Abortion, Induced Clinical Trial
Official title:
Oral Mifepristone and Buccal Misoprostol Administered Simultaneously for Abortion Through 63 Days Gestation
Verified date | September 2006 |
Source | University of Pittsburgh |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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 hours after misoprostol administration will be 90% (95% CI 78%, 97%) within
each gestational age group.
This is a prospective clinical trial. Women will be enrolled such that 40 women are in each
of three gestational age ranges: ≤49, 50-56, and 57-63 days gestation on the day treatment
is initiated. Once a gestational age range includes 40 subjects, enrollment in that group
will be closed. Subjects will swallow mifepristone 200 mg and then place four 200 µg
misoprostol tablets between the check and gum (2 tablets on each side). The women will be
instructed to keep the tablets in place for 30 minutes; any remaining portions of the
tablets will be swallowed after this time. Participants will follow-up 24 hours after
receiving the misoprostol. Vaginal ultrasonography will be performed to assess for expulsion
of the gestational sac. Women who have not aborted by the first follow-up visit will be
given a dose of vaginal misoprostol and will return for a follow-up visit in one week.
Subjects who have not aborted by the two-week follow-up will be offered a surgical abortion.
At each visit, data will be collected on bleeding, cramping, other side effects, and
medication use.
Status | Completed |
Enrollment | 120 |
Est. completion date | August 2006 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: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 Criteria: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. |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Office of Family Planning Research, Magee-Womens Hospital | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
University of Pittsburgh |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To determine the complete abortion rate, at 24 hours after misoprostol administration, when using mifepristone 200 mg orally and misoprostol 800 mcg buccally simultaneously in women at <49, 50-56, and 57-63 days gestation. | |||
Secondary | To compare the complete abortion rates, at 24 hours after misoprostol administration, by gestational age (up to and including 49, from 50-56, and 57-63 days gestation) with this medical abortion regimen. | |||
Secondary | To determine the complete medical abortion rate at approximately 14 days after treatment, among those women who receive a second dose of misoprostol. | |||
Secondary | To assess side effects (i.e. nausea, vomiting) and pain medication use after treatment. | |||
Secondary | To assess the acceptability of this medical abortion regimen. | |||
Secondary | To compare the accuracy of transvaginal and abdominal ultrasonography in gestational age dating and treatment failure in this cohort. |
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