Cargando…

CLINICAL ORAL ABSTRACTS: Safety and efficacy of no-test medication abortion: A retrospective multi-site study

INTRODUCTION: The COVID-19 pandemic brought new attention to medication abortion because it does not require direct physical contact between patient and clinical staff. No-test approaches for medication abortion preserve the usual standard of care, except that they replace the in-person ultrasound o...

Descripción completa

Detalles Bibliográficos
Autores principales: Upadhyay, U., Raymond, E., Koenig, L., Coplon, L., Ricci, S., Kaneshiro, B., Boraas, C., Winikoff, B.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Published by Elsevier Inc. 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9748671/
http://dx.doi.org/10.1016/j.contraception.2021.03.007
_version_ 1784849873371136000
author Upadhyay, U.
Raymond, E.
Koenig, L.
Coplon, L.
Ricci, S.
Kaneshiro, B.
Boraas, C.
Winikoff, B.
author_facet Upadhyay, U.
Raymond, E.
Koenig, L.
Coplon, L.
Ricci, S.
Kaneshiro, B.
Boraas, C.
Winikoff, B.
author_sort Upadhyay, U.
collection PubMed
description INTRODUCTION: The COVID-19 pandemic brought new attention to medication abortion because it does not require direct physical contact between patient and clinical staff. No-test approaches for medication abortion preserve the usual standard of care, except that they replace the in-person ultrasound or physical exam before the abortion with other evidence-based methods to assess the patient's duration of pregnancy and screen for ectopic pregnancy. Early in the pandemic, a no-test sample protocol was published to offer guidance for clinical practice. However, little has been published on the safety and efficacy outcomes of no-test approaches. METHOD: Through webinars and personal contacts, we invited US-based clinics that had adopted the no-test medication abortion protocol to join the study. A no-test medication abortion was defined as not having a preabortion ultrasound or physical exam. Participating clinics abstracted data from medical records of all patients who received a no-test medication abortion and entered them into a REDCap database. We conducted descriptive analyses of the clinic protocols and the patient sample. We also developed a multilevel, multivariable model that accounted for clustering at the clinic-level to estimate the adjusted odds of medication abortion failure and adverse events. RESULTS: We included 11 clinics, 4 of which contributed some data from the TelAbortion Study. Clinics shared data on 791 patients served from Jan. 1 to Dec. 31, 2020. Among all patients, 58.1% received mifepristone in person and 41.9% received it by mail. At mifepristone provision, patients’ pregnancy durations ranged from 27 to 74 days; 36.4% were <=42 days, 45.3% were 43 to 56 days, 16.4% were 57 to 70 days, and 1.9% were >71 days. We received at least some follow-up data for 626 patients (79.1%) and excluded 14 patients who did not take mifepristone. Of the remaining 612 patients, 5 (0.8%) experienced serious adverse events defined as hospital admission, abdominal surgery and blood transfusion. One patient had a confirmed ectopic pregnancy and was admitted to a hospital for salpingectomy 9 days after provision of mifepristone (included as a serious adverse event). Abortion outcome data were available for 394 patients (64.4%). Overall, 94.7% (95% CI: 92.0% to 96.7%) of patients had a complete abortion with <1600 mcg of misoprostol, without an aspiration, procedure, or more mifepristone and misoprostol. 2 patients had suspected or confirmed ongoing pregnancies. Outcomes were similar for those who received medications in-person and those who received them by mail. CONCLUSIONS: No-test medication abortion with either in-person pick up or mailing of medications is effective and safe, with outcomes similar to rates found in the published literature. Moreover, omitting tests reduce COVID-19 risk and conform with FDA REMS requirements when combined with in-person pick up. Follow up rates (64.4%) with the NTMA approach were similar to other medication abortion protocols. Combining no-test medication abortion protocols with mailing of medications to patients would support public health efforts for those who want to avoid a clinic visit.
format Online
Article
Text
id pubmed-9748671
institution National Center for Biotechnology Information
language English
publishDate 2021
publisher Published by Elsevier Inc.
record_format MEDLINE/PubMed
spelling pubmed-97486712022-12-14 CLINICAL ORAL ABSTRACTS: Safety and efficacy of no-test medication abortion: A retrospective multi-site study Upadhyay, U. Raymond, E. Koenig, L. Coplon, L. Ricci, S. Kaneshiro, B. Boraas, C. Winikoff, B. Contraception Article INTRODUCTION: The COVID-19 pandemic brought new attention to medication abortion because it does not require direct physical contact between patient and clinical staff. No-test approaches for medication abortion preserve the usual standard of care, except that they replace the in-person ultrasound or physical exam before the abortion with other evidence-based methods to assess the patient's duration of pregnancy and screen for ectopic pregnancy. Early in the pandemic, a no-test sample protocol was published to offer guidance for clinical practice. However, little has been published on the safety and efficacy outcomes of no-test approaches. METHOD: Through