Status:
COMPLETED
A Prospective Randomized Comparison Trial on the Use of Mifepristone With Sublingual or Buccal Misoprostol for Medical Abortions of Less Than 9 Weeks Gestation
Lead Sponsor:
The University of Hong Kong
Conditions:
Abortion, Legal
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
Brief Summary
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 gestatio...
Detailed Description
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 car...
Eligibility Criteria
Inclusion
- good general health
- older than the age of legal consent (i.e. \>18 years old)
- requesting medical abortion and eligible for abortion
- on Day 1 of the study (day of mifepristone administration) the duration of pregnancy not more than 63 days as confirmed by pelvic ultrasound examination
- intrauterine pregnancy (intrauterine amniotic sac seen in US)
- willing to use other than hormonal or intra-uterine contraception until the first menses after termination of pregnancy
- if treatment fails she agrees to termination of pregnancy with the surgical method
- willing and able to participate after the study has been explained
- haemoglobin higher than 10g/L
Exclusion
- a history or evidence of adrenal pathology, steroid-dependent cancer, porphyria, diastolic pressure over 95mm Hg, bronchial asthma, arterial hypotension.
- a history or evidence of thrombo-embolism, severe or recurrent liver disease or pruritus of pregnancy
- the regular use of prescription drugs before admission to the study
- the presence of an IUCD in utero
- breast-feeding
- multiple pregnancies
- heavy smokers
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2011
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT01156688
Start Date
August 1 2010
End Date
August 1 2011
Last Update
August 5 2011
Active Locations (1)
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1
Family Planning Association
Hong Kong, Hong Kong