Evaluation of telemedicine medical abortion using a no-test protocol in the Eastern Europe and Central Asian region: Evidence from Ukraine, Uzbekistan, and Azerbaijan.

OBJECTIVE: To evaluate safety, feasibility, and acceptability of a telemedicine medical abortion service without pre-treatment in-person tests in Ukraine, Uzbekistan, and Azerbaijan. METHODS: We conducted an open-label, prospective, observational clinical study at five clinics in the three countries. Interested and eligible participants scheduled a telemedicine consultation with a study provider by phone or video. Medical abortion pills could be obtained by mail or courier or picked up at the study clinic or a pharmacy. Study providers contacted participants 1 week after mifepristone ingestion to assess abortion outcomes based on symptoms, and 3 weeks later to review the result of an at-home, high-sensitivity, urine pregnancy test. Participants were referred to in-person visit based on symptoms, urine pregnancy test results, or initiative by the participant. RESULTS: In all, 300 women participated in the study. Almost all participants received medical abortion medications the same day as their first contact with the study clinic, and the majority (n = 297, 99.0%) did not experience any problems receiving them. All except two women (0.67%) followed provider instructions on administration of medications. The majority of participants had a complete abortion without a procedure (Ukraine: n = 115, 95.8%; Uzbekistan: n = 127, 97.7%; Azerbaijan: n = 49, 98.0%), few had in-person visits (Ukraine: n = 30, 25.0%; Uzbekistan: n = 3, 2.3%; Azerbaijan: n = 4, 8.0%), and most were very satisfied or satisfied with the service (Ukraine: n = 116, 96%; Uzbekistan: n = 128, 98%; Azerbaijan: n = 45, 90%). No serious adverse events occurred. CONCLUSION: Telemedicine medical abortion using the no-test protocol is safe, feasible and acceptable for women in Ukraine, Uzbekistan, and Azerbaijan.

Telemedicine medical abortion service in Georgia: an evaluation of a strategy with reduced number of in-Clinic visits.

PURPOSE: To evaluate feasibility and acceptability of a medical abortion service that offers: a telemedicine visit (in place of an in-person visit) during a mandatory waiting period, and at-home follow-up with the use of multi-level pregnancy tests (MLPT). METHODS: Participants were screened for eligibility in clinic, and during the waiting period, received a telephone call to confirm desire to proceed with the service. Participants were mailed a study package containing mifepristone, misoprostol, two multi-level pregnancy tests, and instructions for their use. Follow-up consultation took place by phone to evaluate abortion completeness. The analysis was descriptive. RESULTS: One-hundred twenty-two participants were enrolled in the study, and 120 chose to proceed with the abortion after the waiting period and were sent a study package. One participant was lost to follow up. The majority of participants did not experience problems receiving the study package (94.1%, n = 112), took mifepristone (100%, n = 119), misoprostol (99.2%, n = 118), and MLPTs (99.1%, n = 116) as instructed, and forwent additional clinic visits (91.6%, n = 109). All participants were satisfied with the service. Most participants had a complete abortion without a procedure (95.8%, n = 114). CONCLUSIONS: The adapted telemedicine medical abortion service was feasible and satisfactory to participants and has the potential to make medical abortion more patient-centered where waiting periods are mandated.

A prospective study of mifepristone and unlimited dosing of sublingual misoprostol for termination of second-trimester pregnancy in Uzbekistan and Ukraine.

INTRODUCTION: We aimed to assess the feasibility and acceptability of a second-trimester medical abortion regimen using mifepristone and sublingual misoprostol with no maximum number of misoprostol doses in Uzbekistan and Ukraine. METHODS: This prospective open-label study enrolled 306 women with pregnancies of 13-22 weeks in Uzbekistan (n=134) and Ukraine (n=172). Women took 200 mg mifepristone at a place of their choosing, and 24-48 hours later received 400 µg sublingual misoprostol every 3 hours until the expulsion of both fetus and placenta. Study staff interviewed women about the intensity of pain, side effects, and satisfaction with the procedure. The primary outcome was the rate of complete uterine evacuation without surgical intervention or oxytocin at 15 hours after the first dose of misoprostol. RESULTS: The median gestational age was 18.1 weeks, and half of the women (n=149, 48.9%) chose to take mifepristone at home. The majority of women (n=266, 86.9%, 95% CI 82.6% to 90.5%) expelled by 15 hours after the start of misoprostol treatment, and by 48 hours complete uterine evacuation was achieved in 296 (96.7%) women. Most women found pain (76.1%) and side effects (89.0%) to be acceptable or very acceptable, and reported high satisfaction (89.8%) with the procedure. CONCLUSION: Medical abortion in pregnancies of 13-22 weeks with 200 mg mifepristone followed 24-48 hours later by 400 µg sublingual misoprostol administered every 3 hours until complete expulsion is effective, safe and acceptable to women. Women can be given the option to take mifepristone at home and return to the hospital. CLINICAL TRIALS REGISTRATION NUMBER: ClinicalTrials.gov, www.clinicaltrials.gov, NCT02415894, NCT02235155.