webinars and personal contacts, we invited US-based clinics that had adopted the no-test medication abortion protocol to join the study. A no-test medication abortion was defined as not having a preabortion ultrasound or physical exam. Participating clinics abstracted data from medical records of all patients who received a no-test medication abortion and entered them into a REDCap database. We conducted descriptive analyses of the clinic protocols and the patient sample. We also developed a multilevel, multivariable model that accounted for clustering at the clinic-level to estimate the adjusted odds of medication abortion failure and adverse events. RESULTS: We included 11 clinics, 4 of which contributed some data from the TelAbortion Study. Clinics shared data on 791 patients served from Jan. 1 to Dec. 31, 2020. Among all patients, 58.1% received mifepristone in person and 41.9% received it by mail. At mifepristone provision, patients’ pregnancy durations ranged from 27 to 74 days; 36.4% were <=42 days, 45.3% were 43 to 56 days, 16.4% were 57 to 70 days, and 1.9% were >71 days. We received at least some follow-up data for 626 patients (79.1%) and excluded 14 patients who did not take mifepristone. Of the remaining 612 patients, 5 (0.8%) experienced serious adverse events defined as hospital admission, abdominal surgery and blood transfusion. One patient had a confirmed ectopic pregnancy and was admitted to a hospital for salpingectomy 9 days after provision of mifepristone (included as a serious adverse event). Abortion outcome data were available for 394 patients (64.4%). Overall, 94.7% (95% CI: 92.0% to 96.7%) of patients had a complete abortion with <1600 mcg of misoprostol, without an aspiration, procedure, or more mifepristone and misoprostol. 2 patients had suspected or confirmed ongoing pregnancies. Outcomes were similar for those who received medications in-person and those who received them by mail. CONCLUSIONS: No-test medication abortion with either in-person pick up or mailing of medications is effective and safe, with outcomes similar to rates found in the published literature. Moreover, omitting tests reduce COVID-19 risk and conform with FDA REMS requirements when combined with in-person pick up. Follow up rates (64.4%) with the NTMA approach were similar to other medication abortion protocols. Combining no-test medication abortion protocols with mailing of medications to patients would support public health efforts for those who want to avoid a clinic visit. Published by Elsevier Inc. 2021-05 2021-04-03 /pmc/articles/PMC9748671/ http://dx.doi.org/10.1016/j.contraception.2021.03.007 Text en Copyright © 2021 Published by Elsevier Inc. Since January 2020 Elsevier has created a COVID-19 resource centre with free information in English and Mandarin on the novel coronavirus COVID-19. The COVID-19 resource centre is hosted on Elsevier Connect, the company's public news and information website. Elsevier hereby grants permission to make all its COVID-19-related research that is available on the COVID-19 resource centre - including this research content - immediately available in PubMed Central and other publicly funded repositories, such as the WHO COVID database with rights for unrestricted research re-use and analyses in any form or by any means with acknowledgement of the original source. These permissions are granted for free by Elsevier for as long as the COVID-19 resource centre remains active.
spellingShingle Article
Upadhyay, U.
Raymond, E.
Koenig, L.
Coplon, L.
Ricci, S.
Kaneshiro, B.
Boraas, C.
Winikoff, B.
CLINICAL ORAL ABSTRACTS: Safety and efficacy of no-test medication abortion: A retrospective multi-site study
title CLINICAL ORAL ABSTRACTS: Safety and efficacy of no-test medication abortion: A retrospective multi-site study
title_full CLINICAL ORAL ABSTRACTS: Safety and efficacy of no-test medication abortion: A retrospective multi-site study
title_fullStr CLINICAL ORAL ABSTRACTS: Safety and efficacy of no-test medication abortion: A retrospective multi-site study
title_full_unstemmed CLINICAL ORAL ABSTRACTS: Safety and efficacy of no-test medication abortion: A retrospective multi-site study
title_short CLINICAL ORAL ABSTRACTS: Safety and efficacy of no-test medication abortion: A retrospective multi-site study
title_sort clinical oral abstracts: safety and efficacy of no-test medication abortion: a retrospective multi-site study
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9748671/
http://dx.doi.org/10.1016/j.contraception.2021.03.007
work_keys_str_mv AT upadhyayu clinicaloralabstractssafetyandefficacyofnotestmedicationabortionaretrospectivemultisitestudy
AT raymonde clinicaloralabstractssafetyandefficacyofnotestmedicationabortionaretrospectivemultisitestudy
AT koenigl clinicaloralabstractssafetyandefficacyofnotestmedicationabortionaretrospectivemultisitestudy
AT coplonl clinicaloralabstractssafetyandefficacyofnotestmedicationabortionaretrospectivemultisitestudy
AT riccis clinicaloralabstractssafetyandefficacyofnotestmedicationabortionaretrospectivemultisitestudy
AT kaneshirob clinicaloralabstractssafetyandefficacyofnotestmedicationabortionaretrospectivemultisitestudy
AT boraasc clinicaloralabstractssafetyandefficacyofnotestmedicationabortionaretrospectivemultisitestudy
AT winikoffb clinicaloralabstractssafetyandefficacyofnotestmedicationabortionaretrospectivemultisitestudy