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).     

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.     

Second trimester medical abortion with mifepristone followed by unlimited dosing of buccal misoprostol in Armenia

Objectives: The aim of the study was to assess the efficacy and acceptability of a regimen using mifepristone and buccal misoprostol with unlimited dosing for second trimester abortion in Armenia.

Methods: Women seeking to terminate 13–22 week pregnancies were enrolled in the study. Participants swallowed 200?mg mifepristone in the clinic and were instructed to return to the hospital for induction 24–48?h later. During induction, women were given 400?μg buccal misoprostol every 3?h until the fetus and placenta were expelled. The abortion was considered a success if complete uterine evacuation was achieved without oxytocin or surgery.

Results: A total of 120 women with a median gestational age of 18 weeks participated in the study. All women began misoprostol induction around 24?h after taking mifepristone. Complete uterine evacuation was achieved in 119 (99.2%) women. The median induction-to-abortion interval was 10.3?h (range 4–17.4) with a mean of 9.5?±?2.5?h. A median of four misoprostol doses (range 2–6) with a mean of 4?±?1 misoprostol doses were administered. The induction-to-abortion interval, number of misoprostol doses, pain score and analgesia use increased as gestational age advanced. Acceptability of the method was high among both patients and providers.

Conclusion: The medical abortion regimen of 200?mg mifepristone followed 24?h later by induction with 400?μg buccal misoprostol administered every 3?h, with no limit on the number of doses used for the termination of pregnancies of 13–22 weeks’ gestation is an effective and acceptable option for women.     

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.     

First trimester abortion with mifepristone and three doses of sublingual misoprostol: a pilot study

OBJECTIVE: To evaluate the efficacy and safety of a medical abortion regimen with multiple doses of sublingual misoprostol 24 h after mifepristone. METHODS: The regimen was designed on the basis of pharmacokinetics of various routes of administration of misoprostol. Forty women < or = 8 weeks' gestation were given mifepristone 200 mg orally, followed 24 h later by three doses of misoprostol 200 microgm sublingually 6 h apart. They were followed up on day 3 and day 14 with transvaginal ultrasound. Pain and bleeding were assessed using a visual analogue scale and acceptability, by a questionnaire. RESULTS: Abortion outcome was assessed in terms of onset of pain and vaginal bleeding, time of expulsion of products and duration of vaginal bleeding. Seventy-five per cent of women experienced pain within 2 h after first dose of misoprostol. Bleeding began at a mean of 1.41 h after pain and expulsion at a mean of 6.1 h after first dose of misoprostol. Complete expulsion was confirmed in all women (100%) by ultrasound on day 14. The longest duration of bleeding was 12 days (mean 7.2 days) with 87.5% bleeding for < 10 days. Acceptability was 100% but 70% perceived pain to be moderate and 67.5% bleeding to be light or slightly more than menses. CONCLUSIONS: Medical abortion using three doses of sublingual misoprostol administered 24 h after mifepristone appears to be the most appropriate in terms of pharmacokinetics of the drugs. This pilot study associates the regimen with a short abortion process, which appears to be safe, highly efficacious and acceptable.     

Use of various ultrasonographic criteria to evaluate the efficacy of mifepristone and misoprostol for medical abortion

OBJECTIVE: This study was undertaken to determine whether applying modern formulas for mean sac diameter and crown-rump length to data from the recently published US mifepristone-misoprostol abortion trial would result in differences in assigned gestational ages and a higher rate of complete abortion. STUDY DESIGN: Data from the US mifepristone-misoprostol trial were reanalyzed. The ultrasonographic findings at baseline examination of the 2121 participants were used to estimate gestational age according to criteria established by Rossavik et al for mean sac diameter and by Robinson and Fleming, Hadlock et al, and Goldstein and Wolfson for embryonic pole. The gestational ages as assigned by the different criteria were then compared and the treatment outcomes at various gestational ages were calculated for each of the dating criteria. These findings were compared with those reported in the original study. RESULTS: Fourteen percent of study subjects were assigned to the incorrect gestational age group according to the criteria used for the original report. Still, outcomes according to gestational age group were similar regardless of which ultrasonographic gestational age criteria were used and were comparable to those calculated in the original report. Overall efficacy for subjects at 相似文献   

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.)     

Introduction of early medical abortion in New Zealand: an audit of the first 67 cases

BACKGROUND: In New Zealand, mifepristone became available in 2001, but because of uncertainty about the law, the first 67 cases were carried out under a very strict protocol. Once the prostaglandin had been administered it was necessary that the woman remain in the unit until the products of conception (POC) had been passed and, if this had not occurred within 8 h, she underwent suction curettage. AIMS: To demonstrate that an early medical termination of pregnancy (EMTOP) service could be offered as a safe option for women, despite the constraints of the law. METHODS: An audit of patient notes was carried out on the first 67 patients undergoing an EMTOP at the Level J Unit (LJU), Wellington Hospital. Data collected included age, ethnicity, parity, previous abortions, gestational age, length of time between the administration of mifepristone and misoprostol, length of time after administration of misoprostol to the completion of abortion, whether a fetal sac was seen, analgesia required, extent of heavy bleeding and any adverse effects. Patient characteristics were compared with those of the 3052 women who underwent surgical termination during the same time period. Data were analysed using EpiInfo 2000 (Centers for Disease Control and Prevention, Atlanta, GA) and Chi square tests for significance. RESULTS: Successful completion of EMTOP occurred in 63 of 67 cases (94%). Only four cases (6%) required completion by suction curettage and this was performed for legal and financial reasons, rather than for medical reasons. Clinical events requiring management, mainly bleeding problems, occurred in 11 patients (16%). CONCLUSIONS: EMTOP with mifepristone and misoprostol was successfully introduced and the experience provides useful data for others contemplating a similar service.     

