Status:
COMPLETED
Oral Mifepristone and Buccal Misoprostol Administered Simultaneously for Abortion Through 63 Days Gestation
Lead Sponsor:
University of Pittsburgh
Conditions:
Abortion, Induced
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
HYPOTHESIS: For women with pregnancies at \<49, 50-56, and 57-63 days gestation who receive mifepristone 200 mg orally and misoprostol 800 mcg buccally at the same time, the complete abortion rate 24 ...
Detailed Description
1. TELEPHONE SCREEN: Initial contact will be by a phone call (or, rarely, a drop-in visit) initiated by a potential study participant. A member of the research staff will advise the potential part...
Eligibility Criteria
Inclusion
- Healthy females: 1) 18 years of age or older, 2) requesting an elective termination of pregnancy by medical abortion, 3) with an intrauterine pregnancy no more than 63 days gestation on the day of mifepristone administration as documented by endovaginal ultrasound, 4) willing and able to sign informed consent, 5) willing to comply with the study protocol and visit schedule, 6) willing to have a surgical abortion/D\&C if indicated, and 7) with easy and ready access to a telephone.
- \-
Exclusion
- 1) ultrasound evidence at the evaluation(s) prior to mifepristone treatment of an early pregnancy failure, 2) contraindication to mifepristone (known allergy to mifepristone, chronic corticosteroid administration, adrenal disease), 3) contraindication to misoprostol (glaucoma, mitral stenosis, sickle cell anemia, poorly controlled seizure disorder, or known allergy to prostaglandin), 4) known or suspected extrauterine pregnancy, 5) known or suspected pelvic infection, 6) hemoglobin \<10 mg/dL, 7) known clotting defect or receiving anticoagulants, 8) cardiovascular disease (angina, valvular disease, arrhythmia, or cardiac failure), 9) current breastfeeding, 10) pregnancy with an IUD in situ, 11) current use of any experimental drug, 12) suspected or confirmed endometrial arteriovenous malformation, 13) active oral herpes lesions per subject report, 14) prior participation in this research study, or 15) current participation in another research study that, in the opinion of the investigator, would interfere with the conduct of this study.
- \-
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
End Date :
August 1 2006
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00330993
Start Date
March 1 2006
End Date
August 1 2006
Last Update
January 25 2007
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Office of Family Planning Research, Magee-Womens Hospital
Pittsburgh, Pennsylvania, United States, 15213