Abortion, Legal Clinical Trial
Official title:
A Prospective Randomized Comparison Trial on the Use of Mifepristone With Sublingual or Buccal Misoprostol for Medical Abortions of Less Than 9 Weeks Gestation
The primary objective of this study is to compare the incidence of side effects of buccal and sublingual misoprostol when combined with mifepristone for medical abortions of less than 9 weeks gestation. The secondary outcome is to compare the complete abortion rate and induction-abortion interval between the two methods of administration of misoprostol.
After mifepristone was approved by the United States Food and Drug Administration in 2000,
the combination of mifepristone 200 mg and vaginal use of misoprostol 800 mcg became almost
a standard of care in early medical abortion up to 63 days of gestation. When combined with
mifepristone for medical abortion in the first trimester, vaginal administration of
misoprostol is more effective, faster, and has a lower rate of ongoing pregnancy, and fewer
gastrointestinal side effects than oral misoprostol.
Although misoprostol is more effective when given vaginally, most women prefer the oral
route because this can avoid the uncomfortable vaginal examination and provide more privacy
during medical induction. Another concern about vaginal administration is the potential risk
of infection. In late March 2006, analyses of serious uterine infections following medical
abortions by a regimen of oral mifepristone followed by vaginal misoprostol led Planned
Parenthood Federation of America health centres to change the route of misoprostol
administration. Given these concerns, alternative administration via sublingual (holding
pills under the tongue) and buccal (holding pills in the cheek) routes have been
investigated, as the misoprostol is absorbed directly and avoids the gastrointestinal system
similar to vaginal administration.
A pharmacokinetic study showed that sublingual administration of misoprostol resulted in the
greatest bioavailability when compared with oral or vaginal administration. In a randomized,
cross-over pharmacokinetic study of 10 women by Schaff and colleagues of sublingual versus
buccal misoprostol 800 mcg, the mean misoprostol plasma concentration-time curves at 4 hours
and the maximum concentration were significantly higher for sublingual administration than
the buccal route. However, buccal misoprostol administration resulted in fewer symptoms and
was found to be more acceptable by women.
Buccal misoprostol 800 mcg after mifepristone 200 mg for terminating pregnancy through 63
days of gestation has a higher success rate and less ongoing pregnancy when compared with
oral misoprostol, especially in pregnancies of 57-63 days. Adverse effect profiles were
similar, although fever and chills were reported approximately 10% more often among women
who took buccal misoprostol. When used for abortion through 56 days of gestation, buccal
administration of misoprostol after mifepristone appears to be a highly effective and
acceptable alternative compared with vaginal administration, and with similar adverse
effects profile.
Medical abortions of less than 9 weeks gestation using sublingual misoprostol 800 mcg after
mifepristone 200 mg has achieved complete abortion rate of 98.2% but is associated with more
gastrointestinal side effects, fever, and chills when compared with vaginal route.
Both buccal and sublingual administration of misoprostol following mifepristone have been
shown to be effective in inducing first trimester medical abortions, but with different side
effects profile. No clinical trials have been conducted comparing buccal and sublingual
administration of misoprostol in first trimester medical abortion. The purpose of the
present study is to compare the incidence of side effects of buccal and sublingual
misoprostol when combined with mifepristone.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
NCT03231904 -
Maternal and Fetal Adrenocorticotropic Hormone (ACTH) and Leukemia Inhibitory Factor (LIF) and Gestational Age
|
N/A |