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.
Previous studies suggest that cervical priming with misoprostol may facilitate vacuum
aspiration for first trimester termination by inducing cervical dilation. This medication is
used routinely at some abortion clinics, not at all at others and is used sporadically at
most Kaiser facilities. The present study is designed to investigate whether the use of
misoprostol noticeably improves the clinical experience. We will determine whether use of
misoprostol compared with placebo during first trimester abortion 1) positively impacts
ratings of pain experienced by the patient, 2) positively impacts physicians’ ratings
regarding difficulty of the procedure, and 3) reduces complications.
Misoprostol is effective for cervical priming prior to vacuum aspiration for first trimester
pregnancy termination.2 Previous studies examined dose3,4, route of administration (oral5 or
vaginal6,7) and time interval to allow maximum dilation while limiting side effects and
bleeding prior to procedure.8,9,10 There is evidence supporting a specific dose, route and
time interval.10 Previous studies also examined amount of bleeding, length of procedure,
force used to dilate the cervix, and cervical dilation in mm.10 However, it is unknown
whether these statistically significant changes translate into clinically relevant changes.
For example, Ngai et al.10 report that the blood loss is significantly decreased. However,
the mean blood loss differed at most by 68 ml. It is widely accepted that during surgical
procedures a difference of 68 ml of blood will not change the patient’s hematocrit or
postoperative clinical course. In the same study preoperative baseline cervical dilation was
only 1.7 mm different, also found to be statistically significant but there is no evidence
that this difference changes the clinical experience for either the physician or the
patient. All previous studies reviewed were also performed with the patient under general
anesthesia so the patient’s perception of pain was not examined. Because the majority of
first trimester terminations in the U.S. are done with the patient awake, it is important to
consider pain.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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