Telemedicine for medical abortion service provision in Mexico: A safety, feasibility, and acceptability study.

OBJECTIVE: We aimed to obtain evidence about the safety, acceptability, and feasibility of a direct-to-patient telemedicine medical abortion service in Mexico's private health sector. STUDY DESIGN: A prospective observational one-group study to evaluate a telemedicine abortion service, referred to as TeleAborto, was conducted at three private clinics and one nonclinician community-based provider. Information about the study was provided by phone, websites, and social media. Abortion seekers were screened for eligibility and underwent any pre-abortion tests requested by the study site at services close to home. Eligible participants received packages with abortion medication, analgesics, and instructions and a remote follow-up contact was scheduled for 7 to 14 days later. Primary outcomes include abortion outcome, management of adverse events, acceptability, and feasibility measures such as package reception and follow-up contact, and challenges to get pre- and post-abortion tests. RESULTS: We conducted 581 screenings and sent 378 study packages, all successfully received, reaching abortion seekers in all 32 states. All participants took medications before 70 days gestational age as per study protocol. Abortion outcome was determined for 87% of participants (330/378); 93% (306/330) had a successful abortion without intervention and 18 with intervention; 6 individuals decided to continue the pregnancy. Participants reported high satisfaction with TeleAborto, citing convenience as their most valued aspect (85%; 264/311). CONCLUSIONS: This study showed that guided self-managed telemedicine abortion is safe, acceptable, and feasible in Mexico. The model has the potential to close the access gap for indigenous and rural populations, and those that rely on public sector services. IMPLICATIONS: The findings contribute evidence in support of telemedicine models for early medical abortion, demonstrating the feasibility of a self-management protocol implemented with supportive health care providers and the potential for a broad geographical reach in Mexico.

Congo red test for identification of preeclampsia: Results of a prospective diagnostic case-control study in Bangladesh and Mexico.

BACKGROUND: Misfolded proteins in the urine of women with preeclampsia bind to Congo Red dye (urine congophilia). We evaluated a beta prototype of a point-of-care test for the identification of urine congophilia in preeclamptic women. METHODS: Prospective diagnostic case-control study conducted in 409 pregnant women (n = 204 preeclampsia; n = 205 uncomplicated pregnancies) presenting for delivery in two tertiary level hospitals located in Bangladesh and Mexico. The GV-005, a beta prototype of a point-of-care test for detecting congophilia, was performed on fresh and refrigerated urine samples. The primary outcome was the prevalence of urine congophilia in each of the two groups. Secondary outcome was the likelihood of the GV-005 (index test) to confirm and rule-out preeclampsia based on an adjudicated diagnosis (reference standard). FINDINGS: The GV-005 was positive in 85% of clinical cases (83/98) and negative in 81% of clinical controls (79/98) in the Bangladesh cohort. In the Mexico cohort, the GV-005 test was positive in 48% of clinical cases (51/106) and negative in 77% of clinical controls (82/107). Adjudication confirmed preeclampsia in 92% of Bangladesh clinical cases (90/98) and 61% of Mexico clinical cases (65/106). The odds ratio of a urine congophilia in adjudicated cases versus controls in the Bangladesh cohort was 34.5 (14.7 - 81.1) (p<0.001) compared to 4.2 (2.1 - 8.4; p<0.001) in the Mexico cohort. INTERPRETATION: The GV-005, a beta prototype of a point-of-care test for detection of urine congophilia, is a promising tool for rapid identification of preeclampsia. FUNDING: Saving Lives at Birth.

A repeat dose of misoprostol 800 mcg following mifepristone for outpatient medical abortion at 64-70 and 71-77 days of gestation: A retrospective chart review.

OBJECTIVE: To compare the effectiveness of outpatient medical abortion with mifepristone 200 mg and two misoprostol 800 mcg doses at 64-70 and 71-77 days of gestation. STUDY DESIGN: We conducted a retrospective chart review of medical abortion outcomes among clients with 64-77 day gestations at a Mexico City public clinic between February 2014 and November 2016 who took mifepristone 200 mg followed 24-48 h later by two doses of misoprostol 800 mcg four hours apart (first dose buccally, second dose sublingually). The primary outcome was successful medical abortion, defined as pregnancy expulsion without surgical intervention. We also assessed additional management and visits to other facilities. We compared outcomes by gestational age (64-70 vs 71-77 days). RESULTS: Of 602 charts reviewed, we analyzed 232 and 218 in the respective groups for effectiveness; nearly 25% of clients were lost to follow up. Treatment success occurred in 231 (99.6%, 95% CI 97.6-100%) clients at 64-70 days and 213 (97.7%, 95% CI 94.7-99.3%) clients at 71-77 days (p = 0.11). Ongoing pregnancy occurred in 1 (0.4%, 95% CI 0-2.4%) and 3 (1.4%, 95% CI 0.3-4.0%) clients, respectively (p = 0.36). Two charts from the 71-77 days group documented visits to other facilities: one bleeding concern prior to scheduled follow up and a hemorrhage during an aspiration intervention. CONCLUSIONS: Regimen effectiveness was high at 64-70 and 71-77 days among clients who attended follow up. However, with 25% attrition, it is difficult to draw definitive conclusions about effectiveness and associated safety. IMPLICATIONS: Mifepristone 200 mg followed by two doses of misoprostol 800 mcg four hours apart is a promising medical abortion regimen to improve efficacy in pregnancies from 64-77 days of gestation as compared to regimens with an initial single misoprostol dose. Prospective research is recommended to achieve more robust efficacy estimates.

