Efficacy and safety of mifepristone and buccal misoprostol versus buccal misoprostol alone for medical abortion

Objectives  

To evaluate the efficacy and safety of mifepristone and buccal misoprostol versus buccal misoprostol alone in medical abortion of ≤56 days.     

A randomized comparison of mifepristone and self-administered oral or vaginal misoprostol for early abortion

In France, mifepristone in association with orally administered misoprostol is widely used for the early termination of pregnancy (up to 49 days' gestation). In other centers, mifepristone in association with vaginally administered misoprostol has also been used. The aim of the present study was to compare the efficacy and tolerance of mifepristone in association with misoprostol administered orally or vaginally for the termination of pregnancy of up to 49 days' gestation.

A total of 237 women were enrolled in the study. All women received 600 mg mifepristone administered orally and 400 μg misoprostol administered either orally (n = 119) or vaginally (n = 118). A second dose of 400 μg misoprostol was administered if women had not expelled the pregnancy within 3 h. Women were randomized into treatment groups according to the day of their admission.

The overall success rate was 98.7% and there was no significant difference in efficacy between the two groups. There was one treatment failure in the group in which misoprostol was administered orally. Of those women who aborted within 3 h of administration of the first dose of misoprostol, the route of administration of misoprostol did not influence the time to abortion. Of the women who received a second dose of misoprostol, the time to abortion was shorter in those who received misoprostol orally (52 min versus 77 min).

Tolerance was assessed by visual analog scales and was similar for both groups. In both groups, women preferred the oral route of administration.     

Risk factors for unsuccessful medical abortion with mifepristone and misoprostol

BACKGROUND: The aim of this study was to determine the effectiveness of medical abortions with mifepristone and misoprostol following the approval of medical abortion in Israel. METHODS: A retrospective review of 377 consecutive medical records at an ambulatory care unit of a university medical centre was performed, screening all women undergoing medical abortion with mifepristone and misoprostol. Transvaginal ultrasonographic study and serum beta hCG measurement were performed 14-20 days after the procedure. The clinical outcome was defined as complete expulsion of intrauterine contents with (failed group) or without (successful group) surgical intervention. RESULTS: Surgical intervention was performed in 7.4% of patients. Residual products of conception were confirmed in 89%. Older age, previous spontaneous abortions, multigravidity, and earlier follow-up visit were independently associated with unsuccessful medical abortion. Significant differences were found in mean serum beta hCG and mean endometrial thickness in the successful versus failed procedure groups. CONCLUSIONS: Medical termination of pregnancy with mifepristone and misoprostol is >90% effective. High risk group for failure of the procedure can be characterised. An algorithm of follow up using follow-up visit date, serum beta hCG and sonographic endometrial stripe is suggested to define high risk patients for failed medical abortion.     

A randomized comparison of mifepristone and self-administered oral or vaginal misoprostol for early abortion.

In France, mifepristone in association with orally administered misoprostol is widely used for the early termination of pregnancy (up to 49 days' gestation). In other centers, mifepristone in association with vaginally administered misoprostol has also been used. The aim of the present study was to compare the efficacy and tolerance of mifepristone in association with misoprostol administered orally or vaginally for the termination of pregnancy of up to 49 days' gestation. A total of 237 women were enrolled in the study. All women received 600 mg mifepristone administered orally and 400 microg misoprostol administered either orally (n = 119) or vaginally (n = 118). A second dose of 400 microg misoprostol was administered if women had not expelled the pregnancy within 3 h. Women were randomized into treatment groups according to the day of their admission. The overall success rate was 98.7% and there was no significant difference in efficacy between the two groups. There was one treatment failure in the group in which misoprostol was administered orally. Of those women who aborted within 3 h of administration of the first dose ofmisoprostol, the route of administration ofmisoprostol did not influence the time to abortion. Of the women who received a second dose ofmisoprostol, the time to abortion was shorter in those who received misoprostol orally (52 min versus 77 min). Tolerance was assessed by visual analog scales and was similar for both groups. In both groups, women preferred the oral route of administration.     

Acceptability and feasibility of medical abortion with mifepristone and misoprostol in Nigeria

Objective

To examine the acceptability and feasibility of medical abortion in Nigeria.