Early medical abortion: a new regimen up to 49 days' gestation

AIM: To evaluate a new regimen of mifepristone and misoprostol in early medical abortion up to 49 days of amenorrhoea. METHODS: One hundred healthy women requesting pregnancy termination up to 49 days gestation received 200 mg mifepristone followed by 800 microg misoprostol orally 24 h later. Statistical analysis was carried out by unpaired t-test. RESULTS: Ninety-six percent of patients aborted completely 4.3 h after they were given misoprostol. No significant side-effects were noted. The duration of bleeding correlated with gestational age (P-value 0.009). CONCLUSION: This new regimen of mifepristone-misoprostol is effective in terminating early pregnancy, with shorter induction to abortion interval and greater acceptability.     

Spontaneous abortion: a randomized, controlled trial comparing surgical evacuation with conservative management using misoprostol

Objective: To compare the efficacy of surgical evacuation of the uterus with medical evacuation using misoprostol in cases of spontaneous abortion.

Design: A prospective, randomized, controlled trial.

Setting: A university teaching hospital.

Patient(s): Six hundred thirty-five women who aborted spontaneously and who consented to pretreatment randomization.

Intervention(s): Routine surgical evacuation or medical evacuation of the uterus using misoprostol.

Main Outcome Measure(s): Immediate, short-term (2–3 weeks), and medium-term (6 months) medical complications.

Result(s): There was a significantly lower incidence of immediate and short-term complications in the group treated with misoprostol compared with the surgically treated group. There were also fewer major complications in the 6 months after treatment in the medically treated group. Approximately 50% of the medically treated group subsequently required surgical evacuation, and these subjects required significantly more analgesia.

Conclusion(s): Treatment with misoprostol can reduce the demand for surgical evacuation in cases of spontaneous abortion, and its use is associated with fewer medical complications.     

Effect of vaginal pH on the efficacy of vaginal misoprostol for induction of midtrimester abortion

AIM: To evaluate the effect of vaginal pH on the efficacy of misoprostol for induction of midtrimester abortion. METHODS: The study comprised 110 women, with a gestational age of 14-26 weeks, with a missed abortion as an indication for the induction of abortion. On admission, the vaginal pH was measured and two groups were generated: (A) those with pH<5 (n=63); and (B) those with pH >or= 5 (n=47). All of the women received intravaginal misoprostol tablets moistened with 3 mL of 5% acetic acid, 200 microg every 4 h for a maximum of 5 doses within 24 h. If the patient did not have adequate uterine contractions, the same regimen was repeated over the following 24 h and if no response was achieved, this was considered a failure of therapy. RESULTS: All patients aborted within 48 h. A significant positive correlation between vaginal pH and the misoprostol application-abortion interval was found. The mean induction-abortion interval was significantly shorter in group A compared to group B (12.1 vs 23.6 h, P<0.001), with abortion rates at 24 h being 100% and 63.8%, respectively. Moreover, a significantly lower dose of misoprostol was used in group A with a lower incidence of fever and abdominal pain. CONCLUSION: Vaginal pH influences the efficacy of misoprostol administered vaginally for the induction of midtrimester abortion. The presence of this relationship, despite premoistening misoprostol with an acidifying agent, suggests that the effect of vaginal pH might extend beyond affecting the pharmacokinetics of the drug.     

Home use of two doses of misoprostol after mifepristone for medical abortion: A pilot study in Sweden and France

Objective To test the feasibility, safety, and efficacy of home use of two doses of misoprostol for medical abortion (MA) in European settings.

Methods One hundred thirty women (100 in Sweden, 30 in France) presenting for first-trimester MA were administered oral mifepristone in the clinic and sent home with two 400 μg doses of misoprostol, along with instructions to take the misoprostol at 24 h intervals. Women were also asked to complete a daily symptom diary. Outcomes of interest included effectiveness, side-effects, and adherence to and acceptability of the home-use regimen.

Results Three women (all in France) were lost to follow-up. Of the remaining 127 women, 124 (98%) had a successful MA. All women adhered successfully to the home-use regimen, and satisfaction with home use was high (98%). Most women experienced noticeable, if transitory, side effects after both the first and second doses of misoprostol (97% and 94%, respectively).

Conclusions Misoprostol may successfully and satisfactorily be used at home as part of a MA regimen in European settings as it has been for years in the US. Further research to determine if two doses of misoprostol are more effective than a single dose would be useful.