Mifepristone pretreatment followed by misoprostol 200 mcg buccal for the medical management of intrauterine fetal death at 14-28 weeks: A randomized, placebo-controlled, double blind trial.

OBJECTIVE: To evaluate whether fetal and placental expulsion is more likely within 48 h if women receive mifepristone pre-treatment vs placebo pre-treatment followed by misoprostol 200 mcg buccally for treatment of fetal death at 14 weeks 0 days to 28 weeks and 6 days gestation. STUDY DESIGN: We randomized 176 women with a confirmed fetal death between 14 weeks and 0 days to 28 weeks and 6 days to mifepristone 200 mg or placebo; 24 h later all participants received misoprostol 200 mcg buccally every 3 h for up to 16 doses or 48 h. The trial took place in Hanoi, Vietnam and Mexico City in 2015-2018. RESULTS: Complete expulsion of the fetus and placenta within 48 h of misoprostol administration occurred in 74 of 90 women (82.2%, 95% confidence interval (CI), 72.7%-89.5%) in the mifepristone-misoprostol group and in 70 of 86 women (81.4%, 95% CI, 71.6%-89.0%) in the placebo-misoprostol group (Relative Risk (RR) 1.01, 95%CI 0.87-1.16, p = 0.887). The median time from the start of the misoprostol induction to fetal expulsion was shorter among women who received mifepristone-misoprostol compared to women assigned to placebo-misoprostol (7 h vs ±5 vs 12 ± 13 h; p < 0.001). Women in the mifepristone-misoprostol group were more likely to expel the fetus within 24 h of the start of misoprostol administration (96% vs 78%; RR 1.22 (1.09-1.39) p = 0.009). CONCLUSION(S): Mifepristone-misoprostol did not result in a higher rate of complete expulsion of the fetus and the placenta within 48 h of the start of misoprostol administration without any additional surgical intervention or medication (e.g. additional misoprostol doses or oxytocin) than placebo-misoprostol. However, treatment with mifepristone-misoprostol did result in a shorter time to expulsion than placebo misoprostol. IMPLICATIONS: Pretreatment with mifepristone followed by misoprostol bucally resulted in a shorter treatment time for medical management of fetal death than treatment with misoprostol alone. Pre-treatment with mifepristone may be more acceptable to women and providers by both reducing the length of hospital stay and the amount of misoprostol required.

Use of an at-home multilevel pregnancy test and an automated call-in system to follow-up the outcome of medical abortion.

OBJECTIVE: To assess the feasibility of using an at-home multilevel pregnancy test (MLPT) and interactive voice response (IVR) call-in system for remote follow-up of medical abortion. METHODS: A prospective pilot study was conducted among women who had a medical abortion at up to 70 days at a clinic in Mexico City, Mexico, between June 1, 2015, and January 30, 2016. Participants took an MLPT at the initial clinic visit and another MLPT at home 2 weeks later. They were requested to report their MLPT results via the IVR system and attend the clinic for follow-up evaluation. RESULTS: Of 200 women considered for inclusion, 163 (81.5%) were included in the analysis. Only 10 (6.6%) of the 152 women who had a medical abortion on or before 63 days from last menstrual period reported MLPT results to the IVR system that required clinical evaluation to assess medical abortion outcome. The remaining 142 (93.4%) women in this group reported MLPT results that ruled out ongoing pregnancy (confirmed at clinical evaluation). Reported MLPT results ruled out ongoing pregnancy among the 11 women who had a medical abortion after 63 days; however, 1 (9%) had an ongoing pregnancy at clinical evaluation. CONCLUSION: Use of MLPTs and the IVR system provided a streamlined approach to follow-up after medical abortion.

Simplified medical abortion screening: a demonstration project.