Methods

In total, 250 women who were eligible for legal pregnancy termination with a gestational age of up to 63 days since last menstrual period were enrolled in Benin City and Zaria between May 2005 and October 2006. Participants received 200 mg of oral mifepristone in the clinic and then took 400 μg of oral misoprostol 2 days later—choosing to either return to the clinic or take it at home. Women returned 2 weeks later for an assessment of abortion status.

Results

The vast majority (96.3%) of women had successful complete abortions. Ultrasound was used to determine outcome in less than one-third (28.9%) of participants. Most women (83.2%) took the misoprostol at home. Almost all (96.2%) participants were satisfied or very satisfied with the abortion method.

Conclusion

The introduction of medical abortion with mifepristone and misoprostol could greatly expand current method options and improve the quality of reproductive health care in Nigeria and other settings in which access to legal abortion services is limited.     

米非司酮配伍米索前列醇行药物流产的安全性评价

目的　评价米非司酮配伍米索前列醇行药物流产的安全性。方法　检索国内外 9个医学数据库及 9种中文期刊。采用循证医学的方法对收集有关药物流产安全性研究的文献 ,进行质量评价和数据提取 ;对数据不能合并进行分析时 ,则行定性系统评价。结果　共收集、纳入文献 10 1篇 ,病例 136 4例。其中为药物严重不良反应 115例 ( 8 4 3% ) ,包括药物过敏性和失血性休克、药物中毒性心律失常、抽搐及胎儿畸形等 ;一般不良反应 10 15例 ( 74 4 1% ) ,包括异常出血和轻、中度过敏反应等。系统评价提示 ,药物流产后出血量过多、腹痛、发热和眩晕的发生率比手术流产高 ,相对危险度(RR)及 95 %可信限 (CI)范围分别为 3 2 7,1 14～ 9 38;1 6 3,1 14～ 2 34;1 5 8,1 0 3～ 2 4 4 ;和1 36 ,1 0 6～ 1 75。药物流产后的出血时间比手术流产长 ,加权均数差 (WMD)为 6 4 9,95 %CI为6 0 8～ 7 80。药物流产有并发症者 177例 ( 12 98% ) ,包括滋养细胞疾病、宫腔粘连和继发不孕。为异位妊娠而误用药物流产者 5 7例 ( 4 18% )。结论　药物流产的严重不良反应发生率较低 ,不影响药物流产的临床应用 ,但需要健全监测药物流产不良反应的制度 ;减少药物流产后出血 ,是需要进一步研究的课题     

The efficacy and acceptability of mifepristone medical abortion with home administration misoprostol provided by private providers linked with the hospital: a prospective study of 433 patients

BACKGROUND: Until July 2001 medical abortion was only authorized in France in public hospitals or private clinics. A new law effective in July 2001 allows private practitioners (gynaecologists or general practitioners) to provide medical abortion in their offices as long as they are linked to a hospital official agreement. Unfortunately mifepristone was not available outside hospitals before September 2004, so the study was conducted still providing the drugs in the hospital family planning clinic. OBJECTIVE: To evaluate the efficacy and the acceptability of mifepristone medical abortion with home administration of misoprostol provided by private practitioners linked with the hospital. PATIENTS AND METHODS: Four hundred thirty-three women seeking medical abortion before 7 weeks LMP were included between 2 January 2003 and 7 July 2004. All consultations before abortion and 2 weeks after abortion took place in a private provider's office. Drugs were administrated in the hospital family planning clinic: patients were given 3 tablets of mifepristone (600 mg) orally by the midwife and received 2 tablets of misoprostol (400 microg) that they would take at home 48 hours later. In case of any problems or complications, patients could phone or meet their private providers, phone the hospital midwife or go to the hospital emergency service. Private providers received training in medical abortion training and could at any time reach a medical specialist in the hospital family planning clinic for information or to refer a patient. RESULTS: - Efficacy was evaluated for 339 women, because 94 patients were lost to follow-up (21.7%). Efficacy of medical abortion was 93.8% (318/339). There were 21 surgical aspirations (6.2%): for women's decision in 1.5% of cases, for medical decision without complications in 3.5% of cases, and for failure of the method in 1.2% of cases (2 ongoing pregnancies and 2 heavy haemorrhages with transfusion). The family planning midwife received a phone call from 21 patients after mifepristone (4.8%), Twenty-five patients had an emergency consultation (5.7%), and 22 patients went back to their private providers before their appointment for follow-up (5%). Twenty-two patients (5%) were referred by the private provider to the hospital medical specialist. Acceptability is known for 26% of patients; 96.2% thought that the abortion procedure was acceptable. DISCUSSION AND CONCLUSIONS: The failure rate of medical abortion in this study is largely due to aspirations for incomplete abortion. To improve the efficacy of medical abortion offered by private providers linked with the hospital, all the relevant professionals (private providers, residents in the emergency service, family planning providers) must be well trained in medical abortion, especially in how to interpret and react to ultrasound images obtained in the follow up visit. The procedure is very acceptable to women. Medical abortion offered via a network should be well accepted by practitioners, since only 5% of women will need more than two consultations and only 6.2% will need surgical aspiration in the hospital. This study allows us to be optimistic about the expansion of medical abortion in France outside the hospital via a provider-hospital network based on the fact that since September 2004 private providers can get mifepristone directly in the pharmacies of the city.     

Emotional impact and acceptability of medical abortion with mifepristone: a German experience

In Germany, four years of experience with mifepristone as an alternative procedure to surgical abortion have revealed a still reluctant use of the new method. In the public discussion, the more participatory role of the women in the abortion procedure is often feared to have negative consequences for the emotional processing of the event. This study compares the women's criteria for selecting a method and the psychological responses before and four weeks after medical or surgical abortion. Two hundred and nineteen women answered questions regarding demographic data, motivation, medical details and social support. Additionally, the women completed the Hospital Anxiety and Depression Scale (HADS) and the Impact of Event Scale (IES). There were no differences regarding sociodemographic and reproductive characteristics among both groups. Comparing data before and a month after the abortion, our study showed a significant decline of both anxiety and depression for both abortion methods. The medical group had significantly lower entrance levels of anxiety than the surgical group. The medical regimen caused significantly more sequelae such as prolonged bleeding, pain and other side effects. However, this did not have a negative influence on the coping process. A vast majority of women in both groups evaluated choosing between different abortion methods as being highly important to them. Our study supports the consensus view that termination of an unwanted pregnancy is a positive first solution to the conflict, regardless of the chosen method. The positive outcome and high satisfaction levels among the participants illustrate the importance of an ongoing and improved accessibility of medical abortion for women in Germany.     

Emotional impact and acceptability of medical abortion with mifepristone: A German experience

In Germany, four years of experience with mifepristone as an alternative procedure to surgical abortion have revealed a still reluctant use of the new method. In the public discussion, the more participatory role of the women in the abortion procedure is often feared to have negative consequences for the emotional processing of the event. This study compares the women's criteria for selecting a method and the psychological responses before and four weeks after medical or surgical abortion. Two hundred and nineteen women answered questions regarding demographic data, motivation, medical details and social support. Additionally, the women completed the Hospital Anxiety and Depression Scale (HADS) and the Impact of Event Scale (IES). There were no differences regarding sociodemographic and reproductive characteristics among both groups. Comparing data before and a month after the abortion, our study showed a significant decline of both anxiety and depression for both abortion methods. The medical group had significantly lower entrance levels of anxiety than the surgical group. The medical regimen caused significantly more sequelae such as prolonged bleeding, pain and other side effects. However, this did not have a negative influence on the coping process. A vast majority of women in both groups evaluated choosing between different abortion methods as being highly important to them. Our study supports the consensus view that termination of an unwanted pregnancy is a positive first solution to the conflict, regardless of the chosen method. The positive outcome and high satisfaction levels among the participants illustrate the importance of an ongoing and improved accessibility of medical abortion for women in Germany.     

Self-administration of vaginal misoprostol after mifepristone for termination of pregnancy: patient acceptability.

This was a questionnaire survey involving women who self-administered vaginal misoprostol in the hospital setting following oral mifepristone for medical termination of pregnancy. The sample number was 89 with a median gestational age of 9 weeks; median dose of misoprostol used was 1600 mug and median induction abortion interval was 5.3 h. The success rate was 100% with the majority finding it easy to self-administer vaginal misoprostol and two-thirds did not mind doing this. Only one-third experienced adverse effects of the medication and 83% were satisfied with the procedure. Only one-third was willing to try it at home in future if necessary. Self-administration of vaginal misoprostol for termination of pregnancy in the hospital is safe and effective. Although women were comfortable in self administering the pessaries in the hospital, they do not appear to be keen to do it at home without any supervision. However, as this is the first study in the UK involving women expressing their views regarding this issue, added research in this area is required.     

Titrated oral misoprostol solution versus vaginal misoprostol for labor induction

Objective

To determine the efficacy and safety of a titrated oral misoprostol solution compared with vaginal misoprostol tablets for labor induction.

Methods

A randomized, triple-blind, multicenter clinical trial was conducted between March 2010 and June 2011. Women with a single gestation (n = 200) were randomized to receive a titrated oral misoprostol solution (initial misoprostol dose 20 μg/hour; dose increased by 20 μg/hour every 6 hours up to 80 μg/hour for a maximum of 48 doses) or vaginal misoprostol tablets (25 μg of misoprostol every 6 hours for a maximum of 8 doses). Risk ratios (RR) and 95% confidence intervals (CIs) were calculated for maternal and perinatal outcomes.

Results

The frequencies of vaginal delivery not achieved within 12 hours (RR 0.87; 95% CI, 0.62–1.22) and within 24 hours (RR 1.11; 95% CI, 0.83–1.49) were similar in the 2 groups. No differences were found in terms of uterine hyperstimulation, unfavorable cervix at 12 and 24 hours, oxytocin augmentation, tachysystole, epidural analgesia, adverse effects, and perinatal outcome. Approximately 70% of the women preferred the oral solution.

Conclusion

A titrated oral misoprostol solution was as effective and safe for labor induction as vaginal misoprostol tablets.ClinicalTrial.gov: NCT00 992524     

Regimens of misoprostol with mifepristone for early medical abortion: a randomised trial

OBJECTIVE: To compare the efficacy, adverse effects and acceptability of the three most common misoprostol regimens used with mifepristone for medical abortion. DESIGN: Randomised nonblinded trial. SETTING: Three clinics associated with major research universities in Canada; two in major urban areas and one in a periurban area. POPULATION: Women of reproductive age. METHODS: Consenting women presenting for abortion services with gestations less than 56 days and who met inclusion criteria were given 200 mg mifepristone orally and then randomised into three misoprostol study groups: (group I) 400 micrograms of oral misoprostol, (group II) 600 micrograms of oral misoprostol, and (group III) 800 micrograms of vaginal misoprostol. Misoprostol was self-administered at home 24-48 hours following mifepristone, and participants were instructed to take a second similar misoprostol dose at 24 hours after the initial dose if bleeding was less than a normal menstrual period. MAIN OUTCOME MEASURES: Successful abortion without surgery was 94.1%, with no significant differences across the three study groups (94.7% in group I, 93.4% in group II, and 94.3% in group III; P= 0.975). RESULTS: Efficacy and adverse effects did not differ significantly across the three study groups. Pain increased significantly across the study and the gestational age groups and was associated with lower acceptability. CONCLUSIONS: There appears to be a range of safe and effective options for early medical abortion with mifepristone including a choice between oral and vaginal administration of misoprostol.     

An outpatient regimen of combined oral mifepristone 400 mg and misoprostol 400 microg for first-trimester legal medical abortion

AIM. To evaluate the success rate of medical abortion using an outpatient regimen of oral mifepristone 400 mg and oral misoprostol 400 microg for legal abortion in women < 56 days pregnant. METHODS. Successful abortion was defined as an endometrial thickness < 20 mm evaluated by transvaginal ultrasound and minimal vaginal bleeding at a control examination performed 14 days after administration of misoprostol. Over a 6-month period in 2003, a questionnaire (completion rate 70%) was used for a spot check of the patients' evaluation of the method. RESULTS. Six hundred and sixty women underwent the procedure over a 3-year period and 606 (92%) experienced successful medical abortion. The remaining 8% had vacuum aspiration performed mainly due to uterine retention (70%). Other reasons were vaginal bleeding (25%), vomiting (2%), or pelvic infection (4%). Most women reported no days with severe pain (67%), 0--1 days with moderate pain (82%), and 0--1 days with light pain (62%). In terms of gastrointestinal side effects, 68% reported nausea, 33% vomiting, and 27% diarrhea. Most women (90%) felt that the information given at the hospital prior to the abortion was sufficient, 74% would prefer medical abortion again in case of a future unwanted pregnancy, and 85% would prefer to abort at home again. CONCLUSION. A high acceptance and success rate was seen using this outpatient oral regimen of mifepristone and misoprostol.     

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.