Volume 27, Number 4, December 2001
Medical Abortion Regimen with Reduced Mifepristone Dose, Home Misoprostol Use Is Feasible and Effective
A regimen of medical abortion involving one-third the usual dose of mifepristone and fewer clinic visits (accomplished by allowing women to take misoprostol at home) appears to be as successful and acceptable as the standard mifepristone-misoprostol regimen. According to a prospective study conducted among Vietnamese and Tunisian women seeking abortion,1 a protocol using 200 mg (instead of the standard 600 mg) of mifepristone had a 91-93% success rate. Moreover, the majority of women (87-88%) chose to take their dose of misoprostol at home two days later rather than return to the clinic for it. Women who took misoprostol in a familiar home environment had even higher efficacy rates--and were generally more satisfied with their experience--than were women who received their misoprostol in the clinic.
Data were collected from December 1997 through December 1998 documenting the experiences of 315 women who agreed to follow a modified version of the standard regimen of medical abortion, which usually involves a 600 mg dose of mifepristone, followed by 400 µg of oral misoprostol administered at the clinic two days later. The sample for the study included 120 pregnant women seeking surgical terminations in a clinic in Ho Chi Minh City, Vietnam, and 195 women in Tunis, Tunisia. Women were eligible to participate if they had been amenorrheic for no more than eight weeks and lived within one hour of the clinic. While all study participants received mifepristone from a clinic provider, they were given the choice of returning to the clinic two days later for their oral tablet of misoprostol or taking it on their own at home after the same time interval. In both countries, the majority of women (87-88%) elected to take misoprostol at home. Participants were also supplied with four 500 mg paracetamol tablets for pain.
On average, Tunisian study participants were significantly older than their Vietnamese counterparts (32 years vs. 25 years) and had had significantly fewer years of schooling (nine years vs. 10 years). Moreover, Tunisian women requesting a termination were far less likely than their Vietnamese counterparts to be pregnant for the first time (5% vs. 50%).
Participants' rate of compliance with the medical abortion protocol did not differ significantly by country (91-94%), nor did the success rate of the regimen (91-93%); at both study sites, procedure failure accounted for a greater proportion of unsuccessful terminations than did user or provider failure (6% vs. 1-4%). The failure rate was much higher among women who received misoprostol at a clinic than among those who took it at home (12-20% vs. 4-7%).
The modified regimen produced relatively few prolonged or serious side effects in either country. In both study sites, heavy bleeding occurred on only one-quarter of all bleeding days, and few days were marked by nausea and vomiting (means of 1.1 and 0.4-0.7 days, respectively). Tunisian and Vietnamese women reported, on average, that they had experienced pain or cramping on 2.3-2.6 days.
The reasons most frequently mentioned by Vietnamese women for deciding to take misoprostol at home (they could cite up to two) were that it was more compatible with their duties at work or school (22%) and that it made them feel more comfortable in general (21%). Among Tunisian women, the two most common reasons were that home administration involved fewer clinic visits (36%) and that it was more compatible with family or home responsibilities (25%). According to the opinions of the Vietnamese women who chose to receive misoprostol at the clinic, the two main reasons they did so were that a physician and clinic staff were on the premises (43%) and that they lived alone (29%); among the Tunisian women who opted for clinic administration of misoprostol, 40% said they thought doing so was easier psychologically and caused less anxiety than taking it at home, and 32% cited the availability of medical staff as influencing their decision.
In both countries, roughly three-quarters of women who took misoprostol at home did so in the company of another person. For Vietnamese women, this person was most often their husband or boyfriend (55%) or another relative (32%); for Tunisian women, this person was equally likely to be their husband or boyfriend (37%) or another relative (37%). The pattern of unscheduled calls or visits for counseling when problems arose differed by site: Vietnamese women were more likely to visit than to call the clinic (29% vs. 8%), while Tunisian women were more likely to call than to make an unscheduled clinic visit (19% vs. 10%).
Women who chose to receive misoprostol at the clinic were significantly more likely than those who elected to take it at home to say that they would choose the other option for any future terminations (33-69% vs. 5-7%). When asked to rate their overall experience with medical abortion, about 90% of all women were very or somewhat satisfied with the mifepristone-misoprostol regimen, with home users of misoprostol being less likely than clinic users to label their experience as unsatisfactory (1-2% vs. 3-7%).
The researchers note that both modifications to the standard regimen appear to have produced favorable results: The two-thirds reduction in the dosage of mifepristone did not alter the regimen's efficacy, and women who elected to take misoprostol at home were able to manage their abortion on their own and thus avoid extra clinic visits. According to the researchers, the fact that efficacy and acceptability in both countries were higher among women who elected to take misoprostol at home might mean that a familiar home environment helped these women to relax, thus improving the experience for them emotionally and clinically.
To reduce the likelihood of unscheduled calls and clinic visits, the investigators recommend developing detailed client materials to inform women about what they can expect when they take misoprostol at home. The researchers conclude that the similar efficacy achieved with the lowered dose of mifepristone, coupled with the higher comfort level and improved clinical outcomes achieved through taking misoprostol at home, "suggest that [the modified regimen] should be considered further in more-developed and less-developed countries."--L. Remez
1. Elul B et al., Can women in less-developed countries use a simplified medical abortion regimen? Lancet, 2001, 357(9266):1402-1405.