A Prospective Randomized Comparison Trial on the Use of Mifepristone With Sublingual or Buccal Misoprostol for Medical Abortions of Less Than 9 Weeks Gestation

• Status: Completed
• Trial end date: 2011-08-01
• Target enrollment: 0
• Participant gender: Female

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 gestation. The secondary outcome is to compare the complete abortion rate and induction-abortion interval between the two methods of administration of misoprostol.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Hong Kong
• Treatments: Mifepristone; Misoprostol

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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