OBJECTIVES: The objectives were to evaluate the safety and acceptability of outpatient medical abortion in selected women without a pretreatment ultrasound or pelvic examination. STUDY DESIGN: We conducted a prospective case-series study to estimate the incidence of serious adverse events (death, life-threatening event, hospitalization, transfusion or any other medical problem that we judged to be significant), surgical completion of the abortion and satisfaction in women provided with medical abortion without a pretreatment ultrasound or pelvic examination. We enrolled 406 women requesting medical abortion in Moldova, Mexico and the United States. To be eligible, a woman must have been certain that her last menstrual period started within the prior 56days, have had regular menses before the pregnancy, not have used hormonal contraceptives in the prior 2months (in the United States and Mexico) or 3months (in Moldova), have no risk factors for or symptoms of ectopic pregnancy, and not have had an ultrasound or pelvic exam in this pregnancy. One site also excluded women with uterine enlargement on abdominal palpation. Each participant received mifepristone (200mg orally) and misoprostol (400 mcg sublingually in Moldova; 800 mcg buccally at all other sites) and was followed until complete abortion, defined as requiring no further treatment. RESULTS: Of the 365 (90%) participants who provided sufficient follow-up information for analysis, 347 (95%) had complete abortion without additional treatment, 5 (1%) had surgical aspiration, and 10 (3%) had extra misoprostol. Three participants (1%) had serious adverse events; these included two hospital admissions for heavy bleeding managed with aspiration and one diagnosis of persistent gestational sac 19days after enrollment. Most (317, 90%) participants were pleased with omitting the pretreatment ultrasound and pelvic exam. CONCLUSIONS: In this study, medical abortion without screening ultrasound or pelvic exam resulted in no serious adverse events that were likely to have been prevented by those tests and was highly acceptable. IMPLICATIONS: Screening for medical abortion without exam or ultrasound shows promise as a means for increasing access to this service. More research is needed to develop screening criteria that are more inclusive and simpler for clinical use.

Effects of Depot Medroxyprogesterone Acetate Injection Timing on Medical Abortion Efficacy and Repeat Pregnancy: A Randomized Controlled Trial.

OBJECTIVE: To evaluate the effects of timing of depot medroxyprogesterone acetate injection on medical abortion outcome and risk of repeat pregnancy within the subsequent 6 months. METHODS: In a multinational randomized trial, we assigned women undergoing medical abortion who wanted depot medroxyprogesterone acetate to administration either with mifepristone (Quickstart group) or after the abortion (Afterstart group). We ascertained abortion outcome, pregnancies, and contraception use over 7 months. RESULTS: From August 2013 to March 2015, we enrolled 461 participants with pregnancy durations of 75 days or less. Of participants included in the abortion outcome analyses, 14 of 220 (6.4%) and 12 of 226 (5.3%) in the Quickstart and Afterstart groups, respectively, had surgery to complete the abortion; the upper 90% confidence limit on this difference was 4.9%, within our prestipulated 5% noninferiority margin. Ongoing pregnancy after initial abortion treatment was significantly more common in the Quickstart group (8/220 [3.6%]) than in the Afterstart group (2/226 [0.9%]); the difference was 2.7% (90% confidence interval 0.4-5.6%). By 6 months, 5 of 213 (2.3%) and 7 of 217 (3.2%) in the Quickstart and Afterstart groups, respectively, became pregnant (exact log-rank test, P=.64). Use of highly effective contraceptives was significantly more common in the Quickstart group at 31 days (P<.001), but no difference was apparent at 6 months. The Quickstart group was significantly more satisfied with group assignment. CONCLUSION: Depot medroxyprogesterone acetate administration with mifepristone did not appreciably increase the risk of surgery after medical abortion but did increase the risk of ongoing pregnancy. It enhanced patient satisfaction, but we found no evidence that it decreased 6-month risk of repeat pregnancy. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, https://clinicaltrials.gov, NCT01902485.

Effect of Immediate Compared With Delayed Insertion of Etonogestrel Implants on Medical Abortion Efficacy and Repeat Pregnancy: A Randomized Controlled Trial.

OBJECTIVE: To evaluate the effect of insertion of etonogestrel implants with mifepristone compared with after the abortion on the risks of medical abortion failure and repeat pregnancy over the subsequent 6 months. METHODS: In a randomized trial, we assigned patients undergoing medical abortion to receive etonogestrel implants either with the mifepristone (Quickstart group) or after the abortion (Afterstart group). We followed them for 7 months to ascertain abortion outcome, pregnancies, and contraception use. RESULTS: Between September 2013 and August 2014, we enrolled 236 participants in the Quickstart group and 240 in the Afterstart group. To examine abortion failure, we conducted a noninferiority analysis from which we excluded nine participants who had missing outcome data and four with specified protocol violations. Of the rest, 9 of 229 (3.9%) and 9 of 234 (3.8%) in the Quickstart and Afterstart groups, respectively, had surgery to complete the abortion; the difference of 0.08% (90% confidence interval -3.1% to 3.3%) excluded our prestipulated noninferiority margin of 5 percentage points. Among participants with pregnancy follow-up through 6 months, 1 of 213 (0.5%) and 3 of 208 (1.4%) in the Quickstart and Afterstart groups, respectively, became pregnant within that time; 6-month pregnancy rates did not differ significantly by group (exact log-rank test, P=.28). At enrollment, significantly more participants in the Quickstart group than in the Afterstart group were satisfied with their group assignments (187/236 [79%] compared with 129/240 [54%], respectively; P<.001). CONCLUSION: Insertion of etonogestrel implants with mifepristone did not appreciably increase medical abortion failure risk and it enhanced patient satisfaction, but we found no evidence that it decreased repeat pregnancy rates. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT01902485.

