What's at stake for science in 'abortion pill' case.

Supreme Court decision this summer could gut FDA's authority over drugs.

Progesterone after mifepristone: A pilot prospective single arm clinical trial for women who have changed their mind after commencing medical abortion.

AIM: This pilot study aimed to assess the utility of an oral progesterone treatment protocol for women who commenced medical abortion and then changed their mind and wished instead to maintain their pregnancy. METHODS: The Progesterone-After-Mifepristone-pilot for efficacy and reproducibility (PAMper) trial was designed as a prospective single-arm pilot clinical trial, conducted via telehealth. Women aged 18 to 45 years in Australia who reported ingesting mifepristone within the last 72 h to initiate medical abortion and had not taken misoprostol were included. Initial contact was by a web-based form. Following informed consent, participants were prescribed oral progesterone to be taken 400 mg twice per day for 3 days then 400 mg at night until completion of a 19 day course. Pregnancy viability was assessed by ultrasound scan after 14 days of progesterone treatment. RESULTS: Between October 2020 and June 2021, nine women contacted the PAMper trial, of whom six enrolled and commenced progesterone treatment. These women reported ingesting mifepristone at 40-70 days of gestation, with progesterone being commenced within 5.7-72 h of mifepristone ingestion. Five participants had ongoing, live pregnancies at the primary endpoint (ultrasound at >2 weeks). One participant had a miscarriage after 9 days of progesterone treatment. There were no clinically significant adverse events. CONCLUSION: This small study demonstrated a clinically sound protocol for researching the use of progesterone-after-mifepristone for women in this circumstance. Results of this pilot study support the need for further larger scale trials in this field.

Early pregnancy loss medical management in clinical practice.

OBJECTIVES: This study aimed to review clinical practice outcomes of early pregnancy loss (EPL) medical management using mifepristone and misoprostol outside of a clinical trial setting. STUDY DESIGN: In this retrospective cohort study, we reviewed a deidentified database of patients who received mifepristone-misoprostol for EPL from May 2018 to May 2021 at our academic center-based clinic, which was a study site for a multicenter mifepristone-misoprostol EPL trial completed in March 2018. All patients received mifepristone 200 mg orally and misoprostol 800 mcg vaginally or buccally, with clinic follow-up typically scheduled within 1 week. The primary outcome was successful medical management, defined as management without the need for aspiration, and the secondary outcomes included additional interventions and indications, follow-up ultrasonography findings, and adverse events requiring treatment. RESULTS: We treated 90 patients with a median ultrasound-measured gestational size of 49 (range 30-80) days and median time from mifepristone to misoprostol of 24 (range 8-66) hours. Follow-up was completed in clinic by 80 (88.9%), completed remotely by five (5.6%), and not completed by five (5.6%) patients. Overall, 76 (95% CI 82.9%-96.0%) of 85 patients (89.4%) with follow-up were successfully managed without uterine aspiration. Eighty patients had initial follow-up ultrasonography interpreted as gestational sac expulsion; seven (8.8%) of these ultimately underwent aspiration, including one patient who had a previously undiagnosed cesarean scar ectopic pregnancy. Two patients had significant safety outcomes: one pelvic infection and one blood transfusion during aspiration in the patient with a cesarean scar ectopic pregnancy. CONCLUSIONS: Outside of a clinical trial setting, medical management of EPL with mifepristone and misoprostol remains effective and safe. IMPLICATIONS: Medical management of EPL with mifepristone and misoprostol is effective and safe outside of a clinical trial setting. A standardized protocol based on the best available clinical trial evidence can be used in clinical practice for the medical management of EPL.

Judicial interference with mifepristone.

In the days since Texas federal judge Matthew J. Kacsmaryk invalidated the approval by the US Food and Drug Administration (FDA) of mifepristone, a medication used to terminate pregnancy, a shock wave of concern has swept through many people, organizations, and companies that work closely with the agency. The strong opposition reflects the high stakes not only for pregnant persons and for the FDA, but also for the scientific process of drug development and public access to safe and effective medications. Twists and turns in the case are already happening. A federal appeals court stayed the full suspension of mifepristone, but permitted multiple restrictions on its availability. Then the Supreme Court, which recently overturned the constitutional right to abortion, kept the status quo in place for a few days while considering the government's appeal. The results of the legal battle will be enormously consequential for reproductive health care-and far beyond, for innovation, science, and health.

