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Early pregnancy loss medical management in clinical practice
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. In this retrospective cohort study, we reviewed a deidentified database of patients who received mifepristone-misoprostol for...
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Published in: | Contraception (Stoneham) 2023-10, Vol.126, p.110134-110134, Article 110134 |
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creator | Baker, Courtney C. Wu, Brenda T. Han, Gloria Flynn, Anne N. Creinin, Mitchell D. |
description | 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.
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.
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.
Outside of a clinical trial setting, medical management of EPL with mifepristone and misoprostol remains effective and safe.
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. |
doi_str_mv | 10.1016/j.contraception.2023.110134 |
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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.
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.
Outside of a clinical trial setting, medical management of EPL with mifepristone and misoprostol remains effective and safe.
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.</description><identifier>ISSN: 0010-7824</identifier><identifier>EISSN: 1879-0518</identifier><identifier>DOI: 10.1016/j.contraception.2023.110134</identifier><identifier>PMID: 37524147</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>Early pregnancy loss ; Mifepristone ; Miscarriage ; Misoprostol</subject><ispartof>Contraception (Stoneham), 2023-10, Vol.126, p.110134-110134, Article 110134</ispartof><rights>2023 Elsevier Inc.</rights><rights>Copyright © 2023. Published by Elsevier Inc.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c436t-d7a64edf77b620dab737c8be6f5904ba2251afc4c10bfa7e1b2672a219d599493</citedby><cites>FETCH-LOGICAL-c436t-d7a64edf77b620dab737c8be6f5904ba2251afc4c10bfa7e1b2672a219d599493</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,777,781,27905,27906</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/37524147$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Baker, Courtney C.</creatorcontrib><creatorcontrib>Wu, Brenda T.</creatorcontrib><creatorcontrib>Han, Gloria</creatorcontrib><creatorcontrib>Flynn, Anne N.</creatorcontrib><creatorcontrib>Creinin, Mitchell D.</creatorcontrib><title>Early pregnancy loss medical management in clinical practice</title><title>Contraception (Stoneham)</title><addtitle>Contraception</addtitle><description>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.
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.
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.
Outside of a clinical trial setting, medical management of EPL with mifepristone and misoprostol remains effective and safe.
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.</description><subject>Early pregnancy loss</subject><subject>Mifepristone</subject><subject>Miscarriage</subject><subject>Misoprostol</subject><issn>0010-7824</issn><issn>1879-0518</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2023</creationdate><recordtype>article</recordtype><recordid>eNqNkE9LxDAQxYMo7rr6FaTgxUtrkqZNi15kWf_Aghc9h3Q6XbK0aU26wn57s1YFb54GZt6bx_sRcsVowijLb7YJ9HZ0GnAYTW8TTnmasHBKxRGZs0KWMc1YcUzmlDIay4KLGTnzfksplWUmT8kslRkXTMg5uVtp1-6jweHGagv7qO29jzqsDeg26rTVG-zQjpGxEbTGfq2HED4awHNy0ujW48X3XJC3h9Xr8ilevzw-L-_XMYg0H-Na6lxg3UhZ5ZzWupKphKLCvMlKKirNecZ0AwIYrRotkVU8l1xzVtZZWYoyXZDr6e_g-vcd-lF1xgO2rbbY77zihRB5EUrzIL2dpOBCEYeNGpzptNsrRtUBn9qqP_jUAZ-a8AX35XfQrgoMfr0_vIJgNQkw1P0w6JQHgxYCL4cwqro3_wr6BJ4aiNc</recordid><startdate>20231001</startdate><enddate>20231001</enddate><creator>Baker, Courtney C.</creator><creator>Wu, Brenda T.</creator><creator>Han, Gloria</creator><creator>Flynn, Anne N.</creator><creator>Creinin, Mitchell D.</creator><general>Elsevier Inc</general><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>20231001</creationdate><title>Early pregnancy loss medical management in clinical practice</title><author>Baker, Courtney C. ; Wu, Brenda T. ; Han, Gloria ; Flynn, Anne N. ; Creinin, Mitchell D.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c436t-d7a64edf77b620dab737c8be6f5904ba2251afc4c10bfa7e1b2672a219d599493</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2023</creationdate><topic>Early pregnancy loss</topic><topic>Mifepristone</topic><topic>Miscarriage</topic><topic>Misoprostol</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Baker, Courtney C.</creatorcontrib><creatorcontrib>Wu, Brenda T.</creatorcontrib><creatorcontrib>Han, Gloria</creatorcontrib><creatorcontrib>Flynn, Anne N.</creatorcontrib><creatorcontrib>Creinin, Mitchell D.</creatorcontrib><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Contraception (Stoneham)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Baker, Courtney C.</au><au>Wu, Brenda T.</au><au>Han, Gloria</au><au>Flynn, Anne N.</au><au>Creinin, Mitchell D.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Early pregnancy loss medical management in clinical practice</atitle><jtitle>Contraception (Stoneham)</jtitle><addtitle>Contraception</addtitle><date>2023-10-01</date><risdate>2023</risdate><volume>126</volume><spage>110134</spage><epage>110134</epage><pages>110134-110134</pages><artnum>110134</artnum><issn>0010-7824</issn><eissn>1879-0518</eissn><abstract>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.
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.
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.
Outside of a clinical trial setting, medical management of EPL with mifepristone and misoprostol remains effective and safe.
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.</abstract><cop>United States</cop><pub>Elsevier Inc</pub><pmid>37524147</pmid><doi>10.1016/j.contraception.2023.110134</doi><tpages>1</tpages><oa>free_for_read</oa></addata></record> |
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subjects | Early pregnancy loss Mifepristone Miscarriage Misoprostol |
title | Early pregnancy loss medical management in clinical practice |
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