Could second-trimester medical abortion be offered as a day service? Assessing the feasibility of a 1-day outpatient procedure using pooled data from six clinical studies.

OBJECTIVES: Current service delivery models for second-trimester medical abortion typically include routine inpatient admission and overnight stays. To assess the feasibility of a day-service model, we evaluated outpatient administration of abortion medications and analyzed the proportion of clients who could avoid an overnight stay. We also examined additional key elements of medical abortion care to evaluate the practicality of this model. STUDY DESIGN: We pooled data from six clinical studies of second-trimester medical abortion conducted by Gynuity over the past 10 years. We include 868 individuals receiving mifepristone-misoprostol abortion between 13 and 22 weeks' gestation. RESULTS: At 8 h post misoprostol initiation, 309/521 (59.3%) participants at 13-18 weeks' gestation had a successful abortion; by 10 h, 382/521 (73.3%) were successful. Taking the mifepristone at home lowered neither the efficacy of the method nor satisfaction with the experience. Nonphysician providers played a significant role in the provision of care. Needed interventions were relatively rare; serious complications were very rare. CONCLUSIONS: Our findings support the provision of second-trimester medical abortion in a day-clinic setting, especially at ≤18 weeks' gestation. Such a model could increase access to quality care in many settings. IMPLICATIONS: Second-trimester medical abortion can safely and effectively be offered as a day service. Nonphysician providers are well suited to provide the majority of care. Developing guidelines for a 1-day model could increase access to quality care in many settings worldwide.

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.

Acceptability and feasibility of 400 µg buccal misoprostol after 200 mg mifepristone for early medical abortion in Georgia.

OBJECTIVES: The aim of the study was to examine the acceptability and feasibility of early medical abortion using 200 mg mifepristone and 400 µg buccal misoprostol in Georgia, outside the capital city of Tbilisi. METHODS: A total of 622 women in four regions of western and eastern Georgia who presented for termination of pregnancy at up to 63 d of gestation were enrolled in the study. In the western regions, women took one 200 mg pill of mifepristone in the clinic and were given the option of administering 400 µg misoprostol buccally, either at the clinic or at home, 24-48 h later. In the eastern region, women were given the option to take both drugs at home. Abortion status was determined 2 weeks after mifepristone administration. RESULTS: Ninety-five percent of participants had a successful abortion. Twenty-one percent of women in the eastern region elected to take mifepristone at home; nearly all participants in both regions (98%) chose to take misoprostol at home. Ninety-five percent of women were very satisfied or satisfied with the method, and 95% said they would prefer medical abortion for a future procedure. CONCLUSIONS: Medical abortion with mifepristone and 400 µg buccal misoprostol is an acceptable and feasible option for women in Georgia, outside the capital city of Tbilisi.

Prospective study of home use of mifepristone and misoprostol for medical abortion up to 10weeks of pregnancy in Kazakhstan.

OBJECTIVE: To evaluate the efficacy of at-home medical abortion in Kazakhstan. METHODS: A comparative, non-randomized study was undertaken at three clinics in Kazakhstan between October 10, 2013, and November 27, 2014. Women who sought medical abortion and had an intrauterine pregnancy of up to 70days were enrolled. All participants took 200mg mifepristone followed by 600µg sublingual misoprostol 24-48hours later. Women were offered the choice to take mifepristone at the clinic or at home; all took misoprostol at home. Abortion completion was assessed at an in-clinic follow-up appointment scheduled for all participants 2weeks after mifepristone administration. RESULTS: Of 290 enrolled women, 185 (63.8%) chose to self-administer mifepristone at home. Three (1.0%) of 289 women included in outcome analyses required surgical intervention for incomplete abortion. Therefore, the overall success rate was 99.0% (95% confidence interval 97.0%-99.7%). No serious adverse events occurred. CONCLUSION: Outpatient medical abortion with mifepristone and misoprostol is safe and effective up to 70days of pregnancy. This service should be offered to women in Kazakhstan. ClinicalTrials.gov: NCT02018796.

The introduction of first trimester medical abortion in Armenia.