At-home urine pregnancy test assessment after mifepristone and misoprostol for undesired pregnancy of unknown location.

OBJECTIVES: The ideal assessment after mifepristone and misoprostol for undesired pregnancy of unknown location (PUL) is unknown. STUDY DESIGN: We prospectively followed patients at Planned Parenthood League of Massachusetts (2019-2021) with PUL who received immediate mifepristone and misoprostol with serial at-home urine pregnancy tests (UPT) and in-office serum HCGs. RESULTS: Of 13 patients, 10 had a successful medication abortion. For those who completed UPTs (N = 9), all were negative by Day 14. Two abnormal pregnancies had positive UPTs on Day 14. CONCLUSION: A negative UPT on Day 14 may help determine complete abortion after medication abortion for undesired PUL. A positive UPT on Day 14 warrants further evaluation. IMPLICATION: Patients taking mifepristone and misoprostol in the setting of undesired PUL who cannot access serum testing may consider an at-home UPT to confirm complete abortion.

Development of a Spanish-language drug facts label prototype for a combination mifepristone and misoprostol medication abortion product.

OBJECTIVE: To develop a Spanish-language drug facts label prototype for medication abortion. STUDY DESIGN: We translated a drug facts label prototype for medication abortion and conducted cognitive video interviews with reproductive age native Spanish speakers to assess and improve its readability. RESULTS: Thirty-eight people ages 15 to 48 completed cognitive interviews, found the drug facts label easy to understand and suggested minor improvements. CONCLUSION: Conducting cognitive interviews with native Spanish speakers is a helpful tool to improve readability of a translated label. IMPLICATIONS: This drug facts label can help to ensure that Spanish speakers have access to easy-to-understand instructions of how to take medication abortion without clinical supervision.

Comparison of vaginal and buccal misoprostol after mifepristone for medication abortion through 70 days of gestation: A retrospective chart review.

OBJECTIVE: To determine the proportion of complete abortion without surgical intervention for patients who chose medication abortion with vaginal compared to buccal misoprostol following oral mifepristone through 70 days of gestation. METHODS: We performed a retrospective cohort study. We reviewed charts via electronic medical record data abstraction of patients receiving medication abortion with mifepristone and buccal or vaginal misoprostol between September 1, 2017 and August 1, 2019. Primary outcome was complete abortion without surgical intervention for any indication. Secondary outcomes were ongoing pregnancy and uterine aspiration for indications other than ongoing pregnancy. RESULTS: There were 14,504 encounters included in the data set. Of the 4814 patients who took vaginal misoprostol and the 4011 patients who took buccal misoprostol for whom follow up data is available, 4640 (96.4%) and 3917 (97.7%) had a complete abortion without surgical intervention, respectively (p = 0.002). At <64 days of gestation, complete abortion was 96.6% for vaginal administration compared to 98.0% for buccal (p = 0.001). At 64 to 70 days of gestation, complete abortion was 92.7% for vaginal administration compared to 93.2% for buccal (p = 0.08). Of the 1128 patients who took vaginal misoprostol at less than 6 hours after mifepristone, 95.3% experienced a complete abortion. CONCLUSION: Buccal administration of misoprostol is associated with a higher proportion of complete abortion before 64 days of gestation compared to vaginal misoprostol. Clinically, vaginal misoprostol is an effective route of administration through 70 days of gestation. IMPLICATIONS: Medication abortion with vaginal misoprostol is effective when administered through 70 days of gestation and with shorter intervals between mifepristone and misoprostol. Prospective research to better estimate effectiveness is warranted. Expanding medication abortion options promotes patient autonomy amid increasing restrictions and bans on abortion.