up to three further ultrasound scans after 7 days following the mifepristone administration in order to ensure that the termination process was complete. None of these women required a suction evacuation of uterus. In the 36- to 48-hour regimen, ten (5%) women had up to two further ultrasound scans to confirm a complete termination without the need for a surgical evacuation of uterus. Therefore, the overall successful termination rate in the 6-hour regimen was 89% (187/210) compared with 96% (207/215) in the 36- to 48-hour regimen (relative risk=0.92, 95% CI 0.84-0.98). Repeat administration of misoprostol or surgical treatment was required in 23 women (11%) in the 6-hour group and 8 women (4%) in the 36- to 48-hour group. A viable pregnancy was found in five women (2%) in the 6-hour group and in three women (1%) in the 36- to 48-hour group. CONCLUSIONS: Oral mifepristone 200 mg followed by vaginal misoprostol 800 micrograms after 6 hours is not as effective at achieving a complete abortion compared with the 36- to 48-hour protocol.     

Sequential use of Foley catheter with misoprostol for second trimester pregnancy termination in women with and without caesarean scars: a prospective cohort study

Purpose: The aim of this study is to evaluate the effectiveness and safety of misoprostol and Foley catheter in second trimester termination in women with and without caesarean section (CS) scars.

Materials and methods: Women with an indication for pregnancy termination between 14 and 22 completed weeks of gestation were included to the study. Enrolled women were allocated into three groups: (1) women with no history of CS, (2) women with one CS and (3) women with ≥2 CS. Study consisted 337 patients (233 group 1, 88 group 2 and 16 group 3). Misoprostol and Foley catheter were used sequentially. The primary outcome was the induction to abortion interval. Secondary outcomes were the successful vaginal abortion rate, the percentage of abortions in 24?h and the rates of surgical removal of the placenta, Foley catheter use and major maternal complications (transfusions, thromboembolic events, uterine rupture and death).

Results: Demographic characteristics were comparable. All study outcomes were statistically similar among groups. There was no major maternal complication among all patients.

Conclusions: Sequential use of misoprostol and Foley catheter is safe and effective in second trimester pregnancy termination for patients with and without CS scars.     

Early pregnancy termination with intravaginally administered sodium chloride solution–moistened misoprostol tablets: Historical comparison with mifepristone and oral misoprostol

Objective: The purpose of this study was to compare the abortifacient effect of intravaginally administered moistened misoprostol tablets with that of the combination regimen of mifepristone and oral misoprostol. Study Design: One hundred women at ≤56 days’ gestation received 800 μg misoprostol intravaginally in the form of sodium chloride solution–moistened tablets. The dose was repeated 24 hours later if a gestational sac persisted on ultrasonographic examination. These 100 subjects (group 1) were then matched with 100 subjects who had received 600 mg mifepristone followed by 400 μg misoprostol orally as part of a large multicenter American trial (group 2). Subjects were monitored for abortion success, adverse side effects, and bleeding characteristics. Abortion failure was defined as persistence of an intrauterine sac or the need to perform a surgical evacuation of the uterus for hemorrhage, for incomplete abortion, or at the subject’s request. Results: In 88 of the 100 women in group 1 and 94 of the 100 women in group 2, abortion occurred and a surgical procedure was not required. Abortion rates were not influenced by gestational age in either group. Prostaglandin-related side effects of fever and chills, vomiting, diarrhea, and uterine pain were all significantly higher in group 1. Excessive uterine bleeding was uncommon in both groups, and no subjects received blood transfusions. Conclusion: The abortion rate with intravaginally administered moistened misoprostol tablets is similar to that with the combination of mifepristone and oral misoprostol. However, intravaginal administration of misoprostol is associated with significantly more prostaglandin-related side effects. (Am J Obstet Gynecol 1999;181:1386-91.)     

Analgesic effects of acetaminophen,diclofenac and hyoscine N-butylbromide in second trimester pregnancy termination: a prospective randomized study

Objectives: This prospective, randomized study aimed to compare the analgesic effects of acetaminophen, diclofenac and hyoscine-N-butylbromide (HnBB) in cases of second trimester pregnancy termination.

Methods: In 60 women with indications for second trimester pregnancy termination, three analgesic agents were randomized into three groups: group 1, acetaminophen; group 2, diclofenac; and group 3, HnBB. A visual analog scale (VAS) used for the evaluation of pain perception. The primary outcome of the study was mean VAS score during the procedure and last VAS score before the completion of termination. The secondary outcomes were the induction-to-abortion interval, the percentage of aborted cases within the first 24?h and finally the need for parenteral analgesia.

Results: Demographic characteristics were similar among the groups. The mean VAS and last VAS scores before termination did not differ among the groups (p?=?0.3 and 0.2, respectively). The need for parenteral analgesia did not differ among the groups (p?=?0.3). Although a shorter induction-to-abortion interval and greater number of cases with successful termination before 24?h were found in the HnBB group, the differences were not statistically significant (p?=?0.6 and 0.5, respectively).

Conclusions: Our study did not demonstrate a difference in pain perception among second trimester pregnancy termination cases using acetaminophen, diclofenac and HnBB.