Efficacy, Safety, and Acceptability of Low-Dose Mifepristone and Self-Administered Misoprostol for Ultra-Early Medical Abortion: A Randomized Controlled Trial

Abstract

The aim of this study was to investigate the efficacy, safety, and acceptability of low-dose mifepristone combined with self-administered misoprostol for ultra-early medical abortion. A total of 744 women with ultra-early pregnancy (amenorrhea ≤35 days) who fulfilled the inclusion criteria were enrolled in the study. Equal numbers of participants were allocated randomly to the hospital administration and self-administration groups. All participants took 75 mg mifepristone at the initial visit and 400 µg oral misoprostol 24 hours later in the hospital or by self-administration. The primary end point was complete abortion. Secondary end points were rates of unscheduled reattendance, time required for and cost of hospital observation and follow-up, vaginal bleeding, adverse effects, menstrual disturbance in the posttreatment period, and satisfaction rating. No differences in the rates of complete abortion, unscheduled reattendance, vaginal bleeding, adverse effects, or return of posttreatment menstruation were observed. The time required for (and costs of) hospital observation and follow-up per participant was 557.82 minutes (and US$40.12) in the hospital administration group and 18.46 minutes (and US$1.96) in the self-administration group (both P < .001). Satisfaction rates were similar in both groups, but the rates of "very satisfied" responses (87.60% vs 25.41%) and follow-up compliance (loss to follow-up, 0.45% vs 7.70%) were higher in the self-administration group (both P < .001). Low-dose mifepristone combined with self-administered misoprostol for ultra-early pregnancy termination was as effective and safe as hospital administration, with greater acceptability and lower cost to the women.

Efficacy of medical abortion prior to 6 gestational weeks: a systematic review

“…The search strategy identified 174 articles, of which 15 met our inclusion criteria (Tables 1-2) [2,10,[12][13][14][15][16][17][18][19][20][21][22][23]. Seven articles met criteria but did not report data disaggregated by gestational age less than 42 days; corresponding authors were contacted to ask for these data [19,[24][25][26][27][28][29].…”

“…Six randomized controlled trials reporting on successful medical abortion at less than 42 days' gestation were identified (Table 1) [10,[12][13][14][15][16]. The quality of the studies ranged from fair to good.…”

“…Method used to assess gestational age and location varied among studies, with a combination of history, clinical exam, hCG testing and use of ultrasonography. Of the six identified trials, four used ultrasound routinely to document pregnancy on study enrollment [13][14][15][16]. One study utilized clinical examination and hCG testing, and resorted to ultrasound only when needed [10].…”

Self‐management of first trimester medical termination of pregnancy: a qualitative study of women's experiences

“…Research suggests that women self-managing first trimester TOP have varied experiences [2][3][4] but are no more likely to re-attend with complications than those treated in hospital. 5 Although a growing body of literature suggests that self-management is acceptable to women, 2,[6][7][8][9][10][11][12][13][14][15][16][17] there is a need to monitor and understand women's needs around this model of provision, to facilitate provision of the best possible support. Our research contributes to this understanding, by examining details of women's experiences of self-management ≤63 days, of which to date, relatively little is known.…”

Comparison of Mifepristone plus Misoprostol with Misoprostol Alone for First Trimester Medical Abortion: A Systematic Review &amp; Meta -Analysis Protocol

“…Endogenous substances with property of uterine contractility include prostaglandins (PGE2 and PGF2a) and their synthetic analogues (gemeprost, sulprostone, meteneprost and misoprostol), cytotoxic drugs as methotrexate, the anti-progesterone mifepristone and aromatic organic compounds as ethacridine lactate [11,12]. It is widely accepted that a remarkable possibility of attaining complete expulsion of conceptus tissue occurs when prostaglandin analogues and mifepristone are used together [13,14]. The introduction of these agents in the maternal healthcare has also brought about a breakthrough to preventing premature mortality and pregnancy related maternal complications [15].…”