Nurse versus physician-provision of early medical abortion in Mexico: a randomized controlled non-inferiority trial.

OBJECTIVE: To examine the effectiveness, safety, and acceptability of nurse provision of early medical abortion compared to physicians at three facilities in Mexico City. METHODS: We conducted a randomized non-inferiority trial on the provision of medical abortion and contraceptive counselling by physicians or nurses. The participants were pregnant women seeking abortion at a gestational duration of 70 days or less. The medical abortion regimen was 200 mg of oral mifepristone taken on-site followed by 800 µg of misoprostol self-administered buccally at home 24 hours later. Women were instructed to return to the clinic for follow-up 7-15 days later. We did an intention-to-treat analysis for risk differences between physicians' and nurses' provision for completion and the need for surgical intervention. FINDINGS: Of 1017 eligible women, 884 women were included in the intention-to-treat analysis, 450 in the physician-provision arm and 434 in the nurse-provision arm. Women who completed medical abortion, without the need for surgical intervention, were 98.4% (443/450) for physicians' provision and 97.9% (425/434) for nurses' provision. The risk difference between the group was 0.5% (95% confidence interval, CI: -1.2% to 2.3%). There were no differences between providers for examined gestational duration or women's contraceptive method uptake. Both types of providers were rated by the women as highly acceptable. CONCLUSION: Nurses' provision of medical abortion is as safe, acceptable and effective as provision by physicians in this setting. Authorizing nurses to provide medical abortion can help to meet the demand for safe abortion services.

Safety, efficacy and acceptability of outpatient mifepristone-misoprostol medical abortion through 70 days since last menstrual period in public sector facilities in Mexico City.

Extensive evidence exists regarding the efficacy and acceptability of medical abortion through 63 days since last menstrual period (LMP). In Mexico City's Secretariat of Health (SSDF) outpatient facilities, mifepristone-misoprostol medical abortion is the first-line approach for abortion care in this pregnancy range. Recent research demonstrates continued high rates of complete abortion through 70 days LMP. To expand access to legal abortion services in Mexico City (where abortion is legal through 12 weeks LMP), this study sought to assess the efficacy and acceptability of the standard outpatient approach through 70 days in two SSDF points of service. One thousand and one women seeking pregnancy termination were enrolled and given 200 mg mifepristone followed by 800 µg misoprostol 24-48 hours later. Women were asked to return to the clinic one week later for evaluation. The great majority of women (93.3%; 95% CI: 91.6-94.8) had complete abortions. Women with pregnancies ≤ 8 weeks LMP had significantly higher success rates than women in the 9th or 10th weeks (94.9% vs. 90.5%; p = 0.01). The difference in success rates between the 9th and 10th weeks was not significant (90.0% vs. 91.2%; p = 0.71). The majority of women found the side effects (82.9%) and the use of misoprostol (84.4%) to be very acceptable or acceptable. This study provides additional evidence supporting an extended outpatient medical abortion regimen through 10 weeks LMP.

Efficacy and acceptability of a mifepristone-misoprostol combined regimen for early induced abortion among women in Mexico City.

OBJECTIVE: To evaluate the experience of women receiving mifepristone-misoprostol for early induced abortion in public sector facilities in the Federal District of Mexico City. METHODS: An open-label prospective study was conducted with 1000 pregnant women who sought induced abortion with a pregnancy of up to 63days of gestation, as measured from the date of their last menstrual period. The study was conducted in three public sector healthcare facilities: two secondary level hospitals and one primary care clinic. Women ingested 200mg mifepristone on day 1, followed by 800µg buccal misoprostol 24hours later, and they returned for follow-up on day 8. The primary outcome was complete abortion without recourse to surgical intervention. RESULTS: A total of 971 women received mifepristone-misoprostol and were included in the analysis for efficacy of treatment. The overall efficacy of the combined medical abortion regimen studied was 97.3% (n=945); the success rate did not vary significantly by gestational age (95.9%-100%; P=0.449). Most women (n=922, 95.0%) had a successful induced abortion with only one dose of misoprostol. CONCLUSION: The combined mifepristone and buccal misoprostol regimen was found to be highly effective and acceptable among Mexican women. www.ClinicalTrials.gov: NCT00386282.