Abortion, Therapeutic Clinical Trial
Official title:
A Randomized Study of Cervical Priming With Misoprostol Prior to Elective First Trimester Pregnancy Termination: Effects on Pain, Ease of Procedure and Complications
The purpose of this study is to determine whether misoprostol administered prior to elective first trimester pregnancy has an effect on pain and ease of procedure and complications.
Status | Completed |
Enrollment | 200 |
Est. completion date | May 2006 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - Subjects must meet the following inclusion criteria: after completion of a full history and physical exam each subject must be judged physically and mentally stable by the enrolling practitioner; subjects must be between 7 and 11 weeks pregnant and desiring termination. Gestation dating must be based on a reliable menstrual history consistent with a bimanual exam or ultrasound. All subjects must give informed consent after the study has been explained. Exclusion Criteria: - Subject must not have a physical or mental health condition which could be adversely affected by the study drug, including a history of allergy to prostaglandins or, specifically, to misoprostol. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Kaiser Permanente, Department of OB/GYN | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
Kaiser Permanente |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The first assessment will be a Visual Box Scale (VBS) for pain administered while the patient is undergoing the abortion procedure. | |||
Secondary | After the procedure the physician will estimate the patient’s pain using a VBS. The physician will also estimate the ease of the procedure using a different VBS. |
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Completed |
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