TY - JOUR
T1 - Simplified medical abortion screening
T2 - a demonstration project
AU - Raymond, Elizabeth G.
AU - Tan, Yi Ling
AU - Comendant, Rodica
AU - Sagaidac, Irina
AU - Hodorogea, Stelian
AU - Grant, Melissa
AU - Sanhueza, Patricio
AU - Van Pratt, Emigdio
AU - Gillespie, Ginger
AU - Boraas, Christy
AU - Weaver, Mark A.
AU - Platais, Ingrida
AU - Bousieguez, Manuel
AU - Winikoff, Beverly
N1 - Funding Information:
This work was supported by a grant from an anonymous donor who had no role in the study design, data collection, analysis, data interpretation, writing or publication.
Publisher Copyright:
© 2017
Copyright:
Copyright 2019 Elsevier B.V., All rights reserved.
PY - 2018/4
Y1 - 2018/4
N2 - 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 56 days, have had regular menses before the pregnancy, not have used hormonal contraceptives in the prior 2 months (in the United States and Mexico) or 3 months (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 (200 mg 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 19 days 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.
AB - 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 56 days, have had regular menses before the pregnancy, not have used hormonal contraceptives in the prior 2 months (in the United States and Mexico) or 3 months (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 (200 mg 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 19 days 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.
KW - Ectopic pregnancy
KW - Last menstrual period
KW - Medical abortion
KW - Ultrasound
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U2 - 10.1016/j.contraception.2017.11.005
DO - 10.1016/j.contraception.2017.11.005
M3 - Article
C2 - 29170088
AN - SCOPUS:85039455124
SN - 0010-7824
VL - 97
SP - 292
EP - 296
JO - Contraception
JF - Contraception
IS - 4
ER -