In Armenia, abortion is the main means of fertility regulation; however, before research activities were initiated only surgical methods were available and the quality of services was low in some areas. Our clinical study from 2008-2011 aimed to show that early medical abortion is an acceptable and feasible option. A total of 700 eligible women with pregnancies up to 63 days LMP presenting for abortion were recruited for the study in five locations. Participants took 200 mg mifepristone and 800 µg buccal misoprostol 24-48 hours later. They returned for a follow-up visit two weeks after mifepristone administration. 95% of the women had successful abortions and 95% were satisfied with the method. In 2012-2013, we conducted a follow-up assessment to examine the ongoing provision and quality of medical abortion services at the former research sites. Medical record reviews, interviews and observations were carried out three times approximately six months apart. The assessment found that all five sites had continued providing medical abortion, with about half of eligible women choosing the medical method. Four of the five sites were achieving high success rates. Staff turnover and the lack of trained providers likely contributed to the higher failure rate at the fifth site. These findings provide evidence that first trimester medical abortion is an acceptable and feasible option for Armenian women and providers, and that high quality services are being delivered.

Acceptability and feasibility of phone follow-up with a semiquantitative urine pregnancy test after medical abortion in Moldova and Uzbekistan.

OBJECTIVE: To evaluate the feasibility and acceptability of phone follow-up with a home semiquantitative pregnancy test and standardized checklist, and compare the alternative method of follow-up with in-clinic follow-up after medical abortion. STUDY DESIGN: Two thousand four hundred women undergoing medical abortion with mifepristone and misoprostol in Moldova and Uzbekistan were randomized to phone or clinic follow-up. All women in the clinic group returned to the clinic 2 weeks later. Women randomized to phone follow-up used a semiquantitative pregnancy test at the initial visit and repeated the test at home 2 weeks later when they also filled out a symptom checklist. Women were called at 2 weeks to review the test results and checklist. Participants who screened "positive" were referred to clinic to verify abortion completion. RESULTS: Most women in the phone group were successfully contacted on the phone (97.6%). Staff were unable to contact one woman in the phone follow-up group, and all women in clinic group returned to the clinic. The ongoing pregnancy rate was similar in both groups (0.4-0.6%), and the semiquantitative pregnancy test identified all ongoing pregnancies in the phone follow-up group. Women in the phone group found the test and checklist easy to use, and most (76.1%) preferred phone follow-up in the future. Overall, 92.8% of women in the phone group did not undergo in-clinic follow-up. CONCLUSION: Phone follow-up with a semiquantitative urine pregnancy test and symptom checklist is a feasible and a highly effective approach in identifying ongoing pregnancy after medical abortion. IMPLICATIONS: The semiquantitative pregnancy test can make home follow-up after medical abortion possible for many women and provide reassurance that ongoing pregnancies will be detected.

Acceptability and feasibility of mifepristone medical abortion in the early first trimester in Azerbaijan.

OBJECTIVE: To examine the acceptability and feasibility of early medical abortion using mifepristone and misoprostol in Azerbaijan. METHODS: A total of 863 women in Baku and two regions of Azerbaijan who sought termination of gestations up to 63 days were enrolled in the study. In the capital, women swallowed 200 mg mifepristone in the clinic and were given the option of taking 800 µg misoprostol buccally either at the clinic or at home 24-48 hours later. In the regions, women were given the option of taking both drugs at home. Follow-up visits were to take place two weeks after mifepristone administration to determine abortion status. RESULTS: Seventy-four percent of women in the regions chose home administration of mifepristone, and 92% of women from all locations selected misoprostol home administration. Ninety-seven percent of women had complete abortions, and 97% were satisfied or very satisfied with the method. The vast majority of participants preferred medical abortion for a future procedure (96%). Nearly all women (98%) would recommend medical abortion for pregnancy termination to a friend. CONCLUSION: Mifepristone-misoprostol medical abortion with the option of home administration of both drugs is an acceptable and feasible option for women in Azerbaijan.

A two-pill sublingual misoprostol outpatient regimen following mifepristone for medical abortion through 70 days' LMP: a prospective comparative open-label trial.

OBJECTIVE: To test the effectiveness and acceptability of an outpatient medical abortion protocol with 200 mg mifepristone and 400 mcg sublingual misoprostol at 64-70 days' last menstrual period (LMP) and compare it to the already known efficacy of the 57-63 days' LMP gestational age range. STUDY DESIGN: We conducted a prospective, comparative open-label trial in six hospitals and clinics in Ukraine, Georgia, India and Tunisia. We enrolled 714 reproductive age women with pregnancies 57 to 70 days who presented requesting abortion. Medical abortions were managed with the current service delivery protocol (200 mg oral mifepristone followed in 24-48 h by 400 mcg sublingual misoprostol). Data on safety, efficacy and acceptability were collected. The main outcome measure was complete abortion without surgical intervention at any point. RESULTS: A total of 703 cases were analyzable for efficacy. Success rates did not differ significantly in the two groups [57-63-day group: 94·8%; 64-70-day group: 91.9%; Relative Risk (RR): 0.79 (0.61-1.04)]. Ongoing pregnancy rates also did not differ significantly (57-63 days: 1.8%; 64-70 days: 2.2%; RR: 1.10 (0.65-1.87)]. CONCLUSION: A medical abortion regimen of 200 mg mifepristone followed in 24-48 h by 400 mcg sublingual misoprostol is effective through 70 days' gestation and may be offered within existing outpatient abortion services. IMPLICATIONS: A regimen of 200 mg mifepristone followed in 24-48 h by 400 mcg sublingual misoprostol is effective up to 70 days' LMP. The findings have important implications for expanding access to outpatient medical abortion services in settings where the cost of misoprostol is of concern or a two-pill misoprostol regimen is the standard of care.

Acceptability and feasibility of the use of 400 µg of sublingual misoprostol after mifepristone for medical abortion up to 63 days since the last menstrual period: evidence from Uzbekistan.

OBJECTIVE: To examine the efficacy, acceptability and feasibility of early medical abortion, with the option of home administration of misoprostol, in Uzbekistan. METHODS: A total of 450 women were enrolled at national, municipal and private facilities in Tashkent, Uzbekistan. Women who presented for termination of pregnancy with gestations up to 63 days were recruited to participate in the study. All eligible pregnant women who consented to participate swallowed a 200 mg mifepristone pill in the clinic and were given the option of taking 400 µg misoprostol sublingually either at the clinic or at home 24-48 hours after mifepristone administration. Abortion status was determined two weeks later. RESULTS: Almost all women (99.5%) chose home administration of misoprostol. The sublingual route of misoprostol administration was acceptable or very acceptable to 89% of participants. Ninety-five percent of women had complete abortions after mifepristone and misoprostol. Almost all participants preferred a medical abortion to surgery for a future procedure (95%). CONCLUSIONS: Mifepristone medical abortion with home administration of misoprostol is an acceptable and feasible option for women in Uzbekistan. The method worked well at all three facility types.

A randomized controlled trial of different buccal misoprostol doses in mifepristone medical abortion.

BACKGROUND: An 800-mcg dose of buccal misoprostol following mifepristone has been shown to be highly effective in terminating pregnancies through 63 days since the last menstrual period (LMP) (B. Winikoff, I.G. Dzuba, M.D. Creinin, et al., Two distinct oral routes of misoprostol in mifepristone medical abortion: a randomized controlled trial. Obstet Gynecol 2008; 112: 1303-1310). However, a two 200-mcg misoprostol pill option would simplify administration, and potentially reduce costs and increase women's satisfaction. This study compares a 400-mcg dose (Group I) to an 800-mcg dose (Group II) of buccal misoprostol. STUDY DESIGN: Eligible and consenting women requesting medical termination of early pregnancy (n=1122) were randomized and instructed to take misoprostol 36 to 48 h after taking 200 mg mifepristone. Follow-up visits occurred 12 to 15 days after mifepristone administration. RESULTS: Ninety-six percent of women in both groups had successful abortions. Women in Group I experienced significantly less vomiting and fever/chills than women in Group II. Ninety-six percent of women in both groups found the procedure very satisfactory or satisfactory. CONCLUSIONS: Four hundred micrograms of buccal misoprostol is as effective as the standard 800-mcg dose in terminating pregnancies up to 63 days LMP and reduces side effects.

Knowledge, attitudes, and practice of abortion among women and doctors in Armenia.

OBJECTIVE: To assess knowledge and attitudes towards abortion among women and obstetricians/gynaecologists in Armenia, in order to facilitate the introduction of medical abortion. METHODS: Ninety-nine doctors and 400 women in three cities in Armenia were purposively selected to participate in face-to-face interviews using structured survey instruments. RESULTS: Most women knew that abortion is legal under any (31%) or certain (50%) circumstances. The majority of women had heard of medical abortion, but had superficial or incorrect knowledge of the method. Thirty percent of women expressed a preference for medical abortion over surgical abortion. Despite the fact that the medications are not readily available in Armenia, nearly one out of three doctors reported having experience in using misoprostol or mifepristone + misoprostol to terminate pregnancies. Doctors not providing medical abortion cited concerns about the method's efficacy and safety, or felt that they did not have enough information. One-third of doctors were very interested in receiving training on medical abortion methods. CONCLUSIONS: Both doctors and women in Armenia are interested in medical abortion as an alternative to surgical abortion. Efforts should focus on informing women about the legality of abortion and the details of the medical abortion procedure, and on training doctors